The Cascade Feasibility Pilot (Ileostomy): Improving Care Processes for New Ileostomy Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Endeavor Health
- Enrollment
- 11
- Locations
- 6
- Primary Endpoint
- Enrollment Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Enrollment Rate
Time Frame: Through study completion, an average of 30 days for each patient
Enrollment rate for entire patient cohort
Attrition Rate
Time Frame: 30 days from patient discharge date
Drop out from study
Secondary Outcomes
- Number of Participants With Stool Regimen Escalation(30 days from patient discharge date)
- 30 Days Readmission(30 days from patient discharge date)
Investigators
Nirav Shah
Medical Director of Quality Innovation and Clinical Practice Analytics, Program Director of Outcomes Research for Quality and Transformation
Endeavor Health