Smartphone App-assisted PPI

Study Overview
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Brief Summary
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Proton pump inhibitors (PPIs) are frequently prescribed for 30 days but taken infinitely. PPIs belong to the most often inappropriate medicines (PIMs). Correct intake of medicines (named adherence) can be supported by digital devices such as smartphone applications. The goal of this interventional study is to test the feasibility of an app-based treatment support provided by community pharmacists in patients prescribed a short-term PPI (30 days). The intervention consists in tracking medication intake, symptom course and well-being over the treatment duration of 30 days with the mednet app on patients' personal smartphones.

Detailed Description
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This is an exploratory study in a primary care setting with community pharmacists recruiting patients who are newly prescribed a PPI for a short-term treatment (30 days). There is no control group and no randomization. After informed consent and installing the app on their personal smartphones, patients will answer three questions from the app once daily. The questions address medication intake (yes/no), symptom course (better, worse, identical, no symptoms) and well-being (satisfactory/needs improvement). Worsening of symptoms will trigger an alarm (via email) at the pharmacy. The pharmacist will call the patients and use information from adherence and well-being to consolidate a supporting counseling. Feasibility and a frequency estimation of the interventions will be the focus of the study in view of a larger implementation study with community pharmacies. Further implementation outcomes will be assessed through interviews and surveys (satisfaction, interprofessional work).

Official Title
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Smartphone App-assisted Discontinuation of Short-term PPI Treatment - an Feasibility Study

Conditions
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Heartburn, Dyspepsia

Intervention / Treatment
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* Other: App-based treatment support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: is ≥18 years old; has symptoms that suggest or correspond to gastroesophageal reflux disease (GERD); is newly prescribed a short-term PPI treatment; accepts to use of the smartphone app mednet during the study period; signs the informed consent form; understands and speaks (Swiss) German. Exclusion Criteria: in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Other: App-based treatment support<br>* The intervention includes a smartphone app that patients will download on their smartphones. Medication intake, symptom course and well-being will be tracked over treatment duration. If symptoms worsen, the pharmacist will contact the patients and counsel them based on their adherence and well-being data. Patients who still have symptoms after the 30 days of treatment will receive a final counseling by the pharmacy, and if necessary will be forwarded to the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with PPI treatment over 30 days | Number of patients who started and stopped a PPI after 30 days | 30 days (treatment duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment extensions | Number of PPI treatment extensions including reasons and number of additional days | 30 days (treatment duration) | 
| Physicians' and pharmacists' satisfaction with the service | Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews | 2 weeks after study completion | 
| Patients' satisfaction with the service | Patients' satisfaction with the service including the app assessed through semi-structured interviews | 2 weeks after the end of treatment | 
| Reliable diagnosis after PPI treatment | Number of reliable diagnosis after short-term PPI treatment including treatment extensions | After 30 days (treatment duration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Adherence, Short-term Therapy, Proton Pump Inhibitors, Mobile Health, Implementation