Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care

NCT03434626 | Completed

• 1 other identifier: 06-17
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Illness; Comorbidities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Agreement between patient's self-reported values and preferences for life sustaining treatment, and what is documented in the form in the chart

  8-12 weeks

• Physician rating of decisional conflict

  8-12 weeks

• Patient-reported satisfaction with the intervention

  8-12 weeks

Study Arms (2)

ACP Education

EXPERIMENTAL

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; Other: Usual care

Usual care

ACTIVE COMPARATOR

Patients in the usual care group will complete a Goals of Care Designation form with the family physician.

Other: Usual care

Interventions

ACP Education BEHAVIORAL

Decision aid and Goals of Care Designation form information administered by Navigator

ACP Education

Usual care OTHER

Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician

ACP Education; Usual care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to communicate with an English-speaking research coordinator

Sponsors & Collaborators

• McMaster University: lead
• Queen's University: collaborator

Study Sites (2)

Family Medical Centre

Lethbridge, Alberta, T1K 3M5, Canada

Location

Chinook Primary Care Network

Lethbridge, Alberta, T1K 5M5, Canada

Location

Related Publications (21)

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MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Howard, PHD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Daren K Heyland, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor conducting interviews does not have information on group assignment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: February 15, 2018
• Study Start: October 20, 2017
• Primary Completion: September 26, 2018
• Study Completion: December 31, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)