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
Phase: NA
Conditions: Post-operative Situation
Sponsor: University Hospital, Strasbourg, France

IC MD Protocol – Version 1 applicable as of 28 April 2022 
PRI 2022 – HUS No. 8706 
 
STUDY SUMMARY 
Title of the clinical investigation 
Evaluation of the feasibility of an expert patient decision-support system for optimizing the 
management of conditionally administered medications in a surgical ward 
Short title 
MORPHEE-2 
Sponsor 
Strasbourg University Hospitals 
Principal Investigator 
Prof. Eric NOLL 
HUS No. 
8706 
IDRCB No. 
2022-A01926-37 
Clinical Trial No. 
NCT05707247 
 
Rationale for the clinical investigation 
The management of the numerous medications prescribed in connection with a surgical 
procedure represents a major challenge. Many new drugs are prescribed simultaneously, 
some of which are administered on an “as needed” basis, leading to a risk of suboptimal 
administration. The development of expert systems providing patient decision support 
represents a promising approach to improving perioperative medication management. 
 

Primary Objective 
To evaluate the feasibility of the INSAMED computerized decision-support tool regarding the 
administration of “as needed” medications after surgery. 
 
Secondary Objectives 
1. To evaluate the time to administration, according to current organizational practices, 
of medications prescribed on an “as needed” basis after surgery, in order to confirm 
the relevance of developing expert systems to improve current practice. 
2. To assess patient satisfaction with the therapeutic response provided as part of 
routine care. 
3. To assess patient satisfaction regarding the ease of use of the investigational device. 
4. To assess the safety of the recommendations generated by the computerized tool. 
 
Primary Evaluation Criterion 
Rate of concordance between the recommendations provided by the INSAMED 
computerized tool and those established by healthcare professionals. 
Recommendations generated by INSAMED will be collected through extraction of the usage 
history from the digital interface (commercial smartphone) hosting the expert system. 
Recommendations established by a healthcare professional based on a best-practice 
algorithm will be determined after receipt of an activation message from the device: a 
research nurse (RN) will generate a recommendation based on the medical algorithm for 
symptom management, medical prescriptions, and patient interview, without consulting 
INSAMED. 
 
Secondary Evaluation Criteria 
1. Time delay, in minutes, between the patient’s request for a nurse according to usual 
practice (e.g., call bell) for pain, nausea/vomiting, or constipation, and administration 
of the therapeutic response. 
This delay will be recorded by the research nurse. The patient will simultaneously 
contact the ward nurse (call bell) and activate INSAMED, which will record the time 
of request. 
2. Patient satisfaction with the therapeutic response provided by the ward nurse, 
measured using a visual analog scale from 0 to 100. Patient satisfaction will be 
analyzed according to whether there is concordance or discordance between the 
INSAMED recommendation and the nurse’s response. 

3. Patient satisfaction regarding the ease of use of the INSAMED device, measured 
using a visual analog scale from 0 to 100. 
4. Grading of potential harm associated with discrepancies between INSAMED 
recommendations and those established by the research nurse, according to the 
National Coordinating Council for Medication Error Reporting and Prevention (NCC 
MERP) scale, adapted into three levels. 
 
Study Design 
Prospective, single-center pilot study. 
 
Inclusion Criteria 
• 
Male or female aged 18 years or older (no upper age limit) 
• 
Undergoing surgery in a surgical department of Hautepierre Hospital, Strasbourg 
University Hospitals 
• 
Able to read and understand French 
• 
Neurosensorially capable of interacting with a tactile graphical interface 
• 
Able to understand the objectives and risks of the research and provide dated and 
signed informed consent 
• 
Affiliated with a social security health insurance scheme 
 
Non-Inclusion Criteria 
• 
Patients with neuropsychiatric or sensory disorders likely to interfere with use of the 
visual interface 
• 
Inability to provide informed information (emergency situation, comprehension 
difficulties, etc.) 
• 
Pregnant or breastfeeding women (self-reported) 
• 
Patients under legal protection (guardianship, curatorship, or judicial safeguard) 
 
Practical Conduct of the Study 
Information and Inclusion Visit (V0) 
• 
Anesthesia consultation or pre-anesthesia visit 
• 
Signing of informed consent 
• 
Training in the use of the INSAMED device 
Visits V1 and V3: Day 0 +1 and Day 0 +2 (morning) 

• 
Provision of the INSAMED device 
• 
Reminder regarding its use 
Vx: In case of pain, nausea/vomiting, or constipation 
• 
Activation of INSAMED by the patient 
• 
Call to the ward nurse for effective symptom management 
• 
Patient answers INSAMED questions 
• 
INSAMED: recommendation based on a programmed algorithm 
• 
Visit by the research nurse (without access to INSAMED) 60 minutes after activation; 
the device sends an email alert upon activation 
o Recommendation based on a standard medical symptom treatment 
algorithm, medical prescriptions, and patient interview 
The patient will be managed according to routine care recommendations, without 
consideration of INSAMED recommendations. 
Visits V2 and V4: Day 0 +1 and Day 0 +2 (evening) 
• 
Retrieval of the INSAMED device 
 
Investigational Medical Device 
The investigational medical device is a software prototype. It consists of a patient interface 
designed to assist patients with the administration of “as needed” medications in the 
postoperative period. The device is presented in the form of a smartphone with a tactile 
interface. 
Participating patients are invited to activate the device when experiencing one of the 
following symptoms: pain, nausea/vomiting, or constipation. The device then asks the 
patient questions via the visual interface, to which the patient responds. The device 
subsequently issues a recommendation. 
This recommendation is not communicated to the ward nurse responsible for patient care, 
who continues treatment according to routine care practices. The smartphone hosting the 
software is a CE-marked commercial smartphone manufactured by Samsung or Apple. 
 
Authorized and/or Prohibited Medications/Treatments 
Prescriptions will be made in accordance with routine practice. No treatment is prohibited. 
 
Number of Subjects Required 

30 subjects 
The required number of subjects for this pilot study was set at 30 based on pragmatic 
feasibility considerations and in accordance with empirical rules described by Arain. 
Additionally, as data are repeated for each of the 30 subjects, the statistical power will be 
greater than that of a test conducted on 30 subjects without repeated measures. 
If a patient never activates the device, an additional patient will be included until 30 patients 
have activated the device at least once. Therefore, the required number of subjects 
corresponds to the number of subjects who have used the device at least once, not the 
number of subjects enrolled, which is expected to be higher. 
To achieve this objective, 60 patients are targeted for inclusion. 
 
Statistical Methods 
Statistical analysis will include an initial descriptive phase (mean, median, standard 
deviation, and interquartile range for quantitative data; counts and percentages for 
qualitative variables). 
Analysis of the primary endpoint will consist of evaluating concordance between the 
application’s recommendation and that of the research nurse. As these are repeated binary 
data, concordance will not be assessed using a kappa coefficient, but rather through 
calculation of an intraclass correlation coefficient (ICC) derived from a mixed-effects logistic 
regression model with a random subject effect. Residual variance will be indirectly estimated 
using the methods described by Chakraborty et al. 
The ICC will be reported with its 95% confidence interval, without formal hypothesis testing, 
as this is a pilot study. 
 
Projected Timeline 
• 
Inclusion period duration: 12 months 
• 
Participation duration per subject: 2 days to a maximum of 2 months 
• 
Total study duration: 14 months 
• 
Exclusion duration: Not applicable 
End of the research 
The end of the research corresponds to the last visit of the last subject participating in the 
study. 
Version 1.2 dated 20/12/2022, approved by the CPP Île-de-France II on 09/01/2023 and 
submitted to the ANSM on 13/01/2023