NCT05046197

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

September 19, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

September 1, 2021

Last Update Submit

November 28, 2023

Conditions

Keywords

Advance care planningEmergency Care Treatment PlansPrimary CareSocial AttitudesReSPECTEvaluation

Outcome Measures

Primary Outcomes (2)

  • Proportion of respondents that would be 'willing' to complete an emergency care treatment plan for themselves (if public survey) and for their patients (if GP survey) compared to those that report that they would be 'unwilling'

    Response to survey questionnaire administered as part of WP2

    Single time point cross-sectional survey during Q4 2021

  • Logistic regression of congruency (Yes/No) between recommendations recorded in the ReSPECT form and actual clinical care.

    Analysis of congruency (yes/no) between the recommendations recorded on the ReSPECT form and the actual clinical care delivered to patients, as recorded on their medical records, via logistic regression.

    Ongoing data collection between Q3 2021 and Q1 2022

Secondary Outcomes (2)

  • How willing patients are to complete an emergency care plan on a scale of 0 (unwilling) till 10 (unwilling).

    Single time point cross-sectional survey during Q4 2021

  • Logistic regression of congruency (Yes/No) between presence of DNACPR decisions recorded in the ReSPECT form and CPR delivered in actual clinical care, as recorded in the patient's medical record.

    Ongoing data collection between Q3 2021 and Q1 2022

Study Arms (9)

Work Package 1 - patients and carers

Qualitative interview of 48 Patients, or their carers where the patient lacks capacity, who have had a ReSPECT form completed in the previous 6 months. To include: 12 patients living in care homes 12 patients living at home (nearing the end of their life) 12 patients living at home (not nearing the end of their life)

Work Package 1 - GPs

Qualitative interview of 30 General Practitioners who are involved in the ReSPECT process

Work Package 1 - Care home managers

Qualitative interview of 24 care home managers.

Work Package 2 - Focus groups/interviews (Members of the Public)

Qualitative interview of 30 members of the public with an interest in healthcare regarding attitudes to the ReSPECT process.

Work Package 2 - Focus groups/interviews (Health and Social Care Professionals)

Qualitative interview of 30 Non-GP Health and Social Care Professionals regarding attitudes to the ReSPECT process.

Work Package 2 - Focus groups/interviews (Faith Leaders)

Qualitative interview of 8 faith leaders regarding attitudes to the ReSPECT process.

Work Package 2 - Survey (Members of the Public)

Survey of 1000 members of the public to measure public awareness and acceptability of emergency care treatment plans

Work Package 2 - Survey (GPs)

Survey of 1000 GPs to measure the views of GPs nationally regarding the use of emergency care treatment plans including ReSPECT, in primary care.

Work Package 3 - Patient records

Patient records of 413 patients within 12 CCGs in England who have had a ReSPECT form completed in the previous 12 months

Eligibility Criteria

Age18 Years - 115 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Adult (18 years and over) patients with ReSPECT form completed in previous 6 months Carer/next of kin of adult patients without capacity, associated with the ReSPECT form completion General Practitioners involved in ReSPECT process Nursing and care home managers

You may not qualify if:

  • Patients in final stages of terminal illness (expected to die within next four weeks) Patients currently in hospital
  • WP2 interviews
  • Faith leaders
  • None
  • WP2 surveys
  • Members of the public General Practitioners
  • None
  • WP3:
  • Adult (18 years and over) patients with a ReSPECT form completed in the previous 12 months
  • Patients who opt-out Patients in final stages of terminal illness (expected to die within next four weeks)
  • WP4:
  • Members of patient and carer organisations Community and faith groups Relevant professional organisations Policy makers and regulatory bodies Members of the national ReSPECT working group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Warwick

Coventry, CV4 7AL, United Kingdom

Location

Related Publications (1)

  • Slowther AM, Harlock J, Bernstein CJ, Bruce K, Eli K, Huxley CJ, Lovell J, Mann C, Noufaily A, Rees S, Walsh J, Bain C, Blanchard H, Dale J, Gill P, Hawkes CA, Perkins GD, Spencer R, Turner C, Russell AM, Underwood M, Griffiths F. Using the Recommended Summary Plan for Emergency Care and Treatment in Primary Care: a mixed methods study. Health Soc Care Deliv Res. 2024 Oct;12(42):1-155. doi: 10.3310/NVTF7521.

Study Officials

  • Anne-Marie Anne-Marie, PhD

    University of Warwick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Anne-Marie Slowther

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 16, 2021

Study Start

September 19, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations