Effect of an Advance Care Planning Intervention

NCT ID: NCT04852055

Last Updated: 2025-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2022-03-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Advance Care Planning Video

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Vincent Mor

Florence Pirce Grant University Professor, Professor of Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Mor, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University, School of Public Health

Locations

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Bluestone Physician Services

Stillwater, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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3U54AG063546-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008002779

Identifier Type: -

Identifier Source: org_study_id

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