Emergency Department (ED) Disability Diagnostic Tool

July 8, 2014 updated by: Yale University

ED Disability Diagnostic Tool: a Health Information Technology Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

635

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University, Emergency Department
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Lori A Post, PhD, Yale University School of Medicine, Emergency Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

August 12, 2011

First Posted (Estimate)

August 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004006652
  • 1R01 HS0184120-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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