Improving Outcomes in Chronic Intestinal Failure Using the ECHO Model: The LIFT-ECHO Last Mile Project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Patient-Reported Quality of Life (PRQOL) Score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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
排除标准
- •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
研究组 & 干预措施
Physicians with No Tele-Mentoring then with Tele-Mentoring
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.
干预措施: Learn Intestinal Failure Tele-ECHO Program (Behavioral)
Physicians with No Tele-Mentoring then with Tele-Mentoring
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.
干预措施: Standard of Care (Behavioral)
Physicians with Tele-Mentoring after No Tele-Mentoring
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).
干预措施: Learn Intestinal Failure Tele-ECHO Program (Behavioral)
Physicians with Tele-Mentoring after No Tele-Mentoring
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).
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Patient-Reported Quality of Life (PRQOL) Score
时间窗: Baseline, 6 months, and 12 months
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
次要结局
- 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)
- Perceived usefulness Scale(Post-intervention (within 1 month after final ECHO session))
- Physician Participation Rate(Baseline through 12 months)
- Number of Emergency Room Visits(Monthly up to 12 months)
- Number of ECHO sessions completed(Baseline through 12 months)
- Likelihood of recommending LIFT-ECHO(Post-intervention (within 1 month after final ECHO session))
- Physician Satisfaction Scale(Post-intervention (within 1 month after final ECHO session))
- Number of Hospital Admissions(Monthly up to 12 months)
研究者
Kishore Iyer
Professor of Surgery, Pediatrics & Global Health
Icahn School of Medicine at Mount Sinai