The Cascade Feasibility Pilot (Ileostomy)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ileostomy; Complications; Ileostomy - Stoma
• Intervention / Treatment: Other: Non-invasive continuous remote monitoring with structured escalation pathway; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nirav S Shah; Phone Number: 8475704208; Email: nshah2@northshore.org

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • NorthShore University HealthSystem Evanston Hospital
    • Glenview, Illinois, United States, 60201
      • Recruiting
      • NorthShore University HealthSystem Glenbrook Hospital
      • Contact: Nirav S Shah; Phone Number: 847-570-4208; Email: nshah2@northshore.org
    • Highland Park, Illinois, United States, 60035-2558
      • Recruiting
      • NorthShore University HealthSystem HighlandPark Hospital
      • Contact: Nirav S Shah; Phone Number: 847-570-1700; Email: nshah2@northshore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Soft Launch; 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; 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; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring; Surveys and interviews with enrolled participants
EXPERIMENTAL: Pilot; 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; 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; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring; Surveys and interviews with enrolled participants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 9, 2021
• Primary Completion (ANTICIPATED): August 31, 2023
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (ACTUAL): September 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Ileostomy
• Other Study ID Numbers: Cascade Ileostomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No