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Screening and Interventions in an Acute Care Setting
This study is currently recruiting participants.
Verified by University of Rochester, February 2009
First Received: October 16, 2007   Last Updated: February 19, 2009   History of Changes
Sponsors and Collaborators: University of Rochester
National Institute on Aging (NIA)
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00545155
  Purpose

The purpose of this study is to: 1) evaluate the reliability and validity of EMS screening for depression, pill taking strategies, and cognitive impairment and 2) to develop and evaluate a pilot ED intervention program to address the needs of older adults found to be at risk for depression, pill taking strategies, and cognitive impairment.


Condition Intervention
Depression
Medication Errors
Cognitive Impairment
Procedure: Information and referral to medical and social agencies

MedlinePlus related topics: Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Open Label, Uncontrolled, Single Group Assignment
Official Title: Screening and Interventions in an Acute Care Setting

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Reliability of screening results [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Concurrent criterion validity of screening results [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Follow up for services [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: June 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Usual medical and social care
2: Active Comparator
Provision of medical and social services through the acute care setting.
Procedure: Information and referral to medical and social agencies
To be determined

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, pill taking strategies, and dementia.
  2. Evaluate the test-retest reliability and concurrent criterion validity of EMS screening for depression, pill taking strategies, and cognitive impairment.
  3. Refine and pilot an ED intervention program that addresses the needs of older adults found by EMS to be at risk for depression, pill taking strategies, and cognitive impairment.
  4. Evaluate the developed pilot ED intervention program using process measures of ED physician, ED nurse, ED social worker, primary care physician, and patient activity.

Upon completion, this study will have demonstrated the reliability and validity of EMS screening for these conditions and the success of an ED intervention program template that can be applied to a wider range of geriatric disorders.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Contacts
Contact: Manish N Shah, MD MPH 585-463-2920 manish.shah@rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
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 ( Manish N. Shah, MD MPH )
Study ID Numbers: AG028942-01, K23 AG028942-01
Study First Received: October 16, 2007
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00545155     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Depression
Mental Disorders
Dementia
Depressive Disorder
Cognition Disorders
Delirium
Behavioral Symptoms

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

ClinicalTrials.gov processed this record on May 06, 2009