- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03860818
Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention (ISTEP)
Improving Transplant Medication Safety Through a Technology and Pharmacist (ISTEP) Intervention in Veterans
Descripción general del estudio
Descripción detallada
Anticipated Impacts on Veterans Health Care: The first three essential strategies listed within the VA's Blueprint for Excellence encompass plans to improve care to vulnerable Veterans, deliver high quality care through achieving the "Triple Aim" and leverage the use of technology to improve the efficiency of care delivery. The intervention this grant proposes focuses on improving medication safety and care coordination within a high risk vulnerable Veteran population, leverages the use of informatics and analytics to support this intervention, and aims to demonstrate improved care at reduced costs through the pharmacist intervention; thus, perfectly aligning with these three essential components of the Blueprint. The overarching goal of this study is to develop a feasibly deployable, technology-enabled intervention that will demonstrate substantial improvements in immunosuppressant medication safety, clinical outcomes and health care costs in Veteran organ transplant recipients; demonstrating this through a randomized controlled trial will provide sufficient evidence to further develop a VA-specific pharmacist learning collaborative aimed at improving care and reducing costs for Veteran organ transplant recipients across the entire VA system.
Background: Organ transplant is the gold-standard treatment for patients with end organ diseases of the kidney, liver, heart and lungs, as it substantially improves survival and quality of life. Over the past 20 years, the use of contemporary immunosuppression has reduced the risk of acute rejection rates by upwards of 80%; yet long-term allograft survival remains suboptimal. Studies have demonstrated that causes of late graft loss is predominantly driven by immunosuppression adverse events and late allograft rejection episodes from medication errors and non-adherence, which encompass issues directly related to medication safety. The investigators' research demonstrates that medication errors occur in nearly two-thirds of transplant recipients, leading to hospitalization in 1 in 8 recipients. Recipients that develop significant medication errors are at considerably higher risk of graft loss, leading to higher costs and mortality. Thus, in order to improve medication safety and long-term outcomes in transplant recipients, enhancements in immunosuppressant therapy management is needed.
Objectives: The central hypothesis for the ISTEP study (Improving Transplant Medication Safety through a TEchnology and Pharmacist Intervention) is that pharmacist-led immunosuppressant therapy management, facilitated through the use of innovative technology, will significantly improve immunosuppressant safety and clinical outcomes in Veteran transplant recipients.
Methods: This is a 24-month, prospective, cluster-randomized controlled clinical trial at 10 sites, randomizing 5 sites to standard clinical care and 5 to standard care and the technology-enabled pharmacist intervention. The technology component of this intervention consists of the use of an expanded dashboard system that has already demonstrated effectiveness in improving immunosuppression monitoring. The dashboard performs population-level surveillance of transplant recipients and identifies those with potential drug-related problems, including non-adherence, drug interactions, missing and worrisome trends in labs; then providing a real-time alert to the pharmacist, who will determine its relevance and intervene in an appropriate protocol-guided manner. Effectiveness will be determined by comparing the rates of hospitalizations and ER visits between groups, while adjusting for baseline patient, provider and facility characteristics. Secondary measures include comparing healthcare costs and determining dashboard functionality, dashboard actionability and pharmacist intervention types and acceptance rates. The investigators will also assess the overall incidence and severity of drug-related problems and graft and patient survival rates and compare these between the intervention and control sites.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29401-5799
- Ralph H. Johnson VA Medical Center, Charleston, SC
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Veteran organ transplant recipients will be identified using ICD-9/10 codes from the VA electronic health record (CPRS).
- Patients must have an active code stating they are a recipient of an organ transplant.
The following codes will be utilized - oICD-9 codes:
- V42.0
- V42.1
- V42.6
- V42.7
- V42.83
- V42.84
- 996.81
- 996.82
- 996.83
- 996.84
- 996.86
- 52.80
OR
oICD-10 codes:
- C80.2
- T86.1
- T86.10
- T86.11
- T86.12
- T86.13
- T86.19
- T86.2
- T86.20
- T86.21
- T86.22
- T86.23
- T86.290
- T86.298
- T86.3
- T86.30
- T86.31
- T86.32
- T86.33
- T86.39
- T86.4
- T86.40
- T86.41
- T86.42
- T86.43
- T86.49
- T86.810
- T86.811
- T86.812
- T86.818
- T86.819
- T86.9
- Z48.2
- Z48.21
- Z48.22
- Z48.23
- Z48.24
- Z48.280
- Z48.288
- Z48.298
- Z94.0
- Z94.1
- Z94.2
- Z94.3
- Z94.4
- Z94.83
AND
- Actively receiving at least one anti-rejection medication dispensed by the VA site.
These medications include:
- tacrolimus
- cyclosporine
- azathioprine
- mycophenolate
- sirolimus
- everolimus
- belatacept
Exclusion Criteria:
- There are no exclusion criteria for patients in this study as recruitment is at the level of the VA site.
- All veterans meeting inclusion criteria will be monitored by the dashboard system and will be included in the outcomes assessment.
- Patients may enter or exit the study in a rolling manner, which will be accounted for during analyses.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Control Arm
Usual Care
|
|
Experimental: Intervention Arm
Technology-enabled pharmacist intervention
|
Technology-enabled pharmacist intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Rate of hospitalization and emergency room visits
Periodo de tiempo: 24-months
|
24-month rate of hospitalization and emergency room visits compared between the intervention and usual care groups
|
24-months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total estimated health care costs
Periodo de tiempo: 24-months
|
24-month total estimated health care costs, compared between the intervention and usual care groups
|
24-months
|
Graft survival
Periodo de tiempo: 24-months
|
Estimated graft survival rates, compared between the intervention and usual care groups and defined as the proportion of patients that continue to have a functioning allograft at the end of the 24-month study
|
24-months
|
Patient survival
Periodo de tiempo: 24-months
|
Estimated patient survival rates, compared between the intervention and usual care groups and defined as the proportion of patients alive at the end of the 24-month study
|
24-months
|
Medication safety issues
Periodo de tiempo: 12-months
|
Potential medication safety issues, defined as the proportion of patients with the following, based on automated reports for the transplant medication dashboard
|
12-months
|
Clinical relevant alerts
Periodo de tiempo: 12-months
|
Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists
|
12-months
|
Accepted interventions
Periodo de tiempo: 12-months
|
Proportion of interventions that were deemed to be accepted when made to other providers based on dashboard reporting information
|
12-months
|
Time requirements
Periodo de tiempo: 12-months
|
Average time each intervention pharmacist spent on assessing the dashboard alerts
|
12-months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David J. Taber, PharmD, Ralph H. Johnson VA Medical Center, Charleston, SC
Publicaciones y enlaces útiles
Publicaciones Generales
- Taber DJ, Ward R, Axon RN, Walker RJ, Egede LE, Gebregziabher M. The Impact of Dual Health Care System Use for Obtaining Prescription Medications on Nonadherence in Veterans With Type 2 Diabetes. Ann Pharmacother. 2019 Jul;53(7):675-682. doi: 10.1177/1060028019828681. Epub 2019 Feb 6.
- Hall CL, Fominaya CE, Gebregziabher M, Milfred-LaForest SK, Rife KM, Taber DJ. Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP): Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2019 Oct 1;8(10):e13821. doi: 10.2196/13821.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IIR 15-359
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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