RAK-PRIDE: Optimizing Proton Pump Inhibitor Use Through Education and Intervention

March 8, 2025 updated by: Syed Arman Rabbani, RAK Medical and Health Sciences University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

479

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Arab Emirates
      • Ras Al Khaimah, United Arab Emirates
        • Recruiting
        • Ibrahim Bin Hamad Obaidullah Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist-Led Educational Intervention
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.
Other: Pharmacist-Led Educational Intervention
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.
Other: Control
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.
Other: Control (Standard treatment)
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. At the end of the 6-month period, the educational materials provided to the intervention group will be offered to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who stopped or reduced the dose of PPIs
Time Frame: From enrollment to the end of treatment at 6 months
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PPI dose (cummulative)
Time Frame: From enrollment to the end of treatment at 6 months
From enrollment to the end of treatment at 6 months
GERD symptom recurrence using the Gastroesophageal Reflux Disease Impact Scale (GIS) questionnaire
Time Frame: From enrollment to the end of treatment at 6 months

Score Range:

Minimum value: 9 (if all items are rated as 1, meaning "Never") Maximum value: 36 (if all items are rated as 4, meaning "Daily")

Interpretation:

A higher GIS score reflects more severe GERD symptoms and a greater negative impact on the patient's daily life.

A lower GIS score suggests fewer or less severe GERD symptoms and a better quality of life.
From enrollment to the end of treatment at 6 months
Number of Medications
Time Frame: From enrollment to the end of treatment at 6 months
From enrollment to the end of treatment at 6 months
Quality of life by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Time Frame: From enrollment to the end of treatment at 6 months

The EQ-5D-5L self-report questionnaire comprised two components: the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS).

  • The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Respondents select one of five levels of severity for each dimension.. Health state index scores typically range from below 0 to 1, where 0 represents a health state considered equivalent to death, and negative values indicate conditions perceived as worse than death. A score of 1 reflects full health, with higher scores signifying greater health utility. These index scores are based on national or regional health preferences, meaning they may vary across different countries or regions.
  • The second component of the questionnaire is the Visual Analogue Scale (VAS). EQ-VAS (Visual Analog Scale) Score: Ranges from 0 to 100 100 = Best imaginable health 0 = Worst imaginable health
From enrollment to the end of treatment at 6 months
Potential adverse effects of PPI use
Time Frame: From enrollment to the end of treatment at 6 months
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
Time Frame: From enrollment to the end of treatment at 6 months
This outcome measure tracks the number of participants who either re-started or increased their PPI dose, or used alternative anti-reflux treatments (such as H2 antagonists, antacids, or prokinetic agents) over the 6-month period. The goal is to assess how many participants needed to resume or adjust their PPI therapy or opt for alternative treatments due to symptom recurrence or insufficient symptom control.
From enrollment to the end of treatment at 6 months
Revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire
Time Frame: From enrollment to the end of treatment at 6 months

The Revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire consists of 22 questions across four subscales: Burden (5), Appropriateness (5), Concerns about Stopping (6), and Involvement (6). Each item is rated on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree), with a total score range of 22 to 110.

Interpretation of Scores:

A low rPATD score (closer to 22) suggests that a patient perceives their medications as necessary, has concerns about stopping them, or prefers not to be involved in deprescribing decisions.

A high rPATD score (closer to 110) indicates that a patient feels their medications may be burdensome, sees some as unnecessary, is less concerned about stopping them, and is more open to discussing deprescribing with their healthcare provider.
From enrollment to the end of treatment at 6 months
Health Care Professionals' Attitudes Towards Deprescribing (HATD) Tool
Time Frame: From enrollment to the end of treatment at 6 months

The Health Care Professionals' Attitudes Towards Deprescribing (HATD) tool assesses perceptions of deprescribing in older adults with limited life expectancy. It includes five domains: concerns, medication burden, organizational support, assurance, and patient involvement. Scores range from 1 to 5.

The total HATD score is the average of five domain scores: concerns, medication burden, organizational support, assurance, and patient involvement. Each domain score is calculated by averaging the responses within that category. The minimum possible score is 1, representing minimal agreement with deprescribing-related concerns or barriers, while the maximum score is 5, indicating strong agreement with those concerns or perceptions. Interpretation of the scores can guide interventions to address barriers and improve deprescribing practices.
From enrollment to the end of treatment at 6 months
Healthcare Costs (Direct Medical Costs of PPI Use)
Time Frame: From enrollment to the end of treatment at 6 months

Monthly PPI medication costs per patient will be calculated before and after the intervention. Costs will be aggregated at the group level to assess total expenditure changes.

Unit of Measure: AED per patient per month.
From enrollment to the end of treatment at 6 months
Quality-Adjusted Life Years (QALY) Gains
Time Frame: From enrollment to the end of treatment at 6 months

Health-related quality of life will be assessed using the EuroQoL EQ-5D-5L questionnaire, administered at baseline and after 6 months. EQ-5D-5L utility scores will be used to calculate QALY gains for each group.

Unit of Measure: QALY (Quality-Adjusted Life Years)
From enrollment to the end of treatment at 6 months
Cost per QALY Gained (Incremental Cost-Effectiveness Ratio, ICER)
Time Frame: From enrollment to the end of treatment at 6 months

The cost per QALY gained will be calculated as the difference in total healthcare costs between the intervention and control groups, divided by the difference in QALYs gained.

Unit of Measure: AED per QALY gained.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAK Medical and Health Sciences University

Investigators

  • Principal Investigator: Syed Arman Rabbani, RAK Medical and Health Sciences University
  • Principal Investigator: Mohamed El-Tanani, RAK Medical and Health Sciences University
  • Principal Investigator: Imran Rashid Rangraze, RAK Medical and Health Sciences University
  • Principal Investigator: Sathvik B Sridhar, RAK Medical and Health Sciences University
  • Principal Investigator: Arwa Alnahdi, Ibrahim Bin Hamad Obaidullah Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RAKMHSU/RES/2024-25/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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