Emergency Department (ED) Disability Diagnostic Tool

This study is currently recruiting participants.
Verified February 2013 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lori Post, Yale University
ClinicalTrials.gov Identifier:
NCT01416857
First received: August 11, 2011
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

Aim 1: To develop and validate an Emergency Department(ED) Rasch Disability Diagnostic Tool (RDDT).

Hypothesis:

  • Rasch modeling will provide an instrument with better measurement properties, including increased reliability and validity compared to currently available ED measure of disability (MOD).

Aim 2: To conduct a randomized controlled trial to evaluate the utility of the ED-RDDT to reduce rehospitalizations in Medicare recipients visiting an urban Emergency Department for non-traumatic illness

Hypotheses:

  • Compared to the standard screening tool, the ED RDDT will reduce reutilization of the hospital (ED visits, hospital admissions, or death) within 60 days of discharge.
  • The ED RDDT will reduce costs to Medicare, hospitals and patients.

Condition Intervention
Disability Diagnosis
Other: RDDT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ED Disability Diagnostic Tool: a Health Information Technology Feasibility Study

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • the presence/absence of at least one visit to the ED, hospital admission or death within 90 days of the initial ED visit. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: MOD
Group evaluated using the currently available ED measure of disability (MOD)
Experimental: RDDT
Group will be evaluated using ED Rasch Disability Diagnostic Tool (RDDT)
Other: RDDT

Detailed Description:

Research Overview - The overarching aim of this study is to improve health outcomes for patients presenting to EDs by modifying and testing a disability diagnostic tool. The investigators expect a more accurate and precise tool will lead to better discharge plans and referrals for ED patients, reduce morbidity and mortality, and reduce unnecessary hospital visits and costs. The investigators will develop the core set of indicators with face (logical) validity from our research team of disability, emergency medicine, and geriatric medicine experts and practitioners. These experts will choose which pieces of information need to be included and group the selected pieces of information into content areas. Each content area will contain pieces of information that measure the same unidimensional concept. The investigators go through a series of Rasch analyses to establish which sets of information are in fact unidimensional and form usable scales. The investigators will test the validity of this preliminary version of the RDDT on existing hospital data by using it to predict health outcomes. Finally the investigators will consult the panel of experts to determine which information items, if any, are essential and missing from each content area. If there are such items they will be added to the RDDT. As described in the Preliminary Studies section, previous measures of disability were used for persons in long term care (LTC) and thus, need to be validated for use in the ED. The retrospective analysis will determine which indicators have superior measurement properties for use in the ED, plus, the retrospective analyses will link ED patient disability to health outcomes a necessary external validation step. A modified RDDT will be used in the prospective phase of the study. As lengthy diagnostic tools are neither feasible nor practical in the ED, Rasch scales are more useful in that subsets scale well and retain their measurement properties that remain accurate and precise. The investigators will conduct a randomized clinical trial (prospective phase) allocating patients into the study arm utilizing the RDDT (new tool) to compare with the control arm (standard care using MOD) to determine which measure is more accurate and precise as a measure of disability. There are both retrospective and prospective aspects to this multi-methodological interdisciplinary study.

  Eligibility

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

Inclusion Criteria:

  • Patients who present to the adult ED at the Yale New Haven Hospital (YNHH)
  • 65 years or older
  • Medicare recipients
  • Community dwellers.

Exclusion Criteria:

  • Patients and their guardians will be excluded for the following reasons:

    1. Non English speaking
    2. suffering from a condition that precludes interview i.e. communication impairment
    3. unable to provide two contact numbers for follow-up
    4. presenting with acute psychosis or are suicidal.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416857

Contacts
Contact: Christal M Esposito 203-737-3313 christal.esposito@yale.edu
Contact: Lori A Post, PhD 203-785-4363 lori.post@yale.edu

Locations
United States, Connecticut
Yale University, Emergency Department Recruiting
New Haven, Connecticut, United States, 06519
Contact: Christal M Esposito    203-737-3313    Christal.esposito@yale.edu   
Yale New Haven Emergency Department Recruiting
New Haven, Connecticut, United States, 06519
Contact: Christal M Esposito    203-737-3313    Christa.esposito@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Lori A Post, PhD Yale University School of Medicine, Emergency Medicine
  More Information

Publications:
Oehmke J, Tsukamati, Post LA. Can health care services attract retirees and contribute to the economic stability of rural places? Agriculture and Resource Economics Review. 2007;36(1):95-106.
Peterson PG. The shape of things to come: Global aging in the twenty-first century. Journal of International Affairs. 2002;56(1):189-210.

Responsible Party: Lori Post, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01416857     History of Changes
Other Study ID Numbers: 1004006652, 1R01 HS0184120-01A1
Study First Received: August 11, 2011
Last Updated: February 5, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Yale University:
Medicare

ClinicalTrials.gov processed this record on April 16, 2014