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

University of Michigan

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Decision tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03427645

1R21NR016332-01A1 (U.S. NIH Grant/Contract)

HUM00118298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Control Surrogate Arm

No Intervention group

Description:

Usual care control group will complete baseline and follow-up questionnaires with standard decision making techniques. This group will not be asked to use the decision making tool.

Surrogate Decision Tool Arm

Experimental group

Description:

This group will complete a baseline questionnaire, then use the tool and complete follow up questionnaires.

Treatment:

Behavioral: Decision tool