NCT04852055

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 11, 2023

Completed
Last Updated

November 4, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

April 16, 2021

Results QC Date

April 21, 2023

Last Update Submit

October 13, 2025

Conditions

Dementia

Keywords

assisted living facilitiesdementiaadvance care planning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Do-Not-Hospitalize

    4 months

  • Advance Care Planning Billing

    4 months

  • Hospitalization

    4 months

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Information

EXPERIMENTAL

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

Interventions

Advance Care Planning VideoBEHAVIORAL

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.

Information

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bluestone Physician Services

Stillwater, Minnesota, 55082-6788, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Project Director
Organization
Brown University
ellen_mccreedy@brown.edu
(401) 863-7345

Study Officials

  • Vincent Mor, PhD

    Brown University, School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Florence Pirce Grant University Professor, Professor of Health

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

March 30, 2021

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

November 4, 2025

Results First Posted

September 11, 2023

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)