search
Back to results

A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest

Primary Purpose

Cardiac Arrest With Successful Resuscitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest With Successful Resuscitation focused on measuring Neurologic Prognosis, Guideline Concordance, Surrogate Decision Makers

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult 18 years of age and older
  • Identified as a surrogate decision maker for patient who is a comatose survivor of out of hospital cardiac arrest

Exclusion Criteria:

  • Illiterate or poor proficiency (unable to read decision aid)
  • Non-english speaking

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Decision Aid for Surrogate Decision Makers

Arm Description

In this pilot trial all participants will be presented with the decision aid and queried as to the feasibility, acceptability and knowledge translation that is gained by exposure to the decision aid

Outcomes

Primary Outcome Measures

Reach
To establish Reach, the investigators will determine the following: (1) number of out-of hospital cardiac arrests that present to the University of Colorado Hospital (UCH) ED; (2) number of Out of Hospital Cardiac Arrest (OHCA) patients with family/surrogate decision makers in the ED; (3) number of surrogate decision makers who agree to participate. Establishing reach is integral as it will allow us to determine the feasibility of intervening in the ED and will characterize the difficulties enrolling decision makers. The research assistant will keep a running tabulation of these data.
Effectiveness - Knowledge
Determine the number of individuals who reviewed the educational tool and completed the follow up knowledge evaluation. The pre-knowledge and post-knowledge/acceptability surveys will establish how effective the tool was at relaying information to the surrogate decision maker.
Adoption
To maximize adoption, 8-10 qualitative interviews will be conducted with emergency medicine providers, nurses and ancillary staff to explore barriers to use and potential adaptations to the implementation that might improve real world use. Providers who did not deploy the device will be included in order to understand their reasons for not adopting the intervention. Surrogate decision makers who did not agree to participate in the pilot intervention will be queried to understand their reasons for non-participation.
Implementation
In order to assess implementation (and prepare for larger implementation) a work-flow analysis will be conducted of the post-cardiac educational tools within the UCH ED. Nurses, ancillary staff (chaplain, social worker) who participate in family meetings within the emergency department will be queried. Via work-flow analysis, an understanding will be gained about when the tool was deployed, potential barriers/facilitators to deployment and how to best implement in a busy ED.

Secondary Outcome Measures

Effectiveness - Patient Outcomes
As a secondary outcome, outcomes data for the cardiac arrest patients will be measured. These data will include the disposition, including withdrawal of life sustaining therapy, survival, or re-arrest.
Effectiveness - Decision Quality
We will measure decision regret using the Ottawa decision Regret Scale, decision conflict, emotional distress using promis measures and self efficacy using a validated scale derived for surrogate decision makers. This data will measure decision quality as a result of the tool.

Full Information

First Posted
April 4, 2019
Last Updated
February 13, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Emergency Medicine Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03908346
Brief Title
A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
Official Title
A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Emergency Medicine Foundation

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
This study will test the feasibility and acceptability of deploying a decision aid for surrogate decision makers of comatose survivors of cardiac arrest early during hospitalization. This decision aid is to inform, educate and support decision makers charged with determining goals of care during post-cardiac arrest treatment.
Detailed Description
Survival and neurological recovery after out-of-hospital cardiac arrest are highly variable, driven in part by inconsistent hospital care following successful resuscitation. International guidelines for post-cardiac arrest care recommend delaying neurologic prognostication until 72-hours after resuscitation because early prognostication is imprecise and may precipitate inappropriate withdrawal of life sustaining therapy (WLST). Early WLST has been observed in-post cardiac arrest care. In order to encourage better guideline concordant care, the study proposes the implementation of an educational tool to support and inform surrogate decision makers in post-cardiac arrest care and neuro-prognostication. This pilot study will test the feasibility of implementing an educational tool for surrogate decision makers, the acceptability of such an intervention and early measures of knowledge translation. This study will inform the creation of a randomized controlled trial to test the ability of the tool to encourage guideline concordant timing of post-cardiac arrest neuro-prognostication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest With Successful Resuscitation
Keywords
Neurologic Prognosis, Guideline Concordance, Surrogate Decision Makers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision Aid for Surrogate Decision Makers
Arm Type
Other
Arm Description
In this pilot trial all participants will be presented with the decision aid and queried as to the feasibility, acceptability and knowledge translation that is gained by exposure to the decision aid
Intervention Type
Other
Intervention Name(s)
Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
Intervention Description
a decision aid has been created that is a four page document meant to support surrogate decision makers for comatose survivors of cardiac arrest
Primary Outcome Measure Information:
Title
Reach
Description
To establish Reach, the investigators will determine the following: (1) number of out-of hospital cardiac arrests that present to the University of Colorado Hospital (UCH) ED; (2) number of Out of Hospital Cardiac Arrest (OHCA) patients with family/surrogate decision makers in the ED; (3) number of surrogate decision makers who agree to participate. Establishing reach is integral as it will allow us to determine the feasibility of intervening in the ED and will characterize the difficulties enrolling decision makers. The research assistant will keep a running tabulation of these data.
Time Frame
Through study completion, on average 2.5 years
Title
Effectiveness - Knowledge
Description
Determine the number of individuals who reviewed the educational tool and completed the follow up knowledge evaluation. The pre-knowledge and post-knowledge/acceptability surveys will establish how effective the tool was at relaying information to the surrogate decision maker.
Time Frame
Through study completion, on average 2.5 years
Title
Adoption
Description
To maximize adoption, 8-10 qualitative interviews will be conducted with emergency medicine providers, nurses and ancillary staff to explore barriers to use and potential adaptations to the implementation that might improve real world use. Providers who did not deploy the device will be included in order to understand their reasons for not adopting the intervention. Surrogate decision makers who did not agree to participate in the pilot intervention will be queried to understand their reasons for non-participation.
Time Frame
Through study completion, on average 2.5 years
Title
Implementation
Description
In order to assess implementation (and prepare for larger implementation) a work-flow analysis will be conducted of the post-cardiac educational tools within the UCH ED. Nurses, ancillary staff (chaplain, social worker) who participate in family meetings within the emergency department will be queried. Via work-flow analysis, an understanding will be gained about when the tool was deployed, potential barriers/facilitators to deployment and how to best implement in a busy ED.
Time Frame
Through study completion, on average 2.5 years
Secondary Outcome Measure Information:
Title
Effectiveness - Patient Outcomes
Description
As a secondary outcome, outcomes data for the cardiac arrest patients will be measured. These data will include the disposition, including withdrawal of life sustaining therapy, survival, or re-arrest.
Time Frame
Through study completion, on average 2.5 years
Title
Effectiveness - Decision Quality
Description
We will measure decision regret using the Ottawa decision Regret Scale, decision conflict, emotional distress using promis measures and self efficacy using a validated scale derived for surrogate decision makers. This data will measure decision quality as a result of the tool.
Time Frame
Through study completion, on average 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult 18 years of age and older Identified as a surrogate decision maker for patient who is a comatose survivor of out of hospital cardiac arrest Exclusion Criteria: Illiterate or poor proficiency (unable to read decision aid) Non-english speaking
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest

We'll reach out to this number within 24 hrs