Effects of an Information-Based Discharge Service on Preterm Infants, Parents, and Hospitals

Официальное название

The Effects of an Information-Based Discharge Preparation Service on the Outcomes of Preterm Infant, Parent, and Hospital: a Randomized Controlled Trial

Обзор

Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied. Objective:To evaluate the impact of IBDPS on parental readiness, caregiving skills, stress, satisfaction, infant development, readmission rates, length of stay, and hospital costs. Design: A randomized controlled trial (RCT) in a NICU in Jiangsu Province, China. Participants: Preterm infants and their parents. Methods:Participants are randomly assigned to receive either IBDPS plus usual care (intervention group) or usual care alone (control group). Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge, along with hospital metrics like length of stay and readmission rates.

Подробное описание

Participants are randomly allocated to the intervention and control groups. The intervention group receives the IBDPS in addition to the usual care, while the control group receives only the usual discharge education. The IBDPS, grounded in the theories of empowerment and "Timing It Right (TIR)," leverages an information-based platform to provide continuous, multidimensional, and customized support to parents from their infants' admission to one month post-discharge, ensuring seamless integration of discharge preparation both online and offline, and within and outside the hospital. Baseline data are collected at allocation (T1). Parental outcomes, including readiness for hospital discharge and stress, are assessed at T1, upon NICU entry (T2), and prior to discharge (T3), while caregiving skills are measured at T1, T2, T3, and one month post-discharge (T4). Parental satisfaction is measured at T3. Infant outcomes, such as weight, length, head circumference, breastfeeding rate, and feeding intolerance rate, are recorded at T1, T2, T3, and T4, with Neonatal Behavior Neurologic Assessment (NBNA) scores evaluated at T4. Hospital outcomes include length of stay and hospitalization costs, assessed at T3, and unplanned readmissions, recorded at T4.

Вмешательства

• Другое The information-based discharge preparation service (IBDPS)
  The main modules of the IBDPS platform include: * Establishing information records for infants and parents. * Collaboratively identifying existing or potential caregiving challenges. * Assessing parents' emotional and psychological states, providing support and intervention. * Collaboratively establishing caregiving objectives with parents. * Collaboratively formulating and executing caregiving plans. * Assessing parental support resources, offering analysis, assistance, and necessary referrals

Первичные конечные точки

• Readiness for Hospital Discharge Scale [Срок оценки: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, and discharge,assessed up to 90 days.]

Вторичные конечные точки (1)

• Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants [Срок оценки: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.]

Критерии участия

Inclusion Criteria for Infants:

• Infants with a gestational age of less than 37 weeks at birth.
• Written informed consent obtained from legal guardians.
• Neonates delivered at the study hospital or transferred within the first 24 hours of life.

Exclusion Criteria for Infants:

• Presence of major life-threatening congenital anomalies.
• Critical illness or conditions requiring immediate intensive intervention.
• Significant developmental abnormalities, including but not limited to severe congenital malformations, metabolic disorders, or central nervous system anomalies.

Removal Criteria for Infants:

• Infants who experience abnormal discharge due to treatment abandonment, death, or transfer to another facility.

Inclusion Criteria for Parents:

• Parents of infants born at less than 37 weeks of gestational age.
• Written informed consent provided by the parents.
• Ability to dedicate at least 4 hours per day to infant care.
• Adequate reading comprehension and proficiency in using electronic devices.
• If multiple caregivers are involved, the primary caregiver with the most hours of caregiving will be selected.

Exclusion Criteria for Parents:

• Health, familial, social, or language barriers that impair effective integration into the healthcare team.

Removal Criteria for Parents:

• Voluntary withdrawal from the study.
• Non-compliance with study protocols.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Zhang J, Cao M, Yue S, Yan J, Shang Y. Exploring Effect of Postdischarge Developmental Support Program on Preterm Infant Neurodevelopment and BDNF Gene DNA Methylation. Adv Neonatal Care. 2023 Apr 1;23(2):E50-E58. doi: 10.1097/ANC.0000000000001046. Epub 2022 Nov 21. PMID 36409665
• Cao G, Liu J, Liu M. Global, Regional, and National Incidence and Mortality of Neonatal Preterm Birth, 1990-2019. JAMA Pediatr. 2022 Aug 1;176(8):787-796. doi: 10.1001/jamapediatrics.2022.1622. PMID 35639401
• Smith VC, Mao W, McCormick MC. Changes in Assessment of and Satisfaction With Discharge Preparation From the Neonatal Intensive Care Unit. Adv Neonatal Care. 2021 Oct 1;21(5):E144-E151. doi: 10.1097/ANC.0000000000000862. PMID 33852448
• O'Connor M, Moriarty H, Schneider A, Dowdell EB, Bowles KH. Patients' and caregivers' perspectives in determining discharge readiness from home health. Geriatr Nurs. 2021 Jan-Feb;42(1):151-158. doi: 10.1016/j.gerinurse.2020.12.012. Epub 2021 Jan 11. PMID 33444923
• Hua W, Wang L, Li C, Simoni JM, Yuwen W, Jiang L. Understanding preparation for preterm infant discharge from parents' and healthcare providers' perspectives: Challenges and opportunities. J Adv Nurs. 2021 Mar;77(3):1379-1390. doi: 10.1111/jan.14676. Epub 2020 Nov 29. PMID 33249653
• Azzuqa A, Chuo J, Zenge J. Tele-medicine: Innovative tools for a safe transition to home in neonatal care. Semin Perinatol. 2021 Aug;45(5):151427. doi: 10.1016/j.semperi.2021.151427. Epub 2021 Apr 6. No abstract available. PMID 34006383
• Banerjee J, Aloysius A, Mitchell K, Silva I, Rallis D, Godambe SV, Deierl A. Improving infant outcomes through implementation of a family integrated care bundle including a parent supporting mobile application. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):172-177. doi: 10.1136/archdischild-2018-316435. Epub 2019 Jun 21. PMID 31227521
• Richardson B, Dol J, Rutledge K, Monaghan J, Orovec A, Howie K, Boates T, Smit M, Campbell-Yeo M. Evaluation of Mobile Apps Targeted to Parents of Infants in the Neonatal Intensive Care Unit: Systematic App Review. JMIR Mhealth Uhealth. 2019 Apr 15;7(4):e11620. doi: 10.2196/11620. PMID 30985282

Идентификаторы

NCT: NCT06613386 · JSPH-NC-2022-18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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