Ileostomy; ComplicationsNCT05048329
The Cascade Feasibility Pilot (Ileostomy)
A study testing Non-invasive continuous remote monitoring with structured escalation pathway and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring in people with Ileostomy; Complications and Ileostomy - Stoma, run by Endeavor Health at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ileostomy; Complications, Ileostomy - Stoma
- What is being tested?
- Non-invasive continuous remote monitoring with structured escalation pathway and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Aug 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, 60201
NorthShore University HealthSystem Glenbrook Hospital
Glenview, Illinois, 60201
NorthShore University HealthSystem HighlandPark Hospital
Highland Park, Illinois, 60035-2558
About this study
Official title: The Cascade Feasibility Pilot (Ileostomy): Improving Care Processes for New Ileostomy Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System
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.
Read the 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.
- Conditions
- Ileostomy; Complications, Ileostomy - Stoma
- Being tested
- Non-invasive continuous remote monitoring with structured escalation pathway, Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Keywords
- Ileostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Ileostomy Cohort | Experimental | The study will include ten eligible patients into the cohort to conduct the study. Receives: Other: Non-invasive continuous remote monitoring with structured escalation pathway; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition Rate
Drop out from study
Measured: 30 days from patient discharge date
Enrollment Rate
Enrollment rate for entire patient cohort
Measured: Through study completion, an average of 30 days for each patient
Secondary outcomes (2)
30 Days Readmission
30-day readmission to hospital
Measured: 30 days from patient discharge date
Number of Participants With Stool Regimen Escalation
Frequency of stool regimen escalation by providers
Measured: 30 days from patient discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start9 Aug 2021
- Primary completion31 May 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ileostomy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav Shah, Endeavor Health
- Investigators
- Nirav S Shah, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048329
- Sponsor's protocol ID
- EH20-288 Cascade Ileostomy
- Status last verified
- May 2024
- First submitted
- 8 Sep 2021
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cascade Feasibility Pilot (Ileostomy): Improving Care Processes for New Ileostomy Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System
- ClinicalTrials.gov ID
- NCT05048329
- Acronym / sponsor ID
- EH20-288 Cascade Ileostomy
- Conditions
- Ileostomy; Complications, Ileostomy - Stoma
- Keywords
- Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ileostomy Cohort | Experimental | Other: Non-invasive continuous remote monitoring with structured escalation pathway, Other: Affective Analysis of Participant Response to Continuous Remote Patient MonitoringThe study will include ten eligible patients into the cohort to conduct the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive continuous remote monitoring with structured escalation pathwayContinuous 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 | Other | Ileostomy Cohort |
| Affective Analysis of Participant Response to Continuous Remote Patient MonitoringSurveys and interviews with enrolled participants | Other | Ileostomy Cohort |
Primary outcome
Attrition Rate
Time frame: 30 days from patient discharge date
Drop out from study
Enrollment Rate
Time frame: Through study completion, an average of 30 days for each patient
Enrollment rate for entire patient cohort
2 secondary outcomes
30 Days Readmission
Time frame: 30 days from patient discharge date
Number of Participants With Stool Regimen Escalation
Time frame: 30 days from patient discharge date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nirav S Shah principal investigator
Endeavor Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive continuous remote monitoring with structured escalation pathway and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring in people with Ileostomy; Complications and Ileostomy - Stoma, run by Endeavor Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition Rate (time frame: 30 days from patient discharge date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.