Clinical trial NCT03239639: Randomized Control Trial of Advance Care Planning in Primary Care
Official title: A Randomized Control Trial of an Advance Care Planning Intervention to Engaged Substitute Decision-makers in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Keywords: Substitute decision makers of patient
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Queen's University
First posted: 2017-08-04
Enrollment: 61
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned in 1:1 ratio to intervention or wait list control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sometimes people with health conditions become ill suddenly and can no longer speak for themselves and another person (such as a family member) will make health care decisions for them. This means it is important to think about your wishes and tell others about them. This is called advance care planning. When people have done advance care planning, if they become very sick and cannot speak for themselves they are more likely to get the kind of health care they want and it is easier for the people who make decisions for them. There are tools such as brochures, questionnaires, and videos that can help people learn about these things. This research is being to done to study whether using tools for advance care planning and goals of care discussions will improve how patients and their substitute decision makers do advance care planning. This study is a randomized trial. This means half of the people in this study will meet with someone at their family practice to talk about advance care planning and review some tools and half will get usual care (a Speak Up workbook). The study will 1) evaluate if reviewing the tools, and having help to complete them, helps patients and their substitute decision maker do advance care planning 2) if this intervention will encourage patients to talk to their family doctor about these issues.

Detailed description: In prospective and randomized trials, advance care planning (ACP) significantly improves outcomes including increased likelihood that clinicians and families understand and comply with a patient's wishes, reduces hospitalization at the end of life, results in less intensive treatments at the end of life (according to patients' wishes) and increases use of hospice services. Trials have not been done in primary care. In this project, we aim to determine the efficacy of a care pathway designed to increase the quality and quantity of ACP in patients and their substitute decision-makers in primary care. The study is a multi-site, patient-based, unblinded, randomized trial conducted in family practices in Canada. Participants will be patients who are determined by their physician to be able to benefit from ACP, and the patient's substitute decision-maker. Participant pairs will be randomized to immediate intervention (care pathway) or delayed (8-12 weeks). The intervention is guided use of tools and decision aids to clarify values and preferences for treatments in the event of serious illness or near end of life. The outcomes will be substitute decision-maker engagement in ACP (including self-efficacy for enacting the role), patient engagement in ACP, and decisional conflict.

Eligibility criteria: Inclusion Criteria:

* Patients being treated for serious illness in outpatient settings or;
* Patients who could benefit from advance care planning self-assessed or assessed by their physician
* Patient able and willing to identify a substitute decision-maker who will participate in the study
* Patient cognitively able to participate

Exclusion Criteria:

* Patient or their substitute decision-maker does not speak English
* Patient unable to identify a substitute decision-maker who will consent to participation
* Patient does not consent to participation

Primary outcomes:
measure: Advance care planning engagement of substitute decision-maker
timeFrame: 8 to 12 weeks (6 weeks for patients from cancer centre)
Secondary outcomes:
measure: Advance care planning engagement of patient
timeFrame: 8 to 12 weeks (6 weeks for patients from cancer centre)
measure: Substitute decision-maker self-efficacy survey
timeFrame: 8 to 12 weeks (6 weeks for patients from cancer centre)
measure: Decisional conflict
timeFrame: immediately after intervention
measure: Satisfaction with intervention
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Dundas
country: Canada
facility: Dundas Family Health Team
state: Ontario
city: Dundas
country: Canada
facility: Michael West Doctor Office
state: Ontario
city: Hamilton
country: Canada
facility: Burlington Family Health Team
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Family Health Team
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre Pain and Symptom Management Team
state: Ontario
Study officials:
affiliation: McMaster University
name: Michelle Howard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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