Pharmacist-led Interventions to Improve Medication Use

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Old Age; Pharmacogenomics
• Intervention / Treatment: Behavioral: Behavioral Intervention; Diagnostic test: Diagnostic Test; Other: Data Analysis

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.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient enrolled in a healthcare organization where Tabula Rasa Healthcare provides pharmacy services during the implementation period.

Description

Inclusion Criteria:

Patients meeting all the following criteria will be considered:

1. Patient enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period.
2. Patient (or legal representative) able to understand, and provide informed consent to publish his/her case story.
3. 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Individual Patient; Each case will represent one individual patient and patient case. The cases may not be related and may cover different clinical practice areas.

Behavioral: Behavioral Intervention; A behavioral intervention could include changing the time of day a drug is taken.; Diagnostic test: Diagnostic Test; A patient may receive a pharmacogenomic test via cheek swab to find PGx results. This is a benign intervention with little to no risk to the patient.; Other: Data Analysis; Medication safety reviews, and retrospective or prospective data analysis may occur as a result of participation in a case study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication safety reviews of patient drug regimen characteristics will be conducted to determine potential drug-drug interactions.	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.	1 year

Collaborators and Investigators

• Sponsor: Tabula Rasa HealthCare
• Investigators: Principal Investigator: Veronique Michaud, PhD, TRHC

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2022
• Primary Completion (ANTICIPATED): January 24, 2024
• Study Completion (ANTICIPATED): July 24, 2024

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (ACTUAL): April 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TRHC-CS-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No