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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427645
• Other study ID #: HUM00118298
• Secondary ID: 1R21NR016332-01A
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: November 22, 2019

Study information

• Verified date: February 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Decision tool
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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the decision tool intervention	The proportion of cases where the surrogate completes use of the tool with high acceptability using the Acceptability E-Scale. The Acceptability E-Scale is a 6-item scale. A score of 1 indicates a negative evaluation and 5 indicates a positive evaluation. A score of 3 indicates a neutral evaluation. An individual will be considered to have high acceptability if the average response across the 6 items is 4 or higher)	Immediately post-intervention
Secondary	Accuracy of the surrogate's prognostic estimate for functional recovery	Calculated as the absolute value of the difference between the surrogate's estimate of the probability (0-100%) of return to functional independence by 90 days and the model based estimate of modified Rankin of 0-2. Range of this measure will be 0-100.	Within approximately 5 days of admission
Secondary	Decisional Self Efficacy scale	11-item scale (a score of 0 indicates not at all confident and a 4 indicates very confident) with ordered categorical responses, converted to a 0-100 scale based on the average of the responses to each item. A score of 0 means extremely low self-efficacy and a score of 100 means extremely high self-efficacy	Within approximately 5 days of admission