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Набор скоро начнётся NCT07383272

We Need to FEED: Facilitating Enteral Education for Discharge

Без фазы С лечением Enteral Nutrition Feeding

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Education Intervention.
Кому может быть актуально
Состояния в реестре: Enteral Nutrition Feeding. Базовые параметры: до 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

We Need to F.E.E.D.: Facilitating Enteral Education for Discharge - Improving the Quality of Discharge for Pediatric Patients With Enteral Tubes

Обзор

Aim: We need to FEED (Facilitating Enteral Education for Discharge) project aims to streamline and enhance the discharge process for pediatric patients with enteral nutrition (including G-tubes, J-tubes, GJ-tubes, and NG-tubes) and ultimately create enteral discharge protocol. The aim of the study is to describe the effectiveness of the discharge education program for children with enteral tubes on caregiver knowledge and determine the impact of the program on unplanned ER, Urgent care or clinic visits. By ensuring that all necessary supplies, orders, and follow-up appointments are in place prior to discharge, and by providing comprehensive education and support to parents, the project seeks to improve patient outcomes, reduce healthcare utilization, enhance coordination and communication among healthcare providers.

Подробное описание

Objectives and Hypothesis Objective: The primary objective of the FEED project is to enhance the discharge process for pediatric patients with enteral nutrition, ensuring adequate education, all necessary supplies, orders, follow-up appointments are in place, thereby improving patient outcomes and reducing healthcare utilization. The secondary objective of the FEED project is to create a standardized enteral discharge protocol. Tertiary goal includes ensuring video swallow studies are completed inpatient to expedite feeding therapy

Hypothesis: The implementation of a structured discharge process for enteral nutrition patients will result in:

1. Reduced number of calls to the NICU, PEDS, PICU, outpatient pediatric and GI departments. 2. Decreased number of unplanned visits to emergency room, urgent care, clinic visits related to enteral nutrition issues. 3. Improved parent confidence and competence in managing enteral nutrition at home. 4. Streamlined access to early intervention and speech therapy services. 5. Enhanced coordination and communication among healthcare providers. Needs Assessment: Gastrostomy tubes (G-tubes) are commonly utilized to facilitate nutrition, hydration, and medication administration in children who have chronic inadequate oral intake due to conditions such as dysphagia, neurological disorders, chronic illnesses, oncologic problems, and other clinical conditions leading to malnutrition. Although G-tube placement is generally safe and frequently performed among pediatric patients, complications such as tube blockage, infection, and over granulation tissue are reported at varying frequencies. Home care plays a significant role in the occurrence of these common, minor, and preventable complications.

Research indicates that families often face challenges in managing home care for children with G-tubes due to insufficient knowledge and inadequate discharge support from healthcare professionals. Many families report that they have not been adequately informed by healthcare providers during discharge, leading to difficulties in providing correct care and disease management. The primary issues in home care include feelings of guilt due to the necessity of tube feeding, difficulties in daily care arising from tube-related complications, and fear of potential complications associated with enteral nutrition. The long-term nature of enteral feeding with G-tubes further increases the burden of care on families.

The American Society for Parenteral and Enteral Nutrition (ASPEN) emphasizes the importance of providing discharge education to patients with chronic illnesses and specific nutritional needs and maintaining safe home nutrition. Implementing a standardized, evidence-based discharge education protocol is expected to improve treatment outcomes, increase caregiver knowledge, and reduce the burden of care and anxiety levels.

The FEED (Facilitating Enteral Education for Discharge) project addresses these identified needs by streamlining the discharge process for pediatric patients with enteral nutrition. The project aims to ensure that all necessary supplies, orders, and follow-up appointments are in place prior to discharge. It also focuses on providing comprehensive education and support to parents, thereby improving patient outcomes, reducing healthcare utilization, and enhancing coordination and communication among healthcare providers. By addressing these key areas, the FEED project aims to improve the overall care for pediatric patients with enteral nutrition, ultimately enhancing patient outcomes and reducing the healthcare burden on families.

Вмешательства

  • Другое Education Intervention
    Education on feeding tubes, booklet, inperson or via zoom education to parents of pediatric patients with newly placed feeding tube ( G-tube, GJ-tube, NG tube). Education on supply company and how to get supplies. The need for back up feeding tube etc. Size of patient feeding tube.

Первичные конечные точки

  • Families Enteral tube knowledge:Change in Enteral Tube Knowledge Score From Baseline and post hospital discharge [Срок оценки: Baseline (while hospitalized prior to initial educational session in the hospital) and after discharge ( up to 3 months)]
  • Number of Unplanned Healthcare Visits Related to Enteral Tube Issues [Срок оценки: post hospital discharge-through study completion, an average 1 year]

Критерии участия

Критерии включения

  • Patients must be within the age range of 0 to 17 years.
  • Patients who have recently had an enteral feeding tube placed (G-tube, J-tube, GJ-tube, or NG-tube).
  • The patient must be hospitalized at the time of the study and scheduled for discharge within the study period (before discharge).
  • A legal guardian must be available to participate in the study, complete questionnaires, and engage in the educational sessions.
  • Both the pediatric patient and their caregiver must be willing to participate in the study, including completing surveys and receiving educational materials.

Критерии исключения

  • Patients who have had an enteral tube (G-tube, J-tube, GJ-tube, or NG-tube) for more than a short period (e.g., those who have had tubes in place for more than 3 months) may be excluded, as the study is focused on newly placed feeding tubes.
  • Patients aged 18 years or older are excluded from the study, as the project targets pediatric patients specifically.
  • If the caregiver (or the child, where applicable) has significant cognitive or language barriers that would prevent them from understanding the educational content or completing the surveys, they may be excluded.
  • Families who do not speak English may be excluded.
  • Patients with significant comorbidities or unstable clinical conditions that would make participation in the discharge education protocol impractical will be excluded. This includes, but is not limited to, patients with severe respiratory failure requiring nitric oxide therapy, hemodynamic instability requiring blood pressure medications (e.g., vasopressors), or other acute medical conditions requiring active intensive care. Patients who are stable and preparing for discharge, even after a prolonged NICU or PICU stay, will not be excluded.
  • Only legal guardian can enroll child.
  • Patients whose caregivers are unable or unwilling to adhere to study protocols (e.g., participating in follow-up assessments or completing questionnaires) may be excluded to ensure consistency and reliable data collection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Illinois at Chicago (UI Health) — Chicago

Публикации

  • Goldberg E, Kaye R, Yaworski J, Liacouras C. Gastrostomy tubes: facts, fallacies, fistulas, and false tracts. Gastroenterol Nurs. 2005 Nov-Dec;28(6):485-93; quiz 493-4. doi: 10.1097/00001610-200511000-00004. PMID 16418584
  • DeLegge, M (2019). Gastrostomy Tubes: Complications and their management, Up To Date DeLegge, M (2019). Gastrostomy Tubes: Placement and routine care, Up To Date
  • Crawley-Coha T. A practical guide for the management of pediatric gastrostomy tubes based on 14 years of experience. J Wound Ostomy Continence Nurs. 2004 Jul-Aug;31(4):193-200. doi: 10.1097/00152192-200407000-00007. PMID 15851861

Идентификаторы

NCT: NCT07383272 · STUDY2025-0139 · NASPGHAN contract award 39608

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗