Clinical trial NCT03247322: mHealth Medication Safety Intervention
Official title: Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Compliance
Keywords: Medication Safety
Mobile Health Technology
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2017-08-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Medication Errors
timeFrame: 1 year
measure: Incidence and Severity of Adverse Drug Events
timeFrame: 1 year
measure: Severity of Medication Errors
timeFrame: 1 year
Secondary outcomes:
measure: Hospitalization Rate
timeFrame: 1 year
Other outcomes:
measure: Infection Rate
timeFrame: 1 year
measure: Opportunistic Infection Rate
timeFrame: 1 year
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: David Taber, PharmD,MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.