Emergency Department (ED) Disability Diagnostic Tool
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| First Received Date ICMJE | August 11, 2011 | ||||||||
| Last Updated Date | February 5, 2013 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01416857 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Emergency Department (ED) Disability Diagnostic Tool | ||||||||
| Official Title ICMJE | ED Disability Diagnostic Tool: a Health Information Technology Feasibility Study | ||||||||
| Brief Summary | Aim 1: To develop and validate an Emergency Department(ED) Rasch Disability Diagnostic Tool (RDDT). Hypothesis:
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:
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Disability Diagnosis | ||||||||
| Intervention ICMJE | Other: RDDT | ||||||||
| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 600 | ||||||||
| Estimated Completion Date | May 2015 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 65 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01416857 | ||||||||
| Other Study ID Numbers ICMJE | 1004006652, 1R01 HS0184120-01A1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Lori Post, Yale University | ||||||||
| Study Sponsor ICMJE | Yale University | ||||||||
| Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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