Video Images About Decisions for Ethical Outcomes in the Emergency Department (VIDEO-ED) (VIDEO-ED)
Primary Purpose
Emergencies
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
video decision aid
control arm ACP information sheet
Sponsored by
About this trial
This is an interventional health services research trial for Emergencies
Eligibility Criteria
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
Sites / Locations
- UC DavisRecruiting
- Massachusetts General HospitalRecruiting
- Brigham and Women's HospitalRecruiting
- Newton Wellesley HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video
Control arm
Arm Description
Video decision aid and advance care planning discussion
Usual advance care planning services provided at the study site.
Outcomes
Primary Outcome Measures
EHR documentation of advance care planning
EHR documentation of advance care planning
Secondary Outcome Measures
patient reported conversations with health care providers and family
patient reported conversations with health care providers and family
concordance between stated and documented preferences
concordance between stated and documented preferences
ACP documentation in the EHR
ACP documentation in the EHR
hospitalization
hospitalization
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.
quality of clinician ACP communication using an ACP quality communication survey
quality of ACP communication using an ACP quality communication survey
place of death
place of death
enrollment in hospice
enrollment in hospice
ED visits
ED visits
mortality
mortality
ICU days
ICU days
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
patient preferences for goals of care
We will ask patient if they wish to receive life prolonging care, limited care or comfort care.
decisional certainty regarding decision making for ACP preferences
we will ask patients how certain they are about their decisions for the goals of care
patient knowledge of ACP
We will ask patients knowledge questions about their understanding of advance care planning
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
patient ACP engagement with ACP topics
We will ask patients how ready and engaged they are with the topic of advance care planning
Full Information
NCT ID
NCT04931797
First Posted
June 1, 2021
Last Updated
April 7, 2023
Sponsor
Massachusetts General Hospital
Collaborators
University of California, Davis, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04931797
Brief Title
Video Images About Decisions for Ethical Outcomes in the Emergency Department (VIDEO-ED)
Acronym
VIDEO-ED
Official Title
Using the Emergency Department Visit to Promote Advance Care Planning
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
University of California, Davis, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized controlled trial of a video decision aid in the Emergency Department Setting to improve advance care planning documentation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
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.
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video
Arm Type
Experimental
Arm Description
Video decision aid and advance care planning discussion
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Usual advance care planning services provided at the study site.
Intervention Type
Behavioral
Intervention Name(s)
video decision aid
Intervention Description
advance care planning video decision aid
Intervention Type
Behavioral
Intervention Name(s)
control arm ACP information sheet
Intervention Description
control arm ACP information sheet
Primary Outcome Measure Information:
Title
EHR documentation of advance care planning
Description
EHR documentation of advance care planning
Time Frame
3 months
Secondary Outcome Measure Information:
Title
patient reported conversations with health care providers and family
Description
patient reported conversations with health care providers and family
Time Frame
at 3 and 6 months
Title
concordance between stated and documented preferences
Description
concordance between stated and documented preferences
Time Frame
at 3 and 6 months
Title
ACP documentation in the EHR
Description
ACP documentation in the EHR
Time Frame
at 6 months
Title
hospitalization
Description
hospitalization
Time Frame
at 3 and 6 months
Title
differential intervention effects of the ACP video intervention on patient ACP documentation based on race and ethnicity
Description
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.
Time Frame
at baseline, 3 and 6 months
Title
quality of clinician ACP communication using an ACP quality communication survey
Description
quality of ACP communication using an ACP quality communication survey
Time Frame
quality of communication at the time of the survey interview (baseline), and then at 3 and 6 months
Title
place of death
Description
place of death
Time Frame
at 3 and 6 months
Title
enrollment in hospice
Description
enrollment in hospice
Time Frame
at 3 and 6 months
Title
ED visits
Description
ED visits
Time Frame
at 3 and 6 months
Title
mortality
Description
mortality
Time Frame
at 3 and 6 months
Title
ICU days
Description
ICU days
Time Frame
at 3 and 6 months
Title
patient CPR and breathing machine preferences
Description
we will ask the patient whether or not they want CPR attempted and whether they would wish to be placed on a breathing machine
Time Frame
at time of survey (baseline) and then after 3 and 6 months
Title
patient preferences for goals of care
Description
We will ask patient if they wish to receive life prolonging care, limited care or comfort care.
Time Frame
at time of survey (baseline) and then after 3 and 6 months
Title
decisional certainty regarding decision making for ACP preferences
Description
we will ask patients how certain they are about their decisions for the goals of care
Time Frame
at baseline survey interview
Title
patient knowledge of ACP
Description
We will ask patients knowledge questions about their understanding of advance care planning
Time Frame
at baseline survey interview
Title
patient confidence in health care delivery that is aligned with patient preferences
Description
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
Time Frame
at time of survey (baseline) and then after 3 and 6 months
Title
patient ACP engagement with ACP topics
Description
We will ask patients how ready and engaged they are with the topic of advance care planning
Time Frame
at baseline survey interview
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelo Volandes
Phone
6177262000
Email
avolandes@partners.org
Facility Information:
Facility Name
UC Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes
Email
avolandes@partners.org
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes, MD
Phone
617-643-4266
Email
avolandes@partners.org
First Name & Middle Initial & Last Name & Degree
Angelo Volandes, MS
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes, MD
Email
avolandes@partners.org
Facility Name
Newton Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes
Email
avolandes@partners.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year after all primary and secondary publications published.
Learn more about this trial
Video Images About Decisions for Ethical Outcomes in the Emergency Department (VIDEO-ED)
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