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

NCT06613386 | Not Yet Recruiting

• 1 other identifier: JSPH-NC-2022-18
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Discharge; Infant, Premature

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

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

  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.

Other Outcomes (9)

• Parental Stressor Scale: NICU

  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

• Parent Satisfaction Scale for Continuity of Care for Preterm Infants

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

• Physical Development Outcomes

  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.

Study Arms (2)

IBDPS intervention

EXPERIMENTAL

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.

Other: The information-based discharge preparation service (IBDPS)

Usual care

NO INTERVENTION

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.

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.

IBDPS intervention

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Chinese Medical Association: collaborator

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Zhang R, Huang RW, Gao XR, Peng XM, Zhu LH, Rangasamy R, Latour JM. Involvement of Parents in the Care of Preterm Infants: A Pilot Study Evaluating a Family-Centered Care Intervention in a Chinese Neonatal ICU. Pediatr Crit Care Med. 2018 Aug;19(8):741-747. doi: 10.1097/PCC.0000000000001586.

  PMID: 29781955 BACKGROUND

• Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.

  PMID: 27990350 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Caoyuan Wang, Master

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Caoyuan Wang, Master

CONTACT

+8615062233877; 1621362717@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study employs a prospective, double-arm, randomized controlled trial (RCT) design, conducted in the Neonatal Intensive Care Units (NICU) of a tertiary first-class hospital in Jiangsu Province, China.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share