The Cascade Feasibility Pilot (Ileostomy)

Study Overview
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Brief Summary
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Existing interventions including improving communication and self-care to improve readmission of patients undergoing high risk colorectal surgery involving new ileostomy formation has shown limited results. Our proposal is to deploy a wearable solution that predicts physiological perturbation with continuous remote patient monitoring and advanced machine learning algorithms which will be connected to structured, cascading, escalation pathways and care coordination involving home health nurses, colorectal and ostomy nurses, and colorectal surgeons, and has the potential to transform surgical management in the post-discharge period, where patients are the most vulnerable for readmission. This feasibility study will contribute to the understanding of post-discharge continuous remote monitoring of ileostomy patients, promote patient self-care, and has the potential of improving patient outcomes.

Detailed Description
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Colorectal surgery is a high-risk surgery that results in significant morbidity, and health care utilization in the form of readmission. Ileostomy creation is a significant risk factor in colorectal surgery rehospitalization. Effective continuous remote patient monitoring (CRPM) can reduce readmissions, but it has only been realized in select heart failure populations via invasive monitoring. The investigators will focus on colorectal CRPM in the elective, new ileostomy population through a structured cascading and escalating alert system. In this feasibility study, the investigators will use a wearable biosensor and collect ambulatory physiological data that are analyzed by machine learning algorithms, to generate personalized alerts of physiological perturbation in colorectal surgery patients in the post-discharge period. Alerts from this algorithm may be cascaded with other patient status data to inform management by the home health team via a structured protocol built into the electronic health record (EHR). The escalation pathway will engage home health nurses, colorectal care team nurses, ostomy nurses, and colorectal surgeons. The investigators will conduct surveys and semi-structured interviews with patients, and semi-structured interviews with providers, which will be used to evaluate the perceptions, acceptance, and experience of this CRPM solution.

Official Title
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The Cascade Feasibility Pilot (Ileostomy): Improving Care Processes for New Ileostomy Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System

Conditions
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Ileostomy; Complications, Ileostomy - Stoma

Intervention / Treatment
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* Other: Non-invasive continuous remote monitoring with structured escalation pathway
* Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is inpatient admission at NorthShore University HealthSystem hospital Patient underwent a new ileostomy formation at index hospitalization Patient is at least 18 years of age Patient is fluent in English Patient agrees to protocol-required procedures Patient discharges with NorthShore Home Health Service Exclusion Criteria: Patient has cognitive or physical limitations that, in the investigator's opinion, limit the patient's ability to maintain patch device and phone Patient has allergy to hydrocolloid adhesives Patient has present skin damage preventing them from wearing a study device Pregnancy Patient discharge location is a Skilled Nursing Facility or other subacute facilities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soft Launch<br>The study will include ten eligible patients into the soft launch to test and reconfigure workflow, protocol, alerting structure and other operation related factors. | Other: Non-invasive continuous remote monitoring with structured escalation pathway<br>* Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and colorectal clinical team<br>Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring<br>* Surveys and interviews with enrolled participants<br>|
| Experimental: Pilot<br>After the soft launch, the study will include 45 eligible patients into the pilot to conduct the rest of the study | Other: Non-invasive continuous remote monitoring with structured escalation pathway<br>* Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and colorectal clinical team<br>Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring<br>* Surveys and interviews with enrolled participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition rate | Drop out from study | Through study completion, an average 2 year | 
| Enrollment rate | Enrollment rate for entire patient cohort | Through study completion, an average 2 year | 
| Adherence to study requirement rate | Patient adherence to patch, daily patient reported status updates and other study requirements | Through study completion, an average 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented Medication adherence counseling | Frequency of medication adherence counseling captured in a note within the electronic health record | 30 days from patient discharge date | 
| Documented Dietary counseling | Frequency of dietary counseling captured in a note within the electronic health record | 30 days from patient discharge date | 
| Stool regimen escalation | Frequency of augmenting stool regimen dosage | 30 days from patient discharge date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ileostomy