Initiating ACP in General Practice. A Phase II Study

Palliative Clinical Trial

Official title:

Evaluation of a Complex Intervention to Initiate Advance Care Planning in General Practice for the Improvement of End-of-life Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02775032
• Other study ID #: VZP_HA_2016
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 13, 2016
• Last updated: May 16, 2016
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Life-threatening Illness
• Palliative

Intervention

Behavioral:
• Advance care planning conversations between patients and their GP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life questionnaire		up to 1 month