Clinical trial NCT03427645: Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
Official title: Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: surrogate decision maker
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-02-09
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the decision tool intervention
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Accuracy of the surrogate's prognostic estimate for functional recovery
timeFrame: Within approximately 5 days of admission
measure: Decisional Self Efficacy scale
timeFrame: Within approximately 5 days of admission
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Darin Zahuranec
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen EP, Arslanian-Engoren C, Newhouse W, Egleston D, Sahgal S, Yande A, Fagerlin A, Zahuranec DB. Development and usability testing of Understanding Stroke, a tailored life-sustaining treatment decision support tool for stroke surrogate decision makers. BMC Palliat Care. 2020 Jul 20;19(1):110. doi: 10.1186/s12904-020-00617-x.