- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00122122
Randomized Controlled Trial of Enhanced Pharmacy Care in Older Veteran Outpatients
Complications resulting from medications, or adverse drug events (ADEs), are prevalent and are a major source of excess morbidity and costs. ADEs are particularly problematic in older patients because of their higher burden of comorbidity and diminished physiologic reserve. In addition, older patients are more likely to be exposed to polypharmacy, a major risk factor for ADEs. While ADEs may be idiosyncratic, many result from medical errors and inadequate systems for ensuring the safe and effective use of medications.
The goal of the proposed study is to test the efficacy of a potentially potent intervention to improve the use of medications in older outpatients enrolled in VA primary care clinics. The intervention-Enhanced Pharmacy Care-involves a formal, multi-dimensional evaluation of patients� medication regimens by a trained clinical pharmacist and board-certified geriatrician.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Background:
Complications resulting from medications, or adverse drug events (ADEs), are prevalent and are a major source of excess morbidity and costs. ADEs are particularly problematic in older patients because of their higher burden of comorbidity and diminished physiologic reserve. In addition, older patients are more likely to be exposed to polypharmacy, a major risk factor for ADEs. While ADEs may be idiosyncratic, many result from medical errors and inadequate systems for ensuring the safe and effective use of medications.
The goal of the proposed study is to test the efficacy of a potentially potent intervention to improve the use of medications in older outpatients enrolled in VA primary care clinics. The intervention-Enhanced Pharmacy Care-involves a formal, multi-dimensional evaluation of patients� medication regimens by a trained clinical pharmacist and board-certified geriatrician.
Objectives:
The study has the following six aims: 1) Compare changes in prescribing practices-as measured by medication appropriateness, number of medications, and cost of prescribed medications-between baseline and follow-up in patients randomized to Enhanced Pharmacy Care and patients randomized to usual care; 2) Compare other medication-based endpoints in the two groups, including the occurrence of potential ADEs, medication compliance, and patient knowledge of medications; 3) Compare changes in health-related-quality-of-life in the two groups; 4) Compare patient perceptions of the quality of VA outpatient care in the two groups; 5) Compare health care utilization during the one-year study period in the two groups; and 6) Examine attitudes of primary care providers (PCPs) about the intervention.
Methods:
Patients were eligible for the trial if they were 65 years and older and receiving prescriptions for > 5 medications in a VA primary care clinic. Patients were randomized to usual care or to the intervention, which included a structured medication history and medical records review. For intervention patients, therapeutic recommendations were developed and presented to primary care providers. Baseline and 3-month measures were obtained and change was assessed by analysis of covariance.
Status:
493 patients have been enrolled in the trial and 12-month follow-up has been completed on over 95% of patients. Preliminary results have been evaluated and abstracts have been submitted to national meetings, including the 2004 VA HSR&D and 2004 SGIM Annual Meetings where it will be presented as an oral presentation. We are completing all the data cleaning and will be performing final analyses on the data, with manuscript preparation. Final outcome assessment using the Medication Appropriateness Index is in the final stage.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Iowa
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Iowa City, Iowa, Stany Zjednoczone, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Patients enrolled in VA primary care clinics who are 65 years and older and who are receiving prescriptions for 5 or more scheduled medications.
Exclusion Criteria:
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Inny: Ramię 1
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Gary E. Rosenthal, MD, Iowa City VA Health Care System, Iowa City, IA
Publikacje i pomocne linki
Publikacje ogólne
- Steinman MA, Rosenthal GE, Landefeld CS, Bertenthal D, Kaboli PJ. Agreement between drugs-to-avoid criteria and expert assessments of problematic prescribing. Arch Intern Med. 2009 Jul 27;169(14):1326-32. doi: 10.1001/archinternmed.2009.206.
- Steinman MA, Rosenthal GE, Landefeld CS, Bertenthal D, Sen S, Kaboli PJ. Conflicts and concordance between measures of medication prescribing quality. Med Care. 2007 Jan;45(1):95-9. doi: 10.1097/01.mlr.0000241111.11991.62.
Daty zapisu na studia
Główne daty studiów
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- SAF 98-152
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 .
Badania kliniczne na Enhanced Pharmacy Care
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Medical College of WisconsinRekrutacyjnyCukrzyca typu 2Stany Zjednoczone
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Kerry KuehlRekrutacyjnyStres zawodowy | Zdrowie psychiczne Wellness 1 | Zachowanie zdrowotne | Problemy z bezpieczeństwemStany Zjednoczone
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Kocaeli Derince Education and Research HospitalKocaeli UniversityNieznanyLepsza rekonwalescencja po operacji | Operacja na otwartym sercuIndyk
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VA Office of Research and DevelopmentIcahn School of Medicine at Mount Sinai; Weill Medical College of Cornell University i inni współpracownicyZakończony
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Sheba Medical CenterNieznany
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Silke Wiegand-Grefe, Prof. Dr.Charite University, Berlin, Germany; Hannover Medical School; University Hospital... i inni współpracownicyAktywny, nie rekrutujący
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David Grant U.S. Air Force Medical CenterZakończonyNapięcie mięśniStany Zjednoczone
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Assiut UniversityJeszcze nie rekrutacjaChoroby przełyku | Powikłanie przełyku
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Johnson & Johnson Vision Care, Inc.ZakończonyOstrość wzroku, biomikroskopia w lampie szczelinowej (ocena barwienia rogówki)Stany Zjednoczone
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University of AlbertaUniversity Hospital FoundationZakończonyMigotanie przedsionkówKanada