Screening and Interventions in an Acute Care Setting

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00545155
First received: October 16, 2007
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition
Depression
Medication Administered in Error
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening and Interventions in an Acute Care Setting

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS) [ Time Frame: Upon testing by EMS. ] [ Designated as safety issue: No ]
    Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.

  • Proportion of Subjects Cognitively Impaired in the Emergency Department (ED) [ Time Frame: Within 2 hours of testing by EMS. ] [ Designated as safety issue: No ]
    Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.

  • Proportion of Subjects Cognitively Impaired in the ED [ Time Frame: Within 2 hours of testing by EMS ] [ Designated as safety issue: No ]
    Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.

  • Test-Retest Reliability of Six Item Screener Screening [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.

  • Concurrent Criterion Validity of Six Item Screener Screening [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

    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).


  • Proportion of Subjects Depressed in EMS. [ Time Frame: Upon testing by EMS. ] [ Designated as safety issue: No ]
    Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel

  • Proportion of Subjects Depressed in the ED [ Time Frame: Within 2 hours of EMS testing. ] [ Designated as safety issue: No ]
    Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.

  • Proportion of Subjects Depressed in the ED [ Time Frame: Within 2 hours of EMS testing ] [ Designated as safety issue: No ]
    Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.

  • Test-Retest Reliability Testing of PHQ-2 Screening [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The test for depression, using the PHQ-2, with scoring yes or no.

  • Concurrent Criterion Validity of PHQ-2 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

    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).



Enrollment: 187
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Geriatric EMS Patients
Cohort for reliability and concurrent validity testing.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Geriatric EMS patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • too ill to participate, not transported to participating hospitals
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545155

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Manish N Shah, MD MPH University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00545155     History of Changes
Other Study ID Numbers: AG028942-01, K23AG028942-01
Study First Received: October 16, 2007
Results First Received: August 2, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cognition Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on April 17, 2014