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

NCT ID: NCT05348252

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-07-11

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.

Conditions

Proton Pump Inhibitor; Inappropriate Drug Use; Discontinuation; E-health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interventional group (Patient Journey App)

The interventional group will receive all information and instructions on discontinuing PPI use through the Patient Journey App.

Group Type: EXPERIMENTAL

Patient Journey App

Intervention Type: OTHER

The group will receive all information and insctructions on discontinuing PPI use through the Patient Journey App which timely deliveres all information.

Control group (Conventional Care)

The control group will receive all information and instructions on discontinuing PPI use through email as a digital information folder.

Group Type: ACTIVE_COMPARATOR

Information folder

Intervention Type: OTHER

The group will receive all information and instructions on discontinuing PPI use through an information folder.

Interventions

Patient Journey App

The group will receive all information and insctructions on discontinuing PPI use through the Patient Journey App which timely deliveres all information.

Intervention Type: OTHER

Information folder

The group will receive all information and instructions on discontinuing PPI use through an information folder.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud university medical center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

N21.079

Identifier Type: -

Identifier Source: org_study_id