Clinical trial NCT00545155: Screening and Interventions in an Acute Care Setting
Official title: Screening and Interventions in an Acute Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Medication Administered in Error
Cognitive Impairment
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2007-10-17
Enrollment: 187
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Geriatric EMS patients

Brief summary: The purpose of this study is to: 1) evaluate the reliability and validity of EMS screening for depression and cognitive impairment and 2) to develop a pilot ED intervention program to address the needs of older adults found to be at risk for depression and cognitive impairment.

Detailed description: Many older adults (age over 64) have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.

The emergency medical services (EMS) system is a unique, community-wide system that can be used to perform in-home evaluations to uniformly screen large numbers of vulnerable older adults during emergency responses. The emergency department (ED) is the entry point for access to medical and social services for many patients. Recent programs have used the EMS system to screen patients or the ED to screen and intervene with mixed results, but little has been done to rigorously evaluate an integrated program of EMS screening that leads to focused ED interventions that promote the health of older adults. This proposed project builds upon the principal investigator's preliminary work and unique resources in Rochester, NY to develop and evaluate a program of EMS screening and ED interventions to help community-dwelling older adults with unmet needs. Specifically, this study aims to:

1. Implement an EMS screening program to identify community-dwelling older adults' unmet needs during emergency responses, identifying patients with needs related to depression and dementia.
2. Evaluate the test-retest reliability and concurrent criterion validity of EMS screening for depression and cognitive impairment.
3. Develop and refine an EMS and ED intervention program that addresses the needs of older adults found by EMS to be at risk for depression and cognitive impairment.

Upon completion, this study will have demonstrated the reliability and validity of EMS screening for these conditions and will have proposed an EMS and ED based intervention program template that can be applied to these and a wider range of geriatric disorders.

Eligibility criteria: Inclusion Criteria:

* age 65 or older, cared for by participating EMS providers

Exclusion Criteria:

* too ill to participate, not transported to participating hospitals

Primary outcomes:
measure: Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)
timeFrame: Upon testing by EMS.
measure: Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)
timeFrame: Within 2 hours of testing by EMS.
measure: Proportion of Subjects Cognitively Impaired in the ED
timeFrame: Within 2 hours of testing by EMS
measure: Test-Retest Reliability of Six Item Screener Screening
timeFrame: 2 hours
measure: Concurrent Criterion Validity of Six Item Screener Screening
timeFrame: 2 hours
measure: Proportion of Subjects Depressed in EMS.
timeFrame: Upon testing by EMS.
measure: Proportion of Subjects Depressed in the ED
timeFrame: Within 2 hours of EMS testing.
measure: Proportion of Subjects Depressed in the ED
timeFrame: Within 2 hours of EMS testing
measure: Test-Retest Reliability Testing of PHQ-2 Screening
timeFrame: 2 hours
measure: Concurrent Criterion Validity of PHQ-2
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Manish N Shah, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: