Effect of an Advance Care Planning Intervention

Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers

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

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Advance Care Planning Video

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 Type: Interventional
• Enrollment (Actual): 2611
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Stillwater, Minnesota, United States, 55082-6788
      • Bluestone Physician Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months
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	4 months
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	4 months

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Vincent Mor, PhD, Brown University, School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: dementia; advance care planning; assisted living facilities
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 2008002779; 3U54AG063546-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No