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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): a Pilot Randomized Controlled Trial

Conditions
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Delirium

Intervention / Treatment
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* Behavioral: Family Support System
* Behavioral: HELP Support System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>Usual care per surgical ward standards | |
| Experimental: HELP Support System<br>This arm will receive the HELP Support System intervention only | Behavioral: HELP Support System<br>* 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.<br>|
| Experimental: Family Support System<br>This arm will receive the Family Support system intervention only | Behavioral: Family Support System<br>* 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.<br>|
| Experimental: Combined Support Systems<br>Participants randomized to this arm will receive both HELP- and family-based support system interventions | Behavioral: Family Support System<br>* 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.<br>Behavioral: HELP Support System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium Severity | For any patient with a positive 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) | morning postoperative day one through afternoon of postoperative day three | 
| Depressive symptoms as assessed by Hospitalized Anxiety and Depression Scale (HADS-D) | 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) | baseline through postoperative day 2 | 
| Anxiety symptoms as assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | 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) | baseline through postoperative day 3 | 
| Falls | Proportion of patients in each group (%) experiencing at least one fall | morning postoperative day one through afternoon of postoperative day three | 
| Length of Hospital Stay | 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 | 
| Discharge Disposition | 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 | Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment | day of hospital discharge, up to 30 days | 
| New non-surgical site infection | Incidence (%) of any new non-surgical site infection while hospitalized | morning of surgery until day of hospital discharge, up to 30 days | 
| Multidrug resistant organism colonization | Incidence (%) of any new multidrug resistant organism colonization | morning postoperative day one through 30 days after surgery | 
| Mortality | Incidence (%) | within 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Clinical Decision Support Systems, Cognitive Dysfunction, Confusion, Delirium, Feasibility Studies, Geriatric Assessment, Neurocognitive Disorders