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Completed

NCT Number: NCT03427645

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Tool

Behavioral

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

Primary outcomes

  1. Acceptability of the decision tool intervention

    Time frame: Immediately post-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)

Secondary outcomes

  1. Accuracy of the surrogate's prognostic estimate for functional recovery

    Time frame: Within approximately 5 days of admission

    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.

  2. Decisional Self Efficacy scale

    Time frame: Within approximately 5 days of admission

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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