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Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention
- Source :
- BMC Palliative Care, Vol 20, Iss 1, Pp 1-15 (2021), BMC PALLIATIVE CARE, BMC Palliative Care
- Publication Year :
- 2021
- Publisher :
- BMC, 2021.
-
Abstract
- Background Advance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner. Ideally situated for this initiation is the general practitioner (GP). The intervention to improve the initiation of ACP for patients with a chronic life-limiting illness in general practice (ACP-GP) includes an ACP workbook for patients, ACP communication training for GPs, planned ACP conversations, and documentation of ACP conversation outcomes in a structured template. We present the study protocol of a Phase-III randomized controlled trial (RCT) of ACP-GP that aims to evaluate its effects on outcomes at the GP, patient, and surrogate decision maker (SDM) levels; and to assess the implementation process of the intervention. Methods This RCT will take place in Flanders, Belgium. Thirty-six GPs, 108 patients with a chronic, life-limiting illness, and their (potential) SDM will be recruited, then cluster-randomized to the ACP-GP intervention or the control condition. The primary outcome for GPs is ACP self-efficacy; primary outcome for patients is level of ACP engagement. Secondary outcomes for GPs are ACP practices, knowledge and attitudes; and documentation of ACP discussion outcomes. Secondary outcomes for patients are quality of life; anxiety; depression; appointment of an SDM; completion of new ACP documents; thinking about ACP; and communication with the GP. The secondary outcome for the SDM is level of engagement with ACP. A process evaluation will assess the recruitment and implementation of the intervention using the RE-AIM framework. Discussion While the general practice setting holds promise for timely initiation of ACP, there is a lack of randomized trial studies evaluating the effectiveness of ACP interventions implemented in this setting. After this Phase-III RCT, we will be able to present valuable evidence of the effects of this ACP-GP intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice. The results of the process evaluation will provide insight into what contributes to or detracts from implementation success, as well as how the intervention can be adapted to specific contexts or needs. Trial registration Prospectively registered at with ISRCTN (ISRCTN12995230); registered 19/06/2020.
- Subjects :
- Advance care planning
medicine.medical_specialty
Palliative care
animal structures
Surrogate decision-maker
Psychological intervention
DIRECTIVES
Process evaluation
law.invention
Study Protocol
Quality of life (healthcare)
Phase III
Randomized controlled trial
Workbook
stomatognathic system
Complex intervention
law
General Practitioners
Intervention (counseling)
Medicine and Health Sciences
Medicine
Humans
SURPRISE QUESTION
Randomized Controlled Trials as Topic
Medicine(all)
BARRIERS
business.industry
Communication
Public Health, Environmental and Occupational Health
RC952-1245
ENGAGEMENT
General Medicine
ASSOCIATION
humanities
Special situations and conditions
Family medicine
oncology
Chronic Disease
PRACTITIONERS
bacteria
lipids (amino acids, peptides, and proteins)
business
General practice
Subjects
Details
- Language :
- English
- ISSN :
- 1472684X
- Volume :
- 20
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMC Palliative Care
- Accession number :
- edsair.doi.dedup.....f80c9af41c1f54de2c45fc0f7200ed6c