N/A
N=57
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)
Delirium
Bottom Line
View on ClinicalTrials.gov: NCT04007523 ↗Enrolled (actual)
57
Serious AEs
21.1%
Results posted
Feb 2024
Primary outcome: Primary: Delirium — 3; 3; 1; 2 Participants — p=0.653
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family Support System (Behavioral); HELP Support System (Behavioral)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delirium |
3; 3; 1; 2 | 0.653 |
| SECONDARY Delirium Severity |
2; 1; 3; 2 | — |
| SECONDARY Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) |
1; 1; 1; 1 | — |
| SECONDARY Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) |
2; 1; 0; 0 | — |
| SECONDARY Falls |
0; 1; 0; 0 | — |
| SECONDARY Length of Hospital Stay |
4; 5; 4; 4 | — |
| SECONDARY Discharge Disposition |
2; 1; 3; 1 | — |
| SECONDARY Delayed Discharge - Cognitive Impairment |
0; 0; 0; 0 | — |
| SECONDARY New Non-surgical Site Infection |
0; 1; 1; 2 | — |
| SECONDARY Multidrug Resistant Organism Colonization |
0; 0; 0; 0 | — |
| SECONDARY Mortality |
1; 0; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04007523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.