NCT04931797

Brief Summary

A randomized controlled trial of a video decision aid in the Emergency Department Setting to improve advance care planning documentation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

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 Progress99%
Apr 2022May 2026

First Submitted

Initial submission to the registry

June 1, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

June 1, 2021

Last Update Submit

November 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • EHR documentation of advance care planning

    EHR documentation of advance care planning

    3 months

Secondary Outcomes (17)

  • patient reported conversations with health care providers and family

    at 3 and 6 months

  • concordance between stated and documented preferences

    at 3 and 6 months

  • ACP documentation in the EHR

    at 6 months

  • hospitalization

    at 3 and 6 months

  • differential intervention effects of the ACP video intervention on patient ACP documentation based on race and ethnicity

    at baseline, 3 and 6 months

  • +12 more secondary outcomes

Study Arms (2)

Video

EXPERIMENTAL

Video decision aid and advance care planning discussion

Behavioral: video decision aid

Control arm

ACTIVE COMPARATOR

Usual advance care planning services provided at the study site.

Behavioral: control arm ACP information sheet

Interventions

advance care planning video decision aid

Video

control arm ACP information sheet

Control arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anyone aged 65 and over or anyone aged over 50-64 with an indicator of serious illness

You may not qualify if:

  • non english or spanish speakers those with a POLST legally blind medically non stable requiring ICU level care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UC Davis

Davis, California, 95616, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02468, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Primary outcome will be obtained through natural language processing (NLP) from the EHR, in which the RA conducting the NLP will not know which arm of the study the patient was in.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 18, 2021

Study Start

April 25, 2022

Primary Completion

June 10, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Time Frame
1 year after all primary and secondary publications published.

Locations