Coached, Coordinated, Enhanced Neonatal Transition (CCENT)

Prematurity Clinical Trial

— CCENT  

Official title:

Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350243
• Other study ID #: 1000057100
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate a new neonatal follow-up model that offers additional support and coping resources for parents during their child's NICU admission as well as during their transition home. The Coached, Coordinated, Enhanced Neonatal Transition (CCENT) model involves a key worker who will be the primary support for families during the first year of their child's life. The key worker's role involves 1) parental coaching using an Acceptance and Commitment Therapy approach, 2) coordinating care across various levels of care as well as supporting families in system and resource navigation, and 3) provided proactive education targeting normal challenges in caring for a child who required intensive care support. The goal is to improve the psychosocial support and medical care coordination beyond the neonatal intensive care unit as many of the medical and social concerns do not end at the time of discharge. Primary objective is parent stress at 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: October 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 4 Months

Eligibility

Inclusion Criteria (meets at least one of the following criteria):

1. Infant born = 26+6 weeks of gestational age (GA)

2. Infant born between 27-29+6 weeks GA with = 1 of the following risk factors:

i)= Grade III intraventricular hemorrhage with post hemorrhagic hydrocephalus ii)Retinopathy of prematurity requiring intraocular bevacizumab/ anti-vascular endothelial growth factor or laser surgery therapy iii)Requires invasive (e.g., intubated) or non-invasive (e.g., CPAP or BiPAP) at = 34 weeks GA and/or supplemental oxygen at = 37 weeks gestational age iv)Requires surgery for management of necrotizing enterocolitis (NEC)- stage 3

3. Infant with = 2 major congenital anomalies as defined by EUROCAT(13) (e.g., congenital heart disease, spina bifida, cleft palate, etc. Not including minor congenital anomalies, e.g., dysmorphic facies), and length of stay in recruiting institution = 14 days.

4. Infant with hypoxic ischemic encephalopathy (HIE) requiring therapeutic hypothermia and in the recruiting institution for = 14 days.

Exclusion Criteria:

1. Families that do not speak English or French

2. Parent will not be involved with child's care over the entirety of the study period (2 years) (e.g., adoption).

3. Infant will be followed by an out-of-province neonatal follow-up program or lives a significant distance from the neonatal follow up program and therefore not routinely followed by the team.

4. Infant that has previously been discharged home from the NICU/hospital.

5. Decision/high likelihood of decision for act of withdrawal of care by clinical teams/families

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Other:
• CCENT Intervention
Acceptance and Commitment Therapy approach: engaging families through structured individual or group sessions within the NICU and continue this support once discharged. Care coordination: supporting providers in clear communication when liaising across various levels of care as well as supporting families in system and resource navigation. Anticipatory guidance: proactive education targeting normal challenges in caring for a child who required intensive care support.

Locations

Country	Name	City	State
Canada	McGill University Health Centre/Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital Eastern Ontario	Ottawa	Ontario
Canada	The Ottawa Hospital	Ottawa
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital and BC Women's Hospital & Health Centre	Vancouver	British Columbia

Sponsors (7)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Children's Hospital of Eastern Ontario, Montreal Children's Hospital of the MUHC, MOUNT SINAI HOSPITAL, Provincial Health Services Authority, Sunnybrook Health Sciences Centre, The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health System Outcomes	The investigators will link the patient-reported evaluation of the CCENT model with health administrative data housed at the Institute for Clinical Evaluative Sciences (ICES) for consenting participants. Case-costing methods will be used to determine direct health care costs related to inpatient (emergency department) and outpatient (pharmaceutical and home health care) services.	12 months
Other	Social support	The Social Support Questionnaire- Short Form (Sarason et al., 1987) is a 6 item measure of social support. For each of the 6 items, respondents indicate the number of people available to provide support in each of 6 areas and then rate the overall level of satisfaction with the support given in each of the areas. Scores range from 0-54 for number of people available, and satisfaction ranges from 6-36. Higher scores indicate more support.	Baseline
Primary	Change in Parental Stress	This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.	12 months
Secondary	Parental Quality of Life (QoL)	The Health Utilities Index (HUI) questionnaire provides a health-related quality of life (HRQL) score for overall health, which will be used to calculate quality-adjusted life years (QALYs) for a cost-utility analysis.	4 months
Secondary	Parental Quality of Life (QoL)	The Health Utilities Index (HUI) questionnaire provides a health-related quality of life (HRQL) score for overall health, which will be used to calculate quality-adjusted life years (QALYs) for a cost-utility analysis.	12 months
Secondary	Parental Empowerment	This outcome will be assessed using the Family Empowerment Scale (FES), which measures empowerment across three specific domains: 1) family, 2) service system, and 3) community/political.	12 months
Secondary	Child Social and Emotional Development	This outcome will be assessed using the Brief Infant-Toddler Social Emotional Assessment (BITSEA), which is a parent self-report questionnaire that is designed as a screener to identify children (1-3 years old) at risk for or currently experiencing social-emotional and/or behavioural problems.	12 months
Secondary	Parent and Child Interaction	This outcome will be assessed using the Nursing Child Assessment Satellite Training Parent-Child Interaction (NCAST-PCI), which is used assess caregiver and infant behaviour during a structured teaching task.	12 months
Secondary	Maternal Depression	This outcome will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), which is a screening tool used to identify those with symptoms associated with postnatal depression in the previous 7 days. Composite score between 0 to 30 will be recorded, with a score of 10 or greater indicating possible depression.	6 weeks
Secondary	Maternal Depression	This outcome will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), which is a screening tool used to identify those with symptoms associated with postnatal depression in the previous 7 days. Composite score between 0 to 30 will be recorded, with a score of 10 or greater indicating possible depression.	4 months
Secondary	Maternal Depression	This outcome will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), which is a screening tool used to identify those with symptoms associated with postnatal depression in the previous 7 days. Composite score is given between 0 to 30. Possible depression is a score of 10 or greater.	12 months
Secondary	Child Development	The Bayley Scales of Infant and Toddler Development (3rd Edition) will be used to assess neurodevelopment with separate composite scores (mean 100 ± SD 15) for cognition, language, and motor skills.	18 months
Secondary	Healthcare Service Delivery	This outcome will be assessed using the Measure of Processes of Care (MPOC20) questionnaire, which is used to measure the parent's perception of the health services they and their child receive.	12 months
Secondary	Maternal Anxiety	This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress.	4 months
Secondary	Maternal Anxiety	This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress.	12 months
Secondary	Resource Utilization	The Resource Use Questionnaire (RUQ) will assess family resource use relating to their child's medical needs, services and programs, as well as parent time losses and family out-of-pocket costs.	4 months
Secondary	Resource Utilization	The Resource Use Questionnaire (RUQ) will assess family resource use relating to their child's medical needs, services and programs, as well as parent time losses and family out-of-pocket costs.	12 months
Secondary	Psychology Inflexibility	The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance. The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.	6 weeks
Secondary	Psychology Inflexibility	The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance. The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.	4 months
Secondary	Psychology Inflexibility	The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance. The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.	12 months
Secondary	Psychology Inflexibility	The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance. The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.	18 months
Secondary	Child Development	The Ages and Stages Questionnaire will also be used to assess child development	18 months
Secondary	Parental perception of transition experience	Parental perception of transition experience will be assessed using the Pediatric Transition Experience Measure (PTEM), an 11 item parent-report questionnaire which measures a parent's perception of transition preparation and support from the hospital.	6 weeks post discharge