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NCT Number: NCT06613386

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

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.

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Key information

Conditions

Patient Discharge Female Urogenital Diseases and Pregnancy Complications Infant, Premature Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Readiness for Hospital Discharge Scale

    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.

    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.

Secondary outcomes

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

    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.

    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.

Other outcomes

  1. Parental Stressor Scale: NICU

    Time frame: From the time of enrollment until the discharge of the preterm infant, with allocations made at enrollment, upon the parent entry into the NICU, and at discharge, assessed over a period of up to 90 days

    The Parental Stressor Scale: NICU (PSS: NICU) was originally developed by Miles and Funk et al. to measure parental stress during NICU hospitalization of their infants. The Chinese version of the Parental Stressor Scale: NICU (C-PSS: NICU), adapted by Li et al. with authorization from the original authors, uses a 5-point Likert scale (1 = no stress or anxiety; 5 = extreme stress or anxiety). This scale, consisting of 25 items, is divided into three dimensions: Infant Behavior and Appearance (13 items), Parental Role Alteration(7 items), and Sights and Sounds(5 items).The total score ranges from 25 to 125, with higher scores reflecting greater levels of parental stress and anxiety. The scale demonstrates strong internal consistency, with a Cronbach α coefficient of 0.856.

  2. Parent Satisfaction Scale for Continuity of Care for Preterm Infants

    Time frame: Through the study completion, one month post-discharge,assessed up to 120 days.

    The Parent Satisfaction Scale for Continuity of Care for Preterm Infants, developed by Qian et al., can be used to assess parental satisfaction with discharge preparation services for preterm infants. This 21-item scale employs a 5-point Likert scale, where responses range from 0 (very dissatisfied) to 4 (very satisfied). The scale is structured into four dimensions: Nurse Appearance and Attitude(3 items),Continuity of Care Competence(11 items), Humanistic Quality(4 items), and Overall Evaluation of Continuity of Care Services(3 items).The scoring method is based on a percentage system, calculated as follows: (sum of scores for valid responses ÷ number of valid responses ÷ 4) × 100. Higher scores indicate greater satisfaction. The Cronbach α coefficient for the overall scale is 0.807.

  3. Physical Development Outcomes

    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.

    Indicators such as weight, length, and head circumference are measured using standardized neonatal techniques with calibrated scales and measuring tapes.

  4. Neurobehavioral Development Outcomes

    Time frame: Through the study completion, one month post-discharge,assessed up to 120 days.

    Assessed using the Neonatal Behavior Neurologic Assessment (NBNA), a tool widely used in China to evaluate neurobehavioral development. NBNAis divided into five components: behavioral capability (6 items), passive muscle tone (4 items), active muscle tone (4 items), primitive reflexes (3 items), and general assessment (3 items). Each item is scored on a 3-point Likert scale ranging from 0 to 2, with a total possible score of 40. A score of ≤35 indicates abnormality.

  5. Breastfeeding rate

    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.

    The breastfeeding rate is calculated using the formula: (Number of breastfed infants ÷ Total number of infants) × 100%, recorded by nursing staff based on feeding logs.

  6. Incidence of feeding intolerance

    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.

    Incidence of feeding intolerance among preterm infants, as determined by the diagnostic criteria outlined in the first edition of Practical Neonatology, calculated using the formula: (Number of preterm infants identified with feeding intolerance ÷ Total number of preterm infants) × 100%, recorded by nursing staff based on feeding logs.

  7. Length of Stay (LOS)

    Time frame: Until the discharge of the preterm infant, at the time of discharge,assessed up to 90 days.

    Length of Stay refers to the total duration of hospitalization for preterm infants during their initial NICU admission，collected the hospital Electronic Medical Record (EMR) system.

  8. Hospitalization Costs

    Time frame: Until the discharge of the preterm infant,at the time of discharge,assessed up to 90 days.

    Hospitalization costs encompass the comprehensive financial expenditure associated with the NICU stay of preterm infants，collected from the hospital Electronic Medical Record (EMR) system

  9. Readmission Rate Within One Month Post-Discharge

    Time frame: Through the study completion,one month post-discharge,assessed up to 120 days.

    The readmission rate within one month post-discharge refers to the proportion of preterm infants who required rehospitalization within 30 days following their discharge from the NICU, collected from the hospital Electronic Medical Record (EMR) system.

Study contacts

Contact information is provided by the study sponsor or research team.

Caoyuan Wang, Master

CONTACT

[email protected]

+8615062233877

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Chinese Medical Association

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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