RAK-PRIDE: Optimizing Proton Pump Inhibitor Use Through Education and Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRAK Medical and Health Sciences University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
They are prescribing PPIs in outpatient department of the study sites
They have patients with potentially inappropriate PPI prescriptions
They are ≥18 years
They are presenting to out-patient departments of the study sites
Disqualifiers
They are unable to give informed consent, as judged by their physicians
They have definitive indications for PPI use
Trial design
Design model
Parallel
Treatments tested in this trial
Control (Standard treatment)
Other interventionParticipants 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.
Pharmacist-Led Educational Intervention
Other interventionPhysicians 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.
Treatment groups
479 Participants
are divided into 2 treatment groupsGroup A: Pharmacist-Led Educational InterventionExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients who stopped or reduced the dose of PPIs
Time frame
From enrollment to the end of treatment at 6 monthsSecondary outcomes
1
Change in PPI dose (cummulative)
Time frame
From enrollment to the end of treatment at 6 months2
GERD symptom recurrence using the Gastroesophageal Reflux Disease Impact Scale (GIS) questionnaire
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.
Time frame
From enrollment to the end of treatment at 6 months3
Number of Medications
Time frame
From enrollment to the end of treatment at 6 months4
Quality of life by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
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
Time frame
From enrollment to the end of treatment at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov