mHealth Medication Safety Intervention

Medication Compliance Clinical Trial

Official title:

Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247322
• Other study ID #: Pro00068746
• Status: Completed
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: May 30, 2020

Study information

• Verified date: February 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Medication Compliance

Intervention

Other:
• Pharmacist-led medication therapy using mHealth application
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).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

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