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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who stopped or reduced the dose of PPIs | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Physicians will be eligible to participate if:
Patients will be eligible to participate if:
Exclusion Criteria:
Physicians will be excluded if:
• They are involved in any other prescribing trial
Patients will be excluded if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syed Arman Rabbani | Contact | +971 7 2043000 | 230 | arman@rakmhsu.ac.ae |
| Name | Affiliation | Role |
|---|---|---|
| Syed Arman Rabbani | RAK Medical and Health Sciences University | Principal Investigator |
| Mohamed El-Tanani | RAK Medical and Health Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ibrahim Bin Hamad Obaidullah Hospital | Recruiting | Ras al-Khaimah | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28220380 | Background | 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. | |
| 32091449 | 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. |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| 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. |
|
| 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 | The EQ-5D-5L self-report questionnaire comprised two components: the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS).
| 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 |
| 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. | From enrollment to the end of treatment at 6 months |
| 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. | From enrollment to the end of treatment at 6 months |
| 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. | From enrollment to the end of treatment at 6 months |
| 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. | From enrollment to the end of treatment at 6 months |
| 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) | From enrollment to the end of treatment at 6 months |
| 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. | From enrollment to the end of treatment at 6 months |
| 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 |
| 15080853 | 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. |
| 34841218 | 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. |
| 27920248 | 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. |
| 27255504 | 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. |
| 25385826 | 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. |
| 28500192 | 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. |
| 39695003 | 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. |
| 28895169 | 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. |
| 35183361 | 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. |
| 37420019 | 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. |
| 29605975 | 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. |
| D013272 | Stomach Diseases |