Comparison of Subacute and Hospital Based Rehabilitation Care

Tracking Information
First Submitted Date ICMJE	May 30, 2002
First Posted Date ICMJE	May 31, 2002
Last Update Posted Date	January 21, 2009
Study Start Date ICMJE	April 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00038363 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	Comparison of Subacute and Hospital Based Rehabilitation Care
Official Title ICMJE	Comparison of Subacute and Hospital Based Rehabilitation Care
Brief Summary	The proposed study objective is to compare hospital-based rehabilitative care with transitional subacute rehabilitation for adults recently diagnosed with a disabling disorder. Clinical outcomes, cost and utilization of services will be compared in order to test the hypotheses that medically-stable patients receiving rehabilitation from subacute care facilities will: 1) function as well physically, 2) report less family dysfunction, 3) have better psychological adjustment and well-being than controls who receive only hospital-based inpatient care, and 4) receive services at lower cost. We intend to assess the impact of hospital-based versus subacute care on clinical and cost outcomes at admission, discharge [3 months post-admission] and at 12 months. The first set of analyses will determine predictors of physical function, family function, psychological adjustment and well-being over a 1 year period.
Detailed Description	Although subacute transitional care is thought to reduce costs by as much as 60 percent of hospital-based care costs (DHHS, 1995), systematic prospective studies of utilization and cost of services have not been done. An important factor to be considered, particularly in elderly patients, is the cost associated with readmission. Some studies have suggested that cost savings and reduced readmissions are associated with the increased availability of post-discharge services (Ludke, MacDowell, Booth et. al., 1990; Weinberger, Smith, Katz et al., 1988). If such cost savings exist, then transitional subacute care may be an important community-based resource for patients returning to independent living. In addition to demonstrating the clinical efficacy of subacute transitional care, the proposed study will also assess long-term outcomes, taking into account patient resource utilization and the incidence of readmission. The current study will determine if subacute transitional care can improve outcomes that are important to the broad goals of long term independent living and enhanced quality of life. Variables assessed will focus on physical and family function, adjustment, resource utilization, skilled care placements, and survival. When compared to hospital-based rehabilitation, subacute rehabilitation is expected to demonstrate improvements in physical abilities, family function, adjustment, well being, and survival. b. Hypothesis. The primary hypothesis is that clinical outcomes will be significantly better for subacute care patients at 3 and 12 months than hospital-based control patients. Costs and resource utilization are hypothesized to be significantly less. c. Objectives and projected timeline. The objective of this study is to conduct a randomized clinical trial to examine the effects of subacute transitional care compared with hospital-based rehabilitative care for disabled patients. Specific objectives will be to: 1] evaluate the type, magnitude and duration of rehabilitative care provided, 2] determine differences in cost of care provided to the two groups, 3] compare clinical outcomes of the two treatments by assessing the magnitude of change, and 4] compare long-term outcomes at 12 months. Secondary objectives will be to describe diagnostic or demographic subgroups who may benefit to a greater or lesser extent than others. Patients will be recruited into the study and followed for 1 year, with measurements occurring at hospital admission, at 3 months, and at 12 months. The time to completion of the study is projected to be 3 years. Recruitment of subjects will begin during the second quarter of the project and will continue for 1.5 years. Follow-up measures will continue for an additional year.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single; Primary Purpose: Treatment
Condition ICMJE	Aging
Intervention ICMJE	Procedure: Rehabilitation; Procedure: Subacute care
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: June 23, 2005)	260
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2004
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Disabling disorders
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00038363
Other Study ID Numbers ICMJE	O2571R
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	VA Office of Research and Development
Collaborators ICMJE	Not Provided
Investigators ICMJE	Investigator: David Wolff, Ph.D. Special Assistant to the Director Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service Investigator: Vicki Mongiardo, Program Analyst Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
PRS Account	VA Office of Research and Development
Verification Date	May 2002
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP