Intervention to Promote Advance Care Planning for Older Adults in the Emergency Department
Primary Purpose
Emergency Medicine, Advance Care Planning
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational Video
Primary Care Provider Email
Sponsored by

About this trial
This is an interventional health services research trial for Emergency Medicine focused on measuring Advance care planning, Older adults, Emergency department
Eligibility Criteria
Inclusion Criteria:
- Ability to provide informed consent
- Ability to communicate in English
- Age 65-79 years with a serious medical illness: (1) Established diagnosis of metastatic cancer, advanced heart failure, chronic obstructive lung disease, end stage liver disease, end stage renal disease, (2) Unable to walk or requires human assistance with walking, (3) Two hospitalizations within the last 6 months
- Age 80 years or older
Exclusion Criteria:
- Critically ill (emergency severity index = 1)
- Cognitively impaired based on Six Item Screener < 4 or lack the capacity to consent
- Currently enrolled in hospice or comfort care program
- No working phone number
- Non English speaker
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Arm
Intervention
Arm Description
Participants receive a short informational handout on the process and choices involved in advance care planning.
Participants are shown a 6-minute video that describe CPR, breathing tube placement, and mechanical breathing support in addition to the general process of advance care planning.
Outcomes
Primary Outcome Measures
Documentation of end-of-life preferences in the electronic health record
Since the ED visit, does the patient have any new preferences about CPR, intubation, or palliative care documented in their electronic health record?
Secondary Outcome Measures
Conversation with Regular Provider
Patient-reported conversation with their regular provider (primary care physician, admitting physician, other outpatient provider) about what they would want done if they became very sick, had serious breathing trouble, heart stopped, or they could not make medical decisions from him or herself.
Conversation with Loved One
Patient-reported conversation with a trusted loved one (spouse, children, or sibling) about what they would want done if they became very sick, had serious breathing trouble, heart stopped, or they could not make medical decisions from him or herself.
Full Information
NCT ID
NCT03402763
First Posted
January 10, 2018
Last Updated
January 10, 2018
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT03402763
Brief Title
Intervention to Promote Advance Care Planning for Older Adults in the Emergency Department
Official Title
Intervention to Promote Advance Care Planning for Older Adults in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is an urgent need to increase advance care planning among older adults in order to ensure that patients receive care of the end of life that is consistent with their values and preferences. Emergency departments (EDs) provide an opportunity to reach a large proportion of older adults who have not yet completed advance care planning at a time when they are likely to recognize the need for such planning. The purpose of this pilot is to examine the potential of a video-supported intervention initiated during the emergency department visit to promote advance care planning.
Detailed Description
The overarching goal of this project is to understand the impact of an ED-initiated intervention on the promotion of advance care planning (ACP) among older adults. Participants are given either a short informational handout on the process and choices involved in ACP or watch a 6-minute video about ACP. The video describes cardiopulmonary resuscitation (CPR), breathing tube placement, and mechanical breathing support in addition to the general process of ACP. Following the video, patients in the intervention will also have an email sent to their primary care provider. The email will inform the primary care provider that the patient has watched a video about ACP, include a brief synopsis of the video, and provide instructions as to how to document the patient's preferences in the hospital's electronic health record in a way that will be accessible to other providers. Outcomes will include documentation of end-of-life care preferences in the electronic health records and patient-reported conversation with their provider as well as conversations with loved ones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Medicine, Advance Care Planning
Keywords
Advance care planning, Older adults, Emergency department
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will (1) be given either a short informational handout on the process and choices involved in advanced care planning or (2) be shown a less 6 minute video describing CPR, breathing tube placement and mechanical breathing support in addition to the general process of advanced care planning.
Masking
None (Open Label)
Masking Description
All patients and researchers are aware if the patient receives a handout or watches the ACP video.
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants receive a short informational handout on the process and choices involved in advance care planning.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants are shown a 6-minute video that describe CPR, breathing tube placement, and mechanical breathing support in addition to the general process of advance care planning.
Intervention Type
Behavioral
Intervention Name(s)
Educational Video
Intervention Description
The intervention is an educational video presented to patients in the ED with the intent to promote ACP among older adults.
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Provider Email
Intervention Description
For intervention patients, an email will be sent to primary care providers explaining that the patient has seen a video about advance care planning, providing a synopsis of the video, and giving instructions about how to document end-of-life care preferences in the electronic health record.
Primary Outcome Measure Information:
Title
Documentation of end-of-life preferences in the electronic health record
Description
Since the ED visit, does the patient have any new preferences about CPR, intubation, or palliative care documented in their electronic health record?
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Conversation with Regular Provider
Description
Patient-reported conversation with their regular provider (primary care physician, admitting physician, other outpatient provider) about what they would want done if they became very sick, had serious breathing trouble, heart stopped, or they could not make medical decisions from him or herself.
Time Frame
3 months
Title
Conversation with Loved One
Description
Patient-reported conversation with a trusted loved one (spouse, children, or sibling) about what they would want done if they became very sick, had serious breathing trouble, heart stopped, or they could not make medical decisions from him or herself.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
CPR and Intubation Preferences
Description
Patient-reported preferences about if they would want CPR if heart stopped or intubation if patient could not breathe.
Time Frame
3 months
Title
CPR Knowledge
Description
True and false questions assessing patient knowledge about CPR.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ability to provide informed consent
Ability to communicate in English
Age 65-79 years with a serious medical illness: (1) Established diagnosis of metastatic cancer, advanced heart failure, chronic obstructive lung disease, end stage liver disease, end stage renal disease, (2) Unable to walk or requires human assistance with walking, (3) Two hospitalizations within the last 6 months
Age 80 years or older
Exclusion Criteria:
Critically ill (emergency severity index = 1)
Cognitively impaired based on Six Item Screener < 4 or lack the capacity to consent
Currently enrolled in hospice or comfort care program
No working phone number
Non English speaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy F Platts-Mills, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to upload the data from the study on Open Science Framework.
IPD Sharing Time Frame
Data will be uploaded within 1 year of study completion.
Learn more about this trial
Intervention to Promote Advance Care Planning for Older Adults in the Emergency Department
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