Clinical trial NCT05048329: The Cascade Feasibility Pilot (Ileostomy)
Official title: The Cascade Feasibility Pilot (Ileostomy): Improving Care Processes for New Ileostomy Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy; Complications
Ileostomy - Stoma
Keywords: Ileostomy
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Attrition Rate
timeFrame: 30 days from patient discharge date
measure: Enrollment Rate
timeFrame: Through study completion, an average of 30 days for each patient
Secondary outcomes:
measure: 30 Days Readmission
timeFrame: 30 days from patient discharge date
measure: Number of Participants With Stool Regimen Escalation
timeFrame: 30 days from patient discharge date
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem Evanston Hospital
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem Glenbrook Hospital
state: Illinois
city: Highland Park
country: United States
facility: NorthShore University HealthSystem HighlandPark Hospital
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Nirav S Shah
role: PRINCIPAL_INVESTIGATOR
References: