OsteoarthritisNCT02734043
Roadmap for Succeeding in Bundled Payment for Orthopedic Joint Replacements
An observational study of Osteoarthritis, run by University of Pennsylvania.
Trial summary
The objective of the study is to provide a road map that can help organizational leaders understand how to sequence their financial and human capital investments related to bundled payment arrangements. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Orthopedic surgeons from one health system who participated over a five year span in bundled payment arrangements
Who may be able to join
- participants in this study will be physicians participating in the bundled payment arrangement at the health system in question. All physicians will be included in the analysis.
Who cannot join
- no exclusion criteria
About this study
The objective of the study is to provide a road map that can help organizational leaders understand how to sequence their financial and human capital investments related to bundled payment arrangements. Although specific strategies will vary between organizations, providing evidence from a health system with extension experience bundling care for orthopedic joint replacements can be instructive for other providers entering new building arrangements. Insights from the experience of the health system can help other organizations prioritize effort and focus energy around strategies that increase the likelihood of succeeding under Comprehensive Care for Joint Replacement (CJR) and other bundled payment contracts.
Read the detailed description
This study will analyze data from a health system with the longest standing experience with bundled payments for orthopedic procedures. The goal of this work is to provide insights from this health system's six years of experience and offer a road map that other organizations around the country can use as they plan and implement their own bundled payment programs. The investigators will conduct a retrospective analysis on quality and cost data from a health system with extensive experience with bundled payments for orthopedic joint replacements. The study design will consist of three parts: first, the team will report trends in quality and cost outcomes over time using descriptive statistics; second, the team will perform multi-variable regression analyses on the data to identify significant predictors of different quality and cost outcomes and provide statistical tests on the trends; third, the team will evaluate changes in physician and hospital level variation along the outcomes.
- Conditions
- Osteoarthritis
- Keywords
- bundled payment
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection at the physician level
The study team will evaluate at the physician level. The quality metric evaluated will be average rate of surgical site infections.
Measured: 12 months
Secondary outcomes (6)
Cost of care during hospitalization
The study team will measure secondary cost outcome variables on the episode level. The cost metric to be evaluated is per episode costs of care during the hospitalization in which the surgery occurred.
Measured: 12 months
Cost of care post-discharge
The study team will measure secondary cost outcome variables on the episode level. The cost metric to be evaluated is per episode costs of care post-discharge.
Measured: 12 months
All-cause readmission rate at the physician level
The study team will evaluate at the physician level. The quality metric measured will be all-cause readmission rate.
Measured: 12 months
Venous thromboembolism at the physician level
The study team will evaluate at the physician level. The quality metric measured will be the rate of venous thromboembolism per physician in each quarter of analysis.
Measured: 12 months
Cost of care at the physician level
The study team will evaluate at the physician level. The cost metric evaluated will be the average costs of care during hospitalization in which the surgery occurred.
Measured: 12 months
Spending at the physician level
The study team will evaluate at the physician level. The cost metric evaluated will be average spending on care in combined hospitalization and post-discharge periods per physician in each quarter of analysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2018
- Study completionMay 2018
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.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amol Navathe, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734043
- Sponsor's protocol ID
- 824614
- Status last verified
- Oct 2018
- First submitted
- 31 Mar 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roadmap for Succeeding in Bundled Payment for Orthopedic Joint Replacements
- ClinicalTrials.gov ID
- NCT02734043
- Acronym / sponsor ID
- 824614
- Conditions
- Osteoarthritis
- Keywords
- bundled payment
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 12 Apr 2016 (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 objective of the study is to provide a road map that can help organizational leaders understand how to sequence their financial and human capital investments related to bundled payment arrangements. Although specific strategies will vary between organizations, providing evidence from a health system with extension experience bundling care for orthopedic joint replacements can be instructive for other providers entering new building arrangements. Insights from the experience of the health system can help other organizations prioritize effort and focus energy around strategies that increase the likelihood of succeeding under Comprehensive Care for Joint Replacement (CJR) and other bundled payment contracts.
Detailed description
This study will analyze data from a health system with the longest standing experience with bundled payments for orthopedic procedures. The goal of this work is to provide insights from this health system's six years of experience and offer a road map that other organizations around the country can use as they plan and implement their own bundled payment programs. The investigators will conduct a retrospective analysis on quality and cost data from a health system with extensive experience with bundled payments for orthopedic joint replacements. The study design will consist of three parts: first, the team will report trends in quality and cost outcomes over time using descriptive statistics; second, the team will perform multi-variable regression analyses on the data to identify significant predictors of different quality and cost outcomes and provide statistical tests on the trends; third, the team will evaluate changes in physician and hospital level variation along the outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthopedic surgeons from one health system who participated over a five year span in bundled payment arrangements
Key inclusion criteria (1 listed)
- participants in this study will be physicians participating in the bundled payment arrangement at the health system in question. All physicians will be included in the analysis.
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical site infection at the physician level
Time frame: 12 months
The study team will evaluate at the physician level. The quality metric evaluated will be average rate of surgical site infections.
6 secondary outcomes
Cost of care during hospitalization
Time frame: 12 months
Cost of care post-discharge
Time frame: 12 months
All-cause readmission rate at the physician level
Time frame: 12 months
Venous thromboembolism at the physician level
Time frame: 12 months
Cost of care at the physician level
Time frame: 12 months
Spending at the physician level
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University of Pennsylvania.
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 1 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: withdrawn, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Surgical site infection at the physician level (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 16 Oct 2018.