NCT07094308

Brief 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). 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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

July 23, 2025

Last Update Submit

March 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 6 months, and 12 months

Secondary Outcomes (11)

  • Intestinal Failure Disease Activity Index (IF-DAI) Score

    Baseline through 12 months

  • Number of physicians recruited

    Baseline through 12 months

  • Proportion of total physicians who completed at least 4 ECHO sessions

    Baseline through 12 months

  • Attendance number at ECHO sessions

    Baseline through 12 months

  • Number of ECHO sessions completed

    Baseline through 12 months

  • +6 more secondary outcomes

Study Arms (2)

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.

Behavioral: Learn Intestinal Failure Tele-ECHO ProgramBehavioral: 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).

Behavioral: Learn Intestinal Failure Tele-ECHO ProgramBehavioral: Standard of Care

Interventions

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.

Also known as: LIFT-ECHO
Physicians with No Tele-Mentoring then with Tele-MentoringPhysicians with Tele-Mentoring after No Tele-Mentoring

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.

Physicians with No Tele-Mentoring then with Tele-MentoringPhysicians with Tele-Mentoring after No Tele-Mentoring

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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
  • Hold an MD or DO degree
  • Be a licensed physician prescriber with a homecare infusion service company

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

New York Academy of Medicine (NYAM)

New York, New York, 10029, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

London School of Economics and Political Science

London, WC2A 2AE, United Kingdom

Location

MeSH Terms

Conditions

Intestinal Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kishore Iyer, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Pediatrics & Global Health

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism Proposals should be submitted to marjorie.nisenholtz@mountsinai.org. All requests will be reviewed for methodological soundness and alignment with original consent and privacy protections. Approved users will be required to sign a Data Use Agreement. Data will be hosted on a secure institutional repository for a minimum of 5 years following publication.

Locations