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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007523
• Other study ID #: HUM00165251
• Secondary ID: 5P30AG024824-15
• Status: Completed
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: July 27, 2022

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Behavioral:
• Family Support System
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.
• HELP Support System
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.

Locations

Country	Name	City	State
United States	University of Michigan Medical School	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA), The Claude D. Pepper Older Americans Independence Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HELP - Duration of Time	Cumulative length of time spent with HELP team members	postoperative day one through postoperative day three
Other	HELP - Visitation	Proportion of patients successfully visited by the program	postoperative day one through postoperative day three
Other	HELP - Time to Evaluation	Time until initial HELP evaluation	postoperative day one through postoperative day three
Other	Family Intervention - Duration of Time	Cumulative duration of time spent with family members/caretakers at the bedside	postoperative day one through postoperative day three
Other	Family Intervention - Proportion of Daily Tasks Completed	The proportion of family-based daily tasks successfully completed will be reported	postoperative day one through postoperative day three
Other	Family Intervention - Length of Time, Stimulating Activity	Cumulative length of time spent on prescribed stimulating activities	postoperative day one through postoperative day three
Other	Agreement - FAM-CAM and Research-based CAM Assessments	Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments.	postoperative day one through postoperative day three
Other	30-Day FAM-CAM Assessments	Incidence (%) of positive FAM-CAM assessments post-discharge	day after discharge through 30 days postoperatively
Other	36-Item Short Form Survey	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)	30 days after hospital discharge
Other	PROMIS Cognitive Abilities (Short Form 4a)	Subjective reporting of cognitive function	30 days postoperatively
Other	Hospital Readmission	Incidence (%) of hospital readmission	within 30 days after discharge
Primary	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	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)	morning postoperative day one through afternoon of postoperative day three
Secondary	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
Secondary	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
Secondary	Falls	Proportion of patients in each group (%) experiencing at least one fall	morning postoperative day one through afternoon of postoperative day three
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Multidrug Resistant Organism Colonization	Incidence (%) of any new multidrug resistant organism colonization	morning postoperative day one through 30 days after surgery
Secondary	Mortality	Incidence (%)	within 30 days after surgery