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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Decision tool

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Surrogate Arm; 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.
Experimental: Surrogate Decision Tool Arm; This group will complete a baseline questionnaire, then use the tool and complete follow up questionnaires.	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.; Other Names: tailored decision support intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Darin Zahuranec, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: surrogate decision maker
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HUM00118298; 1R21NR016332-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No