The Cascade Feasibility Pilot (Ileostomy)

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05048329
Study type	Interventional
Source	NorthShore University HealthSystem
Contact
Status	Completed
Phase	N/A
Start date	August 9, 2021
Completion date	August 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03746353` - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer	N/A
Completed	`NCT03331783` - Assessment of the Effect of Output on New Adhesives	N/A
Completed	`NCT02886455` - Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives	N/A
Completed	`NCT02920294` - Modulation of Microbial Composition in Ileostomy Patients	N/A
Completed	`NCT02517541` - A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products	N/A
Completed	`NCT01957553` - Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece	N/A
Completed	`NCT01939600` - Digestibility of Selected Resistant Starches in Humans	N/A
Terminated	`NCT01994863` - Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy	Phase 2
Completed	`NCT01994876` - Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy	N/A
Completed	`NCT03289013` - Assessement of the Peal Force Needed to Peel New Adhesives From the Skin	N/A
Terminated	`NCT03416023` - Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy	N/A
Completed	`NCT02997267` - Early Closure of Protective Ileostomy in Rectal Cancer Patients	N/A
Recruiting	`NCT01880918` - A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing	N/A
Completed	`NCT01957397` - Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy	N/A
Recruiting	`NCT04577456` - Chyme Reinfusion for Type 2 Intestinal Failure	N/A
Terminated	`NCT03587519` - Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery	N/A
Recruiting	`NCT03872271` - Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial	N/A
Completed	`NCT04606004` - Perianal Maceration in Pediatric Ostomy Closure Patients	N/A
Completed	`NCT02886403` - Evaluation of the Influence of Output on a Newly Develop Adhesive	N/A
Recruiting	`NCT03424447` - Stimulation of the Efferent Loop Before Loop Ileostomy Closure	Phase 2