Overview

Conditions proton pump inhibitors, gastroesophageal reflux disease
Treatment decision aid
Sponsor University of Ottawa
Start date November 2015
End date December 2016
Trial size 54 participants
Trial identifier NCT02558049, 4393

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries Canada

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Patients will receive the patient decision aid during a 15 minute consultation with a clinical pharmacist.
decision 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.

Primary Outcomes

Measure
Change in Decision preference (continue PPI or stop and use on-demand/use a lower dose)
time frame: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)

Secondary Outcomes

Measure
Change in Knowledge
time frame: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)
Change in Realistic expectations
time frame: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)
Values/choice congruence
time frame: Single visit - after decision aid is delivered (15 minutes)
Agreement in rating of extent of shared decision-making
time frame: Single visit - immediately after decision aid is delivered (15 minutes)
Change in Decisional conflict (SURE test)
time frame: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)
Change in PPI prescription
time frame: 8 weeks after decision aid is delivered
Clinical symptoms at 8 weeks
time frame: 8 weeks after decision aid is delivered

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Should I Continue Taking My Acid Reflux Medication? Development and Pilot Testing of a Patient Decision Aid
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Ottawa.