Gastroesophageal Reflux Disease, Proton Pump Inhibitors
Conditions
Keywords
Patient decision aid
Brief summary
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.
Interventions
OTHERDecision aid
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.
Sponsors
University of Ottawa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decision preference (continue PPI or stop and use on-demand/use a lower dose) | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Realistic expectations | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | Difference in mean test score before and after assessed using paired t-test |
| Values/choice congruence | Single visit - after decision aid is delivered (15 minutes) | 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). |
| Agreement in rating of extent of shared decision-making | Single visit - immediately after decision aid is delivered (15 minutes) | Agreement between pharmacist and participant rating measured using kappa coefficient |
| Change in Knowledge | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | Difference in mean test score before and after assessed using paired t-test; two different versions of the knowledge test will be used |
| Change in PPI prescription | 8 weeks after decision aid is delivered | 95% confidence interval around the proportion of patients whose PPI prescription is changed after 8 weeks |
| Clinical symptoms at 8 weeks | 8 weeks after decision aid is delivered | 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 |
| Change in Decisional conflict (SURE test) | Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes) | Paired t test comparing SURE score before and after patient receives PDA |
Countries
Canada
Outcome results
None listed