Cardiac Arrest With Successful ResuscitationNCT03908346
A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
A study testing Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest in people with Cardiac Arrest With Successful Resuscitation, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation
- What is being tested?
- Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Illiterate or poor proficiency (unable to read decision aid)
- Non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study
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.
Read the 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.
- Being tested
- Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
- Keywords
- Neurologic Prognosis, Guideline Concordance, Surrogate Decision Makers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac ArrestOther
a decision aid has been created that is a four page document meant to support surrogate decision makers for comatose survivors of cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, on average 2.5 years
Secondary outcomes (2)
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.
Measured: Through study completion, on average 2.5 years
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.
Measured: Through study completion, on average 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start21 Jul 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest With Successful ResuscitationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Emergency Medicine Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908346
- Sponsor's protocol ID
- 19-0795
- Other IDs
- K23HL138164, EMF20_MCRD_00007
- Status last verified
- Feb 2023
- First submitted
- 4 Apr 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study
- ClinicalTrials.gov ID
- NCT03908346
- Acronym / sponsor ID
- 19-0795
- Keywords
- Neurologic Prognosis, Guideline Concordance, Surrogate Decision Makers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Emergency Medicine Foundation
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Aid for Surrogate Decision Makers | Other | Other: Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac ArrestIn 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Illiterate or poor proficiency (unable to read decision aid)
- Non-english speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arresta decision aid has been created that is a four page document meant to support surrogate decision makers for comatose survivors of cardiac arrest | Other | Decision Aid for Surrogate Decision Makers |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Effectiveness - Patient Outcomes
Time frame: Through study completion, on average 2.5 years
Effectiveness - Decision Quality
Time frame: Through study completion, on average 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest in people with Cardiac Arrest With Successful Resuscitation, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Through study completion, on average 2.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.