Ileostomy; Complications, Ileostomy - Stoma
Conditions
Keywords
Ileostomy
Brief 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.
Detailed 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.
Interventions
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
Surveys and interviews with enrolled participants
Sponsors
Endeavor Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attrition Rate | 30 days from patient discharge date | Drop out from study |
| Enrollment Rate | Through study completion, an average of 30 days for each patient | Enrollment rate for entire patient cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Days Readmission | 30 days from patient discharge date | 30-day readmission to hospital |
| Number of Participants With Stool Regimen Escalation | 30 days from patient discharge date | Frequency of stool regimen escalation by providers |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted at three NorthShore Hospitals from August 2021 and September 2022
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screenfail | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ileostomy Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Attrition Rate
Drop out from study
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ileostomy Cohort | Attrition Rate | 2 Participants |
Primary
Enrollment Rate
Enrollment rate for entire patient cohort
Time frame: Through study completion, an average of 30 days for each patient
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ileostomy Cohort | Enrollment Rate | 11 Participants |
Secondary
30 Days Readmission
30-day readmission to hospital
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ileostomy Cohort | 30 Days Readmission | 1 Participants |
Secondary
Number of Participants With Stool Regimen Escalation
Frequency of stool regimen escalation by providers
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ileostomy Cohort | Number of Participants With Stool Regimen Escalation | 2 Participants |