Impact Study of a Digital Solution for Patient Engagement

Sponsor

IHU Strasbourg (Other)

Overall Status

Recruiting

CT.gov ID

NCT04153721

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Name Digital Solution	N/A

Detailed Description

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 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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 11, 2020

Anticipated Primary Completion Date :

Jun 11, 2021

Anticipated Study Completion Date :

Oct 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Digital Solution 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 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

Arm

Intervention/Treatment

Experimental: Digital Solution

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

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

Outcome Measures

Primary Outcome Measures

Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate. [From the inclusion to the surgery]
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
Change, during the preoperative phase, of the physical condition of the patients, assessed by 6MTW scoring. [At the start of the program (6 weeks before the surgery) and at the admission before the surgery]
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.
Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring. [At the start of the program (6 weeks before the surgery) and at the admission before the surgery]
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).
Change, during the preoperative phase, of the psychological condition of the patients, assessed by GAD7 questionnaire scoring. [At the start of the program (6 weeks before the surgery) and at the admission before the surgery]
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)

Secondary Outcome Measures

Evaluation of patients' compliance with their post-operative program [Everyday for 7 days after the discharge from hospital and on the 14th day after the discharge from hospital]
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.
Persistence of program compliance between pre- and post-operative phases [From the inclusion to the end of participation]
Persistence of the program compliance, defined as the difference between the pre and the postoperative completeness rate of the program
Patient satisfaction regarding the program [2 days before the surgery and on the 14th day after the discharge from hospital]
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.
Evaluation, during the preoperative phase, of patient use of the program without compliance, assessed by a rate of undone activities [from 6 weeks before the surgery up to the surgery]
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
Patient interactions with the help desk of the solution [from the inclusion to the end of participation]
Rate of patient interactions with the help desk of the solution, defined as the mean number of phone call and emails per patient
Evaluation of the solution and its use by the patient [Visit Day 30]
Qualitative interview with the patient, carried out during his follow-up consultation J30
Evaluation of the solution and its use by health care providers [End of study]
Qualitative interview with health care providers (physicians, interns), carried out at the end of the study
Evaluation of the postoperative complication rate [Visit Day 30]
Number of postoperative complications identified 30 days after the surgery
Evaluation of duration of hospital stays [from the day before the admission until the end of hospitalisation]
Quantification of the hospital stay duration, defined as defined by the difference between the date of discharge from hospital and the date of admission
Evaluation of the number of postoperative critical values [7 days after the discharge of the hospital]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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