The Cascade Feasibility Pilot (Ileostomy)

NCT ID: NCT05048329

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2022-08-31

Brief 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.

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.

Conditions

Ileostomy; Complications; Ileostomy - Stoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ileostomy Cohort

The study will include ten eligible patients into the cohort to conduct the study.

Group Type: EXPERIMENTAL

Non-invasive continuous remote monitoring with structured escalation pathway

Intervention Type: OTHER

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

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Intervention Type: OTHER

Surveys and interviews with enrolled participants

Interventions

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

Intervention Type: OTHER

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Surveys and interviews with enrolled participants

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Nirav Shah

Medical Director of Quality Innovation and Clinical Practice Analytics, Program Director of Outcomes Research for Quality and Transformation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nirav S Shah

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, United States

NorthShore University HealthSystem Glenbrook Hospital

Glenview, Illinois, United States

NorthShore University HealthSystem HighlandPark Hospital

Highland Park, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

EH20-288 Cascade Ileostomy

Identifier Type: -

Identifier Source: org_study_id