Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-30 @ 2:50 PM
Study NCT ID:
NCT01416857
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2011-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergency Department (ED) Disability Diagnostic Tool
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
ED Disability Diagnostic Tool: a Health Information Technology Feasibility Study
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01 HS0184120-01A1 | None | None | View |