Clinical trial NCT03434626: Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care
Official title: A Randomized Trial of ACP/GCD Care Pathway in Primary Care in Alberta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Comorbidities
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2018-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 for people to think about their 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. In Alberta, there is a form in the health care system that is used to indicate a person's wishes if participants are unable to speak for themselves. There are tools such as brochures, questionnaires, and videos that can help participants learn about advance care planning and serious illness conversations. This research is being done to study whether using tools for advance care planning will help improve goals of care designation completion rates in such a way that they better reflect patient values. In this project, we aim to determine the efficacy of tools to increase the quality and quantity of advance care planning (ACP) and Goals of Care Determinations (GCD) in primary care settings in Alberta.

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. The aim of this study is 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 presence of a goals of care form in the chart, substitute decision-maker engagement in ACP (including self-efficacy for enacting the role), patient engagement in ACP, and decisional conflict.

Eligibility criteria: Inclusion Criteria:

* age 65 years or older
* have at least one chronic condition that may be life-limiting

Exclusion Criteria:

* Unable to communicate with an English-speaking research coordinator

Primary outcomes:
measure: Presence of a completed goals of care designation form in the patient chart
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Agreement between patient's self-reported values and preferences for life sustaining treatment, and what is documented in the form in the chart
timeFrame: 8-12 weeks
measure: Physician rating of decisional conflict
timeFrame: 8-12 weeks
measure: Patient-reported satisfaction with the intervention
timeFrame: 8-12 weeks
Other outcomes:
Locations:
city: Lethbridge
country: Canada
facility: Family Medical Centre
state: Alberta
city: Lethbridge
country: Canada
facility: Chinook Primary Care Network
state: Alberta
Study officials:
affiliation: McMaster University
name: Michelle Howard, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University
name: Daren K Heyland, MD
role: PRINCIPAL_INVESTIGATOR
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