Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication

Study Overview
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Brief Summary
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The experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems. The study hypothesis is that the clinical use of the experimental device is feasible.

Official Title
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Evaluation of the Feasibility of an Expert Decision Support System for Patients Regarding the Optimization of the Management of Drugs With Conditional Administration in the Surgical Department: Pilot Study

Conditions
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Post-operative Situation

Intervention / Treatment
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* Device: software


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or Female 18 years or older (no upper age limit) Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg Patient understanding and reading French Subject neurosensorially able of interacting with a tactile electronical interface Subject able to understand research objectives, risks and provide dated and signed informed consent Subject covered by a health insurance scheme Exclusion criteria: Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.) Pregnant or lactating woman (on declaration) Patient under safeguard of justice, under guardianship, under curatorship

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prototype software<br> | Device: software<br>* The experimental medical device is a prototype software. It is a patient interface. The device comes in the form of a smartphone with a touch screen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility of the INSAMED computer tool | agreement between INSAMED computer tool and the recommendations established by caregivers. The data from INSAMED computer tool will be collected by extracting the history of the digital interface (commercial smartphone) hosting the expert system. | Day 2 post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the time delay, in usual care setting, of rescue drug administrations after surgery, to confirm the interest of developing expert systems to improve the existing one. | Delay, in minutes, between soliciting a ward nurse as usual practice (e.g., doorbell) and the administration of the therapeutic response. This time will be collected by the Research IDE during patient interview. 60 minutes after software activation. The patient will simultaneously request the standard care IDE (doorbell) and the INSAMED tool. | 60 minutes after software activation | 
| Assess patient satisfaction with usual care | Patient satisfaction with the routine care therapeutic response measured by an analog visual scale between 0 and 100, measured 60 minutes after software activation. | 60 minutes after software activation. | 
| Assess patient satisfaction with the ease of use of the experimental device | Patient satisfaction with the ease of use of the INSAMED device measured by an analog visual scale between 0 and 100, measured 60 minutes after software activation | 60 minutes after software activation. | 
| assess the security of the device | Safety analysis of INSAMED software through evaluation of serious adverse events based on a expert panel reviewing. | Day 2 post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prototype software, patient interface, experimental medical device