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

NCT06858384 | Recruiting

• 1 other identifier: RAKMHSU/RES/2024-25/001
• Study Type: interventional
• Target: 479
• Locations: 1 country
• Sites: 1

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.

Conditions

Proton Pump Inhibitors; Deprescribing; Inappropriate Use

Keywords

proton pump inhibitors; peptic ulcer disease; Deprescribing; pharmacist-led educational intervention; inappropriate use; RAK - PRIDE

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who stopped or reduced the dose of PPIs

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (11)

• 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

Study Arms (2)

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.

Other: Pharmacist-Led Educational Intervention

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.

Other: Control (Standard treatment)

Interventions

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.

Control

Pharmacist-Led Educational Intervention OTHER

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.

Pharmacist-Led Educational Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAK Medical and Health Sciences University: lead

Study Sites (1)

Ibrahim Bin Hamad Obaidullah Hospital

Ras al-Khaimah, United Arab Emirates

RECRUITING

Related Publications (13)

• 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.

  PMID: 28220380 BACKGROUND

• 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.

  PMID: 32091449 BACKGROUND

• 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.

  PMID: 15080853 BACKGROUND

• 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.

  PMID: 34841218 BACKGROUND

• 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.

  PMID: 27920248 BACKGROUND

• 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.

  PMID: 27255504 BACKGROUND

• 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.

  PMID: 25385826 BACKGROUND

• 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.

  PMID: 28500192 BACKGROUND

• 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.

  PMID: 39695003 BACKGROUND

• 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.

  PMID: 28895169 BACKGROUND

• 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.

  PMID: 35183361 BACKGROUND

• 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.

  PMID: 37420019 BACKGROUND

• 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.

  PMID: 29605975 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Arman Rabbani

CONTACT

+971 7 2043000; arman@rakmhsu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Syed Arman Rabbani

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)