Dispensing of Antibiotics in Pharmacies for Cystitis According to a Delegation Protocol, Impact of a Decision Support Tool. PHARIBO: PHarmacy and Resolved Antibiotherapy for Urinary Tract Infections
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Share making decision tool, Delegation protocol.
- Кому может быть актуально
- Состояния в реестре: Acute Cystitis. Базовые параметры: 18 лет — 65 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Dispensing of Antibiotics in Pharmacies for Cystitis According to a Delegation Protocol, Impact of a Decision Support Tool : a Randomised Cluster Trial. PHARIBO: PHarmacy and Resolved Antibiotherapy for Urinary Tract Infections
Обзор
The purpose of this trial is to demonstrate that when treating acute cystitis without risk of complication, pharmacists may use share Decision Making tool to help patients to better understand the stakes of taking antibiotics and adapt the management of the delegation protocol. This will select patients in need of antibiotics and preserve the full-capacities of non-treated one.
Подробное описание
Each year, in France, more than 2.000.000 patients visit for a acute cystitis. The literature shows that acute cystitis without risk of complication cause pyelonephritis only on really rare situation, but french delegation protocols to pharmacist ask for systematic antibiotic therapy as soon as the diagnostic is made with the only goal to lowering symptomatology. Studies shows that some informed women would like not to take antibiotics while others studies show us that pain-killers could be as effective as antibiotics on case of low symptomatology.
This study will compare a group following only the French protocols for delegating acute cystitis to the pharmacist with a group using the same protocol, but supplementing it with a shared decision-making tool to determine whether, after being informed of the benefits and risks of this treatment, patients still wish to receive an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.
After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get informations (antibiotic prescription or not, patient socio-demographic criteria). Then patients will be followed by telephone on D14 to know if they've take antibiotics and to obtain the following information: AIA scale, O'Connor Scale, Satisfaction scale, if there has been visit to the emergency room or doctor. Antibiotics delivery on pharmacy will be watch by National assurance number of the included patients
Вмешательства
- Другое Share making decision tool
the experimental group will apply the delegation protocol, but if the protocol recommends antibiotic therapy, the researchers will propose a shared decision using a specific tool to determine with the patient whether to deliver the antibiotic - Другое Delegation protocol
the control group will apply the delegation protocol alone
Первичные конечные точки
- Dispensing of antibiotic [Срок оценки: day 14 after inclusion]
Вторичные конечные точки (4)
- Activity Impairment Assessment(AIA) scale [Срок оценки: day 14 after inclusion]
- Satisfaction scale [Срок оценки: day 14 after inclusion]
- O'Connor scale [Срок оценки: day 14 after inclusion]
- Medical consultation [Срок оценки: day 14 after inclusion]
Критерии участия
Критерии включения
- woman,
- symptom of acute cystitis without risk of complication,
- affiliated to the french public welfare system,
- signed consent.
Критерии исключения
- anomaly of the urinary canal,
- pregnancy, more than 3 cystitis during the last year,
- cancer,
- immunosuppression,
- hemopathy,
- fever,
- back-pain,
- severe renal failure,
- refuse to give consent and previously participate to the study,
- under guardianship.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Франция · 14 центров
- Pharmacie Lemarquis — Aire-sur-l'Adour
- Pharmacie Lafitte — Arès
- CHU de Bordeaux — Bordeaux
- Pharmacie Pattyn Nizard — Caudebec-lès-Elbeuf
- Pharmacie Saint-Jean d'Elbeuf — Elbeuf
- Pharmacie Tranchant — Elbeuf
- Pharmacie du Réolais — La Réole
- Pharmacie de Gascogne — Léguevin
- … и ещё 6 центров
Идентификаторы
NCT: NCT07118748 · CHUBX 2024/66