Emergency Department (ED) Disability Diagnostic Tool

NCT ID: NCT01416857

Last Updated: 2014-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Disability Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MOD

Group evaluated using the currently available ED measure of disability (MOD)

Group Type NO_INTERVENTION

No interventions assigned to this group

RDDT

Group will be evaluated using ED Rasch Disability Diagnostic Tool (RDDT)

Group Type EXPERIMENTAL

RDDT

Intervention Type OTHER

Interventions

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RDDT

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lori A Post, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Medicine, Emergency Medicine

Locations

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Yale New Haven Emergency Department

New Haven, Connecticut, United States

Site Status

Yale University, Emergency Department

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Other Identifiers

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1R01 HS0184120-01A1

Identifier Type: -

Identifier Source: secondary_id

1004006652

Identifier Type: -

Identifier Source: org_study_id

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