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

NCT ID: NCT03908346

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest With Successful Resuscitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Decision Aid for Surrogate Decision Makers

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

Group Type OTHER

Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest

Intervention Type OTHER

a decision aid has been created that is a four page document meant to support surrogate decision makers for comatose survivors of cardiac arrest

Interventions

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Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest

a decision aid has been created that is a four page document meant to support surrogate decision makers for comatose survivors of cardiac arrest

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Emergency Medicine Foundation

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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K23HL138164

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EMF20_MCRD_00007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

19-0795

Identifier Type: -

Identifier Source: org_study_id

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