Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:February 8, 2018
End Date:January 2020
Contact:Darin Zahuranec, MD
Email:zdarin@med.umich.edu
Phone:734-936-9075

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The trial is testing an investigator-developed decision support tool for surrogate decision
makers for stroke patients that are unable to make medical decisions for themselves.

A historical usual care control group will be enrolled during tool development. The tool will
then be tested in surrogates of hospitalized stroke patients.

Decision support tools, specifically recommended in the 2010 Affordable Care Act, have been
shown to improve the quality of decisions and reduce burden on the decision maker in multiple
clinical settings, yet almost none have focused on life-sustaining treatments in acute
critical illness such as stroke. This study proposes a comprehensive frame shift in how the
health care team and surrogates collaborate on decisions regarding life-sustaining treatments
for acute illness, by developing a tailored web-based stroke decision support intervention.
This web-based tool will be developed for use by the surrogate decision maker during the
acute stroke hospitalization and will be designed to facilitate high quality patient-centered
decisions and minimize adverse effects on the surrogate.

The two project phases are: 1) Decision support intervention development; and 2) Pilot
testing in surrogates of hospitalized stroke patients. A novel ordinal prognostic model will
be developed and incorporated into the tool.

The project expects 25 surrogate-patient pairs in the control group, and 25 surrogate-patient
pairs in the intervention group, which equals a total of 100 subjects.

Surrogates:

Inclusion Criteria:

- Self-identify as the surrogate decision maker for eligible patient

- Able to read and communicate in English without an interpreter

- Limited to one surrogate per patient

Exclusion Criteria:

- No prior relationship with patient

- Dementia or other cognitive or health condition that would impair their ability to
participate

Patients:

Inclusion Criteria:

- Ischemic stroke or spontaneous intracerebral hemorrhage

- Impaired decisional capacity (per treating team)

- Enrolled on or before full hospital day 5

- Minimum illness severity (either):

- National Institutes of Health Stroke Scale ≥ 10

- Glasgow coma scale ≤12

Exclusion Criteria:

- No surrogate available for study procedures

- Already on comfort measures only

- Physician refuses to allow approach for consent

- Pregnancy
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-232-4508
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
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Ann Arbor, MI
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