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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
University of Michigan Medical School
Ann Arbor, Michigan, United States
Delirium
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)
Time frame: morning postoperative day one through afternoon of postoperative day three
Delirium Severity
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)
Time frame: 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)
Time frame: 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)
Time frame: baseline through postoperative day 3
Falls
Proportion of patients in each group (%) experiencing at least one fall
Time frame: 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
Time frame: morning of surgery until day of hospital discharge, up to 30 days
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Discharge Disposition
Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days
Time frame: 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
Time frame: day of hospital discharge, up to 30 days
New Non-surgical Site Infection
Incidence (%) of any new non-surgical site infection while hospitalized
Time frame: morning of surgery until day of hospital discharge, up to 30 days
Multidrug Resistant Organism Colonization
Incidence (%) of any new multidrug resistant organism colonization
Time frame: morning postoperative day one through 30 days after surgery
Mortality
Incidence (%)
Time frame: within 30 days after surgery