NCT05053828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173,464

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

September 13, 2021

Last Update Submit

January 30, 2023

Conditions

Type2 DiabetesAntiplatelet DrugsMyocardial InfarctionHeart Failure

Outcome Measures

Primary Outcomes (3)

  • Measure the prevalence of clopidogrel prescription in patients with T2D in the study population.

    Quantitative

    1 year

  • Measure the prevalence of ticagrelor and prasugrel prescription in patients with T2D vs. clopidogrel.

    Quantitative

    1 year

  • 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.

    Quatitative

    1 year

Study Arms (3)

Non-diabetic controls on clopidogrel

Non-diabetic patients prescribed clopidogrel

Drug: Antiplatelet Drug

Diabetic patients on clopidogrel

Diabetic patients on clopidogrel

Drug: Antiplatelet Drug

Diabetic patients on antiplatelet drugs other than clopidogrel

Diabetic patients on antiplatelet drugs other than clopidogrel

Drug: Antiplatelet Drug

Interventions

Antiplatelet DrugDRUG

Antiplatelet drugs and agents

Also known as: Clopidogrel
Diabetic patients on antiplatelet drugs other than clopidogrelDiabetic patients on clopidogrelNon-diabetic controls on clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PACE population is adults aged 55 years and older who are eligible for Medicare and Medicaid.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tabula Rasa Healthcare

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionHeart Failure

Interventions

Platelet Aggregation InhibitorsClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Veronique Michaud

    Tabula Rasa HealthCare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 23, 2021

Study Start

September 20, 2021

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)