Pharmacist-led Interventions to Improve Medication Use

NCT ID: NCT05346770

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-25

Study Completion Date

2024-07-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacogenomics Old Age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 Intervention

Intervention Type BEHAVIORAL

A behavioral intervention could include changing the time of day a drug is taken.

Diagnostic Test

Intervention Type 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.

Data Analysis

Intervention Type OTHER

Medication safety reviews, and retrospective or prospective data analysis may occur as a result of participation in a case study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Intervention

A behavioral intervention could include changing the time of day a drug is taken.

Intervention Type BEHAVIORAL

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.

Intervention Type DIAGNOSTIC_TEST

Data Analysis

Medication safety reviews, and retrospective or prospective data analysis may occur as a result of participation in a case study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tabula Rasa HealthCare

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Veronique Michaud, PhD

Role: PRINCIPAL_INVESTIGATOR

TRHC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Orlando, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRHC-CS-2021-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of PatientToc in Community Pharmacies
NCT05235620 ENROLLING_BY_INVITATION
Polypharmacy Outpatient Clinic
NCT03911934 COMPLETED NA