Clinical trial NCT04153721: Impact Study of a Digital Solution for Patient Engagement
Official title: Evaluation of a Digital Perioperative Support Solution for Colorectal Surgery: Compliance and Impact on Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: enhanced recovery
rehabilitation
prehabilitation
patient engagement
digital health
e-health
colorectal surgery
preparation
follow-up
patient empowerment
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).

Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes.

Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.

The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.

The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.

This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.

Detailed description: The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).

Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Patient engagement promotes accelerated rehabilitation and reduces complications and readmissions, which is also beneficial in terms of public health.

Medtronic has designed a digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery, for which the IHU is a pilot experiment site. This research protocol aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.

Multiple professionals dispense instructions and information to patients. The active accompaniment of the patient in his rehabilitation process is carried out mainly in the postoperative phase, during the hospital stay.

The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.

The solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption). In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team.

The program is personalized by patient, according to its management (type of surgery, duration of the program) and its state of health (choice of options adapted by the doctor).

The solution has three components to interact with the patient:

* A website, offering information and activities adapted to the patient's journey. A second site allows the licensed care team to track adherence and patient-reported data.
* SMS (Short Message Service) notifications, for the patient who can and wants to receive SMS. It encourages the monitoring of the program (reminders).
* An on-site IHU support team, accessible by phone and email. She ensures the smooth running of the program, supervises the information declared by the patient and relays his questions to the relevant interlocutors (care team, technical experts).

The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.

The solution processes personal information. Particular vigilance is therefore given to security: compliance with legislation, state-of-the-art techniques used, respect for privacy from the upstream and by default, transparency and control, security measures (eg data encryption, double authentication, lack of interfaces to other information systems, accredited health host).

According to the literature, the preparation of the patient for surgery makes it possible to shorten the length of stay, the perioperative morbidity, the delay to come back to normal activity. This medical impact results in a reduction in post-operative costs (reduction of the length of stay, complications and readmissions), for the health facility and the payer. Improvement and systematization of the solution should help generate these savings.

The impact of the solution on the workload and the organization of the care team is to be specified.

This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery.

Eligibility criteria: Inclusion Criteria:

1. Major patient candidate for a scheduled colorectal surgery and whose admission is expected within 8 days minimum
2. Patient with an email address and an internet connection
3. Patient able to receive and understand information about the study and give written informed consent

Exclusion Criteria:

1. Patient under the age of 18 years old.
2. Pregnant or lactating patient
3. Patient in exclusion period (determined by a previous or a current study)
4. Patient under guardianship, trusteeship or the protection of justice

Primary outcomes:
measure: Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate.
timeFrame: From the inclusion to the surgery
measure: Change, during the preoperative phase, of the physical condition of the patients, assessed by 6MTW scoring.
timeFrame: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
measure: Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring.
timeFrame: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
measure: Change, during the preoperative phase, of the psychological condition of the patients, assessed by GAD7 questionnaire scoring.
timeFrame: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Secondary outcomes:
measure: Evaluation of patients' compliance with their post-operative program
timeFrame: Everyday for 7 days after the discharge from hospital and on the 14th day after the discharge from hospital
measure: Persistence of program compliance between pre- and post-operative phases
timeFrame: From the inclusion to the end of participation
measure: Patient satisfaction regarding the program
timeFrame: 2 days before the surgery and on the 14th day after the discharge from hospital
measure: Evaluation, during the preoperative phase, of patient use of the program without compliance, assessed by a rate of undone activities
timeFrame: from 6 weeks before the surgery up to the surgery
measure: Patient interactions with the help desk of the solution
timeFrame: from the inclusion to the end of participation
measure: Evaluation of the solution and its use by the patient
timeFrame: Visit Day 30
measure: Evaluation of the solution and its use by health care providers
timeFrame: End of study
measure: Evaluation of the postoperative complication rate
timeFrame: Visit Day 30
measure: Evaluation of duration of hospital stays
timeFrame: from the day before the admission until the end of hospitalisation
measure: Evaluation of the number of postoperative critical values
timeFrame: 7 days after the discharge of the hospital
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne, NHC
Study officials:
affiliation: Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
name: Didier Mutter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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