Clinical trial NCT05348252: Patient Journey Application for Discontinuing Inappropriate PPI Use: a Randomized Controlled Trial
Official title: Patient Journey Application for Discontinuing Inappropriate PPI Use: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proton Pump Inhibitor
Inappropriate Drug Use
Discontinuation
E-health
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Discontinuation rate
timeFrame: At 2 months follow-up
Secondary outcomes:
measure: Upper gastrointestinal symptoms
timeFrame: 2 monthly up to 12 months
measure: Adverse drug reactions
timeFrame: 2 monthly up to 12 months
measure: Frequency of PPI use
timeFrame: Monthly up to 12 months
measure: New medication
timeFrame: Monthly up to 12 months
measure: Association betwee succesful discontinuation of PPIs and patient characteristics
timeFrame: At 2 months follow-up
measure: Lifestyle change
timeFrame: 2 monthly up to 12 months
measure: App usability
timeFrame: At 4 months follow-up
measure: Self-management behavior
timeFrame: 2 monthly up to 12 months
measure: Recurrent PPI use
timeFrame: Monthly up to 12 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: