Impact Study of a Digital Solution for Patient Engagement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Digital Perioperative Support Solution for Colorectal Surgery: Compliance and Impact on Patients

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Name Digital Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient candidate for a scheduled colorectal surgery and whose admission is expected within 8 days minimum Patient with an email address and an internet connection Patient able to receive and understand information about the study and give written informed consent Exclusion Criteria: Patient under the age of 18 years old. Pregnant or lactating patient Patient in exclusion period (determined by a previous or a current study) Patient under guardianship, trusteeship or the protection of justice

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Solution<br>The proposed digital solution 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 | Behavioral: Name Digital Solution<br>* The digital 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate. | Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The first part of the primary endpoint of the study is the average rate of completeness of the preoperative program: percentage based on the status (done / not done) of pre-operative tasks specific to each patient | From the inclusion to the surgery | 
| Change, during the preoperative phase, of the physical condition of the patients, assessed by 6MTW scoring. | Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The second part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the physical condition : comparison between two walk tests, one done at the inclusion, the other when admitted for surgery. The result of the walk test is the distance travelled in meters during the test (6 minutes) by the patient. | At the start of the program (6 weeks before the surgery) and at the admission before the surgery | 
| Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring. | Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The third part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition assessed by the questionnaire PHQ8 (Brief Patient Health Questionnaire depression scale): questions the existence and intensity of depressive symptoms (score from 0 to 24 in case of severe depression). | At the start of the program (6 weeks before the surgery) and at the admission before the surgery | 
| Change, during the preoperative phase, of the psychological condition of the patients, assessed by GAD7 questionnaire scoring. | Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The fourth part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition evaluated by the questionnaire GAD7 (Generalized Anxiety Disorder 7-item): indicates the severity of the anxiety (score from 0 to 21 in case of generalized anxiety disorder) | At the start of the program (6 weeks before the surgery) and at the admission before the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of patients' compliance with their post-operative program | Completeness rate of the postoperative program. This rate is calculated according to the status (done or not done) of the tasks to be performed by the patient after the surgical procedure: daily evaluations the first week and the 14th day after discharge from hospital. Task status is plotted in the digital solution. | Everyday for 7 days after the discharge from hospital and on the 14th day after the discharge from hospital | 
| Persistence of program compliance between pre- and post-operative phases | Persistence of the program compliance, defined as the difference between the pre and the postoperative completeness rate of the program | From the inclusion to the end of participation | 
| Patient satisfaction regarding the program | The satisfaction is assessed on all patients by three questions (useful, adapted, promotable program). The scores obtained on these three questions will be measured pre-operatively, post-operatively and averaged over the whole program. These scores are calculated automatically by the solution. | 2 days before the surgery and on the 14th day after the discharge from hospital | 
| Evaluation, during the preoperative phase, of patient use of the program without compliance, assessed by a rate of undone activities | For patients with a preoperative physical activity and/or nutritional program prescribed, number of declared as undone activities compared to the total number of prescribed activities | from 6 weeks before the surgery up to the surgery | 
| Patient interactions with the help desk of the solution | Rate of patient interactions with the help desk of the solution, defined as the mean number of phone call and emails per patient | from the inclusion to the end of participation | 
| Evaluation of the solution and its use by the patient | Qualitative interview with the patient, carried out during his follow-up consultation J30 | Visit Day 30 | 
| Evaluation of the solution and its use by health care providers | Qualitative interview with health care providers (physicians, interns), carried out at the end of the study | End of study | 
| Evaluation of the postoperative complication rate | Number of postoperative complications identified 30 days after the surgery | Visit Day 30 | 
| Evaluation of duration of hospital stays | Quantification of the hospital stay duration, defined as defined by the difference between the date of discharge from hospital and the date of admission | from the day before the admission until the end of hospitalisation | 
| Evaluation of the number of postoperative critical values | The number of post-operative critical values detected following daily assessments in the week following discharge from hospital, in accordance with the thresholds defined by the care team | 7 days after the discharge of the hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery, rehabilitation, prehabilitation, patient engagement, digital health, e-health, colorectal surgery, preparation, follow-up, patient empowerment