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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ileostomy Cohort | Experimental | The study will include ten eligible patients into the cohort to conduct the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition Rate | Drop out from study | 30 days from patient discharge date |
| Enrollment Rate | Enrollment rate for entire patient cohort | Through study completion, an average of 30 days for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Days Readmission | 30-day readmission to hospital | 30 days from patient discharge date |
| Number of Participants With Stool Regimen Escalation | Frequency of stool regimen escalation by providers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nirav S Shah | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem Evanston Hospital | Evanston | Illinois | 60201 | United States | ||
| NorthShore University HealthSystem Glenbrook Hospital |
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A total of 11 participants were enrolled in the study. One patient withdrew and one was a screen fail, resulting in a total of 9 participants who completed the study.
Recruitment was conducted at three NorthShore Hospitals from August 2021 and September 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Ileostomy Cohort | The study will include 10 eligible patients into the study cohort to conduct the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The number of participants completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Ileostomy Cohort | The study will include ten eligible patients into the cohort to conduct the study. Non-invasive continuous remote monitoring with structured escalation pathway: 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: Surveys and interviews with enrolled participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attrition Rate | Drop out from study | Posted | Count of Participants | Participants | 30 days from patient discharge date |
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We collected adverse event data over the 30-day participation period for each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ileostomy Cohort | The study will include 10 eligible patients into the study cohort to conduct the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nirav S Shah | NorthShore university HealthSystem | 847-570-3542 | nshah@northshore.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2023 | Nov 29, 2023 | Prot_000.pdf |
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| Affective Analysis of Participant Response to Continuous Remote Patient Monitoring | Other | Surveys and interviews with enrolled participants |
|
| 30 days from patient discharge date |
| Glenview |
| Illinois |
| 60201 |
| United States |
| NorthShore University HealthSystem HighlandPark Hospital | Highland Park | Illinois | 60035-2558 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants |
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| Primary | Enrollment Rate | Enrollment rate for entire patient cohort | Posted | Count of Participants | Participants | Through study completion, an average of 30 days for each patient |
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| Secondary | 30 Days Readmission | 30-day readmission to hospital | Posted | Count of Participants | Participants | 30 days from patient discharge date |
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| Secondary | Number of Participants With Stool Regimen Escalation | Frequency of stool regimen escalation by providers | Posted | Count of Participants | Participants | 30 days from patient discharge date |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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