Should I Continue Taking My Acid Reflux Medication? Development and Pilot Testing of a Patient Decision Aid

Study Overview
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Brief Summary
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BACKGROUND: Proton pump inhibitors (PPIs) treat problems such as gastroesophageal reflux disease (GERD). In many patients with mild or moderate GERD, PPIs should be used for 1-2 months but are often continued longer unnecessarily. This is a problem because PPIs may cause harm when used long-term. PPI use is associated with severe C. difficile infections, fractures and pneumonia. Canada's public drug programs spent $247 million on PPIs in 2012 (not including Quebec or PEI). Due to concerns with long-term PPI use, patients may face the decision to continue their PPI, use a lower dose or stop and use on-demand (only when symptoms return). This decision should be made collaboratively between patients and clinicians, though patients tend to have a poor understanding of when reducing a drug is appropriate. Using a lower dose or using on-demand may be viewed as difficult because of the chance of symptoms returning. Patient decision aids (PDAs) inform patients on benefits and risks of treatment options and improve ability to make informed decisions and clarify values. OBJECTIVES: Develop a PDA to help patients with the decision to continue PPI or stop and use on-demand/use a lower dose. Evaluate whether: 1) the PDA changes patient preference to continue or stop and use on-demand/use a lower dose of PPI 2) the PDA improves patient knowledge and realistic expectations 3) patients and pharmacists feel they made a shared decision 4) there is a change in PPI prescribing 8 weeks post-PDA and 5) patients' choices match up with their values. METHODOLOGY: The PDA will be developed by a team of doctors, pharmacists and patients. It will be delivered during a visit with a pharmacist. Patients (n=54) will indicate which choice they prefer (continue PPI/stop or use lower dose) before and after going through the PDA. We will use Mcnemar's test to compare the number of patients preferring to continue their PPI before and after. We will evaluate whether there is a difference in knowledge test scores and expectations test scores before and after the PDA. After the PDA, we will ask patients and pharmacists to rate the extent to which shared decision making occurred and measure the agreement. Values/choice congruence will be evaluated using logistic regression. Eight weeks after patients have received the PDA, we will look at whether there is any reduction in PPI use.

Official Title
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Should I Continue Taking My Acid Reflux Medication? Development and Pilot Testing of a Patient Decision Aid

Conditions
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Proton Pump Inhibitors, Gastroesophageal Reflux Disease

Intervention / Treatment
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* Other: Decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Taking PPI for greater than or equal to 4 weeks, no current symptoms, taking PPI for mild to moderate upper GI symptoms (mild to moderate gastroesophageal reflux disease, grade A/B esophagitis) Exclusion Criteria: Severe esophagitis (grade C/D), severe GERD or upper GI symptoms, currently experiencing upper GI symptoms, taking PPI for gastroprotection due to NSAID therapy (at moderate or high risk of GI bleed), history of Barrett's esophagus, history of bleeding peptic ulcer, taking PPI for treatment of current ulcer not healed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision aid<br>Patients will receive the patient decision aid during a 15 minute consultation with a clinical pharmacist. | Other: Decision aid<br>* Participants will receive a patient decision aid which outlines the potential benefits and harms of proton pump inhibitor use, as well as the potential benefits and harms of switching to a lower dose of PPI or stopping and using on-demand (only when symptoms occur). The decision aid also allows participants to clarify their values regarding these potential benefits and harms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Decision preference (continue PPI or stop and use on-demand/use a lower dose) | Difference in proportion of patients preferring to continue PPI therapy before and after PDA assessed using Mcnemar's test. The choice to continue will be the composite of patients wishing to continue and those unsure (since patients who are unsure would continue on PPI). We plan to conduct subgroup analysis based on decisional conflict at baseline for the primary outcome and secondary outcomes. Our subgroups will be (i) patients who are confident in their choice at baseline (SURE test score of 4) and (ii) patients who are not confident in their choice at baseline (SURE test score <4). The decision preference will be assessed at a single visit (before the PDA is delivered and right after). | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge | Difference in mean test score before and after assessed using paired t-test; two different versions of the knowledge test will be used | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | 
| Change in Realistic expectations | Difference in mean test score before and after assessed using paired t-test | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | 
| Values/choice congruence | Multiple logistic regression with dichotomous outcome of continue PPI or stop/use a lower dose of PPI and the following variables: value rating (continuous measure from 1-5, 1: favours deprescribing - 5: favours continuation), age, gender, level of education. Conducted in patients passing knowledge test (>50% score). | Single visit - after decision aid is delivered (15 minutes) | 
| Agreement in rating of extent of shared decision-making | Agreement between pharmacist and participant rating measured using kappa coefficient | Single visit - immediately after decision aid is delivered (15 minutes) | 
| Change in Decisional conflict (SURE test) | Paired t test comparing SURE score before and after patient receives PDA | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | 
| Change in PPI prescription | 95% confidence interval around the proportion of patients whose PPI prescription is changed after 8 weeks | 8 weeks after decision aid is delivered | 
| Clinical symptoms at 8 weeks | Compare the proportion of patients whose symptoms have returned for patients who continued their PPI versus those who switched to a lower dose or stopped and used on-demand | 8 weeks after decision aid is delivered | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient decision aid