Advance care planning in general practice

Not Applicable

Completed

• Conditions: Chronic, life-limiting illnesses (cancer, heart failure, kidney failure, severe COPD, and mild to severe geriatric frailty); Not Applicable

• Registration Number: ISRCTN12995230
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34172030/ (added 28/06/2021) 2023 Results article in https://doi.org/10.3399/BJGP.2023.0022 (added 05/10/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38925875/ knowledge and attitudes (added 28/06/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38971761/ Process evaluation (added 08/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-19
• Study Completion: 2021-06-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

General practitioners:
1. Dutch-spreaking
2. Working with and caring for patients in Flanders or Brussels, Belgium
3. Able to include at least 3 patients

Patients:
1. Adults (>18 years old)
2. Mentally competent as measured by judgment of the GP OR if Mini-Mental State Examination has been conducted, score is >24
3. GP answers no to the surprise question, Would I be surprised if this patient were to die within the next 12 to 24 months?
4. Diagnosis of a life-limiting illness:
4.1. Locally-advanced unresectable, or metastasized cancer OR
4.2. Organ failure, this being
a) heart failure (New York Heart Association stage 3 or stage 4)
b) chronic kidney failure or end-stage renal disease (ESRD) (stage 4, eGFR=15-29;
or stage 5, eGFR<15)
c) Very severe COPD (GOLD COPD stages stage 3 or stage 4) OR
OR
4.3. Geriatric frailty (Clinical Frailty Scale score 5-7, mildly to severely frail)

Added 13/10/2020:
Surrogate decision-makers:
1. Adults (>18 years old)
2. Identified by the patient as their surrogate decision-maker OR as a person who may be willing to be their surrogate decision-maker

Exclusion Criteria

General practitioners:
1. Participated in Phase-II trial of the intervention
2. Participated in the cognitive testing of intervention materials and translated questionnaires

Patients:
1. Unable to speak or understand Dutch
2. Unable to provide consent or complete the questionnaires due to cognitive impairment
3. GP answers no to the surprise question, Would I be surprised if this patient were to die within the next 6 months?
4. Participated in the phase-II trial of this intervention
5. Participated in the cognitive testing of intervention materials and translated questionnaires

Added 13/10/2020:
Surrogate decision makers:
1. Unable to speak or understand Dutch
2. Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 13/10/2020:<br>1. Level of engagement with advance care planning will be measured using the 15-item version of the ACP Engagement Survey (Dutch translation) at baseline, 3 months, and 6 months<br>2. The general practitioner primary outcome of advance care planning self-efficacy will be measured using the ACP Self-Efficacy Scale (ACP-SE) at baseline (T0), 3 months (T1), and 6 months (T6).<br>Success on any one of these outcomes at T1 may support a conclusion of effectiveness. The researchers will treat T2 scores on these scales as a secondary outcome.<br><br>Previous primary outcome measures:<br>1. Level of engagement with advance care planning will be measured using the 15-item version of the ACP Engagement Survey (Dutch translation) at baseline, 3 months, and 6 months<br>2. The general practitioner primary outcome of advance care planning self-efficacy will be measured using the ACP Self-Efficacy Scale (ACP-SE) at baseline, 3 months, and 6 months.