University of Michigan Medical School
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT04007523
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.
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Notify Me70 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: morning postoperative day one through afternoon of postoperative day three
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
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: baseline through postoperative day 2
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 3
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: morning postoperative day one through afternoon of postoperative day three
Proportion of patients in each group (%) experiencing at least one fall
Time frame: morning of surgery until day of hospital discharge, up to 30 days
Total number of days (n) spent in the hospital, up to 30 days
Time frame: day of hospital discharge, up to 30 days
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
Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment
Time frame: morning of surgery until day of hospital discharge, up to 30 days
Incidence (%) of any new non-surgical site infection while hospitalized
Time frame: morning postoperative day one through 30 days after surgery
Incidence (%) of any new multidrug resistant organism colonization
Time frame: within 30 days after surgery
Incidence (%)
Time frame: postoperative day one through postoperative day three
Cumulative length of time spent with HELP team members
Time frame: postoperative day one through postoperative day three
Proportion of patients successfully visited by the program
Time frame: postoperative day one through postoperative day three
Time until initial HELP evaluation
Time frame: postoperative day one through postoperative day three
Cumulative duration of time spent with family members/caretakers at the bedside
Time frame: postoperative day one through postoperative day three
The proportion of family-based daily tasks successfully completed will be reported
Time frame: postoperative day one through postoperative day three
Cumulative length of time spent on prescribed stimulating activities
Time frame: postoperative day one through postoperative day three
Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments.
Time frame: day after discharge through 30 days postoperatively
Incidence (%) of positive FAM-CAM assessments post-discharge
Time frame: 30 days after hospital discharge
Comprehensive survey that reports on overall health, functional status, physical/mental well-being, and pains (score range, for both overall scale and domain subscales: n, 0-100, 0 = worst score and 100 = best score in relation to the general state of health and quality of life)
Time frame: 30 days postoperatively
Subjective reporting of cognitive function
Time frame: within 30 days after discharge
Incidence (%) of hospital readmission
University of Michigan
Other
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): a Pilot Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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