Tele-Health Learning for Intestinal Failure

Not yet recruiting at 4 trial locations

Overseen By Brandy Haydel

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Parenteral nutrition

Disqualifiers: Impaired decision-making, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a tele-health program called LIFT-ECHO (Learn Intestinal Failure Tele-ECHO Program) can help doctors enhance treatment and quality of life for patients with chronic intestinal failure. LIFT-ECHO includes virtual sessions where doctors learn from experts about managing this condition, which often requires patients to receive nutrition through an IV at home. Patients who have been on home IV nutrition for more than six months, without cancer or HIV, and their doctors, are well-suited for this study. The trial will monitor whether these learning sessions lead to better health outcomes for the patients. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative healthcare solutions and potentially improve their own treatment outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a tele-health program rather than changing your medication regimen.

What prior data suggests that the LIFT-ECHO program is safe for improving clinical outcomes in patients with intestinal failure?

Research has shown that the Learn Intestinal Failure Tele-ECHO (LIFT-ECHO) program is based on the successful ECHO model. This program aids doctors in managing chronic intestinal failure, a condition where the body can't absorb nutrients properly. Importantly, LIFT-ECHO doesn't require new medications or medical procedures. It is a tele-health program focused on education and improving care through discussions and presentations.

Regarding safety, patients face no direct health risks since they aren't receiving new treatments or drugs. The program aims to help doctors provide better care, potentially leading to improved health over time. As an educational initiative designed to enhance knowledge and skills in managing intestinal failure, no negative effects have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tele-Health Learning for Intestinal Failure trial because it explores a novel approach to managing chronic intestinal failure through tele-mentoring. Unlike traditional treatment methods that heavily rely on in-person physician visits and direct clinical interventions, this trial investigates the potential of the LIFT-ECHO program to enhance physician knowledge and patient outcomes via virtual means. By providing continuous education and support to physicians remotely, the trial aims to improve the management of patients requiring parenteral nutrition, potentially leading to better clinical outcomes and quality of life for patients without frequent hospital visits.

What evidence suggests that the LIFT-ECHO program is effective for improving clinical outcomes and patient quality of life in intestinal failure?

Research has shown that the LIFT-ECHO program can improve care for patients with chronic intestinal failure. In this trial, some physicians will not initially receive Tele-Mentoring, while others will join the LIFT-ECHO program after a baseline period. Past studies have demonstrated active participation from many doctors across various regions, indicating that more doctors are learning to better support their patients with this condition. The program educates doctors through online sessions, effectively sharing important knowledge. By enhancing doctors' understanding, patients may experience better health and a higher quality of life. ^{1 3 6 7 8}

Who Is on the Research Team?

Kishore Iyer, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for patients with Intestinal Failure-associated Liver Disease and Intestinal Failure. Clinicians who are non-specialists in CIF but manage these patients can also participate to improve their knowledge through the LIFT-ECHO program.

Inclusion Criteria

Hold an MD or DO degree

I am an adult or a child over 5 with parental consent.

I have been on parenteral nutrition for over 6 months due to chronic intestinal failure without cancer or HIV.

Exclusion Criteria

Prisoners

My child is over 5 years old and does not agree to participate.

I am unable to make medical decisions for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Patients are followed for a baseline period of 6 months to assess clinical outcomes and patient-reported quality of life

6 months

Monthly follow-up phone calls

Intervention

Physicians participate in the LIFT-ECHO program, consisting of 8 one-hour sessions over 2-4 months

2-4 months

8 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly follow-up phone calls

What Are the Treatments Tested in This Trial?

Interventions

• Learn Intestinal Failure Tele-ECHO Program

Trial Overview The study tests the effectiveness of the LIFT-ECHO tele-health learning program, which aims to enhance clinicians' understanding of intestinal failure via case discussions and expert lectures. The impact on patient quality of life and clinical outcomes will be measured.

How Is the Trial Designed?

Group I: Physicians with Tele-Mentoring after No Tele-Mentoring Experimental Treatment 2 Interventions

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).

Group II: Physicians with No Tele-Mentoring then with Tele-Mentoring Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

London School of Economics and Political Science

Collaborator

Trials

26

Recruited

178,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

The New York Academy of Medicine

Collaborator

Trials

14

Recruited

14,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07094308

Study Details | NCT07094308 | The LIFT-ECHO Last Mile ... ... intestinal failure (CIF) on parenteral nutrition (PN). The intervention consists of eight 60-90-minute sessions delivered over 2-4 months ...

2. researchgate.net researchgate.net/publication/349039880_Disseminating_Knowledge_in_Intestinal_Failure_-_Initial_Report_of_the_Learn_Intestinal_Failure_Tele-ECHO_LIFT-ECHO_Project

Initial Report of the Learn Intestinal Failure Tele-ECHO (LIFT ... Results: The LIFT-ECHO program has achieved significant geographic reach and clinician engagement. The program has reached close to two-thirds of the states in ...

3. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/patient-intestinal-failure-echo-project-pif-echo

Patient Intestinal Failure-ECHO Project (PIF-ECHO) Chronic intestinal failure is a severe condition that prevents patients from absorbing essential nutrients and fluids, requiring long-term parenteral nutrition ...

4. withpower.com withpower.com/trial/phase-intestinal-failure-8-2025-13183

Tele-Health Learning for Intestinal Failure Learn Intestinal Failure Tele-ECHO Program. Trial Overview The study tests the effectiveness of the LIFT-ECHO tele-health learning program, which aims to ...

5. patlynk.com patlynk.com/trial/NCT07094308

ECHO Model for Enhancing Chronic Intestinal Failure Care Study AimThis study, ECHO Model for Enhancing Chronic Intestinal Failure Care, aims to improve health services for individuals on home parenteral nutrition.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11170503/

Safety and quality of parenteral nutrition - PubMed Central Based on the ECHO model, the Learn Intestinal Failure Tele-ECHO (LIFT-ECHO) project was launched in 2019 to support the treatment and management of patients ...

7. sciencedirect.com sciencedirect.com/journal/intestinal-failure/vol/6/suppl/S1

Intestinal Failure | Vol 6, Suppl 1, 2025 ... Learn Intestinal Failure Tele-ECHO ... Cost of home parenteral nutrition and intestinal transplantation for children with chronic intestinal failure in Singapore.

8. withpower.com withpower.com/trial/phase-intestinal-failure-2024-23184

Educational Video for Intestinal Failure The goal of this clinical trial is to develop an educational video addressing the aseptic techniques to safely handle central catheters for administrating ...