NCT03402763

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 10, 2018

Last Update Submit

January 10, 2018

Conditions

Keywords

Advance care planningOlder adultsEmergency department

Outcome Measures

Primary Outcomes (1)

  • 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?

    3 months

Secondary Outcomes (2)

  • Conversation with Regular Provider

    3 months

  • Conversation with Loved One

    3 months

Other Outcomes (2)

  • CPR and Intubation Preferences

    3 months

  • CPR Knowledge

    3 months

Study Arms (2)

Control Arm

NO INTERVENTION

Participants receive a short informational handout on the process and choices involved in advance care planning.

Intervention

EXPERIMENTAL

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.

Behavioral: Educational VideoBehavioral: Primary Care Provider Email

Interventions

The intervention is an educational video presented to patients in the ED with the intent to promote ACP among older adults.

Intervention

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Timothy F Platts-Mills, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
All patients and researchers are aware if the patient receives a handout or watches the ACP video.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 18, 2018

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

We plan to upload the data from the study on Open Science Framework.

Time Frame
Data will be uploaded within 1 year of study completion.