How best to involve patients and the public in the implementation of evidence?

ISRCTN	ISRCTN87213384
DOI	https://doi.org/10.1186/ISRCTN87213384
Secondary identifying numbers	NIHR HSDR 150711

Submission date: 29/02/2024
Registration date: 21/03/2024
Last edited: 08/03/2024

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
The National Institute for Health and Social Care Research (NIHR) spends a billion pounds a year on researching what works and what doesn’t work in health and social care. To ensure that this research is not wasted, we need to implement research evidence: to move from ‘what we know’ about a particular condition or health and social care service to ‘what we do’ to provide the best quality care.
Most often, clinicians are the main implementers of research evidence. The aim of this project is to explore the potential roles of patients, their families, and members of the public in using research evidence to improve the quality of care, as supporters, co-producers or leaders. It is important for patients and their families to be involved in all decisions about their care, including how research evidence is implemented.
This research has two main aims. First, the researchers want to learn more about how patients and wider communities can be involved in implementing research evidence. Second, the researchers want to partner with patients and the public to develop a toolkit to support patient and public involvement in implementing research evidence. Ultimately, it is hoped that the toolkit will enhance research implementation practices of best evidence and create better quality care for patients.
The researchers have brought together a team of experts, including patients and public contributors, who will achieve the following objectives.
1. To develop an understanding of how, why, in what context, and with what impact, patients, service users, carers and the public involvement can be involved in the process of using evidence to change practice.
2. To develop a set of ideas or theories that help explain how patients and service users can become involved in using evidence to change health and social care practice. Initially, the researchers will review the literature to find out what is already known about how patients and the public can be implementers of research evidence to develop some initial ideas. They will then interview 40-60 people who will help refine their ideas and theories.
3. To develop a toolkit with advice, information and resources to help patients, service users, carers and the public be involved in putting what we know about public involvement in implementation into practice. The researchers will hold four workshops and invite key experts to think creatively about the design of our toolkit, Pathways to Implementation for Public Engagement in Research (PIPER).
4. To test the PIPER toolkit. Patient and public contributors and collaborators will select four case studies to test PIPER. They will invite the case studies to provide feedback and suggestions to improve PIPER so it is ready to be rolled out and used by patients, service users, patient organisations and different health and social care organisations.
5. To better understand how the co-production approach with patients has worked in this project.

Who can participate?
People who have an interest in or some experience of implementation:
1. Have been involved in or are interested in public involvement activity in research or service development in health and social care at different levels
2. Ideally has some experience of public involvement in implementation or knowledge mobilisation
3. Their inclusion in the sample will add diversity of voice or perspective, either based on their characteristics, their experience or their knowledge

What does the study involve?
Participants are invited to be interviewed and will be invited to further contribute to the co-design stage.

What are the possible benefits and risks of participating?
The researchers are not aware of any risks or any specific benefits that participants may take from the process.

Where is the study run from?
1. University of Warwick (UK)
2. Lab4Living (UK)
3. Keele University (UK)

When is the study starting and how long is it expected to run for?
September 2022 to October 2025

Who is funding the study?
National Institute for Health and Care Research (UK)

Who is the main contact?
Prof. Sophie Staniszewska, Sophie.Staniszewska@warwick.ac.uk

Study website

Contact information

Prof Sophie Staniszewska
Public, Scientific, Principal Investigator

Warwick Research in Nursing
Warwick Medical School
Division of Health Sciences
University of Warwick
Coventry
CV4 7AL
United Kingdom

ORCID ID	0000-0002-7723-9074
Phone	+44 (0)7814242114
Email	sophie.staniszewska@warwick.ac.uk

Dr Julia Walsh
Public, Scientific

Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom

ORCID ID	0000-0002-9787-0349
Phone	None
Email	Julia.walsh@warwick.ac.uk

Study information

Study design	Realist literature review, realist interviews, co-design of the PIPER toolkit, and evaluation of it in three case studies
Primary study design	Observational
Secondary study design	Realist literature review, realist interviews, co-design of the PIPER toolkit, and evaluation of it in three case studies
Study setting(s)	Home, Hospital, Laboratory, University/medical school/dental school, Other
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Developing a role for patients and the public in the implementation of health and social care research evidence into practice
Study acronym	PIPER
Study hypothesis	This study will address the key gap in our knowledge and practice, by answering the overall question, ‘how best can we involve patients, carers, service users and the public in the implementation of health and social care research evidence into practice?’ The overarching aim of this study is to understand the role, contribution and impact of patients, service users, carers and the public in the implementation of evidence into practice in health and social care. Based on the extensive experience of the investigators in realist inquiry, a realist evaluation approach will frame the study because it enables the exploration of what works, for whom, why and in what way. The framing of realist evaluation in context, mechanism and outcome configurations align theoretically with PPI and implementation (Wilson et al 2015, Brett et al 2012, 2014) and can provide ‘theoretical room’ for other approaches. Previous studies of PPI used realist evaluation to develop rich theories for public involvement where it was especially helpful because it values the development of theory with key stakeholders (Wilson et al 2018, Rycroft-Malone et al 2015).
Ethics approval(s)	Approved 20/03/2023, Biomedical and Scientific Research Ethics Committee, University of Warwick (Kirby Corner Road, Coventry, CV4 8UW, United Kingdom; No number available; BSREC@warwick.ac.uk), ref: BSREC 45/22-23
Condition	All conditions and diseases will be included
Intervention	WP1 – Literature review WP2 – Realist interviews (40-60 participants) WP3 – Codesign of PIPER toolkit process (20-25 participants) – led by Lab4Living, Sheffield Hallam WP4 – Piloting of PIPER toolkit on three case studies from Keele Impact Accelerator Unit The researchers' initial theoretical framework provides the focus for the review. Firstly, PPI in implementation may work at different levels (reflecting identified practice so far), micro (individual patient focused on their own care), meso (patient as part of service user group) and macro (patient working at strategic level e.g. national organisation). Secondly, there may be three broad types of involvement, including patient as supporter of implementation, patient as co-producer (in collaboration with others), and patient as active agent or leader of implementation, reflecting common theorisations about the operation of PPI (Gibson et al 2012). Participants are selected because of their likely interest in the research question. They were enrolled via email. Those who consented were invited to be interviewed (WP2) and will be invited to further contribute to the WP3 Co-design stage. Taking part in the WP2 interview does not commit them to any further participation. The co-production group was also enrolled via email and contributed to the research design, methods and findings.
Intervention type	Other
Primary outcome measure	The ways in which patients and the public have been involved in implementation, the roles they have adopted, and what support patients and the public require to be involved in successful implementation of evidence into practice, collected using interviews during work package 2 and 4.
Secondary outcome measures	As this is a realist study there are no secondary outcome measures. The researchers will develop a set of programme theories that explain what works, for whom, why and in what context.
Overall study start date	01/09/2022
Overall study end date	31/10/2025

Eligibility

Participant type(s)	Healthy volunteer, Health professional, Carer, Employee, Population, Service user
Age group	Adult
Lower age limit	18 Years
Upper age limit	110 Years
Sex	Both
Target number of participants	Work package 2: 40-60 people, Work package 3: 25-35 people, Work package 4: 8-12 people in each of three case studies.
Participant inclusion criteria	1. Individuals across the life course 18 years and over 2. Potential interviewees include patients, service users, carers, public, implementation leads/fellows, health and social care professionals, agencies, PPI/implementation leads in agencies such as SCIE, NICE, ARC, AHSN, research commissioners/funders, health and social care managers, policy and decision-makers and patient organisations.
Participant exclusion criteria	Individuals under 18 years of age
Recruitment start date	01/05/2023
Recruitment end date	01/09/2025

Locations

Countries of recruitment

Australia
Canada
England
United Kingdom
United States of America

Study participating centres

University of Warwick Medical School

University of Warwick
Coventry
CV4 7AL
United Kingdom

Lab4Living

The White Building
10 Fitzalan Square
Sheffield
S1 2FH
United Kingdom

Impact Accelerator Unit

David Weatherall Building
Keele University
Keele, Newcastle
ST5 5BG
United Kingdom

Sponsor information

University of Warwick
University/education

University House
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom

Phone	+44 (0)24 765 22746
Email	sponsorship@warwick.ac.uk
Website	http://www2.warwick.ac.uk/
"ROR"	https://ror.org/01a77tt86

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	01/09/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in high-impact peer-reviewed journals.
IPD sharing plan	The datasets generated during this study will be available upon request from Prof. Sophie Staniszewska (sophie.staniszewska@warwick.ac.uk) and subject to appropriate ethical approval. Interviews will be recorded (via Microsoft Teams) and the audio sent to an approved transcription service which will transcribe and anonymise the data. Consent was both required and obtained in line with Warwick BSREC & Sponsorship approvals. Interview data will be anonymised during transcription.

Editorial Notes

29/02/2024: Study's existence confirmed by the NIHR.