Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)
NCT ID: NCT04007523
Last Updated: 2024-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-11-21
2022-07-27
Brief Summary
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Detailed Description
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The primary objectives of this study are to determine whether pager-based clinical decision support systems bolster HELP- and family-based therapeutic activities. A secondary objective will be to identify facilitators and barriers to delivering therapeutic interventions for both HELP and family members. Overall, this pilot trial will test the hypothesis that a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Patients (n=60) will be randomized to one of four groups in a factorial design: usual care (n=15), HELP-based paging system (n=15), family-based paging system (n=15), or both HELP- and family-based paging system (n=15). The support systems will consist of automated pager alerts to the HELP program and/or family members and caretakers, depending on group allocation, for providing additional delirium evaluation and therapeutic prevention activities. Outcomes will include various clinical, neurocognitive, and functional measures, and performance metrics will be collected regarding HELP- and family-based interventions.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Usual Care Group
Usual care per surgical ward standards
No interventions assigned to this group
HELP Support System
This arm will receive the HELP Support System intervention only
HELP Support System
A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Family Support System
This arm will receive the Family Support system intervention only
Family Support System
Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.
Combined Support Systems
Participants randomized to this arm will receive both HELP- and family-based support system interventions
Family Support System
Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.
HELP Support System
A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Interventions
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Family Support System
Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.
HELP Support System
A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Eligibility Criteria
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Inclusion Criteria
* Major non-cardiac, non-intracranial neurologic, and non-major vascular surgery
* Anticipated length of stay at least 72 hours
* At least one family member, or caretaker, available on each of the first three postoperative days for trial operations
Exclusion Criteria
* Severe cognitive impairment (precluding ability to perform delirium assessments)
* Planned postoperative ICU admission
* Non-English speaking
70 Years
ALL
No
Sponsors
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The Claude D. Pepper Older Americans Independence Centers
OTHER
National Institute on Aging (NIA)
NIH
University of Michigan
OTHER
Responsible Party
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Phillip Vlisides
Assistant Professor of Anesthesiology
Principal Investigators
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Phillip E Vlisides, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Medical School
Ann Arbor, Michigan, United States
Countries
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References
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Vlisides PE, Runstadler N, Martinez S, Ragheb JW, Mentz G, Leis A, Schoettinger A, Hickey K, McKinney A, Brooks J, Zierau M, Norcott A, Mody L, Inouye SK, Avidan MS, Min L. Feasibility of Alerting Systems and Family Care Partner Support for Postoperative Delirium Prevention. J Neurosurg Anesthesiol. 2025 Oct 1;37(4):361-370. doi: 10.1097/ANA.0000000000001016. Epub 2024 Dec 19.
Vlisides PE, Ragheb JW, Leis A, Schoettinger A, Hickey K, McKinney A, Brooks J, Zierau M, Norcott A, Yang S, Avidan MS, Min L. Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial. F1000Res. 2019 Sep 24;8:1683. doi: 10.12688/f1000research.20597.2. eCollection 2019.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00165251
Identifier Type: -
Identifier Source: org_study_id
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