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Completed

NCT Number: NCT03239639

Randomized Control Trial of Advance Care Planning in Primary Care

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dundas Family Health Team, Dundas, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advance care planning education session

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

Other

No intervention

Primary outcomes

  1. Advance care planning engagement of substitute decision-maker

    Time frame: 8 to 12 weeks (6 weeks for patients from cancer centre)

    A survey of the substitute decision-maker's engagement in advance care planning

Secondary outcomes

  1. Advance care planning engagement of patient

    Time frame: 8 to 12 weeks (6 weeks for patients from cancer centre)

    A survey of the patient's engagement in advance care planning

  2. Substitute decision-maker self-efficacy survey

    Time frame: 8 to 12 weeks (6 weeks for patients from cancer centre)

    A survey of the substitute decision-maker's confidence to make future decisions

  3. Decisional conflict

    Time frame: immediately after intervention

    A modified short decisional conflict survey

  4. Satisfaction with intervention

    Time frame: immediately after intervention

    A satisfaction and endorsement survey on the process of the educational intervention

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Queen's University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 4, 2017
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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