Dyspepsia, Heartburn
Conditions
Keywords
Medication Adherence, Short-term Therapy, Proton Pump Inhibitors, Mobile Health, Implementation
Brief summary
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
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).
Interventions
OTHERApp-based treatment support
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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients with PPI treatment over 30 days | 30 days (treatment duration) | Number of patients who started and stopped a PPI after 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment extensions | 30 days (treatment duration) | Number of PPI treatment extensions including reasons and number of additional days |
| Physicians' and pharmacists' satisfaction with the service | 2 weeks after study completion | Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews |
| Patients' satisfaction with the service | 2 weeks after the end of treatment | Patients' satisfaction with the service including the app assessed through semi-structured interviews |
| Reliable diagnosis after PPI treatment | After 30 days (treatment duration) | Number of reliable diagnosis after short-term PPI treatment including treatment extensions |
Countries
Switzerland
Outcome results
None listed