- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
South Carolina
-
Charleston, South Carolina, Stany Zjednoczone, 29401-5799
- Ralph H. Johnson VA Medical Center, Charleston, SC
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Brak interwencji: Control Arm
Usual Care
|
|
Eksperymentalny: Intervention Arm
Technology-enabled pharmacist intervention
|
Technology-enabled pharmacist intervention
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Rate of hospitalization and emergency room visits
Ramy czasowe: 24-months
|
24-month rate of hospitalization and emergency room visits compared between the intervention and usual care groups
|
24-months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Total estimated health care costs
Ramy czasowe: 24-months
|
24-month total estimated health care costs, compared between the intervention and usual care groups
|
24-months
|
Graft survival
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 12-months
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Potential medication safety issues, defined as the proportion of patients with the following, based on automated reports for the transplant medication dashboard
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12-months
|
Clinical relevant alerts
Ramy czasowe: 12-months
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Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists
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12-months
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Accepted interventions
Ramy czasowe: 12-months
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Proportion of interventions that were deemed to be accepted when made to other providers based on dashboard reporting information
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12-months
|
Time requirements
Ramy czasowe: 12-months
|
Average time each intervention pharmacist spent on assessing the dashboard alerts
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12-months
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: David J. Taber, PharmD, Ralph H. Johnson VA Medical Center, Charleston, SC
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- IIR 15-359
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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