Medication Compliance
Conditions
Keywords
Medication Safety, Mobile Health Technology
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.
Interventions
OTHERPharmacist-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).
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
In order to minimize bias, data for outcomes will be collected by a blinded study coordinator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Medication Errors | 1 year | Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended |
| Incidence and Severity of Adverse Drug Events | 1 year | 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 |
| Severity of Medication Errors | 1 year | Severity of Medication Errors were measured using the Overhage criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Rate | 1 year | Number of hospitalizations per patient-year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate | 1 year | Number of infections per patient-year |
| Opportunistic Infection Rate | 1 year | Opportunistic infections per patient-year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 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).
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). | 68 |
| Control Group Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. | 68 |
| Total | 136 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 12 | 51 years STANDARD_DEVIATION 14 | 51 years STANDARD_DEVIATION 13 |
| Number of Participants on Dialysis at Transplant | 58 Participants | 56 Participants | 114 Participants |
| Number of Participants with History of Diabetes | 19 Participants | 35 Participants | 54 Participants |
| Number of Participants with History of Hypertension | 63 Participants | 61 Participants | 124 Participants |
| Race/Ethnicity, Customized Black | 40 Participants | 47 Participants | 87 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 27 Participants | 19 Participants | 46 Participants |
| Sex: Female, Male Female | 33 Participants | 26 Participants | 59 Participants |
| Sex: Female, Male Male | 35 Participants | 42 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 68 |
| other Total, other adverse events | 68 / 68 | 68 / 68 |
| serious Total, serious adverse events | 6 / 68 | 16 / 68 |
Outcome results
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
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Incidence and Severity of Adverse Drug Events | Grade 2 | 5.53 adverse events per patient year | Standard Deviation 0.72 |
| Intervention Group | Incidence and Severity of Adverse Drug Events | Grade 4 | .07 adverse events per patient year | Standard Deviation 0.05 |
| Intervention Group | Incidence and Severity of Adverse Drug Events | Grade 1 | 13.96 adverse events per patient year | Standard Deviation 1.47 |
| Intervention Group | Incidence and Severity of Adverse Drug Events | Grade 5 | 0 adverse events per patient year | Standard Deviation 0 |
| Intervention Group | Incidence and Severity of Adverse Drug Events | Grade 3 | 1.10 adverse events per patient year | Standard Deviation 0.22 |
| Intervention Group | Incidence and Severity of Adverse Drug Events | Grade 3 or higher | 1.18 adverse events per patient year | Standard Deviation 0.25 |
| Intervention Group | Incidence and Severity of Adverse Drug Events | Overall | 20.68 adverse events per patient year | Standard Deviation 18.35 |
| Control Group | Incidence and Severity of Adverse Drug Events | Grade 3 or higher | 1.97 adverse events per patient year | Standard Deviation 0.46 |
| Control Group | Incidence and Severity of Adverse Drug Events | Overall | 21.26 adverse events per patient year | Standard Deviation 25.24 |
| Control Group | Incidence and Severity of Adverse Drug Events | Grade 1 | 14 adverse events per patient year | Standard Deviation 15.1 |
| Control Group | Incidence and Severity of Adverse Drug Events | Grade 2 | 5.28 adverse events per patient year | Standard Deviation 0.94 |
| Control Group | Incidence and Severity of Adverse Drug Events | Grade 3 | 1.57 adverse events per patient year | Standard Deviation 0.34 |
| Control Group | Incidence and Severity of Adverse Drug Events | Grade 4 | 0.38 adverse events per patient year | Standard Deviation 0.15 |
| Control Group | Incidence and Severity of Adverse Drug Events | Grade 5 | .01 adverse events per patient year | Standard Deviation 0.01 |
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
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Number of Medication Errors | 9 number of medication errors | Standard Deviation 5.4 |
| Control Group | Number of Medication Errors | 20 number of medication errors | Standard Deviation 14 |
Primary
Severity of Medication Errors
Severity of Medication Errors were measured using the Overhage criteria
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Severity of Medication Errors | Potentially Lethal | 0 number of medication errors |
| Intervention Group | Severity of Medication Errors | Serious | 0 number of medication errors |
| Intervention Group | Severity of Medication Errors | Significant | 586 number of medication errors |
| Intervention Group | Severity of Medication Errors | Minor | 28 number of medication errors |
| Control Group | Severity of Medication Errors | Minor | 64 number of medication errors |
| Control Group | Severity of Medication Errors | Potentially Lethal | 0 number of medication errors |
| Control Group | Severity of Medication Errors | Significant | 1320 number of medication errors |
| Control Group | Severity of Medication Errors | Serious | 1 number of medication errors |
Secondary
Hospitalization Rate
Number of hospitalizations per patient-year
Time frame: 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Hospitalization Rate | 0.65 Hospitalizations per patient-year |
| Control Group | Hospitalization Rate | 1.08 Hospitalizations per patient-year |
Other Pre-specified
Infection Rate
Number of infections per patient-year
Time frame: 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Infection Rate | 1.32 Infections per patient-year |
| Control Group | Infection Rate | 1.26 Infections per patient-year |
Other Pre-specified
Opportunistic Infection Rate
Opportunistic infections per patient-year
Time frame: 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Opportunistic Infection Rate | .19 Opportunistic infection per patient-year |
| Control Group | Opportunistic Infection Rate | .14 Opportunistic infection per patient-year |