Evaluating the Integration of the Recommended Summary Plan for Emergency Care Treatment (ReSPECT) Into Primary Care
Condition: Advance Care Planning
MeSH terms: Emergencies
Study type: Observational

Summary: 
      When a person becomes seriously ill health professionals treating them need to make decisions
      quickly. They may have limited information about the person's medical history or about their
      wishes about treatment. To help health care professionals decide what is the best treatment
      for that person Emergency Care Treatment Plans can be used. These record what the person
      would or would not want to happen in certain situations.

      The plans are usually written by the person's doctor after discussing it with them. One type
      of plan, called ReSPECT (Recommended Summary Plan for Emergency Care and Treatment) is used
      in many National Health Service hospitals in the UK. However, it might be better to write
      these plans when the person is living at home before they are admitted to hospital.

      ReSPECT forms are now being used by GPs and other primary care staff in the UK. This project
      plans to study the ReSPECT process in primary care to determine how, when, and why it is
      used, and what effect it has on patient treatment and care. It will use a mixture of methods
      for collecting information. The investigators will interview patients, their families, GPs
      and care home managers to ask them about their experience of the ReSPECT process.

      To get a wider range of views, the investigators will also speak to groups of other health
      professionals, patient organisations and faith leaders, and carry out national surveys of GPs
      and the general public. The study will also look how at patient records to see how the
      ResPECT process makes a difference to decisions about medical treatment when a person is
      seriously ill. The information from these different methods will be brought together at a
      stakeholder meeting and will be used to work out how the ReSPECT process can work best to
      improve patient treatment and care.
    

Detailed description: 
      This is a mixed methods research project comprised of four work packages. The overall
      theoretical framework within which the study will be analysed is Normalisation Process Theory
      (NPT). The investigators wish to investigate to what extent ReSPECT is embedded in routine
      primary care practice and how it is perceived and enacted by health 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. The investigators will ask how do clinicians, patients
      and their families:

        1. conceptualise ReSPECT (coherence)

        2. initiate or engage with the process (cognitive participation)

        3. use the process and the documentation (collective action)

        4. evaluate it, and how does it change behaviour (reflexive monitoring)

      Work package one This will take place in GP practices and care homes across three CCG areas
      of England where ReSPECT has been implemented. The investigators will recruit 12 GP practices
      across the three areas and two care homes associated with each practice. In each practice the
      investigators will interview patients, the carers of patients who lack capacity, GPs and
      other practice staff. The investigators will ask the practice to identify two care homes for
      which they are the main practice and seek to interview the care home manager or a senior
      member of staff.

      Patient/carer interviews

      The investigators will recruit up to 48 patient/carers across all sites (12 practices)
      equally from three groups, which are people:

        1. living in a care home

        2. living at home, identified as nearing the end of their life (but not in the final stages
           of a terminal illness)

        3. living at home, not identified as nearing the end of life.

      Patients and their carers will be identified and invited by practice staff, or the care homes
      where patients are resident. In each practice the investigators will seek to recruit patients
      who have had a ReSPECT form completed in the previous six months, or for patients who lack
      capacity their primary carer or the person who was involved in completion of the ReSPECT
      form. Potential participants will be invited to take part in an interview, at which the
      investigators will ask participants if they would agree to be contacted to take part in a
      second interview 6 months later.

      At the first interview the investigators will ask participants:

        -  What they understand about the ReSPECT process and form

        -  Their views on the ReSPECT process, when they consider their ReSPECT form should be
           reviewed and who should initiate this review

        -  To describe the ReSPECT process from when it was first considered or mentioned through
           to completion of the form and any updating of the form

        -  Thoughts and feelings the process engendered; whether the process changed how they
           viewed themselves, their health/illness, and the prospect of their death; whether they
           think it resulted in a change to the care, and treatments they received and how they
           viewed these; their sense of trust in their clinicians and in the health service more
           generally including whether they trust that the ReSPECT form will receive attention once
           completed; how the ReSPECT process could be improved. The investigators will ask whether
           COVID-19 has had any impact on their thinking about ReSPECT or advance care planning in
           general.

      At the follow up interview the investigators will ask participants about major changes to the
      patient's life context and health/illness since the first interview, including further
      experience of the ReSPECT process/review. If they have further experience with ReSPECT the
      investigators will explore this in a similar way to the first interview and prompt for any
      differences compared to the first interview. Where participants have experienced
      illness/treatment events the investigators will explore their perception of any influence
      during this event. With all participants the investigators will explore whether and how their
      reflections on the ReSPECT process and its impact have changed and what influenced these
      changes.

      GP interviews, conversations with practice staff, and care home interviews In each practice,
      the investigators will interview the health professional who completed ReSPECT for patient
      participants or the GP most closely involved in their care if the form was completed in
      hospital. The investigators will carry out brief conversations with other members of the
      practice team, for example practice nurses, practice manager, receptionist, asking them about
      their awareness/use of ReSPECT, and how the process runs in the practice. The investigators
      will invite the managers of care homes linked to participating practices to take part in an
      interview about their general experience of ReSPECT and of how clinical decisions are made
      for residents with a ReSPECT form.

      The investigators will also collect pooled anonymous data on;

        -  practice population demographics

        -  number of ReSPECT forms recorded

        -  for people with ReSPECT form: age; ethnicity; eFrailty index; type of residence
           (care/nursing home or own home/family home) and where ReSPECT form completed (if
           recorded).

      The investigators will analyse interview data using Framework analysis to identify themes
      that help us understand how and why implementation of ReSPECT varies, the enablers and
      obstacles to its implementation, and specific ethical concerns.

      Work package two In this work package the investigators will engage the public and health
      professionals in reflection and debate about the concept and use of Emergency Care Treatment
      Plans in general and ReSPECT in particular. As the use of ECTPs relates to ethical issues and
      death, the investigators will engage with representatives of all relevant faith communities.
      Based on the findings of Work Package 1, the investigators will develop two questionnaire
      surveys. One for the public, and one for primary and community health care professionals.

      There are two research strands in this Work Package 2:

        -  Focus groups/interviews

        -  Surveys

      Focus Groups

      Members of the public with an interest in health care will be recruited through patient
      support groups and local community groups in each of the three areas in which the study takes
      place. The investigators will purposively select participants from those people expressing an
      interest to reflect the sociodemographic and ethnic profile of the community until at least
      10 people are willing to participate. Health care professionals will be recruited through
      local branches of professional organisations and social media. The investigators will select
      to ensure diversity of professional background. Focus group members will be prompted to
      discuss the following questions:

        -  What are the benefits for patients, carers, the health service, and wider society of the
           implementation of ReSPECT?

        -  What are the dis-benefits of ReSPECT?

        -  What gets in the way of implementing ReSPECT in a way that optimises its use and value,
           including access to forms and transfer between health and social care organisations?

        -  How can the dis-benefits of ReSPECT, and challenges to its use be mitigated?

      Interviews The investigators will interview six faith leaders from across the three study
      areas selected to reflect a diverse range of faith perspectives. Participants will be asked
      to consider the same topics as the focus group participants and in addition the investigators
      will explore how the values embedded in ReSPECT sit with key values of their faith and areas
      were the faith's teaching supports the premise of ReSPECT or could cause challenges for
      people following that faith. Data from focus groups and interviews will be analysed using
      Framework analysis.

      Surveys Public survey: The investigators will commission the National Centre for Social
      Research to include questions in the annual British Social Attitudes Survey (BSA), to be
      presented to 1000 participants.

      GP survey: The investigators will distribute the survey through a monthly online survey of UK
      GPs. The investigators will refine the questions using think aloud interviews with a small
      number of GPs and pilot the finalised questions with a sample of GPs prior to distribution.
      The survey provides data on commissioned questions presented to a regionally representative
      sample of 1000 GPs including partners, salaried non-principals and locums.

      Analysis The investigators will analyse associations between the survey outcomes and
      covariates such as: age, gender, presence/type of chronic disease, functional status
      (patients), time in practice and practice size (GPs). The most important outcome is the
      binary outcome 'whether they would complete an emergency care treatment plan' (for themselves
      if public survey and for their patients if GP survey) for which the investigators will fit a
      logistic regression model. T.

      Work package three In this work package the investigators will look at the quality of
      completion of ReSPECT forms in primary care and identify to what extent treatment decisions
      in an acute or emergency situation reflect the recommendations on a person's ReSPECT form.
      The method will be a retrospective case analysis of ReSPECT forms and the relevant sections
      of patients' records.

      Due to the challenges to obtaining consent from sufficient patients or their carers to
      achieve a sample that is not biased and includes patients who are likely to have a ReSPECT
      form and experience an event where the ReSPECT recommendations would be crucial to guiding
      treatment decisions, the investigators are seeking Confidentiality Advisory Group approval to
      access the patient records without consent and to use anonymised records for the analysis.
      The investigators will, through the practices or the relevant care home, write to all
      patients (or their carers) who have had a ReSPECT form completed in the previous 12 months
      with information about the study and provide an opportunity for them to opt out.

      The ReSPECT form and print outs of the patient record since ReSPECT form completion including
      hospital discharge letters and ED correspondence up to six months post ReSPECT completion
      will be generated by the practice and transferred securely to the study team. All included
      ReSPECT forms will be reviewed using the evaluation tool that the investigators have
      developed in the recently completed study of ReSPECT in secondary care to assess quality of
      completion of each section of the form.

      For all included ReSPECT forms the relevant data (treatment recommendations including CPR
      decision (Part 4 of the ReSPECT form) will be extracted from the form. The corresponding
      medical record will be reviewed to identify the first hospital admission or significant
      treatment event (defined as an acute episode requiring a medical treatment decision) since
      ReSPECT form completion.

      The record will be compared with the recommendations in section four of the corresponding
      ReSPECT form to look for congruence. The primary analysis will be on congruence of free text
      recommendations and clinical care. The investigators will fit a logistic regression model to
      the binary primary outcome 'congruency or not between what is stated on the ReSPECT form and
      what is actually implemented' with covariates such as: age, gender, place of residence,
      health category and cognitive function.

      Work package four The study design includes a work package (WP4) to work with people with a
      learning disability (LD) to co-produce resources and recommendations for the use of ReSPECT.
      The work package comprises 5 coproduction workshops with up to 16 people with LD.

      They will be iterative, and each workshop will include time/space to collate emerging
      reflections, recommendations and suggestions regarding ReSPECT. An advisory group of 5 people
      with LD will be formed. The advisory group will meet 8 times during the project and help to
      co-design the workshops. Researchers will take notes at reference group meetings and
      workshops and audio record them for the purpose of supplementing fieldnotes. The supplemented
      fieldnotes will be analysed in using thematic analysis to record emerging themes and
      summaries of workshops. These outcomes/messages from each workshop will be discussed,
      reviewed and refined with the Reference Group and presented at the next workshop together
      with resources to inform the next workshop activities. The final reference group meeting will
      consider overall findings from the workshops and the recommendations/resources produced. In
      addition focus groups with up to 20 carers of people with LD will be carried out to explore
      their views on the use of emergency care treatment plans. Existing evidence highlights poor
      health outcomes for people with LD and that their needs often go unmet in emergency
      situations, therefore this work package explores how ReSPECT can be used with people with LD
      and their carers.

      Work package five In this work package the investigators will synthesis their findings from
      the previous work packages and present the key findings at a stakeholder conference.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        WP1:

          -  Patients (Primary Care)

          -  General practitioners

          -  Care home managers

        WP2 Interviews:

          -  Members of the public (Community-based)

          -  Faith Leaders (Community-based)

          -  Health Care Providers

        WP2 surveys

          -  Members of the public (Community-based)

          -  General Practioners

        WP3:

        - Patients (Primary Care)
      
Keywords: Advance care planning; Emergency Care Treatment Plans; Primary Care; Social Attitudes; ReSPECT; Evaluation