CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Non-invasive continuous remote monitoring with structured escalation pathway +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05048329
NCT05048329N/ACompleted

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

Endeavor Health·interventional·Posted Sep 17, 2021·Updated May 21, 2024

In Brief

A clinical study evaluating Non-invasive continuous remote monitoring with structured escalation pathway and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring for Ileostomy; Complications and Ileostomy - Stoma. Completed, enrolled 11 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 17, 2021
Enrollment StartAug 9, 2021
Primary CompletionMay 31, 2022
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.8 years ago

Interventions

Non-invasive continuous remote monitoring with structured escalation pathwayother

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 Monitoringother

Surveys and interviews with enrolled participants