Randomized Control Trial of Advance Care Planning in Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Control Trial of an Advance Care Planning Intervention to Engaged Substitute Decision-makers in Primary Care

Conditions
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Chronic Illness

Intervention / Treatment
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* Behavioral: Advance care planning education session
* Other: Wait list control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned in 1:1 ratio to intervention or wait list control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advance care planning education session<br>Delivery of an advance care planning education session at the family doctor's office | Behavioral: Advance care planning education session<br>* Administration of values clarification tool, elicitation of preference for treatment options, if preference for resuscitation, shown an educational video about cardiopulmonary resuscitation, summary document of values and preferences created by a facilitator to share with doctor<br>|
| Sham Comparator: Wait list control<br>The intervention is not provided. | Other: Wait list control<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance care planning engagement of substitute decision-maker | A survey of the substitute decision-maker's engagement in advance care planning | 8 to 12 weeks (6 weeks for patients from cancer centre) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance care planning engagement of patient | A survey of the patient's engagement in advance care planning | 8 to 12 weeks (6 weeks for patients from cancer centre) | 
| Substitute decision-maker self-efficacy survey | A survey of the substitute decision-maker's confidence to make future decisions | 8 to 12 weeks (6 weeks for patients from cancer centre) | 
| Decisional conflict | A modified short decisional conflict survey | immediately after intervention | 
| Satisfaction with intervention | A satisfaction and endorsement survey on the process of the educational intervention | immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substitute decision makers of patient