- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03508557
Implementing Advance Care Planning Conversation Tools in Family Practice
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T1Y 5S3
- Sunridge Family Medicine Teaching Centre
-
-
British Columbia
-
Langley, British Columbia, Canada
- Safa Medical Clinic
-
Vancouver, British Columbia, Canada, V3L 3C2
- New Westminster Family Practice
-
Vancouver, British Columbia, Canada
- Vancouver General Hospital Gordon and Leslie Diamond Health Care Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Advance care planning tools
Advance care planning education and structured conversation using tools
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Advance care planning engagement
Time Frame: 12 weeks
|
Survey measuring domains of engagement in advance care planning
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Advance care planning engagement-substitute decision maker
Time Frame: 12 weeks
|
survey measuring substitute decision maker domains of engagement in advance care planning
|
12 weeks
|
|
Patient experience
Time Frame: 12 weeks
|
survey of patient experience with intervention
|
12 weeks
|
|
Patient perceived impact on health care
Time Frame: 6-9 months
|
qualitative interviews of patients asking perceived impact of intervention on later health care use
|
6-9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician experience of intervention
Time Frame: 6 months
|
survey of clinician experience using conversation tools
|
6 months
|
|
Clinician confidence having advance care planning conversations
Time Frame: 6 months
|
survey of clinician confidence, satisfaction
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Howard, PhD, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TG2015-03D
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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