The Cascade Feasibility Pilot (Ileostomy)

Phase

N/A

Condition

N/A

Treatment

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Non-invasive continuous remote monitoring with structured escalation pathway

Clinical Study ID

NCT05048329

EH20-288 Cascade Ileostomy

Ages 18-100
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 subacutefacilities

Study Design

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

August 09, 2021

August 31, 2022

Study 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.

Connect with a study center

NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois 60201
United States
Site Not Available
NorthShore University HealthSystem Glenbrook Hospital
Glenview, Illinois 60201
United States
Site Not Available
NorthShore University HealthSystem HighlandPark Hospital
Highland Park, Illinois 60035-2558
United States
Site Not Available

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