Embedding patient and public involvement within research – How to set up a research patient ambassador group within a NHS trust

Abstract

Patient and public involvement in clinical research is vital to ensure the correct research questions are being asked to address patient and public’s needs. Patient and public involvement groups can be set up within individual research departments and local NHS trusts to help guide researchers, but there is a lack of guidance on how to develop and implement patient and public involvement groups. In this paper, we discuss the vital role and benefits of patient and public involvement in clinical research. We also describe how a research patient ambassador group called the Clinical Research Ambassador Group was created at the Heart of England NHS Foundation Trust to offer some advice and guidance for researchers and clinicians wishing to form their own group within a NHS trust.

Why do we need patient and public involvement in clinical research?

Delivering high-quality research that benefits patients and improves care is at the core of the NHS. The role of patient and public involvement (PPI) in the design and running of clinical research is becoming increasingly recognised and valued by clinicians and researchers. In 2009, Professor Dame Sally C Davies, Chief Medical Officer for England instigated the involvement of the patients and the public in research stating ‘No matter how complicated the research or how brilliant the researcher, patients and the public always offer unique, invaluable insight’. ¹ Patients and the public can identify and offer advice on research topics that are relevant to the users and their needs which might not be obvious to the researchers. ² It is also a requirement for funding by the National Institute of Health Research (NIHR) that research studies must have PPI as named co-applicants to ensure adequate emphasis on patient opinion and safety. ³

PPI in research benefits both researchers, public and service users

It is important for researchers to recognise the valuable contribution PPI has in research. The involvement from the public has been shown to influence the research agenda by questioning the relevance of existing research hypotheses and clarifying research questions. In 2015, Crowe et al. compared treatment research priorities from patients and clinicians in the James Lind Alliance Priority Setting Partnerships (PSPs) with those of researcher’s priorities. A prominent difference was found with researchers favouring drug treatment trials as a higher priority and 86% of commercial studies were drug trials, but only 18% of patients and clinicians considered drug trials as a priority. ⁴

PPI can also help to refine the study design by selecting the appropriate research methods and influencing recruitment targets. A review by Boote et al. in 2011 described how the public can help and contribute to numerous aspects of designing and implementing a trial, including review of consent procedures and patient information sheets, suggestions of additional trial outcomes, review of trial data collection procedures and recommendations on trial follow-up data. ⁵ Johns et al. recently conducted a closed study evaluation on 315 questionnaires completed by research teams. They found that 79% of the studies which engaged PPI led to an improvement in the quality of patient information and assisted with meeting performance targets. ⁶ Therefore, the appropriate writing style and format used within study information documents can directly influence patient recruitment into clinical research.

Although there is evidence to demonstrate the positive impacts service user involvement can have on researchers and patients, there is a lack of guidance on how to initiate involvement through creating an advisory group. Sims et al. demonstrated how to create a PPI group from their experience of devising service user and carer advisory group (Sucag). ⁷ However, the group mentioned was designed for a specific research project for three years within a University organisation. To our knowledge, there is no evidence that illustrates how to set up a sustainable PPI group within a research-active NHS organisation. The organisation INVOLVE, affiliated with the NIHR, provides brief guidance notes on their website on how to involve service users; nonetheless, there is still a lack of guidance from researchers’ personal experiences of formulating a PPI group. ⁸ This leaves some researchers and health professionals with the feeling that they lack the time, resources and knowledge on how to involve PPI. ⁹

This article will demonstrate how a PPI group named Clinical Research Ambassador Group (CRAG) has been created at the Heart of England NHS Foundation Trust (HEFT) in an NHS clinical research active trust. It will outline our experience of implementing and maintaining a PPI group and the impact it has had on the research process at HEFT. We aim to provide insight into how to establish and facilitate a PPI research group within an NHS organisation.

Developing the Clinical Research Ambassadors Group

Prior to the development of the group within HEFT, PPI in research was sometimes limited to one person per study and was not representative of the wider patient population that the Trust serves. Patient representation was a ‘token gesture’ to satisfy the funding bodies by including them on grant applications, or patients were only involved after funding was secured for a study meaning that they were not involved from the beginning to shape the research question to address patients’ needs.

It was perhaps fitting that it was our experience of working with a patient representative that inspired us to set up our patient group. The invaluable input from a patient with unique insight and experience of living with the disease throughout the entire process of study design proved instrumental in the successful funding of the study. The Clinical Research Ambassador Group (CRAG) was founded in 2013 with the aim to shape, guide and involve patients, carers and members of the public in clinical research at HEFT. The group was designed to ensure a non-tokenistic approach to PPI and for members to benefit in return for their involvement.

The CRAG management committee is multi-disciplinary and consists of the critical care research manager (chair), clinicians, research nurses, the Head of Patient and Public engagement and a Research and Development portfolio manager. The main focus of CRAG is to recruit members of the public from the community that HEFT serves; thus, valuing patients and family members who have used or had the potential to use the hospital facilities.

Implementing the Clinical Research Ambassadors Group – tips and advice

Branding and advertising the group

A branding strategy was implemented to provide CRAG with a unified identity and assisted in advertising the group to recruit members. The management committee and group members decided to name the group ‘Clinical Research Ambassador Group’ (CRAG) and a distinctive logo was designed (Figure 1). Members preferred this to being labelled PPI as they felt valued being referred to as ambassadors.

Figure 1.

Clinical Research Ambassador Group logo.

Profile and communications

We communicate and update members as well as the wider research community on the activities of the group through an email and twitter account, @CRAGHEFT. Newsletters, an information booklet and written articles published on the INVOLVE website and Anaesthesia News have helped to raise the public profile of the group.^10,11

Open evening events

We recommend an open evening as an effective way to launch a new group and gain initial interest from a wide audience. The first public meeting to showcase CRAG was hosted by the Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation and HEFT Research and development department in April 2013. HEFT communications team were heavily involved in advertising the evening. Email and post invitations were circulated to members of HEFT’s existing patient representative groups, current and former patients, as well as Trust governors, directors and managers.

The evening was chaired by the trust’s Medical Director and a lead academic clinician. The successful CRAG open evening gathered 49 attendees, of whom 28 committed themselves to becoming a member on the CRAG database. Members of the group then chose their own level of involvement, from commenting on circulated information to attending face-to-face meetings and becoming part of the research team.

Regular coffee mornings

CRAG coffee mornings are held every three months, providing opportunities for members to engage in discussions with researchers and to offer their advice in a small informal setting. Educational sessions are also provided during the meetings that include research processes and Good Clinical Practice to enrich members’ knowledge and understanding of clinical research. A wide variety of research areas has been presented to CRAG members on topics such as post-surgical pain, critical care, sepsis, discharge planning, thoracic surgery, resuscitation, hypertension, anti-hypertensive medication compliance, antibiotic resistance, anaesthesia and peri-operative care. On average, 8–12 CRAG members attend the mornings regularly alongside researchers. The meetings last for 2 h, which gives sufficient time for researchers to receive feedback from members and update on study development.

The impact of CRAG – benefit on researchers and patients

CRAG has made a positive impact and benefited many researchers at HEFT, in particular for studies involved in critical care, surgical and resuscitation research. One Chief Investigator commented “CRAG was extremely helpful in making the connections and joining the dots between clinical work and research” and having patients involved “added credibility to the project”. Another researcher conducting a study investigating outcomes in the field of cardiac arrest research, found consultation with CRAG members crucial to the success of subsequent patient interviews and qualitative study. CRAG group members ensured that patient information was relevant and the questions were logical and understandable. Input from the group resulted in successful recruitment and high levels of survey completion in the study. CRAG has allowed researchers to place patient’s needs at the forefront of research and to conduct patient centred studies to improve the quality of clinical trials.

CRAG members have reported benefit from being involved as ambassadors for research as they have developed their knowledge of research and the NHS. There are currently 20 active members in the group and many have worked on 12 NIHR trial applications as co-applicants or trial steering committee members with high funding success rates. One member has been inspired to become a lay member for the NIHR Clinical Research Network (CRN) West Midlands and a Join Dementia Research (JDR) Champion, promoting the need for patients and public participating in dementia research. They commented:

I see CRAG as a trailblazer concept that is active, committed and growing. Three years in, I believe that I belong to a flexible and dynamic partnership offering those of us with experiences of, or interest in, improving the services and successes of the NHS, an effective channel to make a real difference to research, researchers and patient experiences.

The group has retained and increased its membership over the past three years with a consistent turnout of attendees to meetings conducted throughout the year as a result of effective communication and listening to members’ needs.

Future improvements

Since the inception of CRAG, the group has successfully evolved into a self-sustaining PPI group within HEFT. Whilst we have demonstrated how to successfully implement and retain a PPI group within a NHS trust, there is still a need for CRAG to develop to ensure the group represents the population of patients the trust serves. HEFT is the third largest foundation trust in the UK with 1.2 million people seen and treated every year across four hospital sites. The population in Birmingham is diverse with 42% of residents from an ethnic group other than White and 22% of residents are born outside of the UK. The current make-up of CRAG members consists mainly of Caucasian people aged 41–75, and does not fully represent the wider population of patients who will benefit from clinical research. The CRAG management committee recognise this limitation and are in the process of devising strategies to recruit ethnic minority members to the group to reflect the diverse population. We also hope to attract the younger generation through expanding the online presence of the group by increasing the number of followers on social media websites alongside developing an independent website for CRAG. There is also a plan for CRAG members to help facilitate patient recruitment by sharing their own personal experiences as part of a strategy to help the public’s understanding and engagement with clinical research.

The involvement of PPI is crucial to high-quality clinical research. Researchers must strive to involve patients and public throughout the whole research process and to eradicate the non-tokenistic approach to PPI in research. Setting up a local group can create and develop long-term partnership and collaboration between PPI and researchers.