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Proton Pump InhibitorsNCT06858384

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

A study testing Pharmacist-Led Educational Intervention in people with Proton Pump Inhibitors and Deprescribing, run by RAK Medical and Health Sciences University at 1 site in United Arab Emirates.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pharmacist-Led Educational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
479 participants
Where
1 siteUnited Arab Emirates
Study dates
Mar 2025to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Arab Emirates1 site, 1 recruiting
  • Ibrahim Bin Hamad Obaidullah Hospital

    Ras al-Khaimah

    Syed Arman Rabbani, +971 7 2043000 ext. 230, arman@rakmhsu.ac.ae

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: 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:

Read more
  • 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.
Read the 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.

Being tested
Control (Standard treatment), Pharmacist-Led Educational Intervention
Keywords
proton pump inhibitors, peptic ulcer disease, Deprescribing, pharmacist-led educational intervention, inappropriate use, RAK - PRIDE
Medical subject headings
Peptic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control (Standard treatment)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. 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 InterventionOther

    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.

Study groups in NCT06858384
Study groupRoleWhat they receive
Pharmacist-Led Educational InterventionExperimentalPhysicians 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.
Receives: Other: Pharmacist-Led Educational Intervention
ControlOtherParticipants 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.
Receives: Other: Control (Standard treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who stopped or reduced the dose of PPIs

    Measured: From enrollment to the end of treatment at 6 months

Secondary outcomes (11)
  1. Change in PPI dose (cummulative)

    Measured: From enrollment to the end of treatment at 6 months

  2. 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.

    Measured: From enrollment to the end of treatment at 6 months

  3. Number of Medications

    Measured: From enrollment to the end of treatment at 6 months

  4. 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

    Measured: From enrollment to the end of treatment at 6 months

  5. Potential adverse effects of PPI use

    Measured: From enrollment to the end of treatment at 6 months

  6. Number of Participants with Prescription of PPIs (Restart or Dose Increase) and/or Alternative Antireflux Treatments

    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.

    Measured: From enrollment to the end of treatment at 6 months

  7. Revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire

    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.

    Measured: From enrollment to the end of treatment at 6 months

  8. Health Care Professionals' Attitudes Towards Deprescribing (HATD) Tool

    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.

    Measured: From enrollment to the end of treatment at 6 months

  9. Healthcare Costs (Direct Medical Costs of PPI Use)

    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.

    Measured: From enrollment to the end of treatment at 6 months

  10. Quality-Adjusted Life Years (QALY) Gains

    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)

    Measured: From enrollment to the end of treatment at 6 months

  11. Cost per QALY Gained (Incremental Cost-Effectiveness Ratio, ICER)

    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.

    Measured: From enrollment to the end of treatment at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
479 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858384
Sponsor's protocol ID
RAKMHSU/RES/2024-25/001
Status last verified
Mar 2025
First submitted
16 Feb 2025
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wilsdon TD, Hendrix I, Thynne TR, Mangoni AA. Effectiveness of Interventions to Deprescribe Inappropriate Proton Pump Inhibitors in Older Adults. Drugs Aging. 2017 Apr;34(4):265-287. doi: 10.1007/s40266-017-0442-1.

    PubMed 28220380
  • Nallapeta N, Reynolds JL, Bakhai S. Deprescribing Proton Pump Inhibitors in an Academic, Primary Care Clinic: Quality Improvement Project. J Clin Gastroenterol. 2020 Nov/Dec;54(10):864-870. doi: 10.1097/MCG.0000000000001317.

    PubMed 32091449
  • Krol N, Wensing M, Haaijer-Ruskamp F, Muris JW, Numans ME, Schattenberg G, Balen J, Grol R. Patient-directed strategy to reduce prescribing for patients with dyspepsia in general practice: a randomized trial. Aliment Pharmacol Ther. 2004 Apr 15;19(8):917-22. doi: 10.1111/j.1365-2036.2004.01928.x.

    PubMed 15080853
  • Lai A, Odom A, Roskos SE, Phillips JP. Deprescribing Inappropriate Proton Pump Inhibitors in a Family Medicine Residency Practice Office. PRiMER. 2021 Nov 2;5:43. doi: 10.22454/PRiMER.2021.290175. eCollection 2021.

    PubMed 34841218
  • Pratt NL, Kalisch Ellett LM, Sluggett JK, Gadzhanova SV, Ramsay EN, Kerr M, LeBlanc VT, Barratt JD, Roughead EE. Use of proton pump inhibitors among older Australians: national quality improvement programmes have led to sustained practice change. Int J Qual Health Care. 2017 Feb 1;29(1):75-82. doi: 10.1093/intqhc/mzw138.

    PubMed 27920248
  • Clyne B, Smith SM, Hughes CM, Boland F, Cooper JA, Fahey T; OPTI-SCRIPT study team. Sustained effectiveness of a multifaceted intervention to reduce potentially inappropriate prescribing in older patients in primary care (OPTI-SCRIPT study). Implement Sci. 2016 Jun 2;11(1):79. doi: 10.1186/s13012-016-0442-2.

    PubMed 27255504
  • Reeve E, Andrews JM, Wiese MD, Hendrix I, Roberts MS, Shakib S. Feasibility of a patient-centered deprescribing process to reduce inappropriate use of proton pump inhibitors. Ann Pharmacother. 2015 Jan;49(1):29-38. doi: 10.1177/1060028014558290. Epub 2014 Nov 10.

    PubMed 25385826
  • Farrell B, Pottie K, Thompson W, Boghossian T, Pizzola L, Rashid FJ, Rojas-Fernandez C, Walsh K, Welch V, Moayyedi P. Deprescribing proton pump inhibitors: Evidence-based clinical practice guideline. Can Fam Physician. 2017 May;63(5):354-364.

    PubMed 28500192
  • Giles G, Buchan H, Hullick C, Overs M, Duggan A. What next for the Australian Atlas of Healthcare Variation series? Focusing the system on appropriate and sustainable health care. Res Health Serv Reg. 2024 Dec 19;3(1):20. doi: 10.1007/s43999-024-00056-8.

    PubMed 39695003
  • Naunton M, Peterson GM, Deeks LS, Young H, Kosari S. We have had a gutful: The need for deprescribing proton pump inhibitors. J Clin Pharm Ther. 2018 Feb;43(1):65-72. doi: 10.1111/jcpt.12613. Epub 2017 Sep 11.

    PubMed 28895169
  • Targownik LE, Fisher DA, Saini SD. AGA Clinical Practice Update on De-Prescribing of Proton Pump Inhibitors: Expert Review. Gastroenterology. 2022 Apr;162(4):1334-1342. doi: 10.1053/j.gastro.2021.12.247. Epub 2022 Feb 17.

    PubMed 35183361
  • Shanika LGT, Reynolds A, Pattison S, Braund R. Proton pump inhibitor use: systematic review of global trends and practices. Eur J Clin Pharmacol. 2023 Sep;79(9):1159-1172. doi: 10.1007/s00228-023-03534-z. Epub 2023 Jul 7.

    PubMed 37420019
  • Kinoshita Y, Ishimura N, Ishihara S. Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use. J Neurogastroenterol Motil. 2018 Apr 30;24(2):182-196. doi: 10.5056/jnm18001.

    PubMed 29605975

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist-Led Educational Intervention in people with Proton Pump Inhibitors and Deprescribing, run by RAK Medical and Health Sciences University at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Syed Arman Rabbani (+971 7 2043000 ext. 230, arman@rakmhsu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who stopped or reduced the dose of PPIs (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858384, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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