Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
NCT ID: NCT03427645
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
106 participants
INTERVENTIONAL
2018-02-08
2019-11-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life
NCT01507688
Increasing Stroke Treatment Through Interventional Change Tactics Study
NCT00349479
Hybrid Stroke Rehab With Mirror Priming
NCT07324278
Stroke Ready: A Stroke Preparedness Brief Intervention
NCT03831451
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
NCT06797154
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Surrogate Decision Tool Arm
This group will complete a baseline questionnaire, then use the tool and complete follow up questionnaires.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to read and communicate in English without an interpreter
* Limited to one surrogate per patient
* 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
* Dementia or other cognitive or health condition that would impair their ability to participate
Patients:
* No surrogate available for study procedures
* Already on comfort measures only
* Physician refuses to allow approach for consent
* Pregnancy
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Nursing Research (NINR)
NIH
University of Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Darin Zahuranec
Associate Professor of Neurology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Darin Zahuranec
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Michigan
Ann Arbor, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUM00118298
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.