OsteoarthritisJOINTSNCT00499278
JOINTS Study - Joint Replacement Outcome in Inpatient Rehabilitation Facilities and Nursing Treatment Sites
An observational study of Osteoarthritis, run by MedStar National Rehabilitation Network at 1 site in United States.
Trial summary
1. What are the characteristics of joint replacement patients (DRGs 209 \& 210) served in IRFs and SNFs? How are they similar or different? 2. How are the interventions and processes of care for joint replacement patients different in IRFs and SNFs? 3. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Rehabilitation after joint replacement surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,384 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2007
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 21 years of age or older,
- Received a hip or knee replacement of any type for any reason, and
- Admitted from any source.
- To be included in the study's database, the above enrollment criteria need to be met. In addition, patients also must:
- Have a minimum rehabilitation length of stay (LOS) of 3 days, and
- Have complete admission and discharge FIM data.
Who cannot join
- Joint replacements such as shoulder and ankle replacements since the rehabilitation for these patients is quite different. For most study patients, the joint replacement will be their first, but with the aging of the population, revisions are becoming more common. According to the MedPAC-RAND report, 4.8% of IRF and 6.3% of SNF joint replacement patients had a revision.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Joint Replacement Outcome in Inpatient Rehabilitation Facilities and Nursing Treatment Sites
- What are the characteristics of joint replacement patients (DRGs 209 \& 210) served in IRFs and SNFs? How are they similar or different?
- How are the interventions and processes of care for joint replacement patients different in IRFs and SNFs?
- What specific interventions or combinations of interventions in IRFs and SNFs make the biggest difference in outcomes for joint replacement patients taking into account patient differences?
- Which joint replacement patients do better in an IRF and which do better in a SNF?
- What is the relative cost-effectiveness of IRF and SNF care for joint replacement patients?
- Are comorbidities among joint replacement patients an adequate indicator of additional medical need during the rehabilitation process? Can a severity-of-illness measure serve as a better indicator of medical need? Are patients with greater medical needs served better in an IRF or a SNF?
- Can we design a more efficient course of rehabilitation interventions for joint replacement patients in IRFs and SNFs to reduce the length of stay and costs?
Read the detailed description
- What are the characteristics of joint replacement patients (DRGs 209 \& 210) served in IRFs and SNFs? How are they similar or different? We need to know if there are systematic differences among joint replacement patients served in both settings and take these into account when evaluating outcomes and cost effectiveness as outlined below. See also Question 6.
- How are the interventions and processes of care for joint replacement patients different in IRFs and SNFs? How can we best characterize the differences in the care received in an IRF vs. a SNF? What makes the care in an IRF and a SNF different? What do they do similarly and what do they do differently? Consider all interventions, e.g., nursing services, physician interventions, physical and occupational therapies, nutritional support, medications, passive motion exercises, weight-bearing exercises. Also consider timing, intensity, frequency, and duration of therapies.
- What specific interventions or combinations of interventions in IRFs and SNFs make the biggest difference in outcomes for joint replacement patients taking into account patient differences? The relevant outcomes for this study include: (1) the onset of complications during the course of treatment, (2) change in severity of illness from admission to discharge, (3) discharge destination (including unscheduled discharges to acute care), and (4) change in functional status from admission to discharge. We will consider (5) rehospitalizations or readmissions in the first 3-6 months following discharge from post-acute care.
- Which joint replacement patients do better in an IRF and which do better in a SNF? How can we best characterize the differences between patients who do better in one setting or the other? How can these characterizations assist in developing post-acute placement criteria and in characterizing the patient mix that should be used in defining an IRF pursuant to the 75% rule?
- What is the relative cost-effectiveness of IRF and SNF care for joint replacement patients? For which patients is it more cost-effective to be placed in an IRF and which patients in a SNF taking into account outcomes both at discharge and rehospitalizations during the first 3-6 months following discharge?
- Are comorbidities among joint replacement patients an adequate indicator of additional medical need during the rehabilitation process? Can a severity-of-illness measure serve as a better indicator of medical need? Are patients with greater medical needs served better in an IRF or a SNF? Do comorbidities or a severity of illness indicator have better predictive validity in terms of service utilization, costs, and outcomes?
- Can we design a more efficient course of rehabilitation interventions for joint replacement patients in IRFs and SNFs to reduce the length of stay and costs?
- Conditions
- Osteoarthritis
- Being tested
- Rehabilitation after joint replacement surgery
- Keywords
- Osteoarthritis, joint, knee, hip, surgery
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation after joint replacement surgeryBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startNov 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Observational
- Observational model
- Natural history
- Time perspective
- Retrospective
- Enrolment
- 2,384 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedStar National Rehabilitation Network
- Sponsor type
- University, hospital or other
- Collaborators
- HealthSouth
- Investigators
- Gerben DeJong, PhD, Principal investigator, NRHSusan Horn, PhD, Principal investigator, ISIS/ICOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499278
- Sponsor's protocol ID
- 2005-271
- Acronym
- JOINTS
- Status last verified
- Jul 2007
- First submitted
- 9 Jul 2007
- Last updated
- 11 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Replacement Outcome in Inpatient Rehabilitation Facilities and Nursing Treatment Sites
- ClinicalTrials.gov ID
- NCT00499278
- Acronym / sponsor ID
- JOINTS / 2005-271
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, joint, knee, hip, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,384 participants (actual)
- Lead sponsor
- MedStar National Rehabilitation NetworkUniversity, hospital or other
- Collaborators
- HealthSouth
- Study start
- Nov 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 11 Jul 2007 (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.
- What are the characteristics of joint replacement patients (DRGs 209 \& 210) served in IRFs and SNFs? How are they similar or different?
- How are the interventions and processes of care for joint replacement patients different in IRFs and SNFs?
- What specific interventions or combinations of interventions in IRFs and SNFs make the biggest difference in outcomes for joint replacement patients taking into account patient differences?
- Which joint replacement patients do better in an IRF and which do better in a SNF?
- What is the relative cost-effectiveness of IRF and SNF care for joint replacement patients?
- Are comorbidities among joint replacement patients an adequate indicator of additional medical need during the rehabilitation process? Can a severity-of-illness measure serve as a better indicator of medical need? Are patients with greater medical needs served better in an IRF or a SNF?
- Can we design a more efficient course of rehabilitation interventions for joint replacement patients in IRFs and SNFs to reduce the length of stay and costs?
Detailed description
- What are the characteristics of joint replacement patients (DRGs 209 \& 210) served in IRFs and SNFs? How are they similar or different? We need to know if there are systematic differences among joint replacement patients served in both settings and take these into account when evaluating outcomes and cost effectiveness as outlined below. See also Question 6.
- How are the interventions and processes of care for joint replacement patients different in IRFs and SNFs? How can we best characterize the differences in the care received in an IRF vs. a SNF? What makes the care in an IRF and a SNF different? What do they do similarly and what do they do differently? Consider all interventions, e.g., nursing services, physician interventions, physical and occupational therapies, nutritional support, medications, passive motion exercises, weight-bearing exercises. Also consider timing, intensity, frequency, and duration of therapies.
- What specific interventions or combinations of interventions in IRFs and SNFs make the biggest difference in outcomes for joint replacement patients taking into account patient differences? The relevant outcomes for this study include: (1) the onset of complications during the course of treatment, (2) change in severity of illness from admission to discharge, (3) discharge destination (including unscheduled discharges to acute care), and (4) change in functional status from admission to discharge. We will consider (5) rehospitalizations or readmissions in the first 3-6 months following discharge from post-acute care.
- Which joint replacement patients do better in an IRF and which do better in a SNF? How can we best characterize the differences between patients who do better in one setting or the other? How can these characterizations assist in developing post-acute placement criteria and in characterizing the patient mix that should be used in defining an IRF pursuant to the 75% rule?
- What is the relative cost-effectiveness of IRF and SNF care for joint replacement patients? For which patients is it more cost-effective to be placed in an IRF and which patients in a SNF taking into account outcomes both at discharge and rehospitalizations during the first 3-6 months following discharge?
- Are comorbidities among joint replacement patients an adequate indicator of additional medical need during the rehabilitation process? Can a severity-of-illness measure serve as a better indicator of medical need? Are patients with greater medical needs served better in an IRF or a SNF? Do comorbidities or a severity of illness indicator have better predictive validity in terms of service utilization, costs, and outcomes?
- Can we design a more efficient course of rehabilitation interventions for joint replacement patients in IRFs and SNFs to reduce the length of stay and costs?
Study design
- Observational model
- Natural history
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 21 years of age or older,
- Received a hip or knee replacement of any type for any reason, and
- Admitted from any source.
- To be included in the study's database, the above enrollment criteria need to be met. In addition, patients also must:
- Have a minimum rehabilitation length of stay (LOS) of 3 days, and
Key exclusion criteria (1 listed)
- Joint replacements such as shoulder and ankle replacements since the rehabilitation for these patients is quite different. For most study patients, the joint replacement will be their first, but with the aging of the population, revisions are becoming more common. According to the MedPAC-RAND report, 4.8% of IRF and 6.3% of SNF joint replacement patients had a revision.
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 after joint replacement surgery | Behavioural | – |
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 11 Jul 2007.
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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.
Gerben DeJong, PhD principal investigator
NRH
Susan Horn, PhD principal investigator
ISIS/ICOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by MedStar National Rehabilitation Network 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?
The sponsor lists 6 inclusion and 1 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 11 Jul 2007. 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.
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 11 Jul 2007.