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

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Proportion of patients who stopped or reduced the dose of PPIs [Time frame: From enrollment to the end of treatment at 6 months]

Secondary outcome measures (11)

• Change in PPI dose (cummulative) [Time frame: 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]
• Number of Medications [Time frame: 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]
• Potential adverse effects of PPI use [Time frame: 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]
• Revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire [Time frame: 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]
• Healthcare Costs (Direct Medical Costs of PPI Use) [Time frame: 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]
• Cost per QALY Gained (Incremental Cost-Effectiveness Ratio, ICER) [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United Arab Emirates · 1 center

• Ibrahim Bin Hamad Obaidullah Hospital — Ras al-Khaimah

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28500192

Identifiers

NCT: NCT06858384 · RAKMHSU/RES/2024-25/001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗