Screening and Interventions in an Acute Care Setting

Depression Clinical Trial

Official title:

Screening and Interventions in an Acute Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545155
• Other study ID #: AG028942-01
• Secondary ID: K23AG028942-01
• Status: Completed
• Phase: N/A
• First received: October 16, 2007
• Last updated: May 22, 2015
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: May 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• too ill to participate, not transported to participating hospitals

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Depression
• Medication Administered in Error

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)	Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.	Upon testing by EMS.	No
Primary	Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)	Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.	Within 2 hours of testing by EMS.	No
Primary	Proportion of Subjects Cognitively Impaired in the ED	Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.	Within 2 hours of testing by EMS	No
Primary	Test-Retest Reliability of Six Item Screener Screening	The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.	2 hours	No
Primary	Concurrent Criterion Validity of Six Item Screener Screening	This is the Six Item Screener test for cognitive impairment (scoring=yes or no), as compared to performing the Mini-Cog for cognitive impairment (scoring=yes or no) on patients immediately afterwards.; This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice).	2 hours	No
Primary	Proportion of Subjects Depressed in EMS.	Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel	Upon testing by EMS.	No
Primary	Proportion of Subjects Depressed in the ED	Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.	Within 2 hours of EMS testing.	No
Primary	Proportion of Subjects Depressed in the ED	Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.	Within 2 hours of EMS testing	No
Primary	Test-Retest Reliability Testing of PHQ-2 Screening	The test for depression, using the PHQ-2, with scoring yes or no.	2 hours	No
Primary	Concurrent Criterion Validity of PHQ-2	This is the PHQ-2, a test for depression (scoring=yes or no) as compared to the PHQ-9, a test for depression (scoring=yes or no), looking at the presence of depression.; This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice).	2 hours	No