The Perfect-CR Implementation Study
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: Audit and feedback through a quality registry, Implementation support.
- Кому может быть актуально
- Состояния в реестре: Myocardial Infarction, Risk Reduction. Базовые параметры: 18 лет — 79 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Audit and Feedback Within a National Registry and Implementation Support on Guideline Adherence and Patient Outcomes in Cardiac Rehabilitation: an Open-label Cluster-randomized Effectiveness-implementation Hybrid Trial
Обзор
The goal of this open-label cluster-randomized effectiveness-implementation hybrid trial is to study whether a) audit and feedback of cardiac rehabilitation service delivery within a national quality registry and b) structured implementation support can improve center-level adherence to guidelines and short and long-term patient-level outcomes.
Подробное описание
Administering secondary prevention via structured cardiac rehabilitation (CR) programs for patients who have suffered a myocardial infarction (MI) reduces mortality and morbidity and improves quality of life. Still, treatment goal achievement at patient-level and service delivery at center-level are sub-optimal and there is a large variation in program structure and delivery at center-level.
Using an open-label cluster-randomized effectiveness-implementation hybrid trial design, the primary objective of this study is to prospectively evaluate whether a) audit and feedback of CR processes and structures within the national cardiac registry SWEDEHEART and b) supporting CR centers in implementing CR guidelines can increase center-level guideline adherence. The secondary objectives are the following:
* At baseline, to cross-sectionally evaluate the association between center-level adherence to guidelines and patient-level outcomes * To prospectively study whether audit and feedback of CR processes and structures within the SWEDEHEART registry can improve short- and long-term patient-level outcomes * To prospectively evaluate whether supporting CR centers in implementing CR guidelines can improve short- and long-term patient-level outcomes * To evaluate the acceptability, adoption, fidelity, implementation cost, and cost effectiveness of the implementation support
All CR centers in Sweden (approximately 75 centers) will be offered participation in the study. Collectively these centers attend to approximately 8000 patients/year. Patient-level outcome data will be retrieved from national registries.
Вмешательства
- Другое Audit and feedback through a quality registry
Centres answer CR process and structure variables through the SWEDEHEART registry every six months for three years. Feedback will be accessible online and through annual reports, enabling comparisons with own prior and other centres´ results. - Другое Implementation support
On-site support to implement guidelines on secondary prevention applying practice facilitation - a multifaceted approach carried out by CR experts who enable personnel at intervention centres to address and overcome challenges in implementing guidelines.
Первичные конечные точки
- Adherence score [Срок оценки: 3 years]
Вторичные конечные точки (12)
- Blood pressure target attainment [Срок оценки: One year]
- Systolic blood pressure [Срок оценки: One year]
- Low-density lipoprotein cholesterol target attainment [Срок оценки: One year]
- Low-density lipoprotein cholesterol [Срок оценки: One year]
- Self-reported quality of life [Срок оценки: One year]
- Self-reported smoking status [Срок оценки: One year]
- Self-reported dietary habits [Срок оценки: One year]
- Self-reported physical activity [Срок оценки: One year]
- Attendance in an exercise-based CR programme [Срок оценки: One year]
- Major adverse cardiovascular events (MACE) [Срок оценки: Five years]
- Total mortality [Срок оценки: Five years]
- Acceptability of the implementation support [Срок оценки: Assessed at the time of implementation]
Критерии участия
Centre-level
Критерии включения
- Centres report to the SWEDEHEART registry
Критерии исключения
- Unwillingness to participate in the study
Patient-level
Критерии включения
- Diagnosis of a type 1 MI registered in the SWEDEHEART registry
- Age 18-79 years at discharge from hospital
- Attended at least two follow-up visits at CR centres included in the study
Критерии исключения
- None
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
- Организация здравоохранения
Центры проведения
Швеция · 1 центр
- Skåne University Hospital — Malmö
Публикации
- Michelsen HO, Lidin M, Back M, Duncan TS, Ekman B, Hagstrom E, Hagglund M, Lindahl B, Schlyter M, Leosdottir M. The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial. Implement Sci. 2024 May 24;19(1):35. doi: 10.1186/s13012-024 PMID 38790045
Идентификаторы
NCT: NCT05889416 · Perfect-CR V2.0 2023