Randomized Control Trial of Advance Care Planning in Primary Care

NCT ID: NCT03239639

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-12-31

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.

Conditions

Chronic Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Advance care planning education session

Delivery of an advance care planning education session at the family doctor's office

Group Type: EXPERIMENTAL

Advance care planning education session

Intervention Type: BEHAVIORAL

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

Wait list control

The intervention is not provided.

Group Type: SHAM_COMPARATOR

Wait list control

Intervention Type: OTHER

No intervention

Interventions

Advance care planning education session

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

Intervention Type: BEHAVIORAL

Wait list control

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Howard, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Dundas Family Health Team

Dundas, Ontario, Canada

Michael West Doctor Office

Dundas, Ontario, Canada

Burlington Family Health Team

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

McMaster Family Health Team

Hamilton, Ontario, Canada

McMaster University Medical Centre

Hamilton, Ontario, Canada

Juravinski Cancer Centre Pain and Symptom Management Team

Hamilton, Ontario, Canada

Countries

Canada

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Related Links

http://www.ncbi.nlm.nih.gov/pubmed/26948697

Metzger M, Song M-K, Ward S, Chang PP-Y, Hanson LC, Lin F-C. A randomized controlled pilot trial to improve advance care planning for LVAD patients and their surrogates. Hear Lung J Acute Crit Care. 2016 May;45(3):186-92

http://www.ncbi.nlm.nih.gov/pubmed/7748044

Johnston SC, Pfeifer MP, McNutt R. The discussion about advance directives. Patient and physician opinions regarding when and how it should be conducted. End of Life Study Group. Arch Intern Med. 1995 May 22;155(10):1025-30

http://www.ncbi.nlm.nih.gov/pubmed/23028000

Rhee JJ, Zwar NA, Kemp LA. Advance care planning and interpersonal relationships: a two-way street. Fam Pract. 2013 Apr 1;30(2):219-26

Other Identifiers

3714

Identifier Type: -

Identifier Source: org_study_id