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Completed

NCT Number: NCT03908346

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Reach

    Time frame: Through study completion, on average 2.5 years

    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.

  2. Effectiveness - Knowledge

    Time frame: Through study completion, on average 2.5 years

    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.

  3. Adoption

    Time frame: Through study completion, on average 2.5 years

    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.

  4. Implementation

    Time frame: Through study completion, on average 2.5 years

    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 outcomes

  1. Effectiveness - Patient Outcomes

    Time frame: Through study completion, on average 2.5 years

    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.

  2. Effectiveness - Decision Quality

    Time frame: Through study completion, on average 2.5 years

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Emergency Medicine Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2019
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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