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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NR016332-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Surrogate Arm | No Intervention | 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. | |
| Surrogate Decision Tool Arm | Experimental | This group will complete a baseline questionnaire, then use the tool and complete follow up questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Surrogates:
Inclusion Criteria:
Exclusion Criteria:
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):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darin Zahuranec | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32689982 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |