Patient Journey Application for Discontinuing Inappropriate PPI Use: a Randomized Controlled Trial
Condition: Proton Pump Inhibitor; Inappropriate Drug Use; Discontinuation; E-health
Study type: Interventional

Summary: 
      Rationale/objective: This study hypothesizes that offering patient-tailored and dosed
      information on PPI discontinuation in patients with inappropriate chronic PPI use will result
      in an increased discontinuation rate when compared to a conventional information folder
      offering all information on discontinuing inappropriate PPI use at once.

      Study design: Multicenter randomized controlled trial.

      Study population: A minimum 152 patients with chronic PPI use without a valid indication for
      chronic PPI use according to the NHG-guidelines will be included. Possible participants will
      be identified at the outpatient clinics of the departments of Internal Medicine,
      Gastroenterology, Rheumatology and Nephrology in the Radboud University Medical Center,
      Canisius Wilhelmina Hospital and Sint Maartenskliniek.

      Intervention: Timely informing patients on discontinuing PPI use through the Patient Journey
      App.

      Control: Conventional information, consisting of an online information folder on
      discontinuing PPI use.

      Inclusion criteria:

        -  Patients with daily PPI use for at least 4 weeks;

        -  Age 18-70 years.

      Exclusion criteria:

        -  Chronic PPI indication according to NHG-guidelines;

        -  Chronic PPI indication according to treating physician, despite absence of chronic PPI
           indication according to NHG-guidelines;

        -  Patients that underwent anti-reflux surgery;

        -  No understanding of the study or study procedures including the digital application
           (smartphone/computer skills);

        -  No smartphone/computer available;

        -  No informed consent;

        -  Limited life span.

      Primary end point:

      - Discontinuation of PPI use at 2-month follow-up, defined as self-declared intake of a
      maximum of 1 tablet in the previous 14 days.

      Secondary end points:

        -  Upper gastrointestinal symptoms or disorders that are potentially related to
           discontinuation of PPI use, subdivided as:

             -  Upper gastrointestinal symptoms as measured by the Patient Assessment of
                Gastrointestinal Symptom Severity Score (PAGI-SYM);

             -  Any upper gastrointestinal event that requires a doctor's visit or hospitalization.

        -  Potential adverse drug reactions (ADRs) of PPIs, subdivided as:

             -  Most prevalent (1-10%) ADRs according to the Medicines Evaluation Board1:
                obstipation, diarrhea, meteorism, abdominal pain, nausea/vomitus, headache;

             -  Other potential ADRs requiring a doctor's visit or hospitalization. The following
                disorders are considered as potentially related to PPI use: any pneumonia,
                gastroenteritis, vitamin B12 deficiency, iron deficiency, calcium deficiency,
                fractures, acute interstitial nephritis or hypomagnesaemia.

        -  Frequency of PPI use, measured monthly during follow-up, measured as number of PPI
           tablets per month;

        -  Start of new medication for upper gastrointestinal symptoms, other than PPI (e.g.,
           antacids, H2-blockers, analgesics, anti-emetics);

        -  Association between successful discontinuation and variables such as gender, age, fear
           of ADRs, occurrence of potential ADRs or occurrence of rebound effect;

        -  Change in lifestyle (BMI, smoking status and alcohol usage);

        -  Patient Journey App usability as measured by the System Usability Score (SUS);

        -  Self-management behavior as measured by the short Patient Activation Measure (PAM-13);

        -  Recurrent PPI use, defined as the intake of more than 1 PPI tablet in the previous 14
           days measured as self-declared intake during follow-up after successful discontinuation
           during follow-up.
    


Intervention name(s): Patient Journey App; Information folder
Intervention type(s): Other; Other
Intervention description(s): The group will receive all information and insctructions on discontinuing PPI use through the Patient Journey App which timely deliveres all information.; The group will receive all information and instructions on discontinuing PPI use through an information folder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other