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Emergency Department (ED) Disability Diagnostic Tool

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01416857
First received: August 11, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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 ]

Enrollment: 635
Study Start Date: August 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416857

Locations
United States, Connecticut
Yale New Haven Emergency Department
New Haven, Connecticut, United States, 06519
Yale University, Emergency Department
New Haven, Connecticut, United States, 06519
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.
Chelly JEMDPMBA, Conroy LRNMSNMPM, Miller GAS, Elliott MNP, Horne JLBA, Hudson MEMD. Risk Factors and Injury Associated With Falls in Elderly Hospitalized Patients in a Community Hospital. Journal of Patient Safety. 2008;4(3):178-183.
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: 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: July 8, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Yale University:
Medicare

ClinicalTrials.gov processed this record on November 25, 2014