Advance Care Planning & Goals of Care Randomized Controlled Trial 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 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
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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. 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.

Official Title
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A Randomized Trial of ACP/GCD Care Pathway in Primary Care in Alberta

Conditions
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Chronic Illness, Comorbidities

Intervention / Treatment
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* Behavioral: ACP Education
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACP Education<br>Eligible patients in the experimental group will receive an educational intervention from an advance care planning navigator consisting of a 4-item values tool, a Goals of Care Designation form and, if applicable, watch a cardiopulmonary resuscitation video. | Behavioral: ACP Education<br>* Decision aid and Goals of Care Designation form information administered by Navigator<br>Other: Usual care<br>* Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician<br>|
| Active Comparator: Usual care<br>Patients in the usual care group will complete a Goals of Care Designation form with the family physician. | Other: Usual care<br>* Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a completed goals of care designation form in the patient chart | In Alberta there is a form in the health care system that is used to indicate a person's wishes if they are unable to speak for themselves. The form is called a Goal of Care Designation form and is part of a package called the 'Greensleeve'. Alberta Health Services requires that all patients in primary care and in hospital have a green sleeve and goal of care designation (RMC classification: R=resuscitative; M=medical; C=comfort care). | 8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between patient's self-reported values and preferences for life sustaining treatment, and what is documented in the form in the chart | Dichotomous variable of whether there is concordance between what the patient reports and what is in their chart (difference between groups) | 8-12 weeks | 
| Physician rating of decisional conflict | The decisional conflict scale (DCS) measures personal perceptions of uncertainty in choosing options;modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making. The outcome is the agreement between patient's self-reported preference for life sustaining treatment and decisional conflict using a 5-item decisional conflict scale pre- and post-intervention. Each item is scored 0 to 4 (0=Yes; 1=Probably Yes; 2=Unsure; 3=Probably No; 4=No) | 8-12 weeks | 
| Patient-reported satisfaction with the intervention | Do patients who participate in an ACP educational intervention experience greater satisfaction with decision-making than patients who get usual care? | 8-12 weeks |