The Cascade Feasibility Pilot (Ileostomy)

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048329
• Other study ID #: EH20-288 Cascade Ileostomy
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2024
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ileostomy - Stoma
• Ileostomy; Complications

Intervention

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
• Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Surveys and interviews with enrolled participants

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attrition Rate	Drop out from study	30 days from patient discharge date
Primary	Enrollment Rate	Enrollment rate for entire patient cohort	Through study completion, an average of 30 days for each patient
Secondary	30 Days Readmission	30-day readmission to hospital	30 days from patient discharge date
Secondary	Number of Participants With Stool Regimen Escalation	Frequency of stool regimen escalation by providers	30 days from patient discharge date