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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PRIMARY CARE CENTERS IN THE BARAKALDO-SESTAO INTEGRATED HEALTHCARE ORGANISATION OF OSAKIDETZA-BASQUE HEALTH SERVICE:
- •Inclusion Criteria:
- •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
排除标准
- •PATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS:
- •Inclusion Criteria:
- •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.
- •Exclusion Criteria:
- •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
研究组 & 干预措施
Control
All health centre clusters will start under the control condition
干预措施: Usual AF (Behavioral)
Intervention
one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention
干预措施: Usual AF (Behavioral)
Intervention
one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention
干预措施: Facilitated AF (Behavioral)
结局指标
主要结局
Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP
时间窗: From baseline to 16 months
proportion of patients for whom appropriateness is achieved, either through deprescribing or tapering (for example, dose reduction) of any of the drugs potentially inappropriately prescribed in the patients included in the clusters.
次要结局
- Secondary effectiveness: Proportion of patients with deprescribing or tapering for each PIP(From baseline to 16 months)
- Secondary Effectiveness: Rate of new PIP(From baseline to 16 months)
- Adoption: Percentage of General Practitioners who agree to receive the active components of the strategies(From baseline to 16 months)
- Degree of implementation fidelity(From baseline to 16 months)
- General Practitioners´ perception of the feasibility and acceptability(From baseline to 22 months)
研究者
Mikel Baza Bueno
Principal Investigator
Basque Health Service