Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
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|ClinicalTrials.gov Identifier: NCT03427645|
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : February 5, 2020
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|
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 (Clinical Trial)|
|Actual Enrollment :||106 participants|
|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|
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
- 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)
- 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.
- 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
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
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Darin Zahuranec||University of Michigan|