Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038363
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-05-30
Brief Title:
Comparison of Subacute and Hospital Based Rehabilitation Care
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Comparison of Subacute and Hospital Based Rehabilitation Care
Status:
COMPLETED
Status Verified Date:
2002-05
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:
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 15 years Follow-up measures will continue for an additional year
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 15 years Follow-up measures will continue for an additional year
Study Oversight
Has Oversight DMC:
None
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?:
None