Optimization of the Prescription of Gastric Acid Blockers – DROPIT Study: a Randomized Clinical Study in an Outpatient Setting
Descrizione riassuntiva dello studio
In this study, 80 general practitioners and a total of 400 participants will be included. The study participants are adults who have been prescribed gastric acid blockers without reason for a long time or in too high a dosage. Additionally, there must be no additional risk factors to consider. The general practitioners and participants will be randomly assigned to an experimental group and a control group. The experimental group will receive a guideline for the optimal prescription of gastric acid blockers for the included participants, while the participants in the control group will continue to be treated as usual by their general practitioner. The participants will not know which group they have been assigned to (blinded study). The study lasts 12 months. Every 3 months, online questionnaires will be sent to the general practitioners and participants, collecting data on medications, diagnoses, quality of life, and use of medical infrastructure, e.g., number of hospitalizations. Already during the study and also at the end of the study, we will compare the change in prescriptions of gastric acid blockers between the two groups (control group and experimental group). We will also take care of the safety of all participants and check that the optimization guideline does not lead to any uncertainties or dangerous situations. Finally, we will also compare the costs of the two groups and gather the opinions of all participants regarding the study. The collected data will be analyzed anonymously and the study results will subsequently be published in specialized journals.
(BASEC)
Intervento studiato
In this study, the general practitioners will be randomly assigned to a control group or an experimental group. The experimental group will receive a guideline for the optimal prescription of gastric acid blockers for the included participants, while the participants in the control group will continue to be treated as usual by their general practitioner.
This guideline will be developed by the study team before the start of the study. The intervention will include a clearly structured guideline for reviewing the medications of the participants and will guide the general practitioner and the participants through an algorithm that will help them better decide whether it makes sense in individual cases to continue prescribing the gastric acid blocker, reduce it, or even stop it altogether. The decision criteria for adjusting the prescription are based on safe, sustainable, and evidence-based knowledge and will be developed in collaboration with experts, general practitioners, and patients.
(BASEC)
Malattie studiate
This study does not investigate any disease, but rather a guideline for the use of gastric acid blockers. Gastric acid blockers, also known as stomach protectors, are medications that reduce gastric acid. These medications are usually taken as tablets, typically once daily in the morning before meals. The indications for gastric acid blockers are very diverse and range from acid reflux (reflux), as an accompanying medication in pain therapy, to treatment for a known gastric ulcer or after a gastric bleed. Participants in the study are individuals who have been taking a gastric acid blocker for a very long time or at a high dosage. Gastric acid blockers reduce acid production in the stomach and thereby alleviate symptoms. Normally, this medication is discontinued after 8 to 12 weeks. However, it can happen that these are forgotten and remain on the medication list or are simply continued at too high a dosage. This is referred to as inappropriate gastric acid blockers. Like other medications, gastric acid blockers can lead to side effects, e.g., vitamin B12 deficiency, calcium deficiency, an increased risk of bone fractures and infections, etc. Therefore, it is of great interest to verify whether their benefit still exists with long-term use. In some cases, it may be advisable to reduce the dose, stop completely, or use the gastric acid blocker only as needed. This is precisely why we are developing a guideline for general practitioners, which is intended to help evaluate and optimize the use of gastric acid blockers. Our study aims to examine the benefits of using this guideline to optimize the prescription of gastric acid blockers.
(BASEC)
> Patient of the study's general practitioner > Patient ≥18 years > Daily intake of gastric acid blocker for ≥8 weeks > Dosage of gastric acid blocker 2 times daily or too high dosage > Sufficient knowledge of German (BASEC)
Criteri di esclusione
> Life expectancy of less than 12 months as assessed by the general practitioner > No informed consent > Gastric acid blockers at an appropriate dosage or for a known and correct diagnosis such as: o Gastric ulcer bleeding o Gastric ulcer o Barrett's esophagus o Reflux (Los Angeles Class C or D) o Gastroesophageal reflux disease (GERD) o Other indications such as Zollinger-Ellison syndrome; eosinophilic esophagitis sensitive to stomach protectors; chronic pancreatitis with fatty stools that does not respond to enzyme therapy; unexplained pulmonary fibrosis. > If 2 or more of the following medications, or one of the following medications and one of the listed risk factors occur: o Medications: Pain medications > 7 days Platelet aggregation inhibitors such as aspirin cardio Additional platelet aggregation inhibitors such as ticagrelor or similar Anticoagulants Systemic corticosteroids > 1 month o Risk factors: History of gastric or intestinal ulcer Age ≥65 years Antidepressants of the SSRI or SNRI class Diagnoses that increase the risk of gastrointestinal bleeding as assessed by the general practitioner (BASEC)
Luogo dello studio
Aarau, Basilea, Berna, Chur, Luzern, San Gallo, Zurigo, Altro
(BASEC)
Deutschschweiz
(BASEC)
Sponsor
Institute of Primary Health Care (BIHAM) University of Bern, Switzerland.
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Dr. phil. Sven Streit
+41 31 684 58 75
sven.streit@clutterunibe.chInstitute of Primary Health Care (BIHAM) University of Bern, Switzerland.
(BASEC)
Informazioni generali
University of Bern, Institute of Primary Health Care (BIHAM),
+41 31 684 58 75
sven.streit@clutterunibe.ch(ICTRP)
Informazioni scientifiche
University of Bern, Institute of Primary Health Care (BIHAM),
+41 31 684 58 75
sven.streit@clutterunibe.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
19.09.2024
(BASEC)
ID di studio ICTRP
NCT06129474 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Deprescribing inappropriate proton pump inhibitors – the DROPIT Trial: a cluster randomized controlled trial in primary care setting (BASEC)
Titolo accademico
DepRescribing inapprOpriate Proton Pump InhibiTors - the DROPIT Trial: a Cluster Randomized Controlled Trial in Primary Care Setting (ICTRP)
Titolo pubblico
Deprescribing Inappropriate Proton Pump Inhibitors (ICTRP)
Malattie studiate
Inappropriate Prescribing;Reflux Disease;Proton Pump Inhibitors (ICTRP)
Intervento studiato
Other: Proton Pump Inhibitor deprescribing tool (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
1. Patient of a participating GP.
2. Age =18 years old.
3. Daily PPI intake for =8 weeks.
4. PPI twice a day or in a dose as:
>40mg/day pantoprazole; >40mg/day omeprazole; >30mg/day lansoprazole; >30mg/day
dexlansoprazole; >20mg/day esomeprazole; >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 < 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 below risk factors.
Medications (any dose):
- Daily use of non-steroidal anti-inflammatory drug (NSAID) >7 days.
- Antiplatelet therapy.
- Additional antiplatelet therapy (e.g., ticagrelor or similar).
- Anticoagulant(s).
- Systemic steroid(s) >1 month.
Risk factors:
- History of gastrointestinal ulcer.
- Age =65 years.
- 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). (ICTRP)
non disponibile
Endpoint primari e secondari
Effectiveness co-primary endpoint: prescribed PPI dose over 12 months follow-up (superiority endpoint).;Safety co-primary endpoint: upper gastrointestinal symptoms (Non-inferiority endpoint) (ICTRP)
Occurrence of reduction of at least 50% of the prescribed PPI dose over the follow-up time.;Occurrence of PPI discontinuation;Occurrence of PPI sustained discontinuation;Occurrence of a switch to prescription for on-demand use;Occurrence of use of alternative anti-reflux treatments;Regurgitation;Heartburn;Dyspepsia;Atypical gastrointestinal symptoms;Occurrence of ulcers and/or gastrointestinal bleeding;Occurrence of potential side effects of PPI overuse during the conduct of the trial.;Quality of life (EQ-5D-5L);Number of all medications prescribed during the conduct of the trial (ICTRP)
Data di registrazione
23.10.2023 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Swiss National Science Foundation;University of Zurich;University of Basel;Insel Gruppe AG, University Hospital Bern;Patientenstelle Z?rich;Patientenstelle Basel;Centre Hospitalier Universitaire Vaudois (ICTRP)
Contatti aggiuntivi
Sven Streit, Prof. Dr. med. Dr. phil;Sven Streit, Prof. Dr med. Dr. phil., sven.streit@unibe.ch, +41 31 684 58 75, University of Bern, Institute of Primary Health Care (BIHAM), (ICTRP)
ID secondari
DROPIT Trial_v1.0 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06129474 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile