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Completed

NCT Number: NCT00545155

Screening and Interventions in an Acute Care Setting

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Medication Administered in Error Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • too ill to participate, not transported to participating hospitals

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 17, 2007
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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