ClinicalTrials.Veeva

Menu

Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Delirium

Treatments

Behavioral: Family Support System
Behavioral: HELP Support System

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04007523
HUM00165251
5P30AG024824-15 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

60 participants in 4 patient groups

Usual Care Group
No Intervention group
Description:
Usual care per surgical ward standards
HELP Support System
Experimental group
Description:
This arm will receive the HELP Support System intervention only
Treatment:
Behavioral: HELP Support System
Family Support System
Experimental group
Description:
This arm will receive the Family Support system intervention only
Treatment:
Behavioral: Family Support System
Combined Support Systems
Experimental group
Description:
Participants randomized to this arm will receive both HELP- and family-based support system interventions
Treatment:
Behavioral: HELP Support System
Behavioral: Family Support System

Trial documents
2

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems