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Clinical Trials/NCT06858384
NCT06858384RecruitingNot Applicable

From Awareness to Action: Transforming Proton Pump Inhibitor Use in Ras Al Khaimah Through Education and Intervention: the RAK -PRIDE Study

RAK Medical and Health Sciences University1 site in 1 country479 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
479
Locations
1
Primary Endpoint
Proportion of patients who stopped or reduced the dose of PPIs

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pharmacist-Led Educational Intervention

Experimental

Physicians and patients in this arm will receive a multi-faceted pharmacist-led educational intervention. This includes evidence-based deprescribing guidelines, brochures, videos, and decision aids to promote appropriate use of PPIs and reduce unnecessary prescriptions. The intervention is delivered in four parts: educational brochures, deprescribing algorithm, patient action plans, and video-based education sessions.

Intervention: Pharmacist-Led Educational Intervention (Other)

Control

Other

Participants in this arm will continue with their usual care without any pharmacist-led intervention during the 6-month study period. Physicians and patients will follow the standard clinical practice for PPI prescriptions.

Intervention: Control (Standard treatment) (Other)

Outcomes

Primary Outcomes

Proportion of patients who stopped or reduced the dose of PPIs

Time Frame: From enrollment to the end of treatment at 6 months

Secondary Outcomes

  • Change in PPI dose (cummulative)(From enrollment to the end of treatment at 6 months)
  • GERD symptom recurrence using the Gastroesophageal Reflux Disease Impact Scale (GIS) questionnaire(From enrollment to the end of treatment at 6 months)
  • Number of Medications(From enrollment to the end of treatment at 6 months)
  • Quality of life by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire(From enrollment to the end of treatment at 6 months)
  • Potential adverse effects of PPI use(From enrollment to the end of treatment at 6 months)
  • Number of Participants with Prescription of PPIs (Restart or Dose Increase) and/or Alternative Antireflux Treatments(From enrollment to the end of treatment at 6 months)
  • Revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire(From enrollment to the end of treatment at 6 months)
  • Health Care Professionals' Attitudes Towards Deprescribing (HATD) Tool(From enrollment to the end of treatment at 6 months)
  • Healthcare Costs (Direct Medical Costs of PPI Use)(From enrollment to the end of treatment at 6 months)
  • Quality-Adjusted Life Years (QALY) Gains(From enrollment to the end of treatment at 6 months)
  • Cost per QALY Gained (Incremental Cost-Effectiveness Ratio, ICER)(From enrollment to the end of treatment at 6 months)

Investigators

Sponsor
RAK Medical and Health Sciences University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Syed Arman Rabbani

Professor Syed Arman Rabbani

RAK Medical and Health Sciences University

Study Sites (1)

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