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Proton Pump InhibitorsNCT02558049

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

A study testing Decision aid in people with Proton Pump Inhibitors and Gastroesophageal Reflux Disease, run by University of Ottawa at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Decision aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesCanada
Study dates
Nov 2015to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Elisabeth Bruyere Hospital

    Ottawa, Ontario, K1N5C8

  • Melrose FHT

    Ottawa, Ontario

  • Rideau FHT

    Ottawa, Ontario

Other trials in Canada

About this study

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.

Being tested
Decision aid
Keywords
Patient decision aid
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decision aidOther

    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.

Study groups in NCT02558049
Study groupRoleWhat they receive
Decision aidExperimentalPatients will receive the patient decision aid during a 15 minute consultation with a clinical pharmacist.
Receives: Other: Decision aid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)

Secondary outcomes (7)

  1. 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

    Measured: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)

  2. Change in Realistic expectations

    Difference in mean test score before and after assessed using paired t-test

    Measured: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)

  3. 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).

    Measured: Single visit - after decision aid is delivered (15 minutes)

  4. Agreement in rating of extent of shared decision-making

    Agreement between pharmacist and participant rating measured using kappa coefficient

    Measured: Single visit - immediately after decision aid is delivered (15 minutes)

  5. Change in Decisional conflict (SURE test)

    Paired t test comparing SURE score before and after patient receives PDA

    Measured: Single visit - immediately before decision aid delivered (baseline), immediately after decision aid delivered (15 minutes)

  6. Change in PPI prescription

    95% confidence interval around the proportion of patients whose PPI prescription is changed after 8 weeks

    Measured: 8 weeks after decision aid is delivered

  7. 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

    Measured: 8 weeks after decision aid is delivered

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02558049
Sponsor's protocol ID
4393
Status last verified
May 2017
First submitted
17 Sep 2015
Last updated
3 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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. No abstract available.

    PubMed 23419381

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

    PubMed 17956071

  • 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.

    PubMed 23558416

  • 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.

    PubMed 22525304

  • 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.

    PubMed 21605729

  • 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. doi: 10.1080/13814780600757120.

    PubMed 16945866

  • 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.

    PubMed 23912674

  • 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(Suppl 2):S2. doi: 10.1186/1472-6947-13-S2-S2. Epub 2013 Nov 29.

    PubMed 24625093

  • 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.

    PubMed 25577469

  • Legare F, Turcotte S, Stacey D, Ratte 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.

    PubMed 22276987

  • Lachenbruch PA. On the sample size for studies based upon McNemar's test. Stat Med. 1992 Aug;11(11):1521-5. doi: 10.1002/sim.4780111110.

    PubMed 1410964

  • 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. doi: 10.1200/JCO.2004.09.069.

    PubMed 15284259

Questions about this trial

What is this clinical trial studying?

A study testing Decision aid in people with Proton Pump Inhibitors and Gastroesophageal Reflux Disease, run by University of Ottawa at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02558049, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.

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