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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth Group | Experimental | 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). |
|
| Usual Care Group | No Intervention | Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-led medication therapy using mHealth application | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Severity of Medication Errors | Severity of Medication Errors were measured using the Overhage criteria | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization Rate | Number of hospitalizations per patient-year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | Number of infections per patient-year | 1 year |
| Opportunistic Infection Rate | Opportunistic infections per patient-year | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Taber, PharmD,MS | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094829 | Derived | 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. | |
| 34496669 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | mHealth 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). |
| FG001 | Usual Care Group | Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | number of medication errors | 1 year |
|
1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Dysfunction | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Taber, PharmD, MS | Medical University of South Carolina | 843-792-3368 | taberd@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2017 | Feb 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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In order to minimize bias, data for outcomes will be collected by a blinded study coordinator.
|
| 34197699 | Derived | 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. |
| 29500161 | Derived | 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. |
| BG001 | Control Group | Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of Participants with History of Diabetes | Count of Participants | Participants |
|
| Number of Participants with History of Hypertension | Count of Participants | Participants |
|
| Number of Participants on Dialysis at Transplant | Count of Participants | Participants |
|
| OG001 | Control Group | Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. |
|
|
| 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 | Posted | Mean | Standard Deviation | adverse events per patient year | 1 year |
|
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| Primary | Severity of Medication Errors | Severity of Medication Errors were measured using the Overhage criteria | Posted | Number | number of medication errors | 1 year |
|
|
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| Secondary | Hospitalization Rate | Number of hospitalizations per patient-year | Posted | Mean | 95% Confidence Interval | Hospitalizations per patient-year | 1 year |
|
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| Other Pre-specified | Infection Rate | Number of infections per patient-year | Posted | Mean | 95% Confidence Interval | Infections per patient-year | 1 year |
|
|
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| Other Pre-specified | Opportunistic Infection Rate | Opportunistic infections per patient-year | Posted | Mean | 95% Confidence Interval | Opportunistic infection per patient-year | 1 year |
|
|
|
| 0 |
| 68 |
| 6 |
| 68 |
| 68 |
| 68 |
| EG001 | Control Group | Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. | 0 | 68 | 16 | 68 | 68 | 68 |
| Laboratory abnormality | Metabolism and nutrition disorders | Systematic Assessment |
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| General Disorder | General disorders | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous System Disorder | Nervous system disorders | Systematic Assessment |
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| Psychiatric Disorder | Psychiatric disorders | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Abnormal Vital Signs | General disorders | Systematic Assessment |
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| Ear disorders | Ear and labyrinth disorders | Systematic Assessment |
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| Eye disorder | Eye disorders | Systematic Assessment |
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| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
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| Procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Laboratory Abnormality | Investigations | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| musculoskeletal disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous System Disorder | Nervous system disorders | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
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| Respiratory disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D001519 | Behavior |
| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 5 |
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| Grade 3 or higher |
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| Significant |
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| Minor |
|