Initiating ACP in General Practice. A Phase II Study
Evaluation of a Complex Intervention to Initiate Advance Care Planning in General Practice for the Improvement of End-of-life Care
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
End-of-life care often fails in providing optimal patient-centred care and quality of life. Patients frequently suffer from inadequate control of pain, from a lack of communication about their illness and options for treatment, and from poor psychosocial and spiritual support. Advance care planning (ACP) can tackle these problems by providing patients with an opportunity to formulate their wishes and plan their future care, should they become incapable of participating in medical treatment decisions. Previous studies show that ACP improves concordance between patient's preferences and end-of-life care received and quality of care at the end-of-life. However, ACP is yet to be embedded in routine clinical practice and public consciousness. General practitioners (GPs) are in an ideal position to discuss ACP with their patients. By introducing ACP during a routine office visit, GPs can facilitate a structured discussion of the patient's wishes for end-of-life care. However, no ACP models have been systematically developed and tested in general practice. We developed a complex intervention to improve the initiation of ACP in general practice following the steps of an international guidance for development and evaluation of complex interventions. Before performing a full-scale intervention trial to study the effectiveness of this intervention on quality of care and quality of life, this model needs to be validated and tested in a pilot trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 17, 2016
May 1, 2016
1 year
May 13, 2016
May 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life questionnaire
up to 1 month
Interventions
Eligibility Criteria
You may qualify if:
- patients with a serious or life-threatening illness
- older than 18 years
- Dutch speaking
- eligible according to the Surprise question
- able to give informed consent
- able to complete questionnaires and participate in qualitative interview
You may not qualify if:
- younger than 18 years
- incompetent to participate due to mental incapacity
- unable to give informed consent
- unable to complete questionnaires or participate in qualitative interviews
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Dierickx S, Pardon K, Pype P, Stevens J, Vander Stichele R, Deliens L, De Vleminck A. 'Advance care planning, general practitioners and patients: a phase II cluster-randomised controlled trial in chronic life-limiting illness'. BMJ Support Palliat Care. 2020 Dec 2:bmjspcare-2020-002712. doi: 10.1136/bmjspcare-2020-002712. Online ahead of print.
PMID: 33268475DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- HEALTH SERVICES RESEARCH
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 13, 2016
First Posted
May 17, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
May 17, 2016
Record last verified: 2016-05