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Clinical Trials/NCT05346770
NCT05346770
Enrolling By Invitation
Not Applicable

Pharmacist-led Interventions to Improve Medication Use: Series of Case-reports

Tabula Rasa HealthCare1 site in 1 country25 target enrollmentJanuary 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pharmacogenomics
Sponsor
Tabula Rasa HealthCare
Enrollment
25
Locations
1
Primary Endpoint
Medication safety reviews of patient drug regimen characteristics will be conducted to determine potential drug-drug interactions.
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

Brief Summary

The objective of this project is to stimulate identification and report of patient's medical story for whom their clinical conditions beneficiated from pharmacists' interventions based on a medication safety review. Cases will be systematically identified and reported in the scientific (peer review journals) and clinical communities in order to inform and provide better care.

Detailed Description

METHODS TRHC aims to collect data about participants using direct or retrospective observations such as patient's demographics, medical lab tests, clinical decision support systems, and examination of medical records and drugs. Specific case studies could include medication safety reviews, behavioral interventions, pharmacogenomic testings (PGx), and prospective or retrospective analyses of a patient's drug regimen, or medical records. Case reports covered under this protocol will be limited to single case reports. TRHC pharmacists will maintain their routine health care practices. TRHC clinical research scientists and/or pharmacy residents will provide assistance and guidance. The writing process will be performed and supervised by TRHC scientist researchers. Setting and Practice Description 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 100 PACE sites, across the United States. 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 PGx clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). In addition, TRHC provides risk stratification and medication safety review for non-PACE organizations and national health plans to identify trends in medication prescribing, and healthcare expenditures by risk level. This allows TRHC (CareKinesis) to assess large populations throughout the United States to validate the MedWise® clinical decision support system. Each case report will be limited to a single patient.

Registry
clinicaltrials.gov
Start Date
January 25, 2022
End Date
July 24, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tabula Rasa HealthCare
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients meeting all the following criteria will be considered:
  • Patient enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period.
  • Patient (or legal representative) able to understand, and provide informed consent to publish his/her case story.
  • Patient's case will provide generalizable knowledge to the existing literature based on direct observation, interview, benign behavioral intervention, or findings from drug regimen or drugs claims data.

Exclusion Criteria

  • Patients with one of the following criteria will be excluded:
  • a) Patient's refusal to participate in a case study

Outcomes

Primary Outcomes

Medication safety reviews of patient drug regimen characteristics will be conducted to determine potential drug-drug interactions.

Time Frame: 1 year

Medication safety reviews will be conducted and reported using Tabula Rasa Healthcare proprietary software MedWise to assign a Medication Risk Score. This evaluation incorporates over-the-counter medications, herbals, and supplements to illuminate simultaneous, multi-drug interactions. Based on the data, patients are assigned a risk score ranging from 0 to 50, where 0-9 indicates minimal risk, 10-14 indicates low risk, 15-19 indicates intermediate risk, 20-29 indicates high risk, and 30 and above indicates severe risk.

Study Sites (1)

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