The LIFT-ECHO Last Mile Project

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Individuals of adult age (18 years or older), including pregnant women

Disqualifiers

Adults unable to consent (individuals with impaired decision-making capacity)

Prisoners

Children > 5 years who dissent

Trial design

Design model

Crossover

Treatments tested in this trial

  • Learn Intestinal Failure Tele-ECHO Program

    Behavioral

    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 Care

    Behavioral

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Physicians with No Tele-Mentoring then with Tele-MentoringActive comparator 2 interventions
Group B: Physicians with Tele-Mentoring after No Tele-MentoringExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Baseline, 6 months, and 12 months

Secondary outcomes

1

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.

Time frame
Baseline through 12 months
2

Number of physicians recruited

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

Time frame
Baseline through 12 months
3

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).

Time frame
Baseline through 12 months
4

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.

Time frame
Baseline through 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Rhode Island Hospital

Collaborator

The New York Academy of Medicine

Collaborator

University of Utah

Collaborator

London School of Economics and Political Science

Collaborator

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