NCT03247322

Brief Summary

TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as compared to usual post-transplant care. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel information on the incidence, etiologies and outcomes of med errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of med safety issues in kidney transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 25, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

2.3 years

First QC Date

August 9, 2017

Results QC Date

February 1, 2021

Last Update Submit

February 24, 2021

Conditions

Medication Compliance

Keywords

Medication SafetyMobile Health Technology

Outcome Measures

Primary Outcomes (3)

  • Number of Medication Errors

    Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended

    1 year

  • Incidence and Severity of Adverse Drug Events

    Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care. Rates of Events Per Patient Year by AE Grade

    1 year

  • Severity of Medication Errors

    Severity of Medication Errors were measured using the Overhage criteria

    1 year

Secondary Outcomes (1)

  • Hospitalization Rate

    1 year

Other Outcomes (2)

  • Infection Rate

    1 year

  • Opportunistic Infection Rate

    1 year

Study Arms (2)

mHealth Group

EXPERIMENTAL

Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).

Other: Pharmacist-led medication therapy using mHealth application

Usual Care Group

NO INTERVENTION

Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.

Interventions

Pharmacist-led medication therapy using mHealth applicationOTHER

This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).

mHealth Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant recipient between 6 and 36 months post-transplant
  • At least 18 years of age
  • Transplant MD agrees that patient is eligible to participate

You may not qualify if:

  • Multi-organ recipient
  • Patient is incapable of:
  • Measuring their own blood pressure and glucose (if applicable)
  • Self-administering medications
  • Speaking, hearing and reading English
  • Utilizing the mHealth application, after training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (4)

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PMID: 36094829DERIVED

  • Gonzales HM, Fleming JN, Gebregziabher M, Posadas Salas MA, McGillicuddy JW, Taber DJ. A Critical Analysis of the Specific Pharmacist Interventions and Risk Assessments During the 12-Month TRANSAFE Rx Randomized Controlled Trial. Ann Pharmacother. 2022 Jun;56(6):685-690. doi: 10.1177/10600280211044792. Epub 2021 Sep 8.

    PMID: 34496669DERIVED

  • Taber DJ, Fleming JN, Su Z, Mauldin P, McGillicuddy JW, Posadas A, Gebregziabher M. Significant hospitalization cost savings to the payer with a pharmacist-led mobile health intervention to improve medication safety in kidney transplant recipients. Am J Transplant. 2021 Oct;21(10):3428-3435. doi: 10.1111/ajt.16737. Epub 2021 Jul 14.

    PMID: 34197699DERIVED

  • Fleming JN, Treiber F, McGillicuddy J, Gebregziabher M, Taber DJ. Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol. JMIR Res Protoc. 2018 Mar 2;7(3):e59. doi: 10.2196/resprot.9078.

    PMID: 29500161DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
David Taber, PharmD, MS
Organization
Medical University of South Carolina
taberd@musc.edu
843-792-3368

Study Officials

  • David Taber, PharmD,MS

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In order to minimize bias, data for outcomes will be collected by a blinded study coordinator.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 11, 2017

Study Start

October 11, 2017

Primary Completion

February 3, 2020

Study Completion

May 30, 2020

Last Updated

February 25, 2021

Results First Posted

February 25, 2021

Record last verified: 2021-02

Locations

US(1)