Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)
2 other identifiers
interventional
60
1 country
1
Brief Summary
This is a pilot randomized controlled trial that will test whether a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Decision support systems will be tested that provide targeted alerts and recommendations to the Hospital Elder Life Program and family members for delirium prevention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
November 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2022
CompletedResults Posted
Study results publicly available
February 21, 2024
CompletedFebruary 21, 2024
February 1, 2024
2.7 years
June 27, 2019
November 27, 2023
February 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delirium
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)
morning postoperative day one through afternoon of postoperative day three
Secondary Outcomes (10)
Delirium Severity
morning postoperative day one through afternoon of postoperative day three
Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)
baseline through postoperative day 2
Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)
baseline through postoperative day 3
Falls
morning postoperative day one through afternoon of postoperative day three
Length of Hospital Stay
morning of surgery until day of hospital discharge, up to 30 days
- +5 more secondary outcomes
Other Outcomes (11)
HELP - Duration of Time
postoperative day one through postoperative day three
HELP - Visitation
postoperative day one through postoperative day three
HELP - Time to Evaluation
postoperative day one through postoperative day three
- +8 more other outcomes
Study Arms (4)
Usual Care Group
NO INTERVENTIONUsual care per surgical ward standards
HELP Support System
EXPERIMENTALThis arm will receive the HELP Support System intervention only
Family Support System
EXPERIMENTALThis arm will receive the Family Support system intervention only
Combined Support Systems
EXPERIMENTALParticipants randomized to this arm will receive both HELP- and family-based support system interventions
Interventions
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.
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
You may qualify if:
- Age ≥ 70 years of age
- 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
You may not qualify if:
- Emergency surgery
- Severe cognitive impairment (precluding ability to perform delirium assessments)
- Planned postoperative ICU admission
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- The Claude D. Pepper Older Americans Independence Centerscollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Michigan Medical School
Ann Arbor, Michigan, 48109, United States
Related Publications (2)
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.
PMID: 39696755DERIVEDVlisides 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.
PMID: 32934794DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Phillip Vlisides
- Organization
- Michigan Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Phillip E Vlisides, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesiology
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 5, 2019
Study Start
November 21, 2019
Primary Completion
July 27, 2022
Study Completion
July 27, 2022
Last Updated
February 21, 2024
Results First Posted
February 21, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share