N/A
N=136
mHealth Medication Safety Intervention
Medication Compliance
Bottom Line
View on ClinicalTrials.gov: NCT03247322 ↗Enrolled (actual)
136
Serious AEs
16.2%
Results posted
Feb 2021
Primary outcome: Primary: Number of Medication Errors — 9; 20 number of medication errors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacist-led medication therapy using mHealth application (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Medication Errors |
9; 20 | — |
| PRIMARY Incidence and Severity of Adverse Drug Events |
20.68; 21.26; 13.96; 14; 5.53; 5.28 | — |
| PRIMARY Severity of Medication Errors |
0; 0; 0; 1; 586; 1320 | — |
| SECONDARY Hospitalization Rate |
0.65; 1.08 | — |
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
Data sourced from ClinicalTrials.gov (NCT03247322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.