Disability DiagnosisNCT01416857
Emergency Department (ED) Disability Diagnostic Tool
A study testing RDDT in people with Disability Diagnosis, run by Yale University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Disability Diagnosis
- What is being tested?
- RDDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who present to the adult ED at the Yale New Haven Hospital (YNHH)
- 65 years or older
- Medicare recipients
- Community dwellers.
Who cannot join
- Patients and their guardians will be excluded for the following reasons:
- Non English speaking
- suffering from a condition that precludes interview i.e. communication impairment
- unable to provide two contact numbers for follow-up
- presenting with acute psychosis or are suicidal.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Emergency Department
New Haven, Connecticut, 06519
Yale University, Emergency Department
New Haven, Connecticut, 06519
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Disability Diagnosis
- Being tested
- RDDT
- Keywords
- Medicare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDDTOther
| Study group | Role | What they receive |
|---|---|---|
| MOD | No intervention | Group evaluated using the currently available ED measure of disability (MOD) |
| RDDT | Experimental | Group will be evaluated using ED Rasch Disability Diagnostic Tool (RDDT) Receives: Other: RDDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence/absence of at least one visit to the ED, hospital admission or death within 90 days of the initial ED visit.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Disability DiagnosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Lori A Post, PhD, Principal investigator, Yale University School of Medicine, Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416857
- Sponsor's protocol ID
- 1004006652
- Other IDs
- 1R01 HS0184120-01A1
- Status last verified
- Jul 2014
- First submitted
- 11 Aug 2011
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Post LA, Salmon CT, Prokhorov A, Oehmke J, Swierenga SJ. Aging and elder abuse: Projections for Michigan. In: Murdock SH, Swanson DA, eds. Applied Demography in the 21st Century: Springer Publications; 2008.
Post LA, Swierenga SJ, Oehmke J, et al. The implications of an aging population structure. International Journal of the Interdisciplinary Social Sciences. 2006;1(2):47-57.
Bodenheimer T, Fernandez A. High and rising health care costs. Part 4: can costs be controlled while preserving quality? Ann Intern Med. 2005 Jul 5;143(1):26-31. doi: 10.7326/0003-4819-143-1-200507050-00007.
PubMed 15998752Oehmke J, Tsukamati, Post LA. Can health care services attract retirees and contribute to the economic stability of rural places? Agriculture and Resource Economics Review. 2007;36(1):95-106.
Cunningham PJ. Medicaid/SCHIP cuts and hospital emergency department use. Health Aff (Millwood). 2006 Jan-Feb;25(1):237-47. doi: 10.1377/hlthaff.25.1.237.
PubMed 16403760Cunningham PJ. What accounts for differences in the use of hospital emergency departments across U.S. communities? Health Aff (Millwood). 2006 Sep-Oct;25(5):w324-36. doi: 10.1377/hlthaff.25.w324. Epub 2006 Jul 18.
PubMed 16849363Wharam JF, Landon BE, Galbraith AA, Kleinman KP, Soumerai SB, Ross-Degnan D. Emergency department use and subsequent hospitalizations among members of a high-deductible health plan. JAMA. 2007 Mar 14;297(10):1093-102. doi: 10.1001/jama.297.10.1093.
PubMed 17356030McCaig LF, Xu J, Niska RW. Centers for Disease Control and Prevention. Estimates of Emergency Department Capacity: United States, 2007. NCHS Health E-Stat [http://www.cdc.gov/nchs/data/hestat/ed_capacity/ED_capacity.htm. Accessed October 21, 2009, 2009.
AHRQ. National Healthcare Quality Report 2008: March 2009 2009. 09-0001.Accessed www.ahrq.gov/qual/qrdr08.htm
Oliver D, Connelly JB, Victor CR, Shaw FE, Whitehead A, Genc Y, Vanoli A, Martin FC, Gosney MA. Strategies to prevent falls and fractures in hospitals and care homes and effect of cognitive impairment: systematic review and meta-analyses. BMJ. 2007 Jan 13;334(7584):82. doi: 10.1136/bmj.39049.706493.55. Epub 2006 Dec 8.
PubMed 17158580Chelly JEMDPMBA, Conroy LRNMSNMPM, Miller GAS, Elliott MNP, Horne JLBA, Hudson MEMD. Risk Factors and Injury Associated With Falls in Elderly Hospitalized Patients in a Community Hospital. Journal of Patient Safety. 2008;4(3):178-183.
Harbarth S, Fankhauser C, Schrenzel J, Christenson J, Gervaz P, Bandiera-Clerc C, Renzi G, Vernaz N, Sax H, Pittet D. Universal screening for methicillin-resistant Staphylococcus aureus at hospital admission and nosocomial infection in surgical patients. JAMA. 2008 Mar 12;299(10):1149-57. doi: 10.1001/jama.299.10.1149.
PubMed 18334690Rodriguez-Molinero A, Lopez-Dieguez M, Tabuenca AI, de la Cruz JJ, Banegas JR. Functional assessment of older patients in the emergency department: comparison between standard instruments, medical records and physicians' perceptions. BMC Geriatr. 2006 Sep 4;6:13. doi: 10.1186/1471-2318-6-13.
PubMed 16952319Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.
PubMed 19211468Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O'Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):178-87. doi: 10.7326/0003-4819-150-3-200902030-00007.
PubMed 19189907
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED Disability Diagnostic Tool: a Health Information Technology Feasibility Study
- ClinicalTrials.gov ID
- NCT01416857
- Acronym / sponsor ID
- 1004006652
- Conditions
- Disability Diagnosis
- Keywords
- Medicare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOD | No intervention | –Group evaluated using the currently available ED measure of disability (MOD) |
| RDDT | Experimental | Other: RDDTGroup will be evaluated using ED Rasch Disability Diagnostic Tool (RDDT) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who present to the adult ED at the Yale New Haven Hospital (YNHH)
- 65 years or older
- Medicare recipients
- Community dwellers.
Key exclusion criteria (5 listed)
- Patients and their guardians will be excluded for the following reasons:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDDT | Other | RDDT |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- BackgroundPost LA, Salmon CT, Prokhorov A, Oehmke J, Swierenga SJ. Aging and elder abuse: Projections for Michigan. In: Murdock SH, Swanson DA, eds. Applied Demography in the 21st Century: Springer Publications; 2008.
- BackgroundPost LA, Swierenga SJ, Oehmke J, et al. The implications of an aging population structure. International Journal of the Interdisciplinary Social Sciences. 2006;1(2):47-57.
- Background: PubMed 15998752Bodenheimer T, Fernandez A. High and rising health care costs. Part 4: can costs be controlled while preserving quality? Ann Intern Med. 2005 Jul 5;143(1):26-31. doi: 10.7326/0003-4819-143-1-200507050-00007.
- BackgroundOehmke J, Tsukamati, Post LA. Can health care services attract retirees and contribute to the economic stability of rural places? Agriculture and Resource Economics Review. 2007;36(1):95-106.
- Background: PubMed 16403760Cunningham PJ. Medicaid/SCHIP cuts and hospital emergency department use. Health Aff (Millwood). 2006 Jan-Feb;25(1):237-47. doi: 10.1377/hlthaff.25.1.237.
- Background: PubMed 16849363Cunningham PJ. What accounts for differences in the use of hospital emergency departments across U.S. communities? Health Aff (Millwood). 2006 Sep-Oct;25(5):w324-36. doi: 10.1377/hlthaff.25.w324. Epub 2006 Jul 18.
- Background: PubMed 17356030Wharam JF, Landon BE, Galbraith AA, Kleinman KP, Soumerai SB, Ross-Degnan D. Emergency department use and subsequent hospitalizations among members of a high-deductible health plan. JAMA. 2007 Mar 14;297(10):1093-102. doi: 10.1001/jama.297.10.1093.
- BackgroundMcCaig LF, Xu J, Niska RW. Centers for Disease Control and Prevention. Estimates of Emergency Department Capacity: United States, 2007. NCHS Health E-Stat [http://www.cdc.gov/nchs/data/hestat/ed_capacity/ED_capacity.htm. Accessed October 21, 2009, 2009.
- BackgroundAHRQ. National Healthcare Quality Report 2008: March 2009 2009. 09-0001.Accessed www.ahrq.gov/qual/qrdr08.htm
- Background: PubMed 17158580Oliver D, Connelly JB, Victor CR, Shaw FE, Whitehead A, Genc Y, Vanoli A, Martin FC, Gosney MA. Strategies to prevent falls and fractures in hospitals and care homes and effect of cognitive impairment: systematic review and meta-analyses. BMJ. 2007 Jan 13;334(7584):82. doi: 10.1136/bmj.39049.706493.55. Epub 2006 Dec 8.
- BackgroundChelly JEMDPMBA, Conroy LRNMSNMPM, Miller GAS, Elliott MNP, Horne JLBA, Hudson MEMD. Risk Factors and Injury Associated With Falls in Elderly Hospitalized Patients in a Community Hospital. Journal of Patient Safety. 2008;4(3):178-183.
- Background: PubMed 18334690Harbarth S, Fankhauser C, Schrenzel J, Christenson J, Gervaz P, Bandiera-Clerc C, Renzi G, Vernaz N, Sax H, Pittet D. Universal screening for methicillin-resistant Staphylococcus aureus at hospital admission and nosocomial infection in surgical patients. JAMA. 2008 Mar 12;299(10):1149-57. doi: 10.1001/jama.299.10.1149.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Post, PhD principal investigator
Yale University School of Medicine, Emergency Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RDDT in people with Disability Diagnosis, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416857, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.