Type 2 Diabetes With Antiplatelet Drugs

NCT ID: NCT05053828

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173464 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2023-01-30

Brief Summary

Tabula Rasa HealthCare (TRHC), d/b/a CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes. Pharmacist-led clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Through mutual data-sharing agreements, patient data will be collected retrospectively for patients satisfying the inclusion and exclusion criteria.

TRHC via other programs such as the Center for Medicare & Medicaid Enhanced Medication Therapy Management program with BlueCross BlueShield Northern Plain Alliance and ClearStone, or via collaboration as third party with other health plans can have access to de-identified patient's data. TRHC has also established an agreement with the Watson IBM database to retrieve relevant patients' information for research.

Detailed Description

This research is a retrospective observational study which does not involve interaction neither intervention with any subjects or their treatment. Using deidentified data, we plan to collect information about every subject including but not limited to demographic information (age, gender, race), drug claims, health outcomes and disease outcomes (using ICD10 codes), and cost. Data will be collected from the time patient enrolled in PACE in partnership with TRHC or from other health care plans working in collaboration with TRHC. Subjects prescribed antiplatelet agents will be identified. ICD10 codes will be used to determine disease conditions (type 2 diabetes, type 1 diabetes, non-diabetic). Next, patients prescribed clopidogrel will be identified from patients prescribed alternate anti-platelet therapy (excluding aspirin). For each cohort, Major Adverse Cardiac Event (MACE) outcomes, hospitalization data relating to bleeding incidents, stent thrombosis, mortality due to cardiovascular events, and all-cause mortality outcomes will be extracted from ICD10 codes and health insurance data. Using the medication list, the medication risk score (MRS®) and cost data will be extracted and analyses will be conducted to address our study objectives.

Conditions

Type2 Diabetes; Antiplatelet Drugs; Myocardial Infarction; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Non-diabetic controls on clopidogrel

Non-diabetic patients prescribed clopidogrel

Antiplatelet Drug

Intervention Type: DRUG

Antiplatelet drugs and agents

Diabetic patients on clopidogrel

Diabetic patients on clopidogrel

Antiplatelet Drug

Intervention Type: DRUG

Antiplatelet drugs and agents

Diabetic patients on antiplatelet drugs other than clopidogrel

Diabetic patients on antiplatelet drugs other than clopidogrel

Antiplatelet Drug

Intervention Type: DRUG

Antiplatelet drugs and agents

Interventions

Antiplatelet Drug

Antiplatelet drugs and agents

Intervention Type: DRUG

Other Intervention Names

Clopidogrel

Eligibility Criteria

Inclusion Criteria

• Patient is enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period; or patient's data enrolled with health plan organization having partnership with TRHC; or patient's data from the IBM Watson database.
• Patient must be taking anti-platelet medication including clopidogrel, prasugrel, and ticagrelor during the period in which data is collected.

Exclusion Criteria

• Patients not taking above mentioned anti-platelet medications during the period in which data is collected

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tabula Rasa HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronique Michaud

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Locations

Tabula Rasa Healthcare

Orlando, Florida, United States

Countries

United States

Other Identifiers

TRHC-T2D-2021-001

Identifier Type: -

Identifier Source: org_study_id