Intestinal FailureNCT07094308
The LIFT-ECHO Last Mile Project
A study testing Learn Intestinal Failure Tele-ECHO Program in people with Intestinal Failure, run by Icahn School of Medicine at Mount Sinai at 5 sites in 2 countries.
Trial summary
This is a multi-site research study to evaluate the efficacy and effectiveness of the LIFT-ECHO program to improve clinical outcomes in patients and improve patient reported quality of life (PRQOL). Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Failure
- What is being tested?
- Learn Intestinal Failure Tele-ECHO Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jul 2026to 30 Jun 2030
- Phase
- Interventional
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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- Physician Inclusion Criteria:
- Physician participants must meet the following criteria in order to be considered eligible for participation:
Show all 9Show fewer
- Individuals of adult age (18 years or older), including pregnant women
- Hold an MD or DO degree
- Be a licensed physician prescriber with a homecare infusion service company
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Brandy Haydel contact
5 sites in 2 countries
United States4 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Marjorie Nisenholtz, 2126598049 ext. 88049, marjorie.nisenholtz@mountsinai.org
Brandy Haydel, 2126598049 ext. 212-241-0255, brandy.haydel@mountsinai.org
New York Academy of Medicine (NYAM)
New York, New York, 10029
Elisa Fisher
Rhode Island Hospital
Providence, Rhode Island, 02903
Marion Winkler
University of Utah
Salt Lake City, Utah, 84112
Kelly Tappenden
United Kingdom1 site
London School of Economics and Political Science
London, WC2A 2AE
Rocco Friebel
About this study
Official title: Improving Outcomes in Chronic Intestinal Failure Using the ECHO Model: The LIFT-ECHO Last Mile Project
This is a multi-site research study to evaluate the efficacy and effectiveness of the LIFT-ECHO program to improve clinical outcomes in patients and improve patient reported quality of life (PRQOL). LIFT-ECHO (Learn Intestinal Failure Tele-ECHO) is a tele-health learning program whereby non-specialist clinicians meet with and learn from CIF specialist teams with the goal of improving the knowledge of CIF. LIFT-ECHO sessions consist of group discussion of anonymized real-world patient cases, followed by a didactic presentation from an expert in intestinal failure. Sessions are held twice a month and last 60-90 minutes. The study will proceed in three distinct phases, correlating with Project Aims. During phase 1 (Aim 1), an intestinal failure disease activity index (IF-DAI) will be developed as a measure of short- to medium-term clinical activity in CIF patients; this phase will be undertaken through Delphi Rounds. During Phase 2 (corresponding to project Aim 2), the researchers will evaluate the impact of physician participation in LIFT-ECHO on patients with CIF on PN. Lastly, Phase 3, corresponding to Aim 3 will be the dissemination of LIFT-ECHO nationally. For Phase 2, the researchers had originally proposed that patients and physicians will be recruited from the records of Optum Home Infusion services. Patient reported quality of life and clinical status will be assessed using surveys at baseline. Physicians will then be invited to participate in a module of LIFT-ECHO consisting of 8 one- hour-long sessions held over the course of 2-4 months. Patients will then be followed for 12 months to assess if physician participation in LIFT-ECHO improves patient reported quality of life and/or treatment efficacy and effectiveness. The main procedures for physician participants in the study include: completion of baseline and monthly surveys, possible participation in an appreciative inquiry workshop and possible participation in a focus group discussion, optional, but encouraged, participation in LIFT-ECHO. The main procedures for patient participants include: completion of surveys at baseline, participation in 12 monthly follow-up phone calls with a study team member. The proposed trial has a total length of 34 months.
Read the detailed description
The proposed trial includes baseline and post-LIFT-ECHO and consists of a minimum 150 clusters - defined as the unit of randomization, each representing one physician, with at least 1-n nested patients with CIF (>300 patients). The study comprises a minimum of four pre-defined sequences, with the exact number of sequences being based on the total number of physicians recruited for the trial. To perform the trial, all participating physicians are randomly selected to transition from the control group to the LIFT-ECHO intervention group, using a computer-generated algorithm (e.g., nQuery Advisor). Once a cluster crosses over to the intervention, it will remain exposed to the intervention for the remaining duration of the study, even if the actual LIFT-ECHO Module is only for 2 months. After each cluster has crossed over and transitioned to the intervention, there will be a 12-month period of follow-up during which all patients will remain treated. The trial requires that all participating physicians begin the control phase of the trial when the data collection period begins for patients and physicians (baseline period of 6 months).
- Conditions
- Intestinal Failure
- Being tested
- Learn Intestinal Failure Tele-ECHO Program, Standard of Care
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learn Intestinal Failure Tele-ECHO ProgramBehavioural
Also called LIFT-ECHO
LIFT-ECHO (Learn Intestinal Failure Tele-ECHO) is a virtual tele-education program designed to improve the knowledge and clinical decision-making of non-specialist clinicians managing patients with chronic intestinal failure (CIF) on parenteral nutrition (PN). The intervention consists of eight 60-90-minute sessions delivered over 2-4 months. Each session includes the presentation of anonymized real-world CIF cases and a didactic lecture by an expert in intestinal rehabilitation. Participating physicians may also complete baseline and follow-up surveys, and optionally participate in focus groups or appreciative inquiry workshops.
Standard of CareBehavioural
Participants will receive routine clinical care for chronic intestinal failure from their usual providers. No additional educational programming or intervention is delivered during this period.
| Study group | Role | What they receive |
|---|---|---|
| Physicians with No Tele-Mentoring then with Tele-Mentoring | 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. Receives: Behavioral: Learn Intestinal Failure Tele-ECHO Program; Behavioral: Standard of Care |
| Physicians with Tele-Mentoring after No Tele-Mentoring | 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). Receives: Behavioral: Learn Intestinal Failure Tele-ECHO Program; Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Quality of Life (PRQOL) Score
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
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (11)
Intestinal Failure Disease Activity Index (IF-DAI) Score
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.
Measured: Baseline through 12 months
Number of physicians recruited
Feasibility of the LIFT-ECHO intervention will be assessed using physician recruitment.
Measured: Baseline through 12 months
Proportion of total physicians who completed at least 4 ECHO sessions
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).
Measured: Baseline through 12 months
Attendance number at ECHO sessions
Feasibility of the LIFT-ECHO intervention will be assessed using physician attendance at ECHO sessions. Higher participation will indicate greater feasibility.
Measured: Baseline through 12 months
Number of ECHO sessions completed
Feasibility of the LIFT-ECHO intervention will be assessed using completion of ECHO sessions. Higher completion rates will indicate greater feasibility.
Measured: Baseline through 12 months
Physician Satisfaction Scale
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.
Measured: Post-intervention (within 1 month after final ECHO session)
Perceived usefulness Scale
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.
Measured: Post-intervention (within 1 month after final ECHO session)
Likelihood of recommending LIFT-ECHO
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.
Measured: Post-intervention (within 1 month after final ECHO session)
Physician Participation Rate
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.
Measured: Baseline through 12 months
Number of Emergency Room Visits
Number of ER visits reported monthly by patients.
Measured: Monthly up to 12 months
Number of Hospital Admissions
Number of hospital admissions reported monthly by patients.
Measured: Monthly up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The New York Academy of Medicine, University of Utah, London School of Economics and Political Science
- Responsible party
- Principal investigator, Kishore Iyer, Icahn School of Medicine at Mount Sinai
- Investigators
- Kishore Iyer, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094308
- Sponsor's protocol ID
- STUDY-23-00728
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).