Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication (MORPHEE 2)

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

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Situation
• Intervention / Treatment: Device: software

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric NOLL, MD; Phone Number: 0033 03 88 12 70 76; Email: eric.noll@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Eric NOLL, MD; Phone Number: 03 88 12 70 76; Email: eric.noll@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prototype software	Device: software; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Eric NOLL, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): July 4, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: prototype software; patient interface; experimental medical device
• Other Study ID Numbers: 8706

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No