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

NCT ID: NCT06613386

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Patient Discharge; Infant, Premature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

IBDPS intervention

Caregivers receive the IBDPS alongside usual care.

• Grounded in the theories of empowerment and "Timing It Right" (TIR), the IBDPS delivers continuous, individualized support through an information-based platform from admission to one month postdischarge, facilitating seamless integration of discharge preparation across both online and offline environments.
• Upon admission, caregivers register via WeChat, receiving tailored, stage-specific guidance on key topics such as "Growth," "Feeding," and "Sleep," aligned with the evolving needs of preterm infants. They can submit nursing concerns and assess their emotional state, with healthcare providers offering ongoing guidance. When the infant's condition stabilizes, caregivers can schedule NICU visits and engage in supervised bedside care training. Prior to discharge, hands-on training is provided. Postdischarge, caregivers upload growth data for continuous monitoring, with the option of home nurse visits.

Group Type: EXPERIMENTAL

The information-based discharge preparation service (IBDPS)

Intervention Type: 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.

Usual care

Receive the usual care.

• Routine admission education includes inpatient guidelines, breast milk storage, and receiving processes.
• During hospitalization, healthcare providers are responsible for all infant care. Caregivers can visit three times a week at scheduled times, with visiting days arranged by the odd or even numbers of the inpatient ID. Visits are conducted via live video, allowing caregivers to consult with doctors about the infant's condition.
• Upon discharge, healthcare providers educate caregivers on discharge precautions and preterm infant care methods.
• Follow-up is conducted through phone calls and outpatient visits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.
• Conducting outcome assessments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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.

• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caoyuan Wang, Master

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Caoyuan Wang, Master

Role: CONTACT

1621362717@qq.com

+8615062233877

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Other Identifiers

JSPH-NC-2022-18

Identifier Type: -

Identifier Source: org_study_id