Screening and Interventions in an Acute Care Setting

NCT00545155 | Completed Results

• 2 other identifiers: AG028942-01K23AG028942-01
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Medication Administered in Error; Cognitive Impairment

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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

• 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

• 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

• 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.

• 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.

• 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

• Test-Retest Reliability Testing of PHQ-2 Screening

  The test for depression, using the PHQ-2, with scoring yes or no.

  2 hours

• 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

Study Arms (1)

Geriatric EMS Patients

Cohort for reliability and concurrent validity testing.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Geriatric EMS patients

You may qualify if:

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

You may not qualify if:

• too ill to participate, not transported to participating hospitals

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Depression; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

* administration of one measure was done by individuals not blinded to another, potentially improving the concurrent criterion validity results. * a number of subjects did not consent or could not consent to participate in the study.

Results Point of Contact

• Title: Manish N. Shah
• Organization: University of Rochester

manish.shah@rochester.edu

585-463-2920

Study Officials

• Manish N Shah, MD MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 19, 2015
• Results First Posted: September 28, 2012

Record last verified: 2015-05

Locations

US (1)