Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age

NCT ID: NCT03357458

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2019-03-31

Brief Summary

The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of care for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU).

This follow-up study will enroll infants at 6 months CA (± 1 month) recruited to the original FICare randomized controlled trial (clinicaltrials.gov ID: NCT02879799) from four level II NICU sites; two intervention and two control.

Detailed Description

The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). FICare is a psycho-educational intervention that empowers parents (mothers and fathers) to sequentially build their knowledge, skill, and confidence so the family is well-prepared to care for their preterm infant before discharge. FICare is dynamic, whereby parents and healthcare providers openly and mutually negotiate equitable caregiving roles during the infant's NICU stay. Parents are educated and coached to provide routine non-medical care. Healthcare providers continue to provide medical and technical care, such as intravenous medications and procedures, legal documentation, and professional support for families. Using a cluster randomized controlled trial (cRCT), our team is evaluating FICare in all 10 Level II NICUs in Alberta (5 intervention, 5 control sites; stratified by hospital size) with follow-up of infant development and costs at age 2 months corrected age (CA). Unless otherwise indicated, infant ages are corrected for prematurity. For the cRCT, we hypothesized that FICare would reduce length of NICU stay by 10%, reduce infant morbidities (e.g., nosocomial infections, respiratory support, feeding problems), increase breast-milk feeding, reduce maternal psychological distress, and reduce costs to the health care system and families. Maternal and infant data are currently being collected (1) shortly after admission to the NICU (baseline), (2) shortly before discharge from NICU (outcome), and (3) at 2 months CA (follow-up). At 2 months CA, our team will evaluate outcomes related to infant global development and maternal psychosocial distress. A follow-up study at 6 months CA will provide evidence of the sustainability of any effects, upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

There is currently no standardized timeline for follow-up of infants born prematurely. Follow-up at 6 months CA is appropriate as the utility of assessing development in preterm infants is questionable prior to this age, and evidence suggests that inter-individual variability in child development increases after 12 months. After 12 months, it becomes more difficult to capture parent-child interactions and environmental factors may exert a stronger influence on infant development, potentially diluting the ability to directly measure the effect of FICare.

Conditions

Preterm Birth; Prematurity; Infant,Premature; Infant Development; Child Development; Parent-Child Relations; Mental Health Wellness 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Family Integrated Care

Study participants receive FICare, a dynamic psycho-educational intervention, while their infant(s) was/were admitted to a Level II NICU.

Group Type: EXPERIMENTAL

Family Integrated Care

Intervention Type: BEHAVIORAL

FICare is a dynamic psycho-educational intervention. The goal of FICare is a change in culture and practice that permits, encourages and supports parents in their parenting role while their infant is receiving health care in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill and confidence so that the family is well-prepared to care for their infant long before discharge.

FICare Control Group

Study participants received standard care while their infant(s) was/were admitted to a Level II NICU.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Family Integrated Care

FICare is a dynamic psycho-educational intervention. The goal of FICare is a change in culture and practice that permits, encourages and supports parents in their parenting role while their infant is receiving health care in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill and confidence so that the family is well-prepared to care for their infant long before discharge.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Mothers of infants born between 32 weeks and zero days and 34 weeks and 6 days gestation who enrolled in the FICare Alberta cluster controlled trial (cRCT) at one of four of the ten Level II NICU sites. The FICare cRCT enrolled mothers of any age who have decision making capacity; mothers who are able to speak, read and understand English well enough to provide informed consent, and complete surveys online or via telephone.

Exclusion Criteria

• The FICare Alberta Level II NICU cRCT excluded mothers whose infants have serious congenital or chromosomal anomalies that require surgery, or are receiving palliative care; mothers who are not able to communicate in English; mothers with complex social issues.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alberta Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

ACHRI FICare 6mth

Identifier Type: -

Identifier Source: org_study_id