Trial Outcomes & Findings for Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication (NCT NCT05707247)
NCT ID: NCT05707247
Last Updated: 2026-04-14
Results Overview
Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional, The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system. The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan).
COMPLETED
NA
37 participants
Day 2 post operative
2026-04-14
Participant Flow
Participant milestones
| Measure |
Prototype Software
All study participants received the same intervention, i.e. use of our novel CDSS device, in this single-arm study. Before the intervention they received education from study personnel about the purpose and the use of the experimental device. After the surgical procedure, patients were given the experimental device on postoperative days 1 and 2 from 9 am to 5 pm. They were also given another educational session about the use of the device. The device was configured each day by study personnel before being handed to the patient. The configuration included medical prescriptions related to pain, PONV and constipation. The patients were instructed to press the room call button each time they experienced significant symptoms of pain, PONV or constipation to request help from the hospital team providing their routine care. In the educational session, they were instructed to activate the experimental device and go through the questions displayed, after they pressed the room call button.
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|---|---|
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Overall Study
STARTED
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37
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prototype Software
n=30 Participants
All study participants received the same intervention, i.e. use of our novel CDSS device, in this single-arm study. Before the intervention they received education from study personnel about the purpose and the use of the experimental device. After the surgical procedure, patients were given the experimental device on postoperative days 1 and 2 from 9 am to 5 pm. They were also given another educational session about the use of the device. The device was configured each day by study personnel before being handed to the patient. The configuration included medical prescriptions related to pain, PONV and constipation. The patients were instructed to press the room call button each time they experienced significant symptoms of pain, PONV or constipation to request help from the hospital team providing their routine care. In the educational session, they were instructed to activate the experimental device and go through the questions displayed, after they pressed the room call button.
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Age, Continuous
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64 year
n=30 Participants
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Sex: Female, Male
Female
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15 Participants
n=30 Participants
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Sex: Female, Male
Male
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15 Participants
n=30 Participants
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PRIMARY outcome
Timeframe: Day 2 post operativePopulation: The patient may find themselves in several situations where they need advice.
Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional, The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system. The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan).
Outcome measures
| Measure |
Prototype Software
n=54 recommendation pairs (Number of matches)
All study participants received the same intervention, i.e. use of our novel CDSS device, in this single-arm study. Before the intervention they received education from study personnel about the purpose and the use of the experimental device. After the surgical procedure, patients were given the experimental device on postoperative days 1 and 2 from 9 am to 5 pm. They were also given another educational session about the use of the device. The device was configured each day by study personnel before being handed to the patient. The configuration included medical prescriptions related to pain, PONV and constipation. The patients were instructed to press the room call button each time they experienced significant symptoms of pain, PONV or constipation to request help from the hospital team providing their routine care. In the educational session, they were instructed to activate the experimental device and go through the questions displayed, after they pressed the room call button.
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Rate of Agreement Between the Recommendations of the INSAMED Computer Tool and the Recommendations Made by a Healthcare Professional From the Research Team Based on the Best Practice Algorithm.
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51 recommendation pairs (Number of matches)
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Adverse Events
Prototype Software
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eric Noll
Hôpitaux Universitaires de Strasbourg (HUS)/ Strasbourg University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place