Reduction of Low-value Prescribing Through Audit and Feedback

Официальное название

AFFAP Trial: The Comparative Evaluation of Audit and Feedback-based De-implementation Strategies to Reduce Low-value Prescribing in Primary Care in Patients Over 65 Years of Age.

Обзор

The objective is to estimate the effect attributable to a primary care pharmacist-led audit and feedback (AF) strategy compared to the currently used AF strategy as a management tool to evaluate healthcare performance focusing on processes and outcomes, for reducing the rate of patients over 65 years of age with potentially inappropriate prescribing (PIP) of benzodiazepines, proton pump inhibitors and opioids. A closed-cohort stepped-wedge cluster-randomised trial will be conducted in nine PC centres from Barakaldo-Sestao Integrated Health Organization, Basque Health Service (Osakidetza). All health centre clusters will start under the control condition, and after an initial study period of 4 months in the control phase, one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention, under which they will be exposed to an additional component of AF, namely, primary care pharmacist-led facilitation. Mixed-methods analysis will be performed, gathering quantitative data to assess the results of the implementations at health centre and clinician levels, and qualitative data to assess the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and explore the experience and satisfaction of patients regarding the healthcare received. This study will provide useful knowledge on the effect attributable to a more intensive AF strategy (facilitated AF) compared to standard procedures of AF reports, and of the characteristics of AF that are most effective.

Вмешательства

• Поведенческое Usual AF
  The strategy currently used as a management tool to evaluate healthcare performance focusing on processes and outcomes, as part of Osakidetza's operating contract: provision of AF, sent to PC centres every 4 months with data on overall rates of PIP, lists of patients over 65 years old who have a potentially inappropriate prescription of at least one of the drugs of interest, and provision of support materials related to appropriate prescribing and recommendations on deprescribing.
• Поведенческое Facilitated AF
  Based on a facilitation component delivered by PC pharmacy staff. Specifically, the PC pharmacists will conduct a facilitation session with the centre's clinicians in which they will review the magnitude of PIP in the centre (PIP rates), appropriateness/inappropriateness criteria, and guidelines to encourage deprescribing, and draw up an action plan at clinician and centre levels.

Первичные конечные точки

• Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP [Срок оценки: From baseline to 13 months]

Вторичные конечные точки (5)

• Secondary effectiveness: Proportion of patients with deprescribing or tapering for each PIP [Срок оценки: From baseline to 13 months]
• Secondary Effectiveness: Rate of new PIP [Срок оценки: From baseline to 13 months]
• Adoption: Percentage of General Practitioners who agree to receive the active components of the strategies [Срок оценки: From baseline to 13 months]
• Degree of implementation fidelity [Срок оценки: From baseline to 13 months]
• General Practitioners´ perception of the feasibility and acceptability [Срок оценки: From baseline to 19 months]

Критерии участия

PRIMARY CARE CENTERS IN THE BARAKALDO-SESTAO INTEGRATED HEALTHCARE ORGANISATION OF OSAKIDETZA-BASQUE HEALTH SERVICE:

Критерии включения

• collaboration is achieved from at least 51% of the General Practitioners (GP) or at least 4 GPs
• At least 60 patients aged 65 years or older on at least one of the drugs of interest that may be potentially inappropriately prescribed

Критерии исключения

• N/A

PATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS:

Критерии включения

• Patients over 65 years of age with any of the following unsuitability criteria:
• PIP of benzodiazepines: patients on benzodiazepines for more than 3 months
• PIP of proton pump inhibitors: patients on proton pump inhibitors for more than 8 weeks without a diagnosed gastrointestinal disease and with no long-term prescription of gastrotoxic drugs.
• PIP of opioids: patients on opioids for non-cancer pain for more than 3 months.

Критерии исключения

• Patients who, in the opinion of the general practitioner, are not suitable candidates for tapering or discontinuation of the potentially inappropriately prescribed drug
• Patients residing in care homes
• Patients receiving palliative care

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Испания · 1 центр

• Primary Care Research Unit of Bizkaia — Barakaldo

Идентификаторы

NCT: NCT07336550 · 2024111054 · 2018111085 · 2021111024 · PI21/00025 · RD24/0005/0017 · RD21/0016/0003 · RD16/0007/0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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