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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04931797
Collaborator
University of California, Davis (Other), National Institute on Aging (NIA) (NIH)
900
1
2
48
18.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: video decision aid
  • Behavioral: control arm ACP information sheet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCTRCT
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Health Services Research
Official Title:
Using the Emergency Department Visit to Promote Advance Care Planning
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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

A standardized written form that details advance care planning options.

Behavioral: control arm ACP information sheet
control arm ACP information sheet

Outcome Measures

Primary Outcome Measures

  1. EHR documentation of advance care planning [3 months]

    EHR documentation of advance care planning

Secondary Outcome Measures

  1. patient reported conversations with health care providers and family [at 3 and 6 months]

    patient reported conversations with health care providers and family

  2. concordance between stated and documented preferences [at 3 and 6 months]

    concordance between stated and documented preferences

  3. ACP documentation in the EHR [at 6 months]

    ACP documentation in the EHR

  4. hospitalization [at 3 and 6 months]

    hospitalization

  5. differential intervention effects of the ACP video intervention on patient ACP documentation based on race and ethnicity [at baseline, 3 and 6 months]

    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.

  6. quality of clinician 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]

    quality of ACP communication using an ACP quality communication survey

  7. place of death [at 3 and 6 months]

    place of death

  8. enrollment in hospice [at 3 and 6 months]

    enrollment in hospice

  9. ED visits [at 3 and 6 months]

    ED visits

  10. mortality [at 3 and 6 months]

    mortality

  11. ICU days [at 3 and 6 months]

    ICU days

  12. patient CPR and breathing machine preferences [at time of survey (baseline) and then after 3 and 6 months]

    we will ask the patient whether or not they want CPR attempted and whether they would wish to be placed on a breathing machine

  13. patient preferences for goals of care [at time of survey (baseline) and then after 3 and 6 months]

    We will ask patient if they wish to receive life prolonging care, limited care or comfort care.

  14. decisional certainty regarding decision making for ACP preferences [at baseline survey interview]

    we will ask patients how certain they are about their decisions for the goals of care

  15. patient knowledge of ACP [at baseline survey interview]

    We will ask patients knowledge questions about their understanding of advance care planning

  16. patient confidence in health care delivery that is aligned with patient preferences [at time of survey (baseline) and then after 3 and 6 months]

    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

  17. patient ACP engagement with ACP topics [at baseline survey interview]

    We will ask patients how ready and engaged they are with the topic of advance care planning

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • anyone aged over 79 or anyone aged over 49 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angelo E. Volandes, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04931797
Other Study ID Numbers:
  • 2021p001552
  • R01AG065254
First Posted:
Jun 18, 2021
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2021