DepRescribing inapprOpriate Proton Pump InhibiTors - the DROPIT Trial: a Cluster Randomized Controlled Trial in Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Effectiveness co-primary endpoint: prescribed PPI dose over 12 months follow-up (superiority endpoint).
研究概览
简要总结
The DROPIT Trial is an interventional, open-labelled, cluster-randomized controlled trial conducted in the Swiss primary care setting. It aims to evaluate an intervention to guide the deprescribing of inappropriate proton-pump inhibitors (PPIs). Therefore, the trial investigates whether the study intervention leads to the deprescribing of inappropriate PPI prescription while ensuring noninferiority safety, in comparison to usual care. Additionally, the trail aims to investigate the intervention's impact on other clinical aspects, as well as addressing features of the implementation of the intervention and its cost-effectiveness.
详细描述
Background and rational:
Proton pump inhibitors (PPIs) are the most frequent treatment of gastric acid related disorders. The use of PPIs is increasing, as well as concerns about their inappropriate use. Long-term use of PPIs has been associated with adverse events (e.g., nutritional deficiencies, osteoporosis, infections). Therefore, deprescribing (stopping or reducing dose) PPIs when they are not or no longer indicated is expected to benefit the patients. While general practitioners (GPs) and patients may be reluctant to deprescribing, studies suggest that clinicians would be more comfortable with deprescribing after additional training, and that patients' acceptance increases following recommendations from their doctor. This highlights the importance of providing GPs and patients with the necessary tools for safe deprescribing. In Switzerland, there is evidence of PPI use without adequate indication or dose.
In the pilot survey conducted within the current project, which involved 48 GPs, 55% of them reported often encountering patients who were prescribed inappropriate PPIs, and 58% expressed a desire for a PPI deprescribing guideline. Optimizing PPI use in Switzerland is needed and of interest. Therefore, the investigators aim to conduct a clinical trial to evaluate an intervention to guide deprescribing of inappropriate PPIs. Additionally, alongside the trial, there will be an integrated process evaluation of the intervention, and a cost-effectiveness evaluation.
Study design:
This interventional, open-labelled, cluster-randomized controlled trial in Swiss primary care setting, aims to evaluate an intervention to guide deprescribing of inappropriate PPIs. In this trial, adult patients with inappropriate PPI prescription will be recruited by GPs in the German speaking part of Switzerland. Based on 1:1 cluster randomization of GPs, patients will be assigned to either the control group or to the group receiving an intervention to guide deprescribing of inappropriate PPIs. The control group will receive usual care. The investigators will compare the effectiveness and safety of the intervention with usual care, over a 12-month follow-up period. Alongside the trial, an integrated process evaluation of the intervention and a cost-effectiveness evaluation will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Even though this is an open label study, the investigators have measures in place to mask the participants as much as possible. Patients of both groups will receive a description of the trial, which mentions inappropriate prescription of medications but not PPI, which keeps them blinded. However, GPs and patients in the intervention group may not necessarily remain blinded, since they may be questioned about the intervention as part of the integrated process evaluation of the intervention. The control group will remain unaware of the detailed nature of the intervention. In case more than one GP from a group practice takes part in this trial, GPs are instructed to keep trial-related communication and exchanges to a minimum. Team members collecting data will remain blinded to the group allocation of the patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of a participating GP.
- •Age: minimum 18 years old.
- •Daily PPI intake for minimum 8 weeks.
- •PPI in one of the following doses:
- •minimum 40mg/day pantoprazole;
- •minimum 40mg/day omeprazole;
- •more than 30mg/day lansoprazole;
- •more than 30mg/day dexlansoprazole;
- •more than 20mg/day esomeprazole;
- •more than 20mg/day rabeprazole.
- •Sufficient knowledge of German language to understand the trial and follow-up according to GP assessment.
排除标准
- •Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy of less than 12 months.
- •Unable to provide informed consent.
- •PPI in an appropriate dose (see Appendix Table A1) and with an established indication for long-term PPI, such as:
- •History of bleeding ulcer.
- •Peptic ulcer due to cause other than NSAID or H. Pylori.
- •Barrett's oesophagus.
- •Severe erosive reflux disease (Los Angeles grade C/D).
- •GERD with symptoms or complications (oesophageal ulcer, peptic stricture).
- •Other indications (i.e., Zollinger-Ellison-Syndrome, PPI-sensitive eosinophilic esophagitis, chronic pancreatitis with steatorrhea refractory to enzyme replacement therapy, idiopathic pulmonary fibrosis.)
- •Two or more of the following medications, or one of the following medications and one or more of the mentioned risk factors mentioned below.
- •Medications (any dose):
- •Daily use of non-steroidal anti-inflammatory drug (NSAID) for more than 7 days.
- •Antiplatelet therapy.
- •Additional antiplatelet therapy (e.g., ticagrelor or similar).
- •Anticoagulant(s).
- •Systemic steroid(s) for more than 1 month.
- •Risk factors:
- •History of gastrointestinal ulcer.
- •Age of 75 years and older.
- •Selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) use.
- •Severe concomitant disease with increased risk of GI bleeding according to the GP's assessment (e.g., severe liver disease, neoplasia, nicotine or alcohol abuse).
研究组 & 干预措施
DROPIT Intervention
The study intervention is a patient-centred PPI deprescribing intervention aiming to guide GPs and patients through the process of safely deprescribing inappropriate PPIs.
干预措施: Proton Pump Inhibitor deprescribing tool (Other)
Usual Care
The reference or control arm will receive usual care. This means that the GPs and patients in this group will conduct their clinical practice as per usual, without receiving the intervention from the study team.
结局指标
主要结局
Effectiveness co-primary endpoint: prescribed PPI dose over 12 months follow-up (superiority endpoint).
时间窗: 12 months
Safety co-primary endpoint: upper gastrointestinal symptoms (Non-inferiority endpoint)
时间窗: 12 months
Co-primary endpoints measured by the Reflux Disease Questionnaire (RDQ), considering the worst of the subscales dyspepsia and gastroesophageal reflux disease (GERD) (i.e.,regurgitation and heartburn subscales combined).
次要结局
- Occurrence of potential side effects of PPI overuse during the conduct of the trial.(12 months)
- Occurrence of PPI discontinuation(12 months)
- Occurrence of PPI sustained discontinuation(12 months)
- Occurrence of a switch to prescription for on-demand use(12 months)
- Occurrence of use of alternative anti-reflux treatments(12 months)
- Regurgitation(12 months)
- Heartburn(12 months)
- Dyspepsia(12 months)
- Atypical gastrointestinal symptoms(12 months)
- Occurrence of ulcers and/or gastrointestinal bleeding(12 months)
- Occurrence of reduction of at least 50% of the prescribed PPI dose over the follow-up time.(12 months)
- Quality of life (EQ-5D-5L)(12 months)
- Number of all medications prescribed during the conduct of the trial(12 months)
- Occurrence of ulcers and/or gastrointestinal bleeding(12 months)
- Occurrence of reduction of at least 50% of the prescribed PPI dose over the follow-up time.(12 months)
- Occurrence of PPI discontinuation(12 months)
- Occurrence of PPI sustained discontinuation(12 months)
- Occurrence of a switch to prescription for on-demand use(12 months)
- Occurrence of use of alternative anti-reflux treatments(12 months)
- Regurgitation(12 months)
- Heartburn(12 months)
- Dyspepsia(12 months)
- Atypical gastrointestinal symptoms(12 months)
- Occurrence of potential side effects of PPI overuse during the conduct of the trial.(12 months)
- Quality of life (EQ-5D-5L)(12 months)
- Number of all medications prescribed during the conduct of the trial(12 months)