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Completed

NCT Number: NCT05048329

The Cascade Feasibility Pilot (Ileostomy)

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem Evanston Hospital, Evanston, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive continuous remote monitoring with structured escalation pathway

Other

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 Monitoring

Other

Surveys and interviews with enrolled participants

Primary outcomes

  1. Attrition Rate

    Time frame: 30 days from patient discharge date

    Drop out from study

  2. Enrollment Rate

    Time frame: Through study completion, an average of 30 days for each patient

    Enrollment rate for entire patient cohort

Secondary outcomes

  1. 30 Days Readmission

    Time frame: 30 days from patient discharge date

    30-day readmission to hospital

  2. Number of Participants With Stool Regimen Escalation

    Time frame: 30 days from patient discharge date

    Frequency of stool regimen escalation by providers

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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