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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| Children's Hospital of Eastern Ontario | OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
| The Ottawa Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCENT Intervention group | Experimental | Participants will be assigned a dedicated key worker that will support families through the child's first year, in addition to standard medical care, which involves a primary care provider and/or neonatal follow-up at routine times. |
|
| Control group | No Intervention | Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCENT Intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parental Stress | This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Parental Quality of Life (QoL) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria (meets at least one of the following criteria):
Infant born ≤ 26+6 weeks of gestational age (GA)
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
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.
Infant with hypoxic ischemic encephalopathy (HIE) requiring therapeutic hypothermia and in the recruiting institution for ≥ 14 days.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Orkin, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital and BC Women's Hospital & Health Centre | Vancouver | British Columbia | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34233983 | Derived | Orkin J, Major N, Esser K, Parmar A, Couture E, Daboval T, Kieran E, Ly L, O'Brien K, Patel H, Synnes A, Robson K, Barreira L, Smith WL, Rizakos S, Willan AR, Yaskina M, Moretti ME, Ungar WJ, Ballantyne M, Church PT, Cohen E. Coached, Coordinated, Enhanced Neonatal Transition (CCENT): protocol for a multicentre pragmatic randomised controlled trial of transition-to-home support for parents of high-risk infants. BMJ Open. 2021 Jul 7;11(7):e046706. doi: 10.1136/bmjopen-2020-046706. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
| Montreal Children's Hospital of the MUHC | OTHER |
| Provincial Health Services Authority British Columbia | OTHER |
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|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Child Development | The Ages and Stages Questionnaire will also be used to assess child development | 18 months |
| 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 |
| 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 |
| Children's Hospital Eastern Ontario |
| Ottawa |
| Ontario |
| K1H 8L1 |
| Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | Canada |
| McGill University Health Centre/Montreal Children's Hospital | Montreal | Quebec | Canada |
| The Ottawa Hospital | Ottawa | Canada |
| D000091642 | Urogenital Diseases |