N/A
N=11
The Cascade Feasibility Pilot (Ileostomy)
Ileostomy; Complications · Ileostomy - Stoma
Bottom Line
View on ClinicalTrials.gov: NCT05048329 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Attrition Rate — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-invasive continuous remote monitoring with structured escalation pathway (Other); Affective Analysis of Participant Response to Continuous Remote Patient Monitoring (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attrition Rate |
2 | — |
| PRIMARY Enrollment Rate |
11 | — |
| SECONDARY 30 Days Readmission |
1 | — |
| SECONDARY Number of Participants With Stool Regimen Escalation |
2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05048329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.