Pharmacist-led Interventions to Improve Medication Use

Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05346770
• Other study ID #: TRHC-CS-2021-001
• Status: Enrolling by invitation
• Start date: January 25, 2022
• Est. completion date: July 24, 2024

Study information

• Verified date: September 2022
• Source: Tabula Rasa HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: July 24, 2024
• Est. primary completion date: January 24, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Old Age
• Pharmacogenomics

Intervention

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.

Locations

Country	Name	City	State
United States	Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tabula Rasa HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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