The Cascade Feasibility Pilot (Ileostomy)

NCT05048329 | Completed Results

• 1 other identifier: EH20-288 Cascade Ileostomy
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Ileostomy; Complications; Ileostomy - Stoma

Keywords

Ileostomy

Outcome Measures

Primary Outcomes (2)

• Attrition Rate

  Drop out from study

  30 days from patient discharge date

• Enrollment Rate

  Enrollment rate for entire patient cohort

  Through study completion, an average of 30 days for each patient

Secondary Outcomes (2)

• 30 Days Readmission

  30 days from patient discharge date

• Number of Participants With Stool Regimen Escalation

  30 days from patient discharge date

Study Arms (1)

Ileostomy Cohort

EXPERIMENTAL

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

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

Interventions

Non-invasive continuous remote monitoring with structured escalation pathway 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

Ileostomy Cohort

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring OTHER

Surveys and interviews with enrolled participants

Ileostomy Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (3)

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, 60201, United States

Location

NorthShore University HealthSystem Glenbrook Hospital

Glenview, Illinois, 60201, United States

Location

NorthShore University HealthSystem HighlandPark Hospital

Highland Park, Illinois, 60035-2558, United States

Location

Results Point of Contact

• Title: Nirav S Shah
• Organization: NorthShore university HealthSystem

nshah@northshore.org

847-570-3542

Study Officials

• Nirav S Shah

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Quality Innovation and Clinical Practice Analytics, Program Director of Outcomes Research for Quality and Transformation

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: August 9, 2021
• Primary Completion: May 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)