- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04007523
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): a Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Delirium is a distressing and common surgical complication, affecting approximately 20-50% of older surgical patients. Postoperative delirium is associated with increased mortality, cognitive and functional decline, and healthcare resource utilization. Prevention programs have been tested with variable success, but the Hospital Elder Life Program (HELP) has consistently been demonstrated to reduce the incidence and impact of delirium. However, substantial resources are needed for program operations, and complementary support systems may help with patient triage and assessment. Family members and caretakers may be able to provide supplementary support with delirium screening and prevention via targeted, therapeutic activities. Thus, an automated postoperative paging system, which elicits additional, focused support from HELP and family members, may augment delirium prevention activities and reduce associated risk.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Emergency surgery
- Severe cognitive impairment (precluding ability to perform delirium assessments)
- Planned postoperative ICU admission
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care Group
Usual care per surgical ward standards
|
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Experimental: HELP Support System
This arm will receive the HELP Support System intervention only
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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.
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Experimental: Family Support System
This arm will receive the Family Support system intervention only
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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.
|
Experimental: Combined Support Systems
Participants randomized to this arm will receive both HELP- and family-based support system interventions
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delirium
Time Frame: morning postoperative day one through afternoon of postoperative day three
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Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)
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morning postoperative day one through afternoon of postoperative day three
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Falls
Time Frame: morning postoperative day one through afternoon of postoperative day three
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Proportion of patients in each group (%) experiencing at least one fall
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morning postoperative day one through afternoon of postoperative day three
|
Length of Hospital Stay
Time Frame: morning of surgery until day of hospital discharge, up to 30 days
|
Total number of days (n) spent in the hospital, up to 30 days
|
morning of surgery until day of hospital discharge, up to 30 days
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Discharge Disposition
Time Frame: day of hospital discharge, up to 30 days
|
Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days
|
day of hospital discharge, up to 30 days
|
Delayed Discharge - Cognitive Impairment
Time Frame: day of hospital discharge, up to 30 days
|
Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment
|
day of hospital discharge, up to 30 days
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Mortality
Time Frame: within 30 days after surgery
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Incidence (%)
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within 30 days after surgery
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Delirium Severity
Time Frame: morning postoperative day one through afternoon of postoperative day three
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For any patient with a completed delirium assessment, the associated severity score will be recorded using the Confusion Assessment Method Long Form Severity Score (n, 0-19, with higher number indicating more severe delirium)
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morning postoperative day one through afternoon of postoperative day three
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Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)
Time Frame: baseline through postoperative day 2
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Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-D) (n, 0-21, 0 = normal, 21 = presence of severe depression symptoms)
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baseline through postoperative day 2
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Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)
Time Frame: baseline through postoperative day 3
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Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-A) (n, 0-21, 0 = normal, 21 = presence of severe anxiety symptoms)
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baseline through postoperative day 3
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New Non-surgical Site Infection
Time Frame: morning of surgery until day of hospital discharge, up to 30 days
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Incidence (%) of any new non-surgical site infection while hospitalized
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morning of surgery until day of hospital discharge, up to 30 days
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Multidrug Resistant Organism Colonization
Time Frame: morning postoperative day one through 30 days after surgery
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Incidence (%) of any new multidrug resistant organism colonization
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morning postoperative day one through 30 days after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-Day FAM-CAM Assessments
Time Frame: day after discharge through 30 days postoperatively
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Incidence (%) of positive FAM-CAM assessments post-discharge
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day after discharge through 30 days postoperatively
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36-Item Short Form Survey
Time Frame: 30 days after hospital discharge
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Comprehensive survey that reports on overall health, functional status, physical/mental well-being, and pains (score range, for both overall scale and domain subscales: n, 0-100, 0 = worst score and 100 = best score in relation to the general state of health and quality of life)
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30 days after hospital discharge
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PROMIS Cognitive Abilities (Short Form 4a)
Time Frame: 30 days postoperatively
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Subjective reporting of cognitive function
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30 days postoperatively
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Hospital Readmission
Time Frame: within 30 days after discharge
|
Incidence (%) of hospital readmission
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within 30 days after discharge
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HELP - Duration of Time
Time Frame: postoperative day one through postoperative day three
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Cumulative length of time spent with HELP team members
|
postoperative day one through postoperative day three
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HELP - Visitation
Time Frame: postoperative day one through postoperative day three
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Proportion of patients successfully visited by the program
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postoperative day one through postoperative day three
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HELP - Time to Evaluation
Time Frame: postoperative day one through postoperative day three
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Time until initial HELP evaluation
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postoperative day one through postoperative day three
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Family Intervention - Duration of Time
Time Frame: postoperative day one through postoperative day three
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Cumulative duration of time spent with family members/caretakers at the bedside
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postoperative day one through postoperative day three
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Family Intervention - Proportion of Daily Tasks Completed
Time Frame: postoperative day one through postoperative day three
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The proportion of family-based daily tasks successfully completed will be reported
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postoperative day one through postoperative day three
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Family Intervention - Length of Time, Stimulating Activity
Time Frame: postoperative day one through postoperative day three
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Cumulative length of time spent on prescribed stimulating activities
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postoperative day one through postoperative day three
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Agreement - FAM-CAM and Research-based CAM Assessments
Time Frame: postoperative day one through postoperative day three
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Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments.
|
postoperative day one through postoperative day three
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Phillip E Vlisides, MD, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00165251
- 5P30AG024824-15 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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