Back to resultsEffect of an Advance Care Planning Intervention
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advance Care Planning Video
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring assisted living facilities, dementia, advance care planning
Eligibility Criteria
Inclusion Criteria:
- Partnering assisted living center with at least 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
- Patients not on hospice
- Patients who do not have comfort care or do-not-hospitalize orders at baseline
Exclusion Criteria:
- Partnering assisted living center with less than 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
- Patients on hospice
- Patients with comfort care or do-not-hospitalize orders at baseline
Sites / Locations
- Bluestone Physician Services
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Information
Arm Description
Patients and proxies in assisted living centers randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition. There is no standardized decision- or conversation-support tools used to have these discussions.
Patients and proxies in assisted living centers randomized to the information arm will receive a letter from their clinician with a link to an educational video describing the goals of care and how specific treatment decisions align with these goals. Patients and proxies will also continue to receive usual care advance care planning conversations.
Outcomes
Primary Outcome Measures
Do-Not-Resuscitate
Percentage of residents with do-not-resuscitate orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
Secondary Outcome Measures
Do-Not-Hospitalize
Percentage of residents in each arm with do-not-hospitalize or comfort care orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
Advance Care Planning Billing
Percentage of residents in each arm with current procedural terminology billing code for advance care planning during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Requires access to claims data which delays reporting
Hospitalization
Percentage of residents with any inpatient hospitalization during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Requires access to claims data which delays reporting
Full Information
NCT ID
NCT04852055
First Posted
April 16, 2021
Last Updated
September 5, 2023
Sponsor
Brown University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04852055
Brief Title
Effect of an Advance Care Planning Intervention
Official Title
Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
March 23, 2022 (Actual)
Study Completion Date
March 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.
Detailed Description
Eligible patients whose assisted living centers are randomized to the information arm will receive a letter from their clinician with links to informational video. Eligible patients whose assisted living centers are randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
assisted living facilities, dementia, advance care planning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2611 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients and proxies in assisted living centers randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition. There is no standardized decision- or conversation-support tools used to have these discussions.
Arm Title
Information
Arm Type
Experimental
Arm Description
Patients and proxies in assisted living centers randomized to the information arm will receive a letter from their clinician with a link to an educational video describing the goals of care and how specific treatment decisions align with these goals. Patients and proxies will also continue to receive usual care advance care planning conversations.
Intervention Type
Behavioral
Intervention Name(s)
Advance Care Planning Video
Intervention Description
Clinical assistants determine who is the correct person to receive the informational materials. If the patient is the correct recipient, clinicians will send the informational materials to the patient at the assisted living center. If the proxy is the correct recipient, the clinical assistant will determine whether or not the proxy is using the existing online portal. If the proxy is using the portal, the informational materials will be sent electronically. If the proxy does not access the portal, the informational materials will be sent to their residences.
Primary Outcome Measure Information:
Title
Do-Not-Resuscitate
Description
Percentage of residents with do-not-resuscitate orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Do-Not-Hospitalize
Description
Percentage of residents in each arm with do-not-hospitalize or comfort care orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
Time Frame
4 months
Title
Advance Care Planning Billing
Description
Percentage of residents in each arm with current procedural terminology billing code for advance care planning during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Requires access to claims data which delays reporting
Time Frame
4 months
Title
Hospitalization
Description
Percentage of residents with any inpatient hospitalization during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Requires access to claims data which delays reporting
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Partnering assisted living center with at least 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
Patients not on hospice
Patients who do not have comfort care or do-not-hospitalize orders at baseline
Exclusion Criteria:
Partnering assisted living center with less than 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
Patients on hospice
Patients with comfort care or do-not-hospitalize orders at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Mor, PhD
Organizational Affiliation
Brown University, School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bluestone Physician Services
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082-6788
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of an Advance Care Planning Intervention
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