The LIFT-ECHO Last Mile Project
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT07094308
- Status
- Not Yet Recruiting
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Conditions
- Intestinal Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Learn Intestinal Failure Tele-ECHO Program — BEHAVIORALLIFT-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 Care — BEHAVIORALParticipants 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 Details
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.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2030
- Completion
- Jun 30, 2030
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Physicians with No Tele-Mentoring then with Tele-MentoringDyads 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.
- Experimental: Physicians with Tele-Mentoring after No Tele-MentoringDyads 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).
Primary Outcome Measure
Patient-Reported Quality of Life (PRQOL) Score [ Time Frame: Baseline, 6 months, and 12 months ]
Central Contacts
- Marjorie Nisenholtz212-659-8049
- Brandy Haydel
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Kishore Iyer (PRINCIPAL_INVESTIGATOR) |
| New York Academy of Medicine (NYAM) | New York | New York | 10029 | Elisa Fisher (SUB_INVESTIGATOR) |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Marion Winkler (SUB_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84112 | Kelly Tappenden (SUB_INVESTIGATOR) |
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