Effect of an Advance Care Planning Intervention

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04852055
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 2,427
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.8
• Patients Per Site Per Month: 206.3

Study Details

Study Description

Brief Summary

The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: Advance Care Planning Video	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2427 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers
• Actual Study Start Date: Mar 30, 2021
• Actual Primary Completion Date: Mar 23, 2022
• Actual Study Completion Date: Mar 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care 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.
Experimental: Information 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.	Behavioral: Advance Care Planning Video; 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.

Outcome Measures

Primary Outcome Measures

1. Do-Not-Resuscitate [4 months]

   Proportion 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

1. Do-Not-Hospitalize [4 months]

   Proportion 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

2. Advance Care Planning Billing [4 months]

   Proportion 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

3. Hospitalization [4 months]

   Proportion of residents with any inpatient hospitalization during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Outcome only available for a subset of residents enrolled in Bluestone's Accountable Care Organization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bluestone Physician Services	Stillwater	Minnesota	United States	55082-6788

Sponsors and Collaborators

• Brown University
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Vincent Mor, PhD, Brown University, School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vincent Mor, Florence Pirce Grant University Professor, Professor of Health, Brown University
• ClinicalTrials.gov Identifier: NCT04852055
• Other Study ID Numbers: 2008002779; 3U54AG063546-02S1
• First Posted: Apr 21, 2021
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vincent Mor, Florence Pirce Grant University Professor, Professor of Health, Brown University: assisted living facilities; dementia; advance care planning
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Jul 27, 2022