- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00545155
Screening and Interventions in an Acute Care Setting
Study Overview
Status
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:
- 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.
- Evaluate the test-retest reliability and concurrent criterion validity of EMS screening for depression and cognitive impairment.
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Geriatric EMS Patients
Cohort for reliability and concurrent validity testing.
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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.
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Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.
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Upon testing by EMS.
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Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)
Time Frame: Within 2 hours of testing by EMS.
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Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.
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Within 2 hours of testing by EMS.
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Proportion of Subjects Cognitively Impaired in the ED
Time Frame: Within 2 hours of testing by EMS
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Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.
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Within 2 hours of testing by EMS
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Test-Retest Reliability of Six Item Screener Screening
Time Frame: 2 hours
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The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.
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2 hours
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Concurrent Criterion Validity of Six Item Screener Screening
Time Frame: 2 hours
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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
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Proportion of Subjects Depressed in EMS.
Time Frame: Upon testing by EMS.
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Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel
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Upon testing by EMS.
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Proportion of Subjects Depressed in the ED
Time Frame: Within 2 hours of EMS testing.
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Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.
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Within 2 hours of EMS testing.
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Proportion of Subjects Depressed in the ED
Time Frame: Within 2 hours of EMS testing
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Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.
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Within 2 hours of EMS testing
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Test-Retest Reliability Testing of PHQ-2 Screening
Time Frame: 2 hours
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The test for depression, using the PHQ-2, with scoring yes or no.
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2 hours
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Concurrent Criterion Validity of PHQ-2
Time Frame: 2 hours
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manish N Shah, MD MPH, University of Rochester
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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