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Randomized Control Trial of Advance Care Planning in Primary Care

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ClinicalTrials.gov Identifier: NCT03239639
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Queen's University
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 4, 2017
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
SDM-ACP Engagement Survey [ Time Frame: 8 to 12 weeks ]
A survey of the substitute decision-maker's engagement in advance care planning
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • 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
  • 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
  • Decisional conflict [ Time Frame: immediately after intervention ]
    A modified short decisional conflict survey
  • Satisfaction with intervention [ Time Frame: immediately after intervention ]
    A satisfaction and endorsement survey on the process of the educational intervention
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
  • ACP engagement survey [ Time Frame: 8 to 12 weeks ]
    A survey of the patient's engagement in advance care planning
  • SDM self-efficacy survey [ Time Frame: 8 to 12 weeks ]
    A survey of the substitute decision-maker's confidence to make future decisions
  • Decisional conflict [ Time Frame: immediately after intervention ]
    A modified short decisional conflict survey
  • Satisfaction with intervention [ Time Frame: immediately after intervention ]
    A satisfaction and endorsement survey on the process of the educational intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Control Trial of Advance Care Planning in Primary Care
Official Title  ICMJE A Randomized Control Trial of an Advance Care Planning Intervention to Engaged Substitute Decision-makers in Primary Care
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are assigned in 1:1 ratio to intervention or wait list control group
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Illness
Intervention  ICMJE
  • Behavioral: 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
  • Other: Wait list control
    No intervention
Study Arms  ICMJE
  • Experimental: Advance care planning education session
    Delivery of an advance care planning education session at the family doctor's office
    Intervention: Behavioral: Advance care planning education session
  • Sham Comparator: Wait list control
    The intervention is not provided.
    Intervention: Other: Wait list control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2020)
61
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2017)
128
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03239639
Other Study ID Numbers  ICMJE 3714
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Queen's University
Investigators  ICMJE
Principal Investigator: Michelle Howard, PhD McMaster University
PRS Account McMaster University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP