Clinical trial NCT04007523: Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)
Official title: Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Caregivers
Clinical Decision Support Systems
Cognitive Dysfunction
Confusion
Delirium
Feasibility Studies
Geriatric Assessment
Neurocognitive Disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Claude D. Pepper Older Americans Independence Centers
name: National Institute on Aging (NIA)
First posted: 2019-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Delirium
timeFrame: morning postoperative day one through afternoon of postoperative day three
Secondary outcomes:
measure: Delirium Severity
timeFrame: morning postoperative day one through afternoon of postoperative day three
measure: Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)
timeFrame: baseline through postoperative day 2
measure: Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)
timeFrame: baseline through postoperative day 3
measure: Falls
timeFrame: morning postoperative day one through afternoon of postoperative day three
measure: Length of Hospital Stay
timeFrame: morning of surgery until day of hospital discharge, up to 30 days
measure: Discharge Disposition
timeFrame: day of hospital discharge, up to 30 days
measure: Delayed Discharge - Cognitive Impairment
timeFrame: day of hospital discharge, up to 30 days
measure: New Non-surgical Site Infection
timeFrame: morning of surgery until day of hospital discharge, up to 30 days
measure: Multidrug Resistant Organism Colonization
timeFrame: morning postoperative day one through 30 days after surgery
measure: Mortality
timeFrame: within 30 days after surgery
Other outcomes:
measure: HELP - Duration of Time
timeFrame: postoperative day one through postoperative day three
measure: HELP - Visitation
timeFrame: postoperative day one through postoperative day three
measure: HELP - Time to Evaluation
timeFrame: postoperative day one through postoperative day three
measure: Family Intervention - Duration of Time
timeFrame: postoperative day one through postoperative day three
measure: Family Intervention - Proportion of Daily Tasks Completed
timeFrame: postoperative day one through postoperative day three
measure: Family Intervention - Length of Time, Stimulating Activity
timeFrame: postoperative day one through postoperative day three
measure: Agreement - FAM-CAM and Research-based CAM Assessments
timeFrame: postoperative day one through postoperative day three
measure: 30-Day FAM-CAM Assessments
timeFrame: day after discharge through 30 days postoperatively
measure: 36-Item Short Form Survey
timeFrame: 30 days after hospital discharge
measure: PROMIS Cognitive Abilities (Short Form 4a)
timeFrame: 30 days postoperatively
measure: Hospital Readmission
timeFrame: within 30 days after discharge
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
Study officials:
affiliation: University of Michigan
name: Phillip E Vlisides, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.