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

N/ANot Yet RecruitingNCT06613386

The First Affiliated Hospital with Nanjing Medical University86 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Interventions

The information-based discharge preparation service (IBDPS)OTHER

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. * Conducting outcome assessments.

Eligibility

Sex: ALLMax age: 37 Weeks

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Readiness for Hospital Discharge Scale

The Readiness for Hospital Discharge Scale (RHDS) - Parent Form was originally developed by Weiss et al. for assessing the readiness of parents for the discharge of their hospitalized children (0 to 18 years old). The Chinese version of the Readiness for Hospital Discharge Scale (C-RHDS) - Parent Form, adapted by Chen et al. with authorization from the original authors, is utilized to evaluate the readiness of parents for the discharge of preterm infants. This 22-item scale includes four dimensions: Knowledge (9 items), Physical-emotional Status (7 items), Pain Status (2 items), and Expected Support (4 items). Each item is scored on a scale from 0 to 10 (0 = worst; 10 = best), with total scores ranging from 0 to 220. Higher scores reflect better readiness for discharge. The overall Cronbach α coefficient for this scale is 0.91.

Time frame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, and discharge,assessed up to 90 days.

Secondary Outcomes

Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants

The Chinese version of the Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants, developed by Meng et al., is used to evaluate the caregiving ability of parents with preterm infants. This questionnaire consists of 18 items rated on a Likert scale from 1 to 5 (1 = not at all familiar; 5 = very familiar). It is divided into three dimensions: Knowledge of Preterm Infant Care (7 items), Caregiving Skills (7 items), and Caregiving Ability (4 items). The total score ranges from 18 to 90, with higher scores indicating better caregiving ability. The Cronbach α coefficient for the overall scale is 0.956.

Time frame: 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.