💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Patient of a participating GP.
2. Age: minimum 18 years old.
3. Daily PPI intake for minimum 8 weeks.
4. 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.
5. Sufficient knowledge of German language to understand the trial and follow-up according to GP assessment.
Exclusion Criteria:
1. Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy of less than 12 months.
2. Unable to provide informed consent.
3. 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.)
4. 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).
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