Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06018662 |
| Other study ID # |
A medication mobile app |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Ain Shams University |
| Contact |
Mai Fawaz, Master's |
| Phone |
+20 1221190802 |
| Email |
May.gamal21[@]pharma.asu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
An interventional study that aims to design, establish and implement an electronic
application for management of the usage of anesthetics, antimicrobials, and analgesics in a
pediatric surgery department, and assess the impact of the implementation of an electronic
medication management application on the appropriateness of medication use in a pediatric
surgery department
Description:
Mobile health (mHealth) refers to digital health technologies via mobile phones, tablets, and
other electronic devices to enhance health outcomes. mHealth has started to have an impact on
many health care and medical education aspects. With the increased number of smartphones and
increasing interest in using mobile applications (apps), healthcare related mobile apps offer
opportunities for advanced patient care allowing for better patient-provider communication.
Within anesthesia, mobile apps were developed to play an important role; pre, intra- and
postoperatively through providing patient-physician communication, reducing patient anxiety,
and offering on-the-go education.
The development of medical mobile app is challenging. It incorporates producing an
easy-to-use display with appropriate clinical information. Although many medication errors
lead to little or no harm, some have overwhelming consequences for patients and, sometimes,
for practitioners.
In pediatric patients, doses of anesthetics and other medications are calculated based on age
and/or weight. Also, preparations often require further dilutions, specifically for younger
patients like neonates and infants. These steps might increase risk for medication errors in
pediatric anesthesia. For pediatric patients, it is important to use appropriate weight-based
medication doses.
Anesthetics, Antimicrobials and Analgesics are the three drug classes that have shown the
highest number of medication errors in the operating rooms of a pediatric surgery department.
To provide an appropriate age and/or weight-based drug information, we will develop an
electronic application to recommend the most appropriate drugs based on international
guidelines and calculate doses for Anesthetics, Antimicrobials and Analgesics for pediatric
patients in the operating rooms of a pediatric surgery department.
Aim of the study:
To design, establish and implement an electronic application for management of the usage of
anesthetics, antimicrobials, and analgesics in a pediatric surgery department. To assess the
impact of the implementation of an electronic medication management application on the
appropriateness of medication use in a pediatric surgery department
Patients and methods:
Design:
Prospective, Interventional, Single-blinded, Randomized controlled study.
Setting:
The study will be conducted in the pediatric surgery department in the Children's hospital,
Ain Shams University, Cairo, Egypt.
Patients:
Pediatric patients undergoing surgical operations.
Methods:
The study will be performed according to the following phases;
Phase 1: Application Design and Development
- The app will include all database required to provide appropriate medications and dosing
for pediatric patients intraoperatively, postoperatively and on discharge.
- The user will need to enter the patient's age and weight, choose the type of surgery and
the drug class and the app will show the appropriate medications and dosage.
- The app will present all the important information for drug administration by using; the
British National Formulary for children (BNF-C) and Lexicomp online database as the
dosage and administration references, and The American Health System Pharmacists (ASHP)
clinical practice guidelines and UpToDate evidence-based clinical decision support
resource will be used for to determine the appropriate anesthetics, antimicrobials, and
analgesics for the surgeries to be included in the study.
- The researcher will ensure that the application will be displayed properly on the iPhone
operating system (iOS) and Android mobile devices.
Phase 2: Simulation and Validation
- To test app validation, a simulation study will be conducted, where, data of patient's
weight and age will be entered followed by selection of type of surgery and drug class.
- The app will provide the appropriate medications and dosage for each case scenario
according to international treatment protocols and guidelines.
- Medications doses in each drug class will be calculated twice using the app and twice
without the app, for each type of surgery.
Phase 3: Physicians' training Physicians will be trained on how to use the application for
the selected types of surgeries. (List of surgeons will be accurately checked and randomly
50% of them will be allowed to enter training sessions for use of app in their practice
(interventional group), while the rest 50% will not be given the training sessions in order
to use the department policy (Control group).
Phase 4: Patients' recruitment and Application use in pre-, intra-, and post-operative stage
Two hundred and seventy- six 276 patients will be randomly allocated to either control group
or intervention group via simple randomization technique.
Control group (138 patients): The medications selection and dosage will be performed
according to the department policy without using the app.
Intervention group (138 patients): The physicians use the app for appropriate medications
selection and dosage calculation.
All patients will be followed up postoperatively during hospital stay. A follow-up form will
be used to record all required data during hospitalization.
Cost estimation :
Estimated cost savings will be calculated based on reduction in medication errors by using
the electronic app. This will include discontinuing unnecessary medications, modifications of
dose or duration, no medication indication, and inappropriate medication combination.
Medication errors categories according to the National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP) will be included in the cost saving analysis.
Phase 5: Usability testing An electronic form of the System Usability Scale (SUS), a widely
used and validated 10-questions Likert scale, for measuring the app usability will be used to
evaluate physicians' user experience of the app.
Phase 6: Follow-up All patients will be followed up for two weeks after discharge for any
signs and symptoms of drug related problems or postoperative complications including pain,
nausea, vomiting and surgical site infection using an electronic form or phone calls. A
follow-up form will be used after discharge
