Video Images About Decisions for Ethical Outcomes in the Emergency Department (VIDEO-ED) (VIDEO-ED)

Using the Emergency Department Visit to Promote Advance Care Planning

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

Study Overview

• Status: Recruiting
• Conditions: Emergencies
• Intervention / Treatment: Behavioral: video decision aid; Behavioral: control arm ACP information sheet

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angelo Volandes; Phone Number: 6177262000; Email: avolandes@partners.org

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • UC Davis
      • Contact: Angelo Volandes; Email: avolandes@partners.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Angelo Volandes, MD; Email: avolandes@partners.org
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Angelo Volandes, MD; Phone Number: 617-643-4266; Email: avolandes@partners.org
      • Principal Investigator: Angelo Volandes, MS
    • Newton, Massachusetts, United States, 02468
      • Recruiting
      • Newton Wellesley Hospital
      • Contact: Angelo Volandes; Email: avolandes@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video; Video decision aid and advance care planning discussion	Behavioral: video decision aid; advance care planning video decision aid
Active Comparator: Control arm; Usual advance care planning services provided at the study site.	Behavioral: control arm ACP information sheet; control arm ACP information sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EHR documentation of advance care planning	EHR documentation of advance care planning	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient reported conversations with health care providers and family	patient reported conversations with health care providers and family	at 3 and 6 months
concordance between stated and documented preferences	concordance between stated and documented preferences	at 3 and 6 months
ACP documentation in the EHR	ACP documentation in the EHR	at 6 months
hospitalization	hospitalization	at 3 and 6 months
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
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
place of death	place of death	at 3 and 6 months
enrollment in hospice	enrollment in hospice	at 3 and 6 months
ED visits	ED visits	at 3 and 6 months
mortality	mortality	at 3 and 6 months
ICU days	ICU days	at 3 and 6 months
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
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
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
patient knowledge of ACP	We will ask patients knowledge questions about their understanding of advance care planning	at baseline survey interview
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Aging (NIA); University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2021p001552; R01AG065254 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 year after all primary and secondary publications published.

Drug and device information, study documents

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