Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US

April 6, 2016 updated by: Bristol-Myers Squibb

An Early Evaluation of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation (NVAF) Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin in the US

The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S

Primary objective: To determine the proportions of NVAF patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting

Secondary objectives:

  • To determine the cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting
  • To determine the proportions of NVAF patients with all cause hospital readmissions and the associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premier Hospital database is the source of all data

Description

Inclusion Criteria:

  • Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Premier Hospital database between January 1, 2012 and December 31, 2013
  • Age 18 years or older as of initial hospitalization with AF diagnosis

Exclusion Criteria:

  • Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS HEOR studies and is used to ensure that the study populations are NVAF patients
  • Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of new oral anticoagulants (NOACs) during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different NOAC usage groups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient treated with Apixaban
Patient treated with Rivaroxaban
Patient treated with Dabigatran
Patient treated with Warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportions of NVAF patients with bleeding related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the NOACs, dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting
Time Frame: 30 days post treatment
30 days post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting
Time Frame: 30 days post treatment
30 days post treatment
Proportions of NVAF patients with all cause hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting
Time Frame: 30 days post treatment
30 days post treatment
Associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting
Time Frame: 30 days post treatment
30 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nonvalvular Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe