NCT05346770

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 25, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2024

Completed
Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

March 2, 2022

Last Update Submit

September 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 InterventionDiagnostic Test: Diagnostic TestOther: Data Analysis

Interventions

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

Individual Patient
Diagnostic TestDIAGNOSTIC_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.

Individual Patient

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

Individual Patient

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Orlando, Florida, 32827, United States

Location

Related Links

MeSH Terms

Interventions

Behavior TherapyDiagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Veronique Michaud, PhD

    TRHC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2022

First Posted

April 26, 2022

Study Start

January 25, 2022

Primary Completion

January 24, 2024

Study Completion

July 24, 2024

Last Updated

September 2, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations