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This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. The main goal of the study was to compare home-time in Medicare FFS patients with heart failure with mildly reduced or preserved ejection fraction discharged with sacubitril/valsartan versus those discharged without sacubitril/valsartan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure Cohort | Adults hospitalized with heart failure from the Get With The Guidelines - Heart Failure (GWTG-HF) registry and enrolled in Medicare Fee-for-Service at the time of discharge. Patients had heart failure with preserved or mildly reduced ejection fraction. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 30 |
| Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 90 |
| Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 180 |
| Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription | Post-discharge at Days 30, 90, 180, and 365 | |
| Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription |
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Inclusion criteria:
Exclusion criteria:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
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| Post-discharge at Days 30, 90, 180, and 365 |
| Number of All-cause Mortality or Heart Failure (HF) Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 |
| Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 |
| Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription | All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation. | Post-discharge at Days 30, 90, 180, and 365 |
| Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription | All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation. | Post-discharge at Days 30, 90, 180, and 365 |
| Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription | HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes I098.1, I50.*, I11.0, I13.0, I13.2) excluding transfers. | Post-discharge at Days 30, 90, 180, and 365 |
| Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription | HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes I098.1, I50.*, I11.0, I13.0, I13.2) excluding transfers. | Post-discharge at Days 30, 90, 180, and 365 |
| Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription | Hospitalization for dialysis or end-stage kidney disease was defined as any inpatient claim having a primary diagnosis of dialysis or end-stage kidney disease (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes Z99.2, Z49, N18.5, N18.6; or ICD.9 - 585.6, V45.11, V56.0, V56.8) | Post-discharge at Day 365 |
| Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription | Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641. | Post-discharge at Day 365 |
| Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription | Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0. | Post-discharge at Day 365 |
| Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription | Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur. | Post-discharge at Day 365 |
| Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription | Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. | Post-discharge at Days 30, 90, 180, and 365 |
| Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 |
| Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription | Composite measure: all-cause mortality or heart failure hospitalization. | Post-discharge at Days 30, 90, 180, and 365 |
| Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 |
| Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 |
| Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription | Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641. | Post-discharge at Day 365 |
| Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription | Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0. | Post-discharge at Day 365 |
| Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription | Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur. | Post-discharge at Day 365 |
| Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 365 |
| Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 365 |
| All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 365 |
| All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. | Post-discharge at Day 365 |