Patient Journey Application for Discontinuing Inappropriate PPI Use: a Randomized Controlled Trial

Study Overview
=================
Brief 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.

Official Title
-----------------
Patient Journey Application for Discontinuing Inappropriate PPI Use: a Randomized Controlled Trial

Conditions
-----------------
Proton Pump Inhibitor, Inappropriate Drug Use, Discontinuation, E-health

Intervention / Treatment
-----------------
* Other: Patient Journey App
* Other: Information folder


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group (Patient Journey App)<br>The interventional group will receive all information and instructions on discontinuing PPI use through the Patient Journey App. | Other: Patient Journey App<br>* The group will receive all information and insctructions on discontinuing PPI use through the Patient Journey App which timely deliveres all information.<br>|
| Active Comparator: Control group (Conventional Care)<br>The control group will receive all information and instructions on discontinuing PPI use through email as a digital information folder. | Other: Information folder<br>* The group will receive all information and instructions on discontinuing PPI use through an information folder.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuation rate | Succesful discontinuation of PPI use | At 2 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper gastrointestinal symptoms | Change in upper gastrointestinal symptoms or disorders that are potentially related to discontinuation of PPI use | 2 monthly up to 12 months | 
| Adverse drug reactions | Change in potential adverse drug reactions (ADRs) of PPIs | 2 monthly up to 12 months | 
| Frequency of PPI use | Change in frequency of PPI use | Monthly up to 12 months | 
| New medication | Start of new medication for upper gastrointestinal symptoms, other than PPI (e.g., antacids, H2-blockers, analgesics, anti-emetics) | Monthly up to 12 months | 
| Association betwee succesful discontinuation of PPIs and patient characteristics | Association between successful discontinuation and variables such as gender, age, fear of ADRs, occurrence of potential ADRs or occurrence of rebound effect. Fear of ADRs will be evaluated at baseline as a yes/no question. Occurrence of potential ADRs will be measured at 2 months follow-up by asking if patients experience adverse drug reactions that have been registered in 1-10% of users. Occurrence of rebound effect will be measured according to the PAGI-SYM questionnaire. | At 2 months follow-up | 
| Lifestyle change | Change in lifestyle (BMI, smoking status and alcohol usage) | 2 monthly up to 12 months | 
| App usability | Patient Journey App usability as measured by the System Usability Score (SUS) | At 4 months follow-up | 
| Self-management behavior | Change in self-management behavior as measured by the short Patient Activation Measure (PAM-13) | 2 monthly up to 12 months | 
| Recurrent PPI use | Recurrent PPI use | Monthly up to 12 months |