Clinical trial NCT06858384: RAK-PRIDE: Optimizing Proton Pump Inhibitor Use Through Education and Intervention
Official title: From Awareness to Action: Transforming Proton Pump Inhibitor Use in Ras Al Khaimah Through Education and Intervention: the RAK -PRIDE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proton Pump Inhibitors
Deprescribing
Inappropriate Use
Keywords: proton pump inhibitors
peptic ulcer disease
Deprescribing
pharmacist-led educational intervention
inappropriate use
RAK - PRIDE
Lead sponsor: RAK Medical and Health Sciences University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to determine if a pharmacist-led educational intervention can reduce the inappropriate use of proton pump inhibitors (PPIs) among adult patients (≥18 years) with potentially inappropriate PPI prescriptions in Ras Al Khaimah.

The main questions it aims to answer are:

* Can a pharmacist-led education program reduce unnecessary PPI use?
* Does the intervention improve patients' quality of life and reduce healthcare costs? Researchers will compare the intervention group (receiving pharmacist-led education and materials) to the usual care group to see if the intervention reduces PPI use and improves patient outcomes.

Participants will:

* Receive educational materials from pharmacists, including a patient educational brochure, PPI patient decision aid, PPI deprescribing pamphlet, and PPI patient action plan.
* Physicians involved will also receive a pharmaceutical intervention, which includes a physician educational brochure, PPI evidence-based deprescribing guideline, PPI deprescribing algorithm, and whiteboard videos on PPI deprescribing.
* Patients will be followed up for 6 months to monitor changes in PPI use, symptoms, and quality of life.

Detailed description: The RAK-PRIDE Study aims to evaluate the impact of a pharmacist-led educational intervention on the inappropriate use of proton pump inhibitors (PPIs) among adult patients in Ras Al Khaimah. This intervention will focus on both patient education and physician guidance, promoting evidence-based deprescribing practices for PPIs.

Eligibility criteria: Inclusion Criteria:

Physicians will be eligible to participate if:

* They are prescribing PPIs in outpatient department of the study sites
* They have patients with potentially inappropriate PPI prescriptions

Patients will be eligible to participate if:

* They are ≥18 years
* They are presenting to out-patient departments of the study sites
* They have prescriptions of potentially inappropriate PPIs
* Their treating physicians are included in the study

Exclusion Criteria:

Physicians will be excluded if:

• They are involved in any other prescribing trial

Patients will be excluded if:

* They are unable to give informed consent, as judged by their physicians
* They have definitive indications for PPI use

Primary outcomes:
measure: Proportion of patients who stopped or reduced the dose of PPIs
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Change in PPI dose (cummulative)
timeFrame: From enrollment to the end of treatment at 6 months
measure: GERD symptom recurrence using the Gastroesophageal Reflux Disease Impact Scale (GIS) questionnaire
timeFrame: From enrollment to the end of treatment at 6 months
measure: Number of Medications
timeFrame: From enrollment to the end of treatment at 6 months
measure: Quality of life by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
timeFrame: From enrollment to the end of treatment at 6 months
measure: Potential adverse effects of PPI use
timeFrame: From enrollment to the end of treatment at 6 months
measure: Number of Participants with Prescription of PPIs (Restart or Dose Increase) and/or Alternative Antireflux Treatments
timeFrame: From enrollment to the end of treatment at 6 months
measure: Revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire
timeFrame: From enrollment to the end of treatment at 6 months
measure: Health Care Professionals' Attitudes Towards Deprescribing (HATD) Tool
timeFrame: From enrollment to the end of treatment at 6 months
measure: Healthcare Costs (Direct Medical Costs of PPI Use)
timeFrame: From enrollment to the end of treatment at 6 months
measure: Quality-Adjusted Life Years (QALY) Gains
timeFrame: From enrollment to the end of treatment at 6 months
measure: Cost per QALY Gained (Incremental Cost-Effectiveness Ratio, ICER)
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Ras Al Khaimah
country: United Arab Emirates
facility: Ibrahim Bin Hamad Obaidullah Hospital
Study officials:
affiliation: RAK Medical and Health Sciences University
name: Syed Arman Rabbani
role: PRINCIPAL_INVESTIGATOR
affiliation: RAK Medical and Health Sciences University
name: Mohamed El-Tanani
role: PRINCIPAL_INVESTIGATOR
affiliation: RAK Medical and Health Sciences University
name: Imran Rashid Rangraze
role: PRINCIPAL_INVESTIGATOR
affiliation: RAK Medical and Health Sciences University
name: Sathvik B Sridhar
role: PRINCIPAL_INVESTIGATOR
affiliation: Ibrahim Bin Hamad Obaidullah Hospital
name: Arwa Alnahdi
role: PRINCIPAL_INVESTIGATOR
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