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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
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

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

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 10, 2018
    Last Updated
    January 10, 2018
    Sponsor
    University of North Carolina, Chapel Hill
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    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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