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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558049
• Other study ID #: 4393
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: May 1, 2017
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Proton Pump Inhibitors

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Elisabeth Bruyere Hospital	Ottawa	Ontario
Canada	Melrose FHT	Ottawa	Ontario
Canada	Rideau FHT	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Coulter A, Stilwell D, Kryworuchko J, Mullen PD, Ng CJ, van der Weijden T. A systematic development process for patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2:S2. doi: 10.1186/1472-6947-13-S2-S2. Epub 2013 Nov 29. Review. — View Citation

Durand MA, Witt J, Joseph-Williams N, Newcombe RG, Politi MC, Sivell S, Elwyn G. Minimum standards for the certification of patient decision support interventions: feasibility and application. Patient Educ Couns. 2015 Apr;98(4):462-8. doi: 10.1016/j.pec.2014.12.009. Epub 2014 Dec 31. Review. — View Citation

Janz NK, Wren PA, Copeland LA, Lowery JC, Goldfarb SL, Wilkins EG. Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision. J Clin Oncol. 2004 Aug 1;22(15):3091-8. — View Citation

Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. Erratum in: Am J Gastroenterol. 2013 Oct;108(10):1672. — View Citation

Kwok CS, Arthur AK, Anibueze CI, Singh S, Cavallazzi R, Loke YK. Risk of Clostridium difficile infection with acid suppressing drugs and antibiotics: meta-analysis. Am J Gastroenterol. 2012 Jul;107(7):1011-9. doi: 10.1038/ajg.2012.108. Epub 2012 Apr 24. Erratum in: Am J Gastroenterol. 2014 Jan;109(1):144. — View Citation

Lachenbruch PA. On the sample size for studies based upon McNemar's test. Stat Med. 1992 Aug;11(11):1521-5. — View Citation

Légaré F, Turcotte S, Stacey D, Ratté S, Kryworuchko J, Graham ID. Patients' perceptions of sharing in decisions: a systematic review of interventions to enhance shared decision making in routine clinical practice. Patient. 2012;5(1):1-19. doi: 10.2165/11592180-000000000-00000. Review. — View Citation

Leri F, Ayzenberg M, Voyce SJ, Klein A, Hartz L, Smego RA Jr. Four-year trends of inappropriate proton pump inhibitor use after hospital discharge. South Med J. 2013 Apr;106(4):270-3. doi: 10.1097/SMJ.0b013e31828db01f. — View Citation

Ramakrishnan K, Salinas RC. Peptic ulcer disease. Am Fam Physician. 2007 Oct 1;76(7):1005-12. Review. — View Citation

Reeve E, To J, Hendrix I, Shakib S, Roberts MS, Wiese MD. Patient barriers to and enablers of deprescribing: a systematic review. Drugs Aging. 2013 Oct;30(10):793-807. doi: 10.1007/s40266-013-0106-8. Review. — View Citation

Spijker-Huiges A, Winters JC, Meyboom-De Jong B. Patients' views on dyspepsia and acid suppressant drug therapy in general practice. Eur J Gen Pract. 2006;12(1):10-4. — View Citation

Yu EW, Bauer SR, Bain PA, Bauer DC. Proton pump inhibitors and risk of fractures: a meta-analysis of 11 international studies. Am J Med. 2011 Jun;124(6):519-26. doi: 10.1016/j.amjmed.2011.01.007. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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

External Links

•   Decision Aid Toolkit