OsteoarthritisNCT02743507
The Impact of Bundled Payments on Quality and Cost of Care
An observational study of Osteoarthritis and Chronic Obstructive Pulmonary Disease, run by University of Pennsylvania.
Trial summary
Bundled payment is a new payment reform that encourages health care providers to improve quality and contain costs of care. These arrangements are being rapidly expanded across the country, but evidence about their impact are lacking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Chronic Obstructive Pulmonary Disease, Pneumonia
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The target population consists of a subset of provider organizations who participated in CMS's BPCI bundled payment program. From this group, the team will focus on provider organizations that participated in the largest model within the BPCI program (model 2) and accepted bundled payment for the ten most common MS-DRGs.
Who may be able to join
- Provider organizations that participate in model 2 of the BPCI program, accept bundled payment for the ten most common MS-DRGs, and have at least ten or greater episodes in each of the MS-DRGs.
Who cannot join
- Provider organizations who participated in the BPCI program, but do not meet inclusion criteria will be excluded.
About this study
Official title: The Impact of the Bundled Payments for Care Improvement Program on Quality and Costs of Care
Bundled payment is a new payment reform that encourages health care providers to improve quality and contain costs of care. These arrangements are being rapidly expanded across the country, but evidence about their impact are lacking. This study will use Medicare claims data to evaluate the effect of participation in a large Medicare bundled payment program on the quality and costs of care for common medical and surgical conditions.
Read the detailed description
The overall objective is to examine the effects of the Bundled Payments for Care Improvement (BPCI) Model 2 on the quality and costs of care for conditions related to seven of the ten Medicare severity disease-related groups (MS-DRGs) most commonly selected by program participation. Five of these are surgical (major joint replacement of the lower extremity; double joint replacement of the lower extremity; revision of the hip or knee, hip and femur procedures except major joint; lower extremity and humerus procedure except hip, foot, and femur) and two are medical (simple pneumonia and respiratory infections; chronic obstructive pulmonary disease, bronchitis/asthma). These MS-DRGs represent two larger service lines: orthopedics and pulmonary. For each of these seven MS-DRGs, the team will first describe characteristics of provider organizations participating in bundled payment arrangements, including geographic characteristics and clinical volume. We will subsequently empirically test the effect of bundled payment arrangements on quality outcomes and costs of care for these conditions. Additionally, the team will examine any spillover effects that occur within the service lines that contain these seven MS-DRGs.
- Medical subject headings
- Osteoarthritis, Pulmonary Disease, Chronic Obstructive, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned readmission rates
The study team will analyze changes in unplanned admission rates at 30, 60, and 90 days post-discharge.
Measured: Up to 90 days
Emergency department utilization rates for patients post-discharge
The study team will analyze post-discharge emergency department utilization without re-hospitalization in patients with the specific 10 MS-DRGs to test the effect of bundled payment arrangements on quality outcomes and costs of care for these conditions.
Measured: 12 months
All-cause mortality
The study team will analyze all cause mortality in patients with the specified 10 MS-DRGs.
Measured: 12 months
Secondary outcomes (2)
Total Medicare per patient per episode
The study team will analyze total Medicare episode spending for individual patients to test the effect of bundled payment arrangements on quality outcomes and costs of care for these conditions.
Measured: 12 months
Medicare spending per patient for the initial hospitalization
The study team will analyze Medicare spending for initial hospitalization and for services during the initial post-hospitalization period to test the effect of bundled payment arrangements on quality outcomes and costs of care for these conditions.
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 posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion31 Dec 2018
- Study completionDec 2028 (estimated)
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
- 440 participants (estimated)
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
- NCT02743507
- Sponsor's protocol ID
- 824812
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2016
- Last updated
- 20 Feb 2026
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Bundled Payments for Care Improvement Program on Quality and Costs of Care
- ClinicalTrials.gov ID
- NCT02743507
- Acronym / sponsor ID
- 824812
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 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.
Bundled payment is a new payment reform that encourages health care providers to improve quality and contain costs of care. These arrangements are being rapidly expanded across the country, but evidence about their impact are lacking. This study will use Medicare claims data to evaluate the effect of participation in a large Medicare bundled payment program on the quality and costs of care for common medical and surgical conditions.
Detailed description
The overall objective is to examine the effects of the Bundled Payments for Care Improvement (BPCI) Model 2 on the quality and costs of care for conditions related to seven of the ten Medicare severity disease-related groups (MS-DRGs) most commonly selected by program participation. Five of these are surgical (major joint replacement of the lower extremity; double joint replacement of the lower extremity; revision of the hip or knee, hip and femur procedures except major joint; lower extremity and humerus procedure except hip, foot, and femur) and two are medical (simple pneumonia and respiratory infections; chronic obstructive pulmonary disease, bronchitis/asthma). These MS-DRGs represent two larger service lines: orthopedics and pulmonary. For each of these seven MS-DRGs, the team will first describe characteristics of provider organizations participating in bundled payment arrangements, including geographic characteristics and clinical volume. We will subsequently empirically test the effect of bundled payment arrangements on quality outcomes and costs of care for these conditions. Additionally, the team will examine any spillover effects that occur within the service lines that contain these seven MS-DRGs.
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
- The target population consists of a subset of provider organizations who participated in CMS's BPCI bundled payment program. From this group, the team will focus on provider organizations that participated in the largest model within the BPCI program (model 2) and accepted bundled payment for the ten most common MS-DRGs.
Key inclusion criteria (1 listed)
- Provider organizations that participate in model 2 of the BPCI program, accept bundled payment for the ten most common MS-DRGs, and have at least ten or greater episodes in each of the MS-DRGs.
Key exclusion criteria (1 listed)
- Provider organizations who participated in the BPCI program, but do not meet inclusion criteria will be excluded.
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
Unplanned readmission rates
Time frame: Up to 90 days
The study team will analyze changes in unplanned admission rates at 30, 60, and 90 days post-discharge.
Emergency department utilization rates for patients post-discharge
Time frame: 12 months
The study team will analyze post-discharge emergency department utilization without re-hospitalization in patients with the specific 10 MS-DRGs to test the effect of bundled payment arrangements on quality outcomes and costs of care for these conditions.
All-cause mortality
Time frame: 12 months
The study team will analyze all cause mortality in patients with the specified 10 MS-DRGs.
2 secondary outcomes
Total Medicare per patient per episode
Time frame: 12 months
Medicare spending per patient for the initial hospitalization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- 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 and Chronic Obstructive Pulmonary Disease, 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Unplanned readmission rates (time frame: Up to 90 days). The study lists 3 primary outcomes in all. 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 20 Feb 2026.