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ECHO Model for Enhancing Chronic Intestinal Failure Care: The LIFT-ECHO Last Mile Project

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Study AimThis study, ECHO Model for Enhancing Chronic Intestinal Failure Care, aims to improve health services for individuals on home parenteral nutrition. It will measure patients' quality of life using the HPN-PROQ tool, assessing physical health, emotional well-being, social functioning, and treatment burden.
What is being tested

Learn Intestinal Failure Tele-ECHO Program

+ Standard of Care
Behavioral
Who is being recruted

Intestinal Failure

Over 5 Years
+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Services Research Study

Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactMarjorie Nisenholtz
Last updated: July 30, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025Actual date on which the first participant was enrolled.

The study aims to evaluate a specific approach called the LIFT-ECHO model to improve care for patients with Chronic Intestinal Failure (CIF). This condition affects the digestive system, making it hard for the body to absorb nutrients properly. The research involves doctors from at least 150 different sites, each overseeing patients with CIF. By understanding how the LIFT-ECHO model can enhance treatment, the study seeks to offer better health outcomes for these patients, potentially leading to improved quality of life and more effective management of the condition. In this trial, doctors are randomly assigned to either continue their usual practices or switch to using the LIFT-ECHO model. This switch is determined by a computer algorithm. Once a doctor starts using the LIFT-ECHO model, they continue with it throughout the study. Initially, there is a 6-month period where normal practices are observed, followed by a 2-month introduction of the LIFT-ECHO model. After this, patients continue to receive treatment under the new approach for a year. The study looks at how patient care improves over time, helping to determine the model's effectiveness in managing CIF.

Official TitleImproving Outcomes in Chronic Intestinal Failure Using the ECHO Model: The LIFT-ECHO Last Mile Project 
Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactMarjorie Nisenholtz
Last updated: July 30, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
150 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Services Research Study
These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 5 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Intestinal Failure
Criteria
9 inclusion criteria required to participate
CIF patient participants must meet the following criteria in order to be considered eligible for participation
Individuals of adult age (18 years or older), including pregnant women or Individuals of age > 5 years with parental consent and patient assent
Diagnosis of chronic intestinal failure (ie. on PN >6 months with no malignancy, no HIV and a malabsorption or post-surgical diagnosis)
Currently receiving PN from a homecare infusion service company

Show More Criteria

4 exclusion criteria prevent from participating
Participants meeting one or more of the following criteria will be excluded from participation
Adults unable to consent (individuals with impaired decision-making capacity)
Prisoners
Children > 5 years who dissent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Dyads consisting of a prescribing physician and one or more of their patients receiving parenteral nutrition (PN). Physicians in this arm will be invited to participate but would not yet have received the Tele-Mentoring (LIFT-ECHO) focused on the management of chronic intestinal failure. Patients of these physicians will be followed for a baseline period of 6 months (Control period) to assess evolution in clinical outcomes and patient-reported quality of life.
Group II
Experimental
Dyads consisting of a prescribing physician and one or more of their patients receiving parenteral nutrition (PN). Physicians in this arm will participate in the LIFT-ECHO program. After patients complete a baseline period of 6 months (Control period), their physician receives the intervention (LIFT-ECHO).
Study Objectives
Primary Objectives

Patient-reported quality of life will be measured using the HPN-PROQ, a validated instrument designed for individuals receiving home parenteral nutrition (HPN). The total score ranges from 0 to 100, with higher scores indicating better quality of life. Subscales include physical health, emotional well-being, social functioning, and treatment burden, each also scored from 0 to 100, where higher scores indicate more favorable outcomes
Secondary Objectives

Intestinal Failure-Disease Activity Index (IF-DAI) is a composite clinical index to quantify disease activity in patients with chronic intestinal failure, incorporating weighted indicators such as central line infections, liver dysfunction, hospitalization, and GI-related procedures. Scores will be scaled such that higher scores indicate greater disease activity (i.e., worse clinical status). The IF-DAI is still in development and the minimum and maximum scores are to be determined.

Feasibility of the LIFT-ECHO intervention will be assessed using physician recruitment.

Feasibility of the LIFT-ECHO intervention will be assessed using retention rates. Retention rate will be reported as proportion of total physicians who completed at least 4 ECHO sessions (Retention Rate = \[Total # of physician subjects consented / Total # of physicians subjects who attended ≥4 ECHO sessions\] \*100).

Feasibility of the LIFT-ECHO intervention will be assessed using physician attendance at ECHO sessions. Higher participation will indicate greater feasibility.

Feasibility of the LIFT-ECHO intervention will be assessed using completion of ECHO sessions. Higher completion rates will indicate greater feasibility.

Acceptability will be measured using physician satisfaction. Survey is a Likert-scale with items scored from 1 (strongly disagree) to 5 (strongly agree) assessing satisfaction. Total scale is 1-5, with higher scores will indicate greater acceptability of the intervention.

Acceptability will be measured using perceived usefulness. Survey is a Likert-scale with items scored from 1 (strongly disagree) to 5 (strongly agree) assessing perceived usefulness. Total scale is 1-5, with higher scores will indicate greater acceptability of the intervention.

Acceptability will be measured using likelihood of recommending LIFT-ECHO to others. Survey is a Likert-scale with items scored from 1 (strongly disagree) to 5 (strongly agree) assessing likelihood of recommending LIFT-ECHO to others. Total scale is 1-5, with higher scores will indicate greater acceptability of the intervention.

Participation rate will be measured by tracking the number of physicians who enroll in the LIFT-ECHO program and attend at least one session. The proportion of participants who choose to participate, expressed as a percentage. Higher percentages indicate greater engagement with the program.

Number of ER visits reported monthly by patients.

Number of hospital admissions reported monthly by patients.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
Icahn School of Medicine at Mount SinaiNew York, United StatesSee the location
Suspended
New York Academy of Medicine (NYAM)New York, United States
Suspended
Rhode Island HospitalProvidence, United States
Suspended
University of UtahSalt Lake City, United States
Recruiting soon5 Study Centers