Here, we outline the study aims and objectives, and corresponding work packages (WPs), describe the theoretical approach underpinning the research and the ethical considerations raised by the research. Finally, we explain changes made to the original protocol in response to challenges encountered during the research process.
Study aims and objectives
Our overall aim was to evaluate the ReSPECT process for adults in primary care to determine how, when and why it is used, and what effect it has on patient treatment and care.
Our objectives were:
- To understand how ReSPECT is currently used in primary care from the perspective of patients, their families, clinicians and care home staff
- To describe the views of patients, the public, primary and community healthcare professionals, and home care workers on ECTPs in general and ReSPECT in particular
- To identify enablers and obstacles to embedding ReSPECT in primary care practice
- To explore the impact of ReSPECT on patient treatment decisions
- To understand how health and social care professionals can optimally engage people with a learning disability in the ReSPECT process and co-produce relevant support materials
- To develop a consensus on how ReSPECT should be used in primary care.
Study design
Work package 1
A qualitative study exploring the experience of ReSPECT in primary care and community settings drawing on interviews with GPs, patients and their families/carers and staff in care homes, and conversations with other members of staff in the participating GP practices (see Chapters 4, 5 and 6).
Work package 2
Focus groups and interviews with healthcare professionals, home care workers, members of the public and faith leaders to explore their views on the principles and practice of ReSPECT and other forms of anticipatory decision-making; two national surveys, one of the public’s attitudes to ECTPs and one of GPs’ experiences and views of anticipatory decision-making (see Chapters 3 and 4).
Work package 3
Quality assessment of ReSPECT form completion in the GP practice sites involved in WP1 (see Chapter 4).
Work package 4
Co-production workshops with adults with a learning disability to explore their understanding of and views on emergency care treatment planning and to co-create resources to support the engagement of people with a learning disability with ReSPECT; focus groups and interviews with relatives of people with a learning disability to capture their views and experiences of emergency care treatment planning. This WP was added to the original protocol following a successful application to NIHR for additional funding in response to a call for proposals to be submitted by current NIHR award holders for additional research related to social care, to be completed within their current award time frame (see Chapter 7).
Work package 5
An initial synthesis of findings across the WPs informed the content of a stakeholder meeting with participants from professional and patient organisations and implementers of ReSPECT across the UK; final synthesis of all findings (see Chapter 8).
See Report Supplementary Material 2 for study flow-chart.
Theoretical framework
Our overarching theoretical framework for analysis was normalisation process theory (NPT).44,45 We wished to investigate to what extent ReSPECT is embedded in routine primary care practice and how it is perceived and enacted by health and care professionals and patients. NPT characterises a set of mechanisms (coherence, cognitive participation, collective action and reflexive monitoring) that influence the embedding of new interventions or processes into clinical practice.
Data from WPs 1, 2 and 3 primarily informed our NPT analysis. In this analysis, we asked how do clinicians, care home staff, patients and their families:
- conceptualise ReSPECT (coherence)
- initiate or engage with the process (cognitive participation)
- use the process and the documentation (collective action)
- evaluate the impact of ReSPECT and how it changes behaviour (reflexive monitoring).
Data from the focus groups with members of the public and the public attitudes survey (WP2) provided a broader societal perspective to provide context for ReSPECT implementation.
Localities
Three Clinical Research Networks (CRNs) recruited practices across three diverse Clinical Commissioning Group (CCG) areas in England. To maintain participant confidentiality, we are not reporting which CCG areas were involved.
Ethics and regulatory approvals
We gained NHS/Health Research Authority (HRA) ethics approval (21/LO/0455) and Confidentiality Advisory Group (CAG) approvals (21/CAG/0089) for the study. A summary table of the approvals, including amendments, is presented in Report Supplementary Material 3. The sponsor was the University of Warwick.
Ethical considerations
Ethical issues for this study included recruitment and conduct of interviews on a sensitive and emotive topic; responding to distress of participants during interviews and focus groups; verbal consent for conversations with practice staff; responding to concerns raised regarding safeguarding or unprofessional conduct; accessing medical records without explicit consent; and involvement of people with a learning disability in co-production workshops. We describe how we addressed these in Appendix 1. Access to patient records and ReSPECT forms by study researchers was approved by the HRA Confidentiality Advisory Group under Section 251 of the NHS Act. Our justification for CAG approval is in Report Supplementary Material 4.
Changes to the protocol
Changes to recruitment of care homes
In our original protocol, we aimed to recruit two care homes associated with each GP practice site. Planned care home involvement included interviews with senior care home staff, involving care homes in recruitment of patients and their relatives, and identification of ReSPECT forms. Of 23 care homes identified by our GP practices, only 11 agreed to participate and, of those, 8 agreed to take part in the interview element only. Service delivery pressures related to COVID-19 and its consequences and frequent changes in senior staff contributed to the challenge of recruitment. To ensure that we captured the full range of care home experience, we expanded our recruitment through care home networks to include care home staff not linked to our GP sites.
Changes to recruitment approach for patient and relative interviews
Recruitment of patients and relatives of patients who lacked capacity was low. In response, we simplified our recruitment approach by removing the link between interview (WP1) and access to patient records (WP3) in the invitation letter. We also sought to advertise the interview study directly through care home networks.
Decision to stop data collection for congruence
We originally planned a retrospective analysis of patient records and ReSPECT forms to measure congruence between ReSPECT recommendations and clinical decision-making at the time of an acute event for people with a ReSPECT form completed in the previous 6 months. The estimated sample size for this analysis was 413 ReSPECT forms, assuming that the acute clinical event rate within 6 months of a ReSPECT form completion was 70%. Across our first 6 practice sites, we identified 233 patients with a record of a ReSPECT form completed in the previous 12 months, of whom 169 were eligible to participate. Of eligible patients, we were only able to identify and extract data from 65 ReSPECT forms. We had anticipated that GP practices may not always have a copy of a patient’s ReSPECT form as they are designed as patient held forms. However, we had expected that we would be able to identify additional ReSPECT forms through the care homes recruited to the study. As noted above, recruitment of care homes to this element of the study was extremely challenging and so this method of data collection was not possible. Additionally, analysis of the clinical records of patients with a ReSPECT form found an acute event rate of 24%. Following discussion between the study team, the study independent steering committee and the funder, it was agreed that it would not be possible to achieve the required sample size within the parameters of the current study. Therefore, data extraction from clinical records was discontinued for the remaining sites but collection of data from anonymised ReSPECT forms continued to enable a quality analysis of form completion.
We then obtained the relevant approvals to conduct a feasibility study to explore whether a different study design, using care home records only, could answer this research question. We encountered several challenges in recruitment of care homes and recruited two from a target of three homes. We found that 17/75 (22.7%) of residents had both a ReSPECT form and an acute event in a 6-month period. We estimate that we would need to work with 50–60 care homes to complete a congruence analysis (see Appendix 2 for a more detailed report). This finding and our findings on the quality of recorded recommendations in our review of ReSPECT forms in general practices lead us to conclude that at present a congruence analysis as originally conceived is not feasible.
Patient and public involvement
The main aim of ECTPs is to create personalised recommendations for clinical care and treatment in emergency situations where someone cannot make decisions for themselves. Key to this is involving the person, or someone close to them if the person lacks capacity, in conversations about what is important to them so that their preference can inform the clinical recommendations. This aim is set out on the RCUK ReSPECT web pages. As we sought to evaluate how such an explicitly patient-focused process is used in primary care and community settings, we recognised the importance of patient and public involvement (PPI) and engagement at every stage and embedded PPI in our project governance structure.
Scope of patient and public involvement
Project design
Before submission of the application for funding, we held two meetings with the lay advisory group that had contributed to our previous study evaluating ReSPECT in acute NHS trusts. The group was originally recruited through Warwick University’s University/User Teaching and Research Active Partnership and members had lived experience of health conditions or being a carer. During the first meeting, we presented findings from the initial ReSPECT study evaluating its use in secondary care. The group discussed the identified lack of evidence of how the ReSPECT process works in primary care and the difference in how it is viewed between primary and secondary care. We discussed the proposed aim of this research, the suggested research questions and study methods. The group was asked for their views particularly about how to conduct the research in a way that was sensitive to patients and their families, and how to engage with the wider public, including hard to reach groups, to ascertain their opinions on ReSPECT and emergency care treatment planning. At the second meeting, the group considered feedback from our outline application and commented on our proposed responses to reviewers’ comments.
The group agreed that this research was important. They noted that it was crucial for patients and their families to have their preferences about future treatment decisions taken into account and that the process for supporting this needs to be robust and properly evaluated. The group discussed the importance of including the perspectives of marginalised and hard to reach groups and offered suggestions on recruitment from these groups for WP1 and 2. They also gave advice on the approach and conduct of interviews with patients and their families. Our lay advisors also reviewed and contributed to our application for additional funding to include a WP that focused on the experiences and perspectives of people with learning disability with regard to ReSPECT (WP4, see Chapter 7).
Investigator team
The study investigator team included a PPI member (CB) who was involved from inception in the design and development of the project and was also a member of the lay advisory group to support linkage across the project. He provided guidance on the acceptability of proposed methods, attended lay advisory group meetings, commented on all patient and family information materials and contributed to the writing and editing of reports from the different WPs. A PPI lead from the main study team (JH) also ensured linkage, communicated with the advisory group between scheduled meetings regarding project progress and any matters arising.
Advisory group
Our lay advisory group of five members had between them a range of lived experience of health care. The group met at 6-monthly intervals during the project to discuss project progress and develop and review fieldwork instruments and study documentation. They commented on draft questions for the survey of members of the public with their suggestions being incorporated into the final version. They also reviewed and commented on interim analyses of qualitative data to help interpret patient and relative experiences, and the stakeholder meeting report to help shape key messages. The group also advised on approaches and audiences for dissemination of the study findings to the public.
An integral part of WP4 (perspectives of people with a learning disability) was the inclusion of a reference group for this WP. The reference group was recruited through CHANGE (Leeds, UK) a national advocacy group for people with a learning disability, and all members had a lived experience of learning disability. This group worked closely with the study researcher and CHANGE to develop the format and content of the study workshops and pilot activities to be used in the workshops. They also contributed to the development of the resources that were created as part of this WP (see Chapter 7).
Stakeholder meeting
We invited delegates from a range of patient and public support organisations to the stakeholder meeting in addition to our lay advisory group members. Delegates participated in group discussions to develop recommendations on issues to consider in the future development of ReSPECT in community settings. Two members of the learning disability reference group presented findings from their WP at the stakeholder meeting, and examples of the materials produced and used by people with a learning disability during the workshops were displayed for delegates to view throughout the day.
Summary
The importance of PPI was recognised at an early stage of development of the project and was integral to its development, conduct, delivery and successful completion. Embedding the lived experience of people with a learning disability in development and outputs for WP4 was particularly important and enriched the overall study findings. The presence of PPI throughout the project also helped to ensure that the work retained its focus on the person at the heart of the ReSPECT process, and that language and communication was consistently clear and accessible.