NCT02775032

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 13, 2016

Last Update Submit

May 16, 2016

Conditions

Keywords

advance care planninggeneral practicefamily practicepalliative careend-of-life care

Outcome Measures

Primary Outcomes (1)

  • Quality of life questionnaire

    up to 1 month

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

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.

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