AgingPhase 2NCT00038363
Comparison of Subacute and Hospital Based Rehabilitation Care
A Phase 2 study testing Rehabilitation and Subacute care in people with Aging, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Rehabilitation and Subacute care
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Mar 2004
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Disabling disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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.
- 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.
- Conditions
- Aging
- Being tested
- Rehabilitation, Subacute care
- Keywords
- Frail, Disable, Disabled Persons, Physically disabled, Elderly, Rehabilitation, Subacute care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationProcedure or surgery
Subacute careProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2002 (estimated)
- Study startApr 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- David Wolff, Ph.D. Special Assistant to the Director, Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development ServiceVicki Mongiardo, Program Analyst, Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038363
- Sponsor's protocol ID
- O2571R
- Status last verified
- May 2002
- First submitted
- 30 May 2002
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subacute and Hospital Based Rehabilitation Care
- ClinicalTrials.gov ID
- NCT00038363
- Acronym / sponsor ID
- O2571R
- Conditions
- Aging
- Keywords
- Frail, Disable, Disabled Persons, Physically disabled, Elderly, Rehabilitation, Subacute care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2001
- Study completion
- Mar 2004 (actual)
- First posted
- 31 May 2002 (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.
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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Rehabilitation | Procedure or surgery | – |
| Subacute care | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
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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.
David Wolff, Ph.D. Special Assistant to the Director
Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
Vicki Mongiardo, Program Analyst
Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rehabilitation and Subacute care in people with Aging, run by US Department of Veterans Affairs at 1 site 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?
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 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 21 Jan 2009.