Screening and Interventions in an Acute Care Setting

May 22, 2015 updated by: Manish Shah, University of Rochester
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Geriatric EMS patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • too ill to participate, not transported to participating hospitals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Geriatric EMS Patients
Cohort for reliability and concurrent validity testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)
Time Frame: Upon testing by 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.
Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)
Time Frame: Within 2 hours of testing by EMS.
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.
Proportion of Subjects Cognitively Impaired in the ED
Time Frame: Within 2 hours of testing by EMS
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
Test-Retest Reliability of Six Item Screener Screening
Time Frame: 2 hours
The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.
2 hours
Concurrent Criterion Validity of Six Item Screener Screening
Time Frame: 2 hours

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
Proportion of Subjects Depressed in EMS.
Time Frame: Upon testing by 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.
Proportion of Subjects Depressed in the ED
Time Frame: Within 2 hours of EMS testing.
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.
Proportion of Subjects Depressed in the ED
Time Frame: Within 2 hours of EMS testing
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
Test-Retest Reliability Testing of PHQ-2 Screening
Time Frame: 2 hours
The test for depression, using the PHQ-2, with scoring yes or no.
2 hours
Concurrent Criterion Validity of PHQ-2
Time Frame: 2 hours

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Manish N Shah, MD MPH, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • AG028942-01
  • K23AG028942-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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