Implementing Advance Care Planning Conversation Tools in Family Practice
Primary Purpose
Frail Elderly Syndrome, Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Advance care planning tools
Sponsored by
About this trial
This is an interventional other trial for Frail Elderly Syndrome
Eligibility Criteria
Inclusion Criteria:
- age 60 or older
- chronic condition that may reduce life expectancy as per physician's clinical judgement
- able to communicate verbally in English and read English
Exclusion Criteria:
- unable to communicate verbally in English
- unable to read English
- cognitively unable to give informed consent (e.g. memory problems) as judged by referring physician or research assistant
Sites / Locations
- Sunridge Family Medicine Teaching Centre
- Safa Medical Clinic
- New Westminster Family Practice
- Vancouver General Hospital Gordon and Leslie Diamond Health Care Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Advance care planning tools
Arm Description
Advance care planning education and structured conversation using tools
Outcomes
Primary Outcome Measures
Advance care planning engagement
Survey measuring domains of engagement in advance care planning
Secondary Outcome Measures
Advance care planning engagement-substitute decision maker
survey measuring substitute decision maker domains of engagement in advance care planning
Patient experience
survey of patient experience with intervention
Patient perceived impact on health care
qualitative interviews of patients asking perceived impact of intervention on later health care use
Full Information
NCT ID
NCT03508557
First Posted
April 16, 2018
Last Updated
January 17, 2022
Sponsor
McMaster University
Collaborators
Canadian Frailty Network
1. Study Identification
Unique Protocol Identification Number
NCT03508557
Brief Title
Implementing Advance Care Planning Conversation Tools in Family Practice
Official Title
Implementing Advance Care Planning Conversation Tools in Family Practice
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Canadian Frailty Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the use of advance care planning conversation tools with patients attending their family doctor's office. Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.
Detailed Description
Structured tools are helpful for advance care planning. Tools have been developed to help with advance care planning because it is a process which has multiple steps and people involved. This study will help health care teams in primary care learn to use the tools with frail or older seriously ill patients and will evaluate the perceptions of patients, family members and health care providers, as well as the impact of having the discussions on subsequent health care interactions the patient has.
Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Chronic Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group before-after
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advance care planning tools
Arm Type
Experimental
Arm Description
Advance care planning education and structured conversation using tools
Intervention Type
Behavioral
Intervention Name(s)
Advance care planning tools
Intervention Description
Structured conversations between patients/substitute decision-maker and clinician based on education about advance care planning using locally relevant booklet/website, values clarification tool for patient engagement, clinician use of the Serious Illness Conversation Guide
Primary Outcome Measure Information:
Title
Advance care planning engagement
Description
Survey measuring domains of engagement in advance care planning
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Advance care planning engagement-substitute decision maker
Description
survey measuring substitute decision maker domains of engagement in advance care planning
Time Frame
12 weeks
Title
Patient experience
Description
survey of patient experience with intervention
Time Frame
12 weeks
Title
Patient perceived impact on health care
Description
qualitative interviews of patients asking perceived impact of intervention on later health care use
Time Frame
6-9 months
Other Pre-specified Outcome Measures:
Title
Clinician experience of intervention
Description
survey of clinician experience using conversation tools
Time Frame
6 months
Title
Clinician confidence having advance care planning conversations
Description
survey of clinician confidence, satisfaction
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 60 or older
chronic condition that may reduce life expectancy as per physician's clinical judgement
able to communicate verbally in English and read English
Exclusion Criteria:
unable to communicate verbally in English
unable to read English
cognitively unable to give informed consent (e.g. memory problems) as judged by referring physician or research assistant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Howard, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunridge Family Medicine Teaching Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 5S3
Country
Canada
Facility Name
Safa Medical Clinic
City
Langley
State/Province
British Columbia
Country
Canada
Facility Name
New Westminster Family Practice
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V3L 3C2
Country
Canada
Facility Name
Vancouver General Hospital Gordon and Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Implementing Advance Care Planning Conversation Tools in Family Practice
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