Medication Compliance Clinical Trial
Official title:
Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)
Verified date | February 2021 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | May 30, 2020 |
Est. primary completion date | February 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Infection Rate | Number of infections per patient-year | 1 year | |
Other | Opportunistic Infection Rate | Opportunistic infections per patient-year | 1 year | |
Primary | 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 | |
Primary | 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 | |
Primary | Severity of Medication Errors | Severity of Medication Errors were measured using the Overhage criteria | 1 year | |
Secondary | Hospitalization Rate | Number of hospitalizations per patient-year | 1 year |
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