Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05046197 |
| Other study ID # |
SOC18/20-21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 19, 2021 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University of Warwick |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
