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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04931797
Other study ID # 2021p001552
Secondary ID R01AG065254
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2022
Est. completion date June 30, 2025

Study information

Verified date March 2024
Source Massachusetts General Hospital
Contact Angelo Volandes
Phone 6177262000
Email avolandes@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

A randomized controlled trial of a video decision aid in the Emergency Department setting shown to patients followed by a brief advance care planning discussion and then relay that discussion to the patient's primary care provider and/or admitting clinical team and look at rates of advance care planning documentation in the electronic health record over time. Primary outcome is advance care planning documentation in the EHR at 3 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - anyone aged 65 and over or anyone aged over 50-64 with an indicator of serious illness Exclusion Criteria: - non english or spanish speakers those with a POLST legally blind medically non stable requiring ICU level care

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
video decision aid
advance care planning video decision aid
control arm ACP information sheet
control arm ACP information sheet

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States UC Davis Davis California
United States Newton Wellesley Hospital Newton Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital National Institute on Aging (NIA), University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary EHR documentation of advance care planning EHR documentation of advance care planning 3 months
Secondary patient reported conversations with health care providers and family patient reported conversations with health care providers and family at 3 and 6 months
Secondary concordance between stated and documented preferences concordance between stated and documented preferences at 3 and 6 months
Secondary ACP documentation in the EHR ACP documentation in the EHR at 6 months
Secondary hospitalization hospitalization at 3 and 6 months
Secondary differential intervention effects of the ACP video intervention on patient ACP documentation based on race and ethnicity We will look at ACP documentation in the intervention and control arms to see if there are differential intervention effects based on race and ethnicity. We will look at the ACP documentation rate in Whites in both arms, and compare them to African Americans and Latinx populations. We will be able to see if the intervention had a greater or lesser effect on ACP rates in sub groups of our population by race and ethnicity. at baseline, 3 and 6 months
Secondary quality of clinician ACP communication using an ACP quality communication survey quality of ACP communication using an ACP quality communication survey quality of communication at the time of the survey interview (baseline), and then at 3 and 6 months
Secondary place of death place of death at 3 and 6 months
Secondary enrollment in hospice enrollment in hospice at 3 and 6 months
Secondary ED visits ED visits at 3 and 6 months
Secondary mortality mortality at 3 and 6 months
Secondary ICU days ICU days at 3 and 6 months
Secondary patient CPR and breathing machine preferences we will ask the patient whether or not they want CPR attempted and whether they would wish to be placed on a breathing machine at time of survey (baseline) and then after 3 and 6 months
Secondary patient preferences for goals of care We will ask patient if they wish to receive life prolonging care, limited care or comfort care. at time of survey (baseline) and then after 3 and 6 months
Secondary decisional certainty regarding decision making for ACP preferences we will ask patients how certain they are about their decisions for the goals of care at baseline survey interview
Secondary patient knowledge of ACP We will ask patients knowledge questions about their understanding of advance care planning at baseline survey interview
Secondary patient confidence in health care delivery that is aligned with patient preferences We will ask patients how confident they are in that they will receive the type of medical care they wish in their health care system at time of survey (baseline) and then after 3 and 6 months
Secondary patient ACP engagement with ACP topics We will ask patients how ready and engaged they are with the topic of advance care planning at baseline survey interview
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