research project quality improvement

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Quality Improvement Projects and Clinical Research Studies

Every day, I witness firsthand the amazing things that advanced practitioners and nurse scientists accomplish. Through the conduct of quality improvement (QI) projects and clinical research studies, advanced practitioners and nurse scientists have the opportunity to contribute exponentially not only to their organizations, but also towards personal and professional growth.

Recently, the associate editors and staff at JADPRO convened to discuss the types of articles our readership may be interested in. Since we at JADPRO believe that QI projects and clinical research studies are highly valuable methods to improve clinical processes or seek answers to questions, you will see that we have highlighted various QI and research projects within the Research and Scholarship column of this and future issues. There have also been articles published in JADPRO about QI and research ( Gillespie, 2018 ; Kurtin & Taher, 2020 ). As a refresher, let’s explore the differences between a QI project and clinical research.

Quality Improvement

As leaders in health care, advanced practitioners often conduct QI projects to improve their internal processes or streamline clinical workflow. These QI projects use a multidisciplinary team comprising a team leader as well as nurses, PAs, pharmacists, physicians, social workers, and program administrators to address important questions that impact patients. Since QI projects use strategic processes and methods to analyze existing data and all patients participate, institutional review board (IRB) approval is usually not needed. Common frameworks, such as Lean, Six Sigma, and the Model for Improvement can be used. An attractive aspect of QI projects is that these are generally quicker to conduct and report on than clinical research, and often with quantifiable benefits to a large group within a system ( Table 1 ).

Clinical Research

Conducting clinical research through an IRB-approved study is another area in which advanced practitioners and nurse scientists gain new knowledge and contribute to scientific evidence-based practice. Research is intended for specific groups of patients who are protected from harm through the IRB and ethical principles. Research can potentially benefit a larger group, but benefits to participants are often unknown during the study period.

Clinical research poses many challenges at various stages of what can be a lengthy process. First, the researcher conducts a review of the literature to identify gaps in existing knowledge. Then, the researcher must be diligent in their self-reflection (is this phenomenon worth studying?) and in developing the sampling and statistical methods to ensure validity and reliability of the research ( Higgins & Straub, 2006 ). A team of additional researchers and support staff is integral to completing the research and disseminating findings. A well-designed clinical trial is worth the time and effort it takes to answer important clinical questions.

So, as an advanced practitioner, would a QI project be better to conduct than a clinical research study? That depends. A QI project uses a specific process, measures, and existing data to improve outcomes in a specific group. A research study uses an IRB-approved study protocol, strategic methods, and generates new data to hopefully benefit a larger group.

In This Issue

Both QI projects and clinical research can provide evidence to base one’s interventions on and enhance the lives of patients in one way or another. I hope you will agree that this issue is filled with valuable information on a wide range of topics. In the following pages, you will learn about findings of a QI project to integrate palliative care into ambulatory oncology. In a phenomenological study, Carrasco explores patient communication preferences around cancer symptom reporting during cancer treatment.

We have two excellent review articles for you as well. Rogers and colleagues review the management of hematologic adverse events of immune checkpoint inhibitors, and Lemke reviews the evidence for use of ginseng in the management of cancer-related fatigue. In Grand Rounds, Flagg and Pierce share an interesting case of essential thrombocythemia in a 15-year-old, with valuable considerations in the pediatric population. May and colleagues review practical considerations for integrating biosimilars into clinical practice, and Moore and Thompson review BTK inhibitors in B-cell malignancies.

• Higgins P. A., & Straub A. J. (2006). Understanding the error of our ways: Mapping the concepts of validity and reliability . Nursing Outlook , 54 ( 1 ), 23–29. 10.1016/j.outlook.2004.12.004 [ PubMed ] [ CrossRef ] [ Google Scholar ]
• Gillespie T. W. (2018). Do the right study: Quality improvement projects and human subject research—both valuable, simply different . Journal of the Advanced Practitioner in Oncology , 9 ( 5 ), 471–473. 10.6004/jadpro.2018.9.5.1 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
• Kurtin S. E., & Taher R. (2020). Clinical trial design and drug approval in oncology: A primer for the advanced practitioner in oncology . Journal of the Advanced Practitioner in Oncology , 11 ( 7 ), 736–751. 10.6004/jadpro.2020.11.7.7 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

Research and Quality Improvement: How Can They Work Together?

Affiliations.

• 1 Director, Data Science, Quality Insights, Williamsburg, VA.
• 2 Chair, ANNA Research Committee.
• 3 President, ANNA's Old Dominion Chapter.
• 4 Instructor, Case Western Reserve University, Cleveland, OH.
• 5 Associate Degree Nursing Instructor, Northeast Wisconsin Technical College, Green Bay, WI.
• PMID: 35503694

Research and quality improvement provide a mechanism to support the advancement of knowledge, and to evaluate and learn from experience. The focus of research is to contribute to developing knowledge or gather evidence for theories in a field of study, whereas the focus of quality improvement is to standardize processes and reduce variation to improve outcomes for patients and health care organizations. Both methods of inquiry broaden our knowledge through the generation of new information and the application of findings to practice. This article in the "Exploring the Evidence: Focusing on the Fundamentals" series provides nephrology nurses with basic information related to the role of research and quality improvement projects, as well as some examples of ways in which they have been used together to advance clinical knowledge and improve patient outcomes.

Keywords: kidney disease; nephrology; quality improvement; research.

Copyright© by the American Nephrology Nurses Association.

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Quality Improvement Projects vs  Quality Improvement Research Activities

In general, a quality improvement (QI) project does not need to be submitted to the IRB. The comparison chart below is intended to help you determine whether an activity is a "Project or "Research"

EQUIP TIPS Additional Guidance:

Qi project vs. qi research , definitions.

Definitition

An activity that is specifically initiated with a goal of improving the performance of institutional practices in relationship to an established standard.

However, if a project was originally initiated as a local QI project but the findings are of interest and the project investigator chooses to expand the findings into a research study, IRB review would be required at that time.

QI Research

An activity that is initiated with a goal of improving the performance of institutional practices in relationship to an established standard , with the intent to contribute to generalizable knowledge (“widely applicable”)

Meets the definition of Human Subjects Research :

• Human Subjects

Core Elements

Core  Elements

HIPAA Rule:   the following activities are considered “ healthcare operations ” (they are not considered “research” ):

• Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, if the obtaining of generalizable knowledge is not the primary purpose of studies resulting from the activities
• Population-based activities relating to improving health or reducing healthcare costs
• [Clinical] protocol development, case management and care coordination

Authorization: 

• HIPAA Rule does not require a covered entity to secure individual authorization (nor a waiver) for use or disclosure of PHI for these activities, as long as the covered entity describes the activities in its Notice of Privacy Practices
• “Release to” section:  UCI faculty/resident name
• “Purpose” section:  QI activity publication
• the signed authorization should be uploaded and maintained in the patient’s record; note, the patient has the right to ask for a copy of the signed authorization form
• translated HIPAA Authorizations

Privacy and confidentiality:  A QI activity retains the standard for ensuring the privacy and confidentiality of the population and data being accessed and studied; also, review the above note regarding HIPAA Authorization

Intent:  generate generalizable results

Additional risk or burden:  the project includes risks or burdens beyond the standard of practice to make the results generalizable

Design:  involves randomization or an element that may be considered less (or more) than standard of care

HIPAA Rule:  requirements for waiving informed consent and/or waiving the requirements for documentation of informed consent must be met

Documentation

DOCUMENTATIAON

Documentation:

• Journals and conference platforms typically ask whether your project received an IRB review
• Recommendation: submission of a NHSR determination request and maintain the IRB email determination for the life of the project
• Submit a non-human subject research (NHSR) determination request via Kuali Research (KR) Protocols .

Publication: 

• Publications must describe the activity as a “project” and NOT use the term "research" ; also, review the above note regarding HIPAA Authorization

IRB review:  activities that meet the definition of Human Subjects Research require IRB review

• How to apply  

Additonal Resources

• EQUIP-TIPS Quality Improvement Project vs. Research Guidance
• 45 CFR 46. 102(e)(1) :  Federal Policy’s definition of Human Subject (v 2018)
• 45 CFR 46. 102(l) :  Federal Policy’s definition of Research (v 2018)
• 45 CFR 46 (v 2018):  Preamble for Quality Improvement Activities
• IRB Ethics & Human Research, Vol 39(3), May-June 2017, Pages 1-10
• 45 CFR 164.506 (2013):  Definition of Health Care Operations
• IRB Ethics & Human Research, Vol 35(5), September-October 2013, Pages 1-8
• Research Compliance Professional’s Handbook, 2nd Edition, 2013, Chapter 8, Page 79
• OHRP Quality Improvement Activities FAQ (2010)
• Institutional Review Board, Management and Function, 2nd Edition, 2006, Chapter 4-3, Pages 102-103
• 2005 California Senate Bill 13 (SB 13) (*when applicable)
• Example of a published QI Project

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How to get started in quality improvement

Linked opinion.

The benefits of QI are numerous and the challenges worth overcoming

Read the full collection

• Related content
• Peer review
• Bryan Jones , improvement fellow 1 ,
• Emma Vaux , consultant nephrologist 2 ,
• Anna Olsson-Brown , research fellow 3
• 1 The Health Foundation, London, UK
• 2 Royal Berkshire NHS Foundation Trust. Reading, UK
• 3 Department of Molecular and Clinical Pharmacology, The Institute of Translational Medicine, University of Liverpool, Liverpool, UK
• Correspondence to B Jones bryan.jones{at}health.org.uk

What you need to know

Participation in quality improvement can help clinicians and trainees improve care together and develop important professional skills

Effective quality improvement relies on collaborative working with colleagues and patients and the use of a structured method

Enthusiasm, perseverance, good project management skills, and a willingness to explain your project to others and seek their support are key skills

Quality improvement ( box 1 ) is a core component of many undergraduate and postgraduate curriculums. 1 2 3 4 5 Numerous healthcare organisations, 6 professional regulators, 7 and policy makers 8 recognise the benefits of training clinicians in quality improvement.

Defining quality improvement 1

Quality improvement aims to make a difference to patients by improving safety, effectiveness, and experience of care by:

Using understanding of our complex healthcare environment

Applying a systematic approach

Designing, testing, and implementing changes using real time measurement for improvement

Engaging in quality improvement enables clinicians to acquire, assimilate, and apply important professional capabilities 7 such as managing complexity and training in human factors. 1 For clinical trainees, it is a chance to improve care 9 ; develop leadership, presentation, and time management skills to help their career development 10 ; and build relationships with colleagues in organisations that they have recently joined. 11 For more experienced clinicians, it is an opportunity to address longstanding concerns about the way in which care processes and systems are delivered, and to strengthen their leadership for improvement skills. 12

The benefits to patients, clinicians, and healthcare providers of engaging in quality improvement are considerable, but there are many challenges involved in designing, delivering, and sustaining an improvement intervention. These range from persuading colleagues that there is a problem that needs to be tackled, through to keeping them engaged once the intervention is up and running as other clinical priorities compete for their attention. 13 You are also likely to have competing priorities and will need support to make time for quality improvement. The organisational culture, such as the extent to which clinicians are able to question existing practice and try new ideas, 14 15 16 also has an important bearing on the success of the intervention.

This article describes the skills, knowledge, and support needed to get started in quality improvement and deliver effective interventions.

What skills do you need?

Enthusiasm, optimism, curiosity, and perseverance are critical in getting started and then in helping you to deal with the challenges you will inevitably face on your improvement journey.

Relational skills are also vital. At its best quality improvement is a team activity. The ability to collaborate with different people, including patients, is vital for a project to be successful. 17 18 You need to be willing to reach out to groups of people that you may not have worked with before, and to value their ideas. 19 No one person has the skills or knowledge to come up with the solution to a problem on their own.

Learning how systems work and how to manage complexity is another core skill. 20 An ability to translate quality improvement approaches and methods into practice ( box 2 ), coupled with good project and time management skills, will help you design and implement a robust project plan. 27

Quality improvement approaches

Healthcare organisations use a range of improvement methods, 21 22 such as the Model for Improvement , where changes are tested in small cycles that involve planning, doing, studying, and acting (PDSA), 23 and Lean , which focuses on continually improving processes by removing waste, duplication, and non-value adding steps. 24 To be effective, such methods need to be applied consistently and rigorously, with due regard to the context. 25 In using PDSA cycles, for example, it is vital that teams build in sufficient time for planning and reflection, and do not focus primarily on the “doing.” 26

Equally important is an understanding of the measurement for improvement model, which involves the gradual refinement of your intervention based on repeated tests of change. The aim is to discover how to make your intervention work in your setting, rather than to prove it works, so useful data, not perfect data, are needed. 28 29 Some experience of data collection and analysis methods (including statistical analysis tools such as run charts and statistical process control) is useful, but these will develop with increasing experience. 30 31

Most importantly, you need to enjoy the experience. It is rare that a clinician can institute real, tangible change, but with quality improvement this is a real possibility, which is both empowering and satisfying. Finally, don’t worry about what you don’t know. You will learn by doing. Many skills needed to implement successful quality improvement will be developed as you go; this is a fundamental feature of quality improvement.

How do you get started?

The first step is to recruit your improvement team. Start with colleagues and patients, 32 but also try to bring in people from other professions, including non-clinical staff. You need a blend of skills and perspectives in your team. Find a colleague experienced in quality improvement who is willing to mentor or supervise you.

Next, identify a problem collaboratively with your team. Use data to help with this (eg, clinical audits, registries of data on patients’ experiences and outcomes, and learning from incidents and complaints) ( box 3 ). Take time to understand what might be causing the problem. There are different techniques to help you (process mapping, five whys, appreciative inquiry). 35 36 37 Think about the contextual factors that are contributing to the problem (eg, the structure, culture, politics, capabilities and resources of your organisation).

Clinical audit and quality improvement

Quality improvement is an umbrella term under which many approaches sit, clinical audit being one. 33 Clinical audit is commonly used by trainees to assess clinical effectiveness. Confusion of audit as both a term for assurance and improvement has perhaps limited its potential, with many audits ending at the data collection stage and failing to lead to improvement interventions. Learning from big datasets such as the National Clinical Audits in the UK is beginning to shift the focus to a quality improvement approach that focuses on identifying and understanding unwanted variation in the local context; developing and testing possible solutions, and moving from one-off change to multiple cycles of change. 34

Next, develop your aim using the SMART framework: Specific (S), Measurable (M), Achievable (A), Realistic (R), and Timely (T). 38 This allows you to assess the scale of the intervention and to pare it down if your original idea is too ambitious. Aligning your improvement aim with the priorities of the organisation where you work will help you to get management and executive support. 39

Having done this, map those stakeholders who might be affected by your intervention and work out which ones you need to approach, and how to sell it to them. 40 Take the time to talk to them. It will be appreciated and increases the likelihood of buy in, without which your quality improvement project is likely to fail irrespective of how good your idea is. You need to be clear in your own mind about the reasons you think it is important. Developing an “elevator pitch” based on your aims is a useful technique to persuade others, 38 remembering different people are hooked in for different reasons.

The intervention will not be perfect first time. Expect a series of iterative changes in response to false starts and obstacles. Measuring the impact of your intervention will enable you to refine it. 28 Time invested in all these aspects will improve your chances of success.

Right from the start, think about how improvement will be embedded. Attention to sustainability will mean that when you move to your next job your improvement efforts, and those of others, and the impact you have collectively achieved will not be lost. 41 42

What support is needed?

You need support from both your organisation and experienced colleagues to translate your skills into practice. Here are some steps you can take to help you make the most of your skills:

Find the mentor or supervisor who will help identify and support opportunities for you. Signposting and introduction to those in an organisation who will help influence (and may hinder) your quality improvement project is invaluable

Use planning and reporting tools to help manage your project, such as those in NHS Improvement’s project management framework 27

Identify if your local quality improvement or clinical audit team may be a source of support and useful development resource for you rather than just a place to register a project. Most want to support you.

Determine how you might access (or develop your own) local peer to peer support networks, coaching, and wider improvement networks (eg, NHS networks; Q network 43 44 )

Use quality improvement e-learning platforms such as those provided by Health Education England or NHS Education for Scotland to build your knowledge 45 46

Learn through feedback and assessment of your project (eg, via the QIPAT tool 47 or a multi-source feedback tool. 48 49

Quality improvement approaches are still relatively new in the education of healthcare professionals. Quality improvement can give clinicians a more productive, empowering, and educational experience. Quality improvement projects allow clinicians, working within a team, to identify an issue and implement interventions that can result in true improvements in quality. Projects can be undertaken in fields that interest clinicians and give them transferable skills in communication, leadership, project management, team working, and clinical governance. Done well, quality improvement is a highly beneficial, positive process which enables clinicians to deliver true change for the benefit of themselves, their organisations, and their patients.

Quality improvement in action: three doctors and a medical student talk about the challenges and practicalities of quality improvement

This box contains four interviews by Laura Nunez-Mulder with people who have experience in quality improvement.

Alex Thompson, medical student at the University of Cambridge, is in the early stages of his first quality improvement project

We are aiming to improve identification and early diagnosis of aortic dissections in our hospital. Our supervising consultant suspects that the threshold for organising computed tomography angiography for a suspected aortic dissection is too high, so to start with, my student colleague and I are finding out what proportion of CT angiograms result in a diagnosis of aortic dissection.

I fit the project around my studies by working on it in small chunks here and there. You have to be very self motivated to see a project through to the end.

Anna Olsson-Brown, research fellow at the University of Liverpool, engaged in quality improvement in her F1 year, and has since supported junior doctors to do the same. This extract is adapted from her BMJ Opinion piece ( https://blogs.bmj.com/bmj/ )

Working in the emergency department after my F1 job in oncology, I noticed that the guidelines on neutropenic sepsis antibiotics were relatively unknown and even less frequently implemented. A colleague and I devised a neutropenic sepsis pathway for oncology patients in the emergency department including an alert label for blood tests. The pathway ran for six months and there was some initial improvement, but the benefit was not sustained after we left the department.

As an ST3, I mentored a junior doctor whose quality improvement project led to the introduction of a syringe driver prescription sticker that continues to be used to this day.

My top tips for those supporting trainees in quality improvement:

Make sure the project is sufficiently narrow to enable timely delivery

Ensure regular evaluation to assess impact

Support trainees to implement sustainable pathways that do not require their ongoing input.

Amar Puttanna, consultant in diabetes and endocrinology at Good Hope Hospital, describes a project he carried out as a chief registrar of the Royal College of Physicians

The project of which I am proudest is a referral service we launched to review medication for patients with diabetes and dementia. We worked with practitioners on the older adult care ward, the acute medical unit, the frailty service, and the IT teams, and we promoted the project in newsletters at the trust and the Royal College of Physicians.

The success of the project depended on continuous promotion to raise awareness of the service because junior doctors move on frequently. Activity in our project reduced after I left the trust, though it is still ongoing and won a Quality in Care Award in November 2018.

Though this project was a success, not everything works. But even the projects that fail contain valuable lessons.

Mark Taubert, consultant in palliative medicine and honorary senior lecturer for Cardiff University School of Medicine, launched the TalkCPR project

Speaking to people with expertise in quality improvement helped me to narrow my focus to one question: “Can videos be used to inform both staff and patients/carers about cardiopulmonary resuscitation and its risks in palliative illness?” With my team I created and evaluated TalkCPR, an online resource that has gone on to win awards (talkcpr.wales).

The most challenging aspect was figuring out which tools might get the right information from any data I collected. I enrolled on a Silver Improving Quality Together course and joined the Welsh Bevan Commission, where I learned useful techniques such as multiple PDSA (plan, do, study, act) cycles, driver diagrams, and fishbone diagrams.

Education into practice

In designing your next quality improvement project:

What will you do to ensure that you understand the problem you are trying to solve?

How will you involve your colleagues and patients in your project and gain the support of managers and senior staff?

What steps will you take right from the start to ensure that any improvements made are sustained?

How patients were involved in the creation of this article

The authors have drawn on their experience both in partnering with patients in the design and delivery of multiple quality improvement activities and in participating in the Academy of Medical Royal Colleges Training for Better Outcomes Task and Finish Group 1 in which patients were involved at every step. Patients were not directly involved in writing this article.

Sources and selection material

Evidence for this article was based on references drawn from authors’ academic experience in this area, guidance from organisations involved in supporting quality improvement work in practice such as NHS Improvement, The Health Foundation, and the Institute for Healthcare Improvement, and authors’ experience of working to support clinical trainees to undertake quality improvement.

Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies.

The authors declare the following other interests: none.

Further details of The BMJ policy on financial interests is here: https://www.bmj.com/about-bmj/resources-authors/forms-policies-and-checklists/declaration-competing-interests

Contributors: BJ produced the initial outline after discussions with EV and AOB. AO-B produced a first complete draft, which EV reworked and expanded. BJ then edited and finalised the text, which was approved by EV and AO-B. The revisions in the resubmitted version were drafted by BJ and edited and approved by EV and AO-B. BJ is responsible for the overall content as guarantor.

Provenance and peer review: This article is part of a series commissioned by The BMJ based on ideas generated by a joint editorial group with members from the Health Foundation and The BMJ, including a patient/carer. The BMJ retained full editorial control over external peer review, editing, and publication. Open access fees and The BMJ’s quality improvement editor post are funded by the Health Foundation.

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ .

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• Networks NHS
• ↵ Community Q. The Health Foundation. 2018. https://q.health.org.uk/
• ↵ Health Education England. e-learning for healthcare. https://www.e-lfh.org.uk/programmes/research-audit-and-quality-improvement/
• ↵ Scotland Quality Improvement Hub NHS. QI e-learning. http://www.qihub.scot.nhs.uk/education-and-learning-xx/qi-e-learning.aspx
• ↵ Joint Royal Colleges of Physicians Training Board. Quality Improvement Assessment Tool (QIPAT). 2017. https://www.jrcptb.org.uk/documents/may-2012-quality-improvement-assessment-tool-qipat
• ↵ Joint Royal Colleges of Physicians Training Board. Quality improvement assessment tool. May 2017. https://www.jrcptb.org.uk/documents/may-2012-quality-improvement-assessment-tool-qipat
• ↵ Joint Royal Colleges of Physicians Training Board. Multi-source feedback. August 2014. https://www.jrcptb.org.uk/documents/multi-source-feedback-august-2014 .

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• Volume 11, Issue 2
• Quality improvement research: understanding the science of change in health care
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• R Baker 1 ,
• 1 Guest Editors, Quality Improvement Research Series
• 2 Editor in Chief, Quality and Safety in Health Care
• Correspondence to:
 Professor R Grol, Centre for Research on Quality in Health Care (WOK), PO Box 9101, 6500 HB Nijmegen, The Netherlands;
 R.Grol{at}hsv.kun.nl

https://doi.org/10.1136/qhc.11.2.110

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• quality improvement research
• change management

Essential for all who want to improve health care.

Expectations of healthcare services are ever increasing and those delivering care no longer hold the monopoly of opinion on what constitutes good or best care. To earn the label “good enough”, care must meet standards expected by consumers as well those of expert providers. Headlines in newspapers, statements in policy documents, and many analyses, surveys and reports repeatedly highlight serious problems in healthcare delivery related to underuse, overuse, or misuse of care. 1 Health systems are sometimes unsafe and frequently we harm patients who have trusted us with their care. There is an endemic failure to engage patients with decisions about their care. We know there are problems; we just need to change so that care can be made safer and better.

Everyone—authorities, policy makers, and professionals—seems to accept the need for change. New initiatives aiming to cure our ailing systems come in droves. This is an international phenomenon. Many initiatives are linked to programmes that capture a particular approach—for example, evidence based medicine; accreditation and (external) accountability; total quality management; professional development and revalidation; risk management and error prevention; organisational development and leadership enhancement; disease management and managed care; complex adaptive systems; and patient empowerment. They may differ in perspective. Some focus on changing professionals, others on changing organisations or interactions between parts of the system; some emphasise self-regulation, others external control and incentives; some advocate “bottom up” and others “top down” methods. Despite their differences, however, each aims to contribute to better patient care—and they might, but the evidence for understanding their likely impact is not robust and many seem based more on belief than rigorous research of value, efficacy, or feasibility. 2 From what we know, no quality improvement programme is superior and real sustainable improvement might require implementation of some aspects of several approaches—perhaps together, perhaps consecutively. We just do not know which to use, when to use them, or what to expect.

More evidence and understanding is required. At least 40 good systematic reviews and numerous controlled trials are available, 3, 4 but many of the trials can be criticised because, for example, randomisation or analysis was conducted at the patient level while the intervention focused on professionals or teams, and outcome parameters are often poorly chosen or are difficult to compare. Most studies were conducted in the USA, limiting generalisations to other systems. Some strategies are better studied than others. We know more about CME, audit and feedback, reminders and computerised decision support than about organisational, economic, administrative and patient mediated interventions. New methods including the effects of problem based education or portfolio learning, TQM, breakthrough projects, risk management methods, business process redesign, leadership enhancement, or sharing decisions with patients are not well studied. Studying the effects of specific strategies in controlled trials will provide some answers to some questions about effective change, but will not address some of the basic questions about the critical success factors in change processes. They need to be complemented by observational and qualitative studies.

Health care is becoming increasingly complex and the problems are large. It is unrealistic to expect that one specific approach can solve everything. A qualitative study by Solberg et al 5 of critical factors supporting implementation of change showed that a mixture of professional and organisational factors is crucial. “Give attention to many different factors and use multiple strategies” is the message. 6 Although we may know that multifaceted strategies combining different actions and measures linked to specific obstacles to change are usually more successful than single interventions, 7 we know little about which components of such complex interventions are effective in different target groups. So, while there is some general knowledge, there is little detailed understanding of the “black box” of change.

We need to learn about change in the real world of health care and the crucial determinants of successful improvement. New thinking about healthcare settings as complex adaptive systems emphasises the importance of experimenting with multiple approaches and discovering what works best. 8 Small changes can sometimes have large effects—but we have little understanding about which small changes to use in which settings and their likely impact.

For real change and sustained improvement a tailored research methodology is essential. The full range of methodology has yet to be established, but will include contributions from epidemiology, behavioural sciences, educational research, organisational and management studies, economics, and statistics (box 1). Theoretical models of evaluations of complex interventions propose a phased approach (theoretical phase, definition of the components of the intervention, small scale explanatory trial, followed by larger trials and research into long term implementation). Clearly, different research methods are required for different phases, 9 but it is essential that, despite the eclectic base of the research, researchers from different faculties and disciplines come together to collaborate in this complex field and that the vogue for “quick fixes” is replaced with sustained research.

Box 1 Some research approaches for quality improvement research

Observational studies of existing change processes

In-depth qualitative studies on critical success factors and barriers to change improvement programmes

Systematic reviews of both the impact of different strategies and the influence of specific factors on change

Well designed cluster randomised trials

Systematic sampling and interpretation of experiences of change

Methods for developing valid and sensitive indicators for measuring change

Meta-analyses of large samples of improvement projects

Methods for evaluation of large scale implementation and change programmes

Economic analyses of resources needed for effective change and improvement of care

Statistical process control

To stimulate and support debate about research on quality improvement and change management in health care we have commissioned a series of papers to provide an overview of some relevant methodologies. The first two papers are published in this issue and more will follow. Pope et al 10 explore some of the qualitative methods that can be used to gather information about the delivery of good quality care, and Wensing and Elwyn 11 consider some of the key issues related to measurement of patients' views. Forthcoming issues of QSHC will include papers that describe research methods for indicator development in primary care; a methodology for evaluating small scale improvement projects; methods for evaluating quality improvement programmes; research designs for randomised controlled trials in quality improvement; and economic evaluations of change management.

There is a recognised process for the development of new drugs, their introduction into routine practice, and their establishment in the treatment of defined conditions. As knowledge about a drug is accrued, new and better patterns of treatment gradually become established. Similar measured approaches are needed to help develop and establish better, safer systems of care. “Change management” is a discipline central to health care. The academic base that supports change management and quality improvement in health care should underpin all clinical and managerial learning programmes. The science of change management is not new, but there is a long way to go before we will understand enough to be able to transform care so that it is “good enough” to meet everyone's expectations of quality and safety.

• ↵ Bodenheimer T . The American health care system. The movement for improved quality in health care. N Engl J Med 1999 ; 340 : 488 –92. OpenUrl CrossRef PubMed Web of Science
• ↵ Grol R . Beliefs and evidence in changing clinical practice. BMJ 1997 ; 315 : 418 –21. OpenUrl FREE Full Text
• ↵ Grol R . Improving the quality of medical care. Building bridges among professional price, payer profit, and patient satisfaction. JAMA 2001 ; 286 : 2578 –85. OpenUrl CrossRef PubMed Web of Science
• ↵ Grimshaw JM , Shirran L, Thomas R, et al . Changing provider behavior: an overview of systematic reviews of interventions. Med Care 2001 ; 39 (8 Suppl 2): II2 –45. OpenUrl CrossRef PubMed Web of Science
• ↵ Solberg L , Brekke M, Fasio J, et al . Lessons from experienced guideline implementers: attend to many factors and use multiple strategies. Jt Comm J Qual Improv 2000 ; 26 : 171 –88. OpenUrl PubMed
• ↵ Solberg L . Guideline implementations: what the literature doesn't tell us. Jt Comm J Qual Improv 2000 ; 26 : 525 –37. OpenUrl PubMed
• ↵ Wensing M , van der Weijden T, Grol R. Implementing guidelines and innovations in general practice: which interventions are effective? Br J Gen Pract 1998 ; 48 : 991 –7. OpenUrl Abstract / FREE Full Text
• ↵ Plsek PE , Greenhalgh T. The challenge of compexity in health care. BMJ 2001 ; 323 : 625 –8. OpenUrl FREE Full Text
• ↵ Campbell M , Fitzpatrick R, Haines A, et al . Framework for design and evaluation of complex interventions to improve health. BMJ 2000 ; 321 : 694 –6. OpenUrl FREE Full Text
• ↵ Pope C , van Royen P, Baker R. Qualitative methods in research on healthcare quality. Qual Saf Health Care 2002 ; 11 : 148 –52. OpenUrl Abstract / FREE Full Text
• ↵ Wensing M , Elwyn G. Research on patients' views on the evaluation and improvement of quality of care. Qual Saf Health Care 2002 ; 11 : 153 –7. OpenUrl Abstract / FREE Full Text

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Khaled Al-Surimi; Research versus Quality Improvement in Healthcare. Global Journal on Quality and Safety in Healthcare 1 November 2018; 1 (2): 25–27. doi: https://doi.org/10.4103/JQSH.JQSH_16_18

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We are pleased to publish the second issue of the Global Journal on Quality and Safety in Healthcare (JQSH). In this issue, we would like to discuss the similarities and differences between research and quality improvement (QI) projects in health care. Imagine you are working in a hospital or a department within a hospital and you want to improve an aspect of health-care quality and safety by focusing on the issue of medication errors. Given that situation, you decide to implement a “zero harm” rule because of medication errors. The question is will this be a QI or a research project? In another example, you are a resident working in an oncology department and you noticed that most patients receiving certain chemotherapeutic agents had neuropathy complications, so you decided to collaborate with the physical therapist on a project to compare patients who received chemotherapy drugs and exercise with those who did not exercise. Again, the question is will this be a research project or a QI project? Regardless of the answer, it is important to implement the project systematically. If your project is focused on QI, then you should consult the QI specialists in your hospital who can help you to use the appropriate QI methodology, which includes Plan, Do, Study, Act (PDSA) cycles. If your project qualifies as research, then you should consult a research methodologist and biostatistician regarding study design, sample size, and others and work with the institutional review board (IRB) to provide guidance and templates.

Many health professionals do not know how a research project differs from a QI project and when they complement each other. [ 1 – 3 ] Our traditional thinking is that quality and safety improvement in health care as well as the effectiveness of an intervention can only be studied in the form of a traditional scientific research project, as it has its own well-established rigorous approach. We may be ignorant or unaware of how to use the QI scientific approach to study the performance of a health-care system. [ 4 , 5 ] The problem lies within our frame of thinking because we are prioritizing the proof of effectiveness over bringing about and sustaining improvement. We use the results of pre-assessment and post-assessment research as the gold standard for evidence-based policy and practice, whereas in reality, sustaining the improvement is continuous and more dynamic. [ 1 , 6 ]

Research projects are question-driven and focus on providing proof of effectiveness. The main purpose of research is to generate new generalizable knowledge about a particular subject to a study population, where the study results often end up published in academic journals. In this case, researchers must follow a strict study protocol approved by the IRB, including obtaining the consent from study participants before starting the project and report any deviation from the protocol to the IRB, if needed. [ 7 – 9 ] However, QI projects are data-driven and focus on showing sustained improvement to a specific process and system or outcomes within a health-care organization using, if possible, the research evidence generated as the basis for developing the improvement interventions. [ 10 ] A QI project does not aim to generate new knowledge as a research project does, rather, it generates several learning lessons as to what actually works and does not work and why. A QI project produces empirical evidence to benefit other organizations within a similar context and setting, which are interested in replicating the change to improve a process or system using the rapid PDSA cycle approach. [ 11 ] Through cycles of testing, we learn what is going to improve and why, without the need to generalize the results to another context, as research projects usually aim to do. Also in QI projects, the measurement framework is not about pre and post. It is about continually measuring the metric of interest that you want to improve and coming up with not just one intervention but multiple interventions based on learning from prior PDSA cycles. At the end, you reach the point of realizing sustained improvement through a series of interventions that were informed by testing in the actual system that you want to improve. The PDSA cycle is repeated, and new changes are made to continue to improve a process and, ultimately, the outcome. The essential measurements included in a QI project are process measures, outcomes measures, and balancing measures, which are used to show that the improvement occurs over time. Data from QI activities are usually aggregated and presented in run/control charts, histograms, and line graphs, whereas data from research are analyzed using statistical tests such as t -test, chi-square test, and regression analysis, and then aggregated and presented in appropriate tables and/or graphs.

Typically, QI results are shared within the organization and might be implemented in other departments. The lessons learned from QI activities can be published; however, it must be clear to the readers that the project was for QI, not traditional research. Although a QI project does not require IRB approval, some organizations have QI committees that approve and coordinate QI project activities, and some organizations require articles to be approved before submitting for publication.

In summary, the sustained improvement realized in a QI project can be complemented and validated with a thorough research-based assessment of effectiveness. [ 12 ] We should not consider the proof of effectiveness the same as the proof of sustained improvement, but they both are very important. I would like to emphasize that both research and QI projects use scientific and systematic approaches, albeit different, but both methods are scientific and rigorous in their own ways. The aims, methods, and outcomes in research and QI projects are quite different. Hence, understanding the differences and similarities between research and QI projects will help to determine the right approach when designing and implementing the right project for the right purpose using the right method. Table 1 is a snapshot comparison between QI and research with more focus on the project's aim and method aspects.

Comparison of quality improvement and research projects in health care

Do we have a clear question to be investigated and answered?

What do we hope to accomplish by answering the question?

What is currently known about the topic?

What are the risks and benefits for patients involved with the study of this topic?

What type of study design will be used (observational vs. experimental)?

How will the data be analyzed and presented (statistical tests, P -values, etc.)?

What is the magnitude of the quality problem based on available data?

What types of quality tools have been used to measure and assess the problem?

What is the measurement plan to be used during implementation of the project?

What types of changes/interventions will be tested during the PDSA cycles?

Has the proposed change/intervention been used in other health-care settings or reported in the literature?

Will the results of this project directly improve patient-care outcomes or processes?

Is the organization's management supportive of the project and willing to dedicate employee's time and supplies to do the project?

What is the sustainability plan for the results?

Financial support and sponsorship

The author disclosed no funding related to this article.

Conflicts of interest

The author disclosed no conflicts of interest related to this article.

Author notes

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Quality Improvement Activities FAQs

How does hhs view quality improvement activities in relation to the regulations for human research subject protections.

Protecting human subjects during research activities is critical and has been at the forefront of HHS activities for decades. In addition, HHS is committed to taking every appropriate opportunity to measure and improve the quality of care for patients. These two important goals typically do not intersect, since most quality improvement efforts are not research subject to the HHS protection of human subjects regulations. However, in some cases quality improvement activities are designed to accomplish a research purpose as well as the purpose of improving the quality of care, and in these cases the regulations for the protection of subjects in research (45 CFR part 46) may apply.

To determine whether these regulations apply to a particular quality improvement activity, the following questions should be addressed in order:

• does the activity involve research ( 45 CFR 46.102(d) );
• does the research activity involve human subjects ( 45 CFR 46.102(f) );
• does the human subjects research qualify for an exemption ( 45 CFR 46.101(b) ); and
• is the non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA approved by OHRP.

For those quality improvement activities that are subject to these regulations, the regulations provide great flexibility in how the regulated community can comply. Other laws or regulations may apply to quality improvement activities independent of whether the HHS regulations for the protection of human subjects in research apply.

Do the HHS regulations for the protection of human subjects in research (45 CFR part 46) apply to quality improvement activities conducted by one or more institutions whose purposes are limited to: (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes?

No, such activities do not satisfy the definition of “research” under 45 CFR 46.102(d) , which is “...a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge...” Therefore the HHS regulations for the protection of human subjects do not apply to such quality improvement activities, and there is no requirement under these regulations for such activities to undergo review by an IRB, or for these activities to be conducted with provider or patient informed consent.

Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes include:

• A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.
• A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates, and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected.
• A clinic increasingly utilized by geriatric patients implements a widely accepted capacity assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit patient charts in order to see if the assessments are performed with appropriate patients, and will implement additional in-service training of clinic staff regarding the use of the capacity assessment in geriatric patients if it finds that the assessments are not being administered routinely.

Do quality improvement activities fall under the HHS regulations for the protection of human subjects in research (45 CFR part 46) if their purposes are limited to: (a) delivering healthcare, and (b) measuring and reporting provider performance data for clinical, practical, or administrative uses?

No, such quality improvement activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…” Therefore the HHS regulations for the protection of human subjects do not apply to such quality improvement activities, and there is no requirement under these regulations for such activities to undergo review by an IRB, or for these activities to be conducted with provider or patient informed consent.

The clinical, practical, or administrative uses for such performance measurements and reporting could include, for example, helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery data or infection rates. Other practical or administrative uses of such data might be to enable insurance companies or health maintenance organizations to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.

Can I analyze data that are not individually identifiable, such as medication databases stripped of individual patient identifiers, for research purposes without having to apply the HHS protection of human subjects regulations?

Yes, whether or not these activities are research, they do not involve “human subjects.” The regulation defines a “human subject” as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information….Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.” Thus, if the research project includes the analysis of data for which the investigators cannot readily ascertain the identity of the subjects and the investigators did not obtain the data through an interaction or intervention with living individuals for the purposes of the research, the analyses do not involve human subjects and do not have to comply with the HHS protection of human subjects regulations.

(See OHRP Guidance on Research Involving Coded Private Information or Biological Specimens , October 2008; available at http://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/cdebiol.pdf .)

Are there types of quality improvement efforts that are considered to be research that are subject to HHS human subjects regulations?

Yes, in certain cases, a quality improvement project may constitute non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA. For example, if a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute nonexempt human subjects research under the HHS regulations.

If I plan to carry out a quality improvement project and publish the results, does the intent to publish make my quality improvement project fit the regulatory definition of research?

No, the intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research. The regulatory definition under 45 CFR 46.102(d) is “ Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of nonresearch activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results.

Does a quality improvement project that involves research need to be reviewed by an IRB?

Yes, in some cases. IRB review is needed if the research involves human subjects, is not exempt, and is conducted or supported by HHS or otherwise covered by an applicable FWA.

For more information see exempt categories .

Does IRB review of a quality improvement project that is also non-exempt human subjects research always need to be carried out at a convened IRB meeting?

No, if the human subjects research activity involves no more than minimal risk and fits one or more of the categories of research eligible for expedited review, the IRB chair or another member designated by the IRB chair may conduct the review. 

The categories of research eligible for expedited review are available at: http://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html .

If a quality improvement project involves non-exempt research with human subjects, do I always need to obtain informed consent from all subjects (patients and/or providers) involved in the research?

No, the HHS regulations protecting human subjects allow an IRB to waive the requirements for obtaining informed consent of the subjects of the research when

• the risk to the subjects is minimal,
• subjects’ rights and welfare will not be adversely affected by the waiver,
• conducting the research without the waiver is not practicable, and
• if appropriate, subjects are provided with additional pertinent information after their participation ( 45 CFR 46.116(d) ).

Other applicable regulations or laws may require the informed consent of individuals in such projects independent of the HHS regulations for the protection of human subjects in research.

If a quality improvement project is human subjects research requiring IRB review, do I need to obtain separate IRB approval from every institution engaged in the project?

No, not if certain conditions are met. The HHS protection of human subjects regulations allow one IRB to review and approve research that will be conducted at multiple institutions. An institution has the option of relying upon IRB review from another institution by designating that IRB on its FWA and submitting the revised FWA to OHRP, and having an IRB Authorization Agreement with the other institution.

See IRBs and Assurances for information on FWAs and IRB Authorization Agreements.

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Quality improvement & quality assurance

Defining research vs. quality improvement/quality assurance.

IU Human Research Protection Program (HRPP) irb@iu.edu

This information is intended as guidance in making a preliminary determination regarding the need for IRB oversight. Whenever there is uncertainty as to whether a project is considered Research or QI/QA, the investigator should request guidance from the HRPP.

To establish the definition of Research versus Quality Improvement (QI) or Quality Assurance (QA)—referred to collectively in this guidance as ‘QI/QA.’

Research projects must comply with specific policies and regulations designed to protect human subjects and privacy rights. QI/QA projects are not required to be carried out in accordance with research policies and regulations; however, it may be difficult for an investigator to determine if the project is Research or QI/QA. Since this determination may have a significant impact on the project design, procedures, and regulatory compliance, the investigator should not hesitate to ask the HSO for guidance. There are serious consequences for not following Indiana University policies and Federal regulations when conducting research.

The first section provides definitions for Research and QI/QA. The second section provides certain characteristics typically associated with Research and QI/QA projects. Once you review the definitions and characteristics, you should be able to determine the appropriate category for your project. If you determine that the project is similar to both definitions, then the project is Research.

Section 1: Definitions

What is research? The Common Rule defines research as “a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge”. [Source: Code of Federal Regulations 45CFR46.102]]

Please be aware the intent to publish is an insufficient criterion for determining whether a project involves research. Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of nonresearch activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results. [Source: OHRP FAQs]

What is Quality Improvement / Quality Assurance (QI/QA)? The human subjects regulations offer no formal definition of Quality Improvement or Quality Assurance. The HRPP considers QI/QA to involve:

• the data collection and analysis is limited to the use of data originally collected for any purpose other than the currently proposed activity, or
• is obtained through oral or written communications with individuals
• altering the utilization of the accepted practice; and
• collecting data to evaluate the effects on the utilization of the practice

NOTE: QI/QA activities are not designed to contribute to generalizable knowledge.

VA researchers should refer to additional definitions and guidance in VHA Program Guide 1200.21 - VHA Operations Activities That May Constitute Research.

Section 2: Distinction between Human Subjects Research and Quality Improvement

Section 3: similarities and differences between human subjects research and qi/qa.

Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes [purposes are limited to (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes] include:

• A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.
• A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates, and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected.
• A clinic increasingly utilized by geriatric patients implements a widely accepted capacity assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit patient charts in order to see if the assessments are performed with appropriate patients, and will implement additional in-service training of clinic staff regarding the use of the capacity assessment in geriatric patients if it finds that the assessments are not being administered routinely.

Section 4: IRB Oversight

Retroactive approval: The IRB cannot retroactively approve research. If a project commenced without IRB approval and was later determined to constitute research with human subjects, please review the Guidance on Reportable Events .

Publication considerations: Some academic journals require documentation of IRB oversight, or in lieu of IRB oversight, a determination that IRB oversight is not required of a project that does not represent human subjects research. In these cases, the HSO recommends investigators complete and submit an Application for Not-Human Subjects Research via Kuali Protocols prior to commencing the project.

Funding considerations: If a project is funded as ‘human subjects research’, please submit the appropriate human subjects research application for IRB review . If a funder requires documentation of IRB oversight or determination that oversight is not required for a project which does not represent human subjects research, please follow the instructions in ‘Publication considerations’ above.

Projects utilizing data collected for a QI/QA project: Some projects propose to utilize data that are already in existence and that were collected as part of a QI/QA endeavor. Depending on the design of the project, this may represent research with human subjects. Please contact the HRPP for assistance in making this determination.

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Learning, improvement and innovation

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We focus on continuous learning, innovation and improvement across our organisation and the local system. We encourage creative ways of delivering equality of experience, outcome and quality of life for people. We actively contribute to safe, effective practice and research.

What does good look like:

The trust has a systematic approach to improvement. It works to embed a quality improvement method aligned with the NHS improvement approach to support increased productivity and enable improved health outcomes for people.

Improvement capability is enabled across the trust. All teams can access in-house expertise and/or an external partner for support to improve. Staff at the trust work together across teams and services to improve services by:

• facilitating and promoting research
• using research evidence
• offering opportunities to take part in research
• implementing innovations.

Staff are actively encouraged to improve how the trust uses its resources. They can access analytical experts to support specific improvement projects to do this. There is appropriate strategy, governance, oversight, evaluation and accountability to ensure research, innovation and improvement projects are taken forward effectively. This incorporates learning from patient safety events and appropriate data protection requirements. The trust participates effectively in national improvement initiatives. Plans to improve services take into account the resources required to deliver them.

Leaders build a shared purpose and vision that provides the strategic goals for all the trust’s improvement activities and alignment of improvements to individual processes. There are clear goals for research, improvement, and innovation in terms of outcomes for people who use services and staff. There is evaluation against these goals.

The trust invests in its people and culture. It gives those closest to the point of care the opportunities to develop skills. This includes through continued professional development and through leaders being role models for research, innovation and improvement. This helps to ensure quality improvement is embedded in the way all staff work. The trust has a culture of research, innovation and improvement and staff feel supported by leaders, with support and reflection if new approaches do not work. The trust invests in delivering digital transformation in line with its digital and data strategy. This empowers staff by giving them the tools, services and skills they need to do their jobs effectively.

There are plans to build capacity and capability for developing the behaviours and skills needed to facilitate and nurture research, innovation and improvement. In doing this, leaders make effective use of data and team coaching to enhance their workplace and practices. There is an active approach to finding out what has worked elsewhere and examples of ideas that have been successfully adopted. The trust uses digital tools to transform pathways, increase productivity and improve services. It works proactively to enable applications for research funding and recruitment to research trials. There are robust processes to ensure the timely adoption of proven innovation and processes to identify promising innovations that align with local health needs working with system partners.

The trust has a structured approach to quality assurance, quality management, quality improvement and quality planning, as recommended by the National Quality Board. Insights gained from responding to patient safety incidents feed into the trust’s improvement efforts. The trust’s patient safety incident response plan (PSIRP) demonstrates a thorough understanding of ongoing improvement work and demonstrably takes this into consideration as part of patient safety incident response planning.

People and communities, particularly those who are more likely to have poor access, experience and outcomes from care, are involved and empowered to take part in identifying clinical and care needs, research opportunities, and in developing and co-producing improvements and innovations. This aims to actively tackle and reduce health inequalities.

Further detail and context:

Quality improvement.

NHS IMPACT is the single shared NHS improvement approach. It provides an aligned focus on improving access, quality and productivity through:

• a focus on building a shared purpose and vision
• building improvement capability
• developing leadership behaviours for improvement
• investing in culture and people, quality management and drivers and enablers such as co-production and digital transformation.

A National Improvement Board underpins the work of NHS Impact in driving national and system-wide improvement across the NHS. A range of tools, resources and data from NHS England supports improvement work in trusts and systems. Resources for gathering insight from safety events are available to support wider improvement work.

The term ‘quality improvement’ (QI) refers to ‘the systematic use of methods and tools to try to continuously improve quality of care and outcomes for patients’. Lessons from the evaluation of the NHS-Virginia Mason Institute Partnership highlighted the need for visible and sustained commitment to improvement programmes from trust leaders – without this, performance gains from improvement programmes are restricted to specific care pathways and services.

Innovation has the potential to drive transformative change in health care delivery, experience, outcomes and in reducing health inequalities. Outcomes for patients can improve by developing, identifying, evaluating and adopting innovative products (including medicines, medical technologies, diagnostics, digital and artificial intelligence innovations). This happens through preventing ill-health, earlier diagnosis, more effective treatments, and faster recovery. Furthermore, implementing highly effective and cost-effective or cost-saving innovation on a larger scale can relieve financial and workforce pressures on the NHS.

The NHS Long Term Plan highlighted research and innovation as integral to improving outcomes for patients. The joint CQC and NHS England publication ‘ Enabling innovation and adoption in health and social care: developing a shared view ’ identified 6 principles for enabling innovation that any health or social care provider, including trusts and trust leaders, can commit to. It includes case studies from across different health and care settings that are intended to illustrate how these principles can be applied in practice.

Organisations that actively engage in research demonstrate better patient outcomes, including for those not directly involved in research. They also have improved staff recruitment and retention. Research can provide early access to new treatments and technologies, and commercial research brings direct economic benefits for trusts. Research leads to evidence-based practice which, in turn, enables the development and implementation of local and national clinical guidelines, for example through NICE reviews and recommendations. Individual trusts adopt varying methods to implement changes in practice in response to research evidence.

Promoting, conducting and using research is explicitly mentioned in the Health and Care Act 2022 and the NHS Constitution. It is an essential component of providing high-quality care. The NHS Long Term Plan and NHS Operational Planning Guidance include commitments around research. To fulfil the rights of patients, the NHS also commits to inform patients about research studies in which they may be eligible to participate.

Having proactive healthcare knowledge and library services is vital to improve education, lifelong learning, research, the spread and adoption of innovation and evidence-based practice. These resources supply the evidence base to the NHS workforce to make decisions on treatment options, patient care and safety, service delivery and policy.

Learning from deaths

Learning from the deaths of people in their care can help trusts improve the quality of care for patients and their families and identify where they could do more.

CQC’s ‘Learning, candour and accountability’ found some providers did not prioritise learning from deaths and so were missing valuable opportunities to identify and make improvements to care.

The National Quality Board (NQB) guidance details how NHS providers should learn from the deaths of people in their care. All healthcare providers need to have mechanisms to receive and act on intelligence and information from medical examiner offices. New methodology under the Patient Safety Incident Response Framework (PSIRF) enables organisations to take a systems approach to investigating deaths as well as a more proactive approach to risk management.

Best practice / guidance

Quality improvement resources.

NHS England: NHS IMPACT

NHS England: Operational Delivery Networks

NHS England: Always Events

NHS England: Patient safety learning response toolkit

NHS England: NHS England: Patient Safety Incident Response Framework

NHS England: PSIRF Oversight roles and responsibilities specification

Quality and Improvement Outcomes Framework for NHS Funded Library and Knowledge Services in England

Innovation and research resources

CQC: Enabling innovation and adoption in health and social care: Developing a shared view

NHS England: Maximising the benefits of research: Guidance for Integrated Care Systems

NICE: Cost-saving guidance

NHS Providers: Digital Board Development Programme

National Institute for Health and Care Research: Clinical Research Network Performance

DHSC: The Future of UK Clinical Research Delivery

NHS England: Increasing Diversity in Research Participation: a good practice guide for engaging with underrepresented groups

GOV.UK (2021) Saving and Improving Lives: the Future of UK Clinical Research Delivery.

Knowledge and evidence resources

Knowledge for Healthcare strategy: Mobilising evidence; sharing knowledge; improving outcomes

Policies for NHS funded Knowledge and Library Services in England

NHS Knowledge and Library Hub

Clinical Decision Support tool

The NHS Education contract

Learning from deaths resources

CQC: Learning, candour and accountability : a review of the way trusts review and investigate the deaths of patients in England

NHS England: Medical Examiner System

National Quality Board: Learning from deaths: Guidance for NHS trusts on working with bereaved families and carers

Link to regulations

Regulation 17: Good governance

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Incident ID: 14604593417767129979

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