Initiating ACP in General Practice. A Phase II Study

Phase 2

• Conditions: Life-threatening Illness; Palliative

• Registration Number: NCT02775032
• Lead Sponsor: Vrije Universiteit Brussel

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.

Detailed Description

Aim

1) to conduct the Phase II trial with GPs who will facilitate a structured ACP session with patients with a serious or life-threatening illness versus usual care and 2) to evaluate and validate the ACP intervention in terms of feasibility, acceptance to GPs and patients with a serious or life-threatening illness, and preliminary proof of effectiveness

Method

The implementation and preliminary evaluation of this intervention will be done by following the steps of the Medical Research Council (MRC) framework on complex intervention designs. This framework proposes a stepwise approach going from phase 0 to phase IV.

Phase 0-I were previously conducted by the research team and comprised the development of the intervention. This project proposal comprises phase II (exploratory trial) in which the feasibility and acceptability of the intervention will be evaluated.

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-16
• Last Update Submitted: 2016-05-16
• Study First Posted: 2016-05-17
• Last Update Posted: 2016-05-17
• Study Start: 2016-10
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaire	up to 1 month