Heart FailureNCT05096039
Role of Sacubitril/Valsartan in Improving Provider Performance in Managing Heart Failure Under Medicare Alternative Payment Models
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study evaluated the association between sacubitril/valsartan utilization and HF patients' Part A \& B expenditures within the reimbursement framework of BPCI and MSSP, and identified BPCI/MSSP participants with the greatest potential for performance improvement (with respect to improving quality and efficiency of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sacubitril/valsartan and ACEI or ARB and no sacubitril/valsartan
- How many people
- 1,614,719 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2020to 30 Sep 2020
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Medicare FFS beneficiaries diagnosed with HF and who received care from a BPCI or MSSP participant
Who may be able to join
- ≥18 years old during year of index date with valid gender and geographic information
- Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)
- CE with medical and pharmacy benefits for ≥18 months (540ii days) beginning on the index date (post-index period)
- All patients had uniform 6-month pre-index and 18-month post-index periods
- ≥1 medical claim with an MS diagnosis codeiii in any position during the pre-or post-index periods
- ≥1 claim for fingolimod after the index date (i.e., from index date +1 to 539 days post-index)
- By requiring ≥1 medical claim with an MS diagnosis code and ≥2 claims with an NDC for fingolimod, the inclusion criteria essentially incorporated the preferred/overall best performing MS case-finding definition validated by Culpepper et al. The criteria for that definition required at least 3 separate encounters from any of the following: MS-related ambulatory visits, MS-related inpatient stays, and DMT claims during a 12-month period. Slightly higher accuracy was found when a 24-month period was used.
Who cannot join
- ≥1 pharmacy or medical claim for any MS DMT during the pre-index period
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
This study evaluated the association between sacubitril/valsartan utilization and HF patients' Part A \& B expenditures within the reimbursement framework of BPCI and MSSP, and identified BPCI/MSSP participants with the greatest potential for performance improvement (with respect to improving quality and efficiency of care for HF patients) through optimized utilization of sacubitril/valsartan.
Read the detailed description
This drug utilization study employed a retrospective cohort design using the 100% files of 2015-2018 Medicare enrollment and Part A, B \& D claims data in conjunction with publicly available information on providers participating in Bundled Payments for Care Improvement (BPCI) and/or Medicare Shared Savings Program (MSSP).
BPCI Study Design The unit of analysis for addressing study objectives was a unique Congestive Heart Failure (CHF) episode of care, which encompassed an initial acute inpatient stay plus all Part A \& B covered medical services during the 90 days post hospital discharge. Episode index date was defined as the date of a beneficiary's initial acute hospital stay with a qualifying Medicare Severity-Diagnosis Related Group (MS-DRG) for CHF, triggering a CHF episode of care. Beneficiaries were followed longitudinally from episode index date through episode end date to measure their utilization of sacubitril/valsartan and Part A \& B expenditures during the CHF episode of care. A 12-month lookback period, based on when the episode was initiated, was utilized to capture beneficiaries' baseline characteristics. For example, episodes initiated on 2/1/2018 will have a 2/1/2017 to 1/31/2018 baseline lookback period. Balancing the need for data recency, all qualifying CHF episodes from 2016-2018 were included in the analysis. Given this is an episode-level analysis, a beneficiary may have contributed multiple CHF episodes to the data analysis. To account for potential within-subject clustering, a generalized linear model with a gamma distribution was applied for estimating the association between sacubitril/valsartan use and CHF episode costs.
MSSP Study Design The unit of analysis for addressing study objectives was a HF patient's Part A \& B expenditures within the MSSP. Given the most recent year of data available at the time the study was conducted was 2018, the study population included HF patients for whom the MSSP participants were accountable in 2018 per Centers for Medicare \& Medicaid Services (CMS) assignment. These beneficiaries' utilization of sacubitril/valsartan and annual Part A \& B expenditures was measured from January 1, 2018 - December 31, 2018. Data from CY 2017 was leveraged for capturing these patients' baseline characteristics.
- Conditions
- Heart Failure
- Being tested
- Sacubitril/valsartan, ACEI or ARB and no sacubitril/valsartan
- Keywords
- Heart failure,, Medicare,, Alternative Payment Models,, HFrEF,, Healthcare Expenditures
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/valsartanDrug
Beneficiaries with one or more prescription claim with an NDC for sacubitril/valsartan (from the PDE file) during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'
ACEI or ARB and no sacubitril/valsartanDrug
Beneficiaries with one or more prescription claim with an NDC for any ACEI/ARB and no prescription claims for sacubitril/valsartan during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 (use of sacubitril/valsartan) | Beneficiaries with one or more prescription claim with an NDC for sacubitril/valsartan during the 90-day episode window (for BPCA) and CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' Receives: Drug: Sacubitril/valsartan | |
| Treatment Group 2 (use of ACEI or ARB and no use of sacubitril/valsartan) | Beneficiaries with one or more prescription claim with an NDC for any ACEI/ARB and no prescription claims for sacubitril/valsartan during the 90-day episode window (for BPCA) and CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' Receives: Drug: ACEI or ARB and no sacubitril/valsartan | |
| Treatment Group 3 (no use of ACEI, ARB, or sacubitril/valsartan) | Beneficiaries who did not qualify for Group 1 or Group 2 were assigned a value of '1'; patients that did not meet this criteria were assigned a value of '0' | |
| Cohort Group 1 (Overall cohort) | The beneficiaries who met the inclusion criteria and were divided into the three treatment groups were considered Cohort Group 1 or the "overall cohort." | |
| Cohort Group 2 (subgroup 1) | Patients with evidence of systolic HF defined as: having at least 2 medical claims (on different dates) with an ICD-9/-10 diagnosis code for systolic HF in any position during the lookback period and/or during the entire 90-day episode window (for BPCA) and CY2017 and/or CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' | |
| Cohort Group 3 (subgroup 2) | Patients with evidence of Heart Failure Reduced Ejection Fraction (HFrEF) identified based on a published algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bundled Payments for Care Improvement (BPCI) Congestive Heart Failure (CHF) episode costs
BPCI CHF episode costs defined as the sum of expenditures for Part A \& B covered medical services during the CHF episode
Measured: 90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)
Secondary outcomes (5)
Medicare Shared Savings Program (MSSP) beneficiary annual Medicare
MSSP beneficiary annual Medicare Part A \& B expenditures defined as the sum of all Part A \& B expenditures within the calendar year (CY)
Measured: Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)
Outpatient utilization of sacubitril/valsartan during 90-day post-discharge period of the CHF episode
yes/no binary variable
Measured: 90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)
Difference in actual Congestive Heart Failure (CHF) episode costs vs. benchmark CHF episode costs
A benchmark was created to assess performance and determine savings for the BPCI. Difference in actual Congestive Heart Failure (CHF) episode costs vs. benchmark CHF episode costs were reported
Measured: 90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)
Outpatient utilization of sacubitril/valsartan among Medicare Shared Savings Program (MSSP) Heart Failure (HF) patients
yes/no binary variable
Measured: Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)
Difference in actual HF patient annual Medicare Part A & B expenditures vs. benchmark HF patient annual Medicare Part A & B expenditures
A benchmark was created to assess performance and determine savings for the MSSP. Difference in actual HF patient annual Medicare Part A \& B expenditures vs. benchmark HF patient annual Medicare Part A \& B expenditures were reported
Measured: Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start10 Apr 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,614,719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096039
- Sponsor's protocol ID
- CLCZ696BUS29
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sacubitril/Valsartan in Improving Provider Performance in Managing Heart Failure Under Medicare Alternative Payment Models
- ClinicalTrials.gov ID
- NCT05096039
- Acronym / sponsor ID
- CLCZ696BUS29
- Conditions
- Heart Failure
- Keywords
- Heart failure,, Medicare,, Alternative Payment Models,, HFrEF,, Healthcare Expenditures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,614,719 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 27 Oct 2021 (actual)
- 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.
This study evaluated the association between sacubitril/valsartan utilization and HF patients' Part A \& B expenditures within the reimbursement framework of BPCI and MSSP, and identified BPCI/MSSP participants with the greatest potential for performance improvement (with respect to improving quality and efficiency of care for HF patients) through optimized utilization of sacubitril/valsartan.
Detailed description
This drug utilization study employed a retrospective cohort design using the 100% files of 2015-2018 Medicare enrollment and Part A, B \& D claims data in conjunction with publicly available information on providers participating in Bundled Payments for Care Improvement (BPCI) and/or Medicare Shared Savings Program (MSSP).
BPCI Study Design The unit of analysis for addressing study objectives was a unique Congestive Heart Failure (CHF) episode of care, which encompassed an initial acute inpatient stay plus all Part A \& B covered medical services during the 90 days post hospital discharge. Episode index date was defined as the date of a beneficiary's initial acute hospital stay with a qualifying Medicare Severity-Diagnosis Related Group (MS-DRG) for CHF, triggering a CHF episode of care. Beneficiaries were followed longitudinally from episode index date through episode end date to measure their utilization of sacubitril/valsartan and Part A \& B expenditures during the CHF episode of care. A 12-month lookback period, based on when the episode was initiated, was utilized to capture beneficiaries' baseline characteristics. For example, episodes initiated on 2/1/2018 will have a 2/1/2017 to 1/31/2018 baseline lookback period. Balancing the need for data recency, all qualifying CHF episodes from 2016-2018 were included in the analysis. Given this is an episode-level analysis, a beneficiary may have contributed multiple CHF episodes to the data analysis. To account for potential within-subject clustering, a generalized linear model with a gamma distribution was applied for estimating the association between sacubitril/valsartan use and CHF episode costs.
MSSP Study Design The unit of analysis for addressing study objectives was a HF patient's Part A \& B expenditures within the MSSP. Given the most recent year of data available at the time the study was conducted was 2018, the study population included HF patients for whom the MSSP participants were accountable in 2018 per Centers for Medicare \& Medicaid Services (CMS) assignment. These beneficiaries' utilization of sacubitril/valsartan and annual Part A \& B expenditures was measured from January 1, 2018 - December 31, 2018. Data from CY 2017 was leveraged for capturing these patients' baseline characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 (use of sacubitril/valsartan) | – | Drug: Sacubitril/valsartanBeneficiaries with one or more prescription claim with an NDC for sacubitril/valsartan during the 90-day episode window (for BPCA) and CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' |
| Treatment Group 2 (use of ACEI or ARB and no use of sacubitril/valsartan) | – | Drug: ACEI or ARB and no sacubitril/valsartanBeneficiaries with one or more prescription claim with an NDC for any ACEI/ARB and no prescription claims for sacubitril/valsartan during the 90-day episode window (for BPCA) and CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' |
| Treatment Group 3 (no use of ACEI, ARB, or sacubitril/valsartan) | – | –Beneficiaries who did not qualify for Group 1 or Group 2 were assigned a value of '1'; patients that did not meet this criteria were assigned a value of '0' |
| Cohort Group 1 (Overall cohort) | – | –The beneficiaries who met the inclusion criteria and were divided into the three treatment groups were considered Cohort Group 1 or the "overall cohort." |
| Cohort Group 2 (subgroup 1) | – | –Patients with evidence of systolic HF defined as: having at least 2 medical claims (on different dates) with an ICD-9/-10 diagnosis code for systolic HF in any position during the lookback period and/or during the entire 90-day episode window (for BPCA) and CY2017 and/or CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' |
| Cohort Group 3 (subgroup 2) | – | –Patients with evidence of Heart Failure Reduced Ejection Fraction (HFrEF) identified based on a published algorithm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Medicare FFS beneficiaries diagnosed with HF and who received care from a BPCI or MSSP participant
Key inclusion criteria (7 listed)
- ≥18 years old during year of index date with valid gender and geographic information
- Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)
- CE with medical and pharmacy benefits for ≥18 months (540ii days) beginning on the index date (post-index period)
- All patients had uniform 6-month pre-index and 18-month post-index periods
- ≥1 medical claim with an MS diagnosis codeiii in any position during the pre-or post-index periods
Key exclusion criteria (1 listed)
- ≥1 pharmacy or medical claim for any MS DMT during the pre-index period
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 |
|---|---|---|
| Sacubitril/valsartanBeneficiaries with one or more prescription claim with an NDC for sacubitril/valsartan (from the PDE file) during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' | Drug | Treatment Group 1 (use of sacubitril/valsartan) |
| ACEI or ARB and no sacubitril/valsartanBeneficiaries with one or more prescription claim with an NDC for any ACEI/ARB and no prescription claims for sacubitril/valsartan during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0' | Drug | Treatment Group 2 (use of ACEI or ARB and no use of sacubitril/valsartan) |
Primary outcome
Bundled Payments for Care Improvement (BPCI) Congestive Heart Failure (CHF) episode costs
Time frame: 90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)
BPCI CHF episode costs defined as the sum of expenditures for Part A \& B covered medical services during the CHF episode
5 secondary outcomes
Medicare Shared Savings Program (MSSP) beneficiary annual Medicare
Time frame: Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)
Outpatient utilization of sacubitril/valsartan during 90-day post-discharge period of the CHF episode
Time frame: 90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)
Difference in actual Congestive Heart Failure (CHF) episode costs vs. benchmark CHF episode costs
Time frame: 90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)
Outpatient utilization of sacubitril/valsartan among Medicare Shared Savings Program (MSSP) Heart Failure (HF) patients
Time frame: Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)
Difference in actual HF patient annual Medicare Part A & B expenditures vs. benchmark HF patient annual Medicare Part A & B expenditures
Time frame: Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)
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 16 Dec 2021.
- Results for CLCZ696BUS29 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Heart Failure, run by Novartis Pharmaceuticals 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 7 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 16 Dec 2021. 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.
What does the primary outcome measure?
Bundled Payments for Care Improvement (BPCI) Congestive Heart Failure (CHF) episode costs (time frame: 90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)). 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 Dec 2021.