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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427645
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Darin Zahuranec, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Stroke Behavioral: Decision tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : November 22, 2019

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 Name: tailored decision support intervention




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427645


Locations
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United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Darin Zahuranec University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Darin Zahuranec, Associate Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT03427645    
Other Study ID Numbers: HUM00118298
1R21NR016332-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Darin Zahuranec, University of Michigan:
surrogate decision maker
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases