Emergency Department (ED) Disability Diagnostic Tool

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT01416857
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
635
2
2
31
317.5
10.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: RDDT
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
635 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
ED Disability Diagnostic Tool: a Health Information Technology Feasibility Study
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. the presence/absence of at least one visit to the ED, hospital admission or death within 90 days of the initial ED visit. [90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Yale New Haven Emergency Department New Haven Connecticut United States 06519
2 Yale University, Emergency Department New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University
  • Agency for Healthcare Research and Quality (AHRQ)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT01416857
Other Study ID Numbers:
  • 1004006652
  • 1R01 HS0184120-01A1
First Posted:
Aug 15, 2011
Last Update Posted:
Jul 9, 2014
Last Verified:
Jul 1, 2014
Keywords provided by Yale University

Study Results

No Results Posted as of Jul 9, 2014