Advance care planning in general practice

ISRCTN	ISRCTN12995230
DOI	https://doi.org/10.1186/ISRCTN12995230
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2020/068
Sponsor	Vrije Universiteit Brussel
Funder	Fonds Wetenschappelijk Onderzoek

Submission date: 16/06/2020
Registration date: 19/06/2020
Last edited: 08/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Rather than a one-time documentation of care goals and preferences, advance care planning (ACP) is currently conceptualized as an ongoing, communication process that should be initiated early in the disease trajectory. General practitioners (GPs) play a critical role in timely initiation of ACP. By discussing ACP with their GP, patients have time to think about and communicate their preferences, increasing their engagement with the process. However, little evidence exists of how GPs and patients can initiate these conversations effectively. In this project, we will conduct a randomized-controlled trial of an ACP intervention for general practice. We aim to compare the complex, multi-component ACP intervention to care as usual.

Who can participate?
Dutch-speaking GPs who treat patients in Flanders and Brussels, Belgium, are eligible to participate. GPs will identify which of their patients are eligible to participate. Eligible patients are adults (older than 18 years) with a chronic, life-limiting illness. Each patient may also indicate a surrogate decision maker for participation.

What does the study involve?
The intervention developed for this trial will be compared to a usual care control group. The intervention consists of the following components: 1) ACP knowledge and communication skills training for GPs, 2) a workbook about ACP for the patient, 3) at least 2 structured ACP conversations between the GP and patient, and 4) documentation of the ACP discussion in a template. A process evaluation with focus groups and interviews will be conducted to evaluate how the intervention was implemented. The control group GPs will provide their patients with the usual standard of care. No additional materials will be provided for this group, nor will additional ACP conversations be planned.

GPs, patients, and surrogate decision-makers in both groups will complete questionnaires at baseline, at 3 months, and at 6 months. The GP questionnaire will evaluate knowledge, attitudes, and self-efficacy regarding ACP, as well as the GP’s current ACP practices. The patient questionnaires will evaluate the patient’s level of engagement with ACP, quality of life, anxiety, depression, and their communication with the GP. Surrogate decision-maker questionnaires will evaluate the level of engagement with ACP.

What are the possible benefits and risks of participating?
This study can deliver valuable evidence about the effects of ACP in general practice, and of the effectiveness of the tools developed for this intervention. The training and tools presented to GPs and the workbook and conversations offered to patients can support GPs and patients in starting conversations about ACP. GPs in the control group will also be offered the chance to attend the training after the conclusion of the study.
There are minimal risks to participating. Patients are able to indicate what they wish to discuss ACP. We will also monitor patient depression and anxiety to allow a timely response to adverse events.

Where is the study run from?
The study is run from the Vrije Universiteit Brussels (VUB) and Ghent University (UGent) (Belgium)

When is the study starting and how long is it expected to run for?
The first participant is expected by 15/8/2020. The study will run until March 2021 (approximately 7 months).

Who is funding the study?
The Research Foundation - Flanders (Belgium) (Fonds Wetenschappelijk Onderzoek)

Who is the main contact?
1. Julie Stevens
Julie.joseph.stevens@vub.be
2. Prof. Koen Pardon
Koen.pardon@vub.e
3. Dr. Aline De Vleminck
Aline.de.vleminck@vub.be
4. Prof. Luc Deliens
Luc.deliens@vub.be

Contact information

Miss Julie Stevens
Public

End of Life Care Research Group
Brussels Health Campus - Building K
Laarbeeklaan 103
Jette
1090
Belgium

ORCID ID	0000-0002-1417-0436
Phone	+32 470890527
Email	julie.joseph.stevens@vub.be

Miss Julie Stevens
Scientific

End of Life Care Research Group
Brussels Health Campus - Building K
Laarbeeklaan 103
Jette
1090
Belgium

ORCID ID	0000-0002-1417-0436
Phone	+32 470890527
Email	julie.joseph.stevens@vub.be

Study information

Primary study design	Interventional
Study design	Multicenter cluster-randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Improving patients’ level of engagement in advance care planning with their general practitioner: a cluster randomized controlled trial
Study acronym	ACP-GP
Study objectives	Current study hypothesis as of 13/10/2020: 1. To test the effectiveness of the ACP-GP intervention on: 1.1. The patient’s level of engagement with ACP (primary outcome at patient level) 1.2. The GP’s self-efficacy for conducting ACP (primary outcome at GP level) 2. To explore the effect of the ACP-GP intervention on: 2.1. Patient quality of life; symptoms of anxiety; symptoms of depression; the appointment of a substitute decision-maker; completion of new ACP documents; thinking about ACP, and communication with the GP (secondary outcomes at patient level) 2.2. GP ACP practices, attitudes and knowledge about ACP, and the documentation of ACP discussions in the patient medical file (secondary outcomes at GP level) 2.3. The SDM’s level of engagement with ACP (secondary outcome at the SDM level) 3. To evaluate the recruitment and implementation process of the intervention in terms of its reach, efficacy, adoption, implementation, and maintenance; as reported by patients, their SDM if present, and GPs Previous study hypothesis: 1. To compare the complex, multi-component advance care planning (ACP) intervention to care as usual in terms of their effect on: 1.1. the patient’s level of engagement with ACP (primary outcome at patient level) 1.2. the general practitioner (GP)’s self-efficacy for conducting ACP (primary outcome at GP level) 1.3. patient quality of life, symptoms of anxiety, symptoms of depression (secondary outcomes at patient level) 1.4. the appointment of a substitute decision-maker (secondary outcome at patient level) 1.5. GP self-confidence for conducting ACP, attitudes and knowledge about ACP (secondary outcomes at GP level) 1.6. the documentation of ACP discussions in the patient medical file (secondary outcome at GP level) 1.7. the surrogate decision maker’s level of engagement with ACP (secondary outcome at surrogate decision-maker level) 2. To evaluate the recruitment and implementation process of the intervention in terms of its reach, efficacy, adoption, implementation, and maintenance, as reported by patients, their surrogate decision maker if they are present, and GPs; by means of a process evaluation running parallel with the study
Ethics approval(s)	Approved 18/03/2020, Commission for Medical Ethics (O.G. 016) of the Vrije Universiteit Brussel/UZ Brussel (Laarbeeklaan 101, 1090 Brussels, Belgium; + 32 (0)2 477 55 84; commissie.ethiek@uzbrussel.be), ref: 2020/068
Health condition(s) or problem(s) studied	Chronic, life-limiting illnesses (cancer, heart failure, kidney failure, severe COPD, and mild to severe geriatric frailty)
Intervention	An independent statistician not affiliated with the research group will randomize the participating general practitioners (GPs) along with their patient cluster to the intervention or control group. Randomization occurs at the GP level to prevent contamination between the intervention and control group, as all patients within one cluster will receive either consultations from a GP who has received the intervention, or care as usual from a GP who did not receive the intervention. The control group GPs will provide their included patients with the usual standard of care, which may or may not include spontaneous ACP discussions according to the GP’s judgment. No additional materials will be provided and no additional GP appointments will be required. The intervention consists of following components for 6 months: 1. An advance care planning (ACP) training for GPs, where GPs can practice ACP conversations with feedback 2. An ACP workbook for patients called "Mijn Wensen Voor Toekomstige Zorg" (My Wishes for Future Care) which encourages reflection about what the patient considers a good quality of life and quality of care 3. At least 2 ACP conversations between the GP and patient, using materials such as a conversation guide for GPs (provided during the training) and the patient's workbook 4. Documentation of the ACP conversation outcomes in a standardized template
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measures as of 13/10/2020: 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 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). 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. Previous primary outcome measures: 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 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.
Key secondary outcome measure(s)	Current secondary outcome measures as of 13/10/2020: Patient-level secondary outcome measures: 1. Patient health-related quality of life measured using the 12-item Short-Form Survey (SF-12) at baseline, 3 months, and 6 months 2. Patient anxiety measured using the Generalized Anxiety Disorder (GAD-7) Questionnaire at baseline, 3 months, and 6 months 3. Patient depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3 months, and 6 months 4. Appointment of a substitute decision maker will be evaluated by patient report, GP report, and by the response to the ACP engagement survey “readiness to sign official papers assigning a SDM” item, at baseline, 3 months, and 6 months 5. Completion of new advance care planning documents will be evaluated by patient report, GP report, and ACP engagement survey “readiness to sign official papers stating medical wishes” item, at 3 months and 6 months 7. "Thinking about ACP" will be measured using 1 self-developed item, 10-point Likert (“How much have you thought about ACP in the last 3 months?”) at baseline, 3 months, and 6 months 8. Communication with the GP will be measured using 4 self-developed items, 10-point Likert (e.g., “To what extent did the GP listen to your concerns about your future health?”), at baseline, 3 months, and 6 months GP secondary outcome measures: 1. General practitioner knowledge and attitudes regarding advance care planning measured using the Next Steps training program questionnaire at baseline, 3 months, and 6 months 2. ACP practices will be measured using the Next Steps training program questionaire; 2 items specific to practices with patients with chronic, life-limiting illness; 8 additional items regarding ACP practices (e.g., “Where do the ACP conversations you conduct usually take place?”); at baseline, 3 months, and 6 months 3. Documentation of ACP discussion outcomes evaluated through anonymized documentation template review, at 3 months and 6 months SDM secondary outcome measures: 1. Surrogate decision-maker level of engagement with advance care planning measured using the ACP Engagement Survey, substitute decision maker version (Dutch translation) at baseline, 3 months, and 6 months Process evaluation: 1. Process measures (RE-AIM framework) evaluated through general practitioner focus group discussions at 6 months 2. Process measures (RE-AIM framework) evaluated through semi-structured interviews with patients and surrogate decision makers at 6 months 3. Process measures (RE-AIM framework) reported throughout the study period: 3.1. Documentation of the recruitment process 3.2. Monitoring of trainings (topic checklist) and follow-up by trainers 3.3. Analysis of audio-recorded ACP conversations between patients (and SDM if present) and GP 3.4. Workbook contents from a selection of intervention group patients 3.5. GP and patient questionnaire regarding ACP discussions and practices at 3 months 3.6. Satisfaction questionnaires for patients and GPs at 3 months Previous secondary outcome measures from 01/09/2020 to 13/10/2020: 1. Patient health-related quality of life measured using the 12-item Short-Form Survey (SF-12) at baseline, 3 months, and 6 months 2. Patient anxiety measured using the Generalized Anxiety Disorder (GAD-7) Questionnaire at baseline, 3 months, and 6 months 3. Patient depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3 months, and 6 months 4. Appointment of a substitute decision maker will be evaluated by GP report, and by the response to the ACP engagement survey “readiness to sign official papers assigning a SDM” item, at baseline, 3 months, and 6 months 5. Completion of new advance care planning documents will be evaluated by patient report, GP report, and ACP engagement survey “readiness to sign official papers stating medical wishes” item, at 3 months and 6 months 6. General practitioner knowledge, attitudes, and self-confidence regarding advance care planning measured using the Next Steps training program questionnaire, at baseline, 3 months, and 6 months 7. Documentation of ACP discussion outcomes evaluated through anonymized documentation template review, at 3 months and 6 months 8. Surrogate decision maker level of engagement with advance care planning measured using the ACP Engagement Survey, substitute decision maker version (Dutch translation) at baseline, 3 months, and 6 months 9. Process outcome measures (RE-AIM framework) evaluated through general practitioner focus group discussions at 6 months 10. Process outcome measures (RE-AIM framework) evaluated through semi-structured interviews with patients and surrogate decision makers at 6 months 11. Process outcome measures (RE-AIM framework) reported throughout the study period: documentation of the recruitment process; monitoring of trainings and follow-up by trainers; analysis of audio-recorded ACP conversations between patients (and SDM if present) and GP; workbook contents from a selection of intervention group patients; GP and patient questionnaire regarding ACP discussions and practices at 3 months; and satisfaction questionnaires for patients and GPs at 3 months Original secondary outcome measures: 1. Patient health-related quality of life measured using the 12-item Short-Form Survey (SF-12) at baseline, 3 months, and 6 months 2. Patient anxiety measured using the Generalized Anxiety Disorder (GAD-7) Questionnaire at baseline, 3 months, and 6 months 3. Patient depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3 months, and 6 months 4. Appointment of a substitute decision maker will be evaluated by GP report, and by the response to the ACP engagement survey “readiness to sign official papers assigning a SDM” item, at baseline, 3 months, and 6 months 5. Completion of new advance care planning documents will be evaluated by patient report, GP report, and ACP engagement survey “readiness to sign official papers stating medical wishes” item, at 3 months and 6 months 6. General practitioner knowledge, attitudes, and self-confidence regarding advance care planning measured using the Next Steps training program questionnaire, at baseline, 3 months, and 6 months 7. Documentation of ACP discussion outcomes evaluated through anonymized documentation template review, at 3 months and 6 months 8. Surrogate decision maker level of engagement with advance care planning measured using the ACP Engagement Survey, substitute decision maker version (Dutch translation) at baseline, 3 months, and 6 months 9. Process outcome measures (RE-AIM framework) evaluated through general practitioner focus group discussions at 6 months 10. Process outcome measures (RE-AIM framework) evaluated through semi-structured interviews with patients and surrogate decision makers at 6 months
Completion date	01/06/2021

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Sex	All
Target sample size at registration	252
Total final enrolment	208
Key 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
Key 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
Date of first enrolment	30/06/2020
Date of final enrolment	21/12/2020

Locations

Countries of recruitment

Belgium

Study participating centres

Vrije Universiteit Brussel

Laarbeeklaan 101
Jette
1090
Belgium

Universiteit Gent

Campus UZ Gent
C. Heymanslaan 10
Gent
B-9000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request. Requests may be addressed to the main contact persons (Julie Stevens, Prof. Koen Pardon, Dr. Aline De Vleminck, Prof. Luc Deliens). Every request will be evaluated on an individual basis and the ethics committee of the Vrije Universiteit Brussels will be contacted for approval before any sharing of participant-level data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/09/2023	05/10/2023	Yes	No
Results article	knowledge and attitudes	26/06/2024	28/06/2024	Yes	No
Protocol article		25/06/2021	28/06/2021	Yes	No
Other publications	Process evaluation	06/07/2024	08/07/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/07/2024: Publication reference added.
28/06/2024: Publication reference added.
05/10/2023: Publication reference added.
28/06/2021: Publication reference added.
18/05/2021: The total final enrolment was changed from 206 to 208.
06/04/2021: The following changes have been made:
1. The final enrolment number has been added.
2. The overall trial end date has been changed from 31/03/2021 to 01/06/2021.
3. The intention to publish date has been changed from 31/03/2022 to 01/05/2022.
27/11/2020: The recruitment end date has been changed from 30/11/2020 to 21/12/2020.
13/10/2020: The following changes were made to the trial record:
1. The study hypothesis, primary and secondary outcome measures, inclusion and exclusion criteria were updated.
2. The target number of participants was changed from "40 general practitioners, each with a cluster of 3 patients (120 patients total), up to 120 surrogate decision-makers (1 per patient)" to "36 general practitioners, each with a cluster of 3 patients (108 patients total), up to 108 surrogate decision-makers (1 per patient)".
01/09/2020: The following changes have been made:
1. An acronym has been added.
2. The secondary outcome measures have been updated.
3. The target number of participants has been changed from "36 general practitioners, each with a cluster of 3 patients (108 patients total), up to 108" to "40 general practitioners, each with a cluster of 3 patients (120 patients total), up to 120 surrogate decision makers (1 per patient)".
4. The total target enrolment number has been changed from 144 to 160.
23/06/2020: Internal review.
19/06/2020: Trial’s existence confirmed by FWO ethics committee.