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

NCT03908346 | Completed

• 3 other identifiers: 19-0795K23HL138164EMF20_MCRD_00007
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest With Successful Resuscitation

Keywords

Neurologic Prognosis; Guideline Concordance; Surrogate Decision Makers

Outcome Measures

Primary Outcomes (4)

• 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.

  Through study completion, on average 2.5 years

• 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.

  Through study completion, on average 2.5 years

• 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.

  Through study completion, on average 2.5 years

• 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.

  Through study completion, on average 2.5 years

Secondary Outcomes (2)

• Effectiveness - Patient Outcomes

  Through study completion, on average 2.5 years

• Effectiveness - Decision Quality

  Through study completion, on average 2.5 years

Study Arms (1)

Decision Aid for Surrogate Decision Makers

OTHER

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

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

Interventions

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

Decision Aid for Surrogate Decision Makers

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Emergency Medicine Foundation: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 9, 2019
• Study Start: July 21, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (1)