Clinical trial NCT05053828: Type 2 Diabetes With Antiplatelet Drugs
Official title: Impact of Type 2 Diabetes on Outcomes Associated With Antiplatelet Drugs: A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Antiplatelet Drugs
Myocardial Infarction
Heart Failure
Lead sponsor: Tabula Rasa HealthCare
Sponsor class: INDUSTRY
First posted: 2021-09-23
Enrollment: 173464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PACE population is adults aged 55 years and older who are eligible for Medicare and Medicaid.

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.

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

Primary outcomes:
measure: Measure the prevalence of clopidogrel prescription in patients with T2D in the study population.
timeFrame: 1 year
measure: Measure the prevalence of ticagrelor and prasugrel prescription in patients with T2D vs. clopidogrel.
timeFrame: 1 year
measure: Calculate MedWise Risk Score (TM) of <10, 11-14, 15-19, 20-30, >30 for T2D patients to examine patient risk for adverse drug events.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Tabula Rasa Healthcare
state: Florida
Study officials:
affiliation: Tabula Rasa HealthCare
name: Veronique Michaud
role: PRINCIPAL_INVESTIGATOR
References: