Deprescribing, Inappropriate Use, Proton Pump Inhibitors
Conditions
Keywords
proton pump inhibitors, peptic ulcer disease, Deprescribing, pharmacist-led educational intervention, inappropriate use, RAK - PRIDE
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.
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
OTHERControl (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.
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.
Sponsors
RAK Medical and Health Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who stopped or reduced the dose of PPIs | From enrollment to the end of treatment at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GERD symptom recurrence using the Gastroesophageal Reflux Disease Impact Scale (GIS) questionnaire | From enrollment to the end of treatment at 6 months | 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. |
| 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 | 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 |
| 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 | From enrollment to the end of treatment at 6 months | 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. |
| Change in PPI dose (cummulative) | From enrollment to the end of treatment at 6 months | — |
| Health Care Professionals' Attitudes Towards Deprescribing (HATD) Tool | From enrollment to the end of treatment at 6 months | 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. |
| Healthcare Costs (Direct Medical Costs of PPI Use) | From enrollment to the end of treatment at 6 months | 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. |
| Quality-Adjusted Life Years (QALY) Gains | From enrollment to the end of treatment at 6 months | 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) |
| Cost per QALY Gained (Incremental Cost-Effectiveness Ratio, ICER) | From enrollment to the end of treatment at 6 months | 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. |
| Revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire | From enrollment to the end of treatment at 6 months | 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. |
Countries
United Arab Emirates
Contacts
Primary ContactSyed Arman Rabbani
Outcome results
None listed