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Trial record 1 of 2 for:    22364677 [PUBMED-IDS]
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A Cluster Randomized Controlled Trial of FICare at 18 Months

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ClinicalTrials.gov Identifier: NCT03337659
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Alberta
Alberta Health Services
Information provided by (Responsible Party):
Karen Benzies, University of Calgary

Tracking Information
First Submitted Date  ICMJE October 23, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE September 27, 2017
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Global development [ Time Frame: At 18-months corrected age ]
Ages and Stages Questionnaire, 3rd edition
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03337659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • Infant social and emotional development [ Time Frame: At 18-months corrected age ]
    Ages and Stages Questionnaire:Social-Emotional, 2nd edition; Brief Infant Toddler Social Emotional Assessment
  • Number of emergency room visits [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • Number of re-admissions to hospital [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • Number of unplanned visits to physician or other provider [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • Number of antibiotic prescriptions [ Time Frame: At 18-months corrected age ]
    Number of antibiotic prescriptions will be compromised of maternal self-report data, and from the infant chart as collected the provincial healthcare provider in Alberta, Canada. A data disclosure agreement has been executed such that AHS Analysts with the Analytics, Data Integration, Measurement & Reporting (DIMR) team will link FICare data with antibiotic prescriptions from infant discharge home to 18 months corrected age. The number antibiotics prescribed will be summed to provide a total number of antibiotic prescriptions.
  • General self-efficacy in parenting [ Time Frame: At 18-months corrected age ]
    General Self-Efficacy Scale (GSE): A self-administered scale that assesses a general sense of perceived self-efficacy. Self-efficacy as it relates to parenting is addressed by including items in the participant questionnaire related to parenting. Responses are made on a 4-point scale. Sum up the responses to all 10 items to yield the final composite score with a range from 10 to 40. There are no sub-scales and no recoding is required. There is no cut-off score, therefore individuals are not categorized as high or low self-efficacious. The GSE score can be correlated with other traits such as anxiety, and depression.
  • Parenting stress [ Time Frame: At 18-months corrected age ]
    A 36-item scale, captures general parenting stress and three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Responses 1, 2, 3, 7, 8, 9 and 11 are summed for Defensive Responding. Subscale scores are calculated by summing response items 1-12 for Parental Distress, items 13 - 24 for Parent-Child Dysfunctional Interaction, and items 25 - 36 for Difficult Child. Total Stress score is calculated by summing the raw scores of the subscales. Raw scores are converted to T scores and percentiles. Normal range for scores is within the 16th to 84th percentiles. Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.
  • Maternal-reported toddler sleep [ Time Frame: At 18-months corrected age ]
    Extended Brief Infant Sleep Questionnaire
  • Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times). [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • State Anxiety [ Time Frame: At 18-months corrected age ]
    Two sub-scales: 1) long-standing quality of trait anxiety (20 items), and 2) the temporary condition of state anxiety (20 items). Items are rated on a 4-point scale. Item scores are added to obtain subtest total scores. Scoring is reversed for anxiety-absent items (19/40 items). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the state anxiety scale. Normative values are available in the manual. Trait anxiety was collected previously in the FICare cRCT (NCT02879799) therefore, only state anxiety will be collected at 18 months.
  • Depression [ Time Frame: At 18-months corrected age ]
    Centre for Epidemiologic Studies Depression Scale Revised (CESD-R): This scale is a 20 item self-report measure of depression. A 5-point Likert scale measures symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition: (1) Sadness; (2) Loss of Interest; (3) Appetite; (4) Sleep; (5) Thinking/Concentration; (6) Guilt; (7) Tired; (8) Movement; and (9) Suicidal Ideation. The total score is calculated as a sum of responses to all 20 questions. The range of possible scores is between 0 and 60. Internal consistency (0.92) was high, and the CESD-R is highly correlated with the score for the original CESD (Pearson correlation coefficient 0.89), the latter of which has an internal consistency of 0.85 - 0.90, and test-retest reliability of 0.45 - 0.70.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • Infant social and emotional development [ Time Frame: At 18-months corrected age ]
    Ages and Stages Questionnaire:Social-Emotional, 2nd edition; Brief Infant Toddler Social Emotional Assessment
  • Number of emergency room visits [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • Number of re-admissions to hospital [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • Number of unplanned visits to physician or other provider [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • Number of antibiotic prescriptions [ Time Frame: At 18-months corrected age ]
    This data will be collected in two ways: 1) maternal self-report as part of a study questionnaire, and 2) from the patient chart as collected by Alberta Health Services (AHS), the provincial healthcare provider in Alberta, Canada. A data disclosure agreement has been executed such that AHS Analysts with the Analytics, Data Integration, Measurement & Reporting (DIMR) team will link FICare data with fields related to the number antibiotic prescriptions in AHS data holdings. The specific variables related to this outcome will be selected for and identified in consultation with AHS Analysts who have extensive knowledge of their metadata.
  • General self-efficacy in parenting [ Time Frame: At 18-months corrected age ]
    General Self-Efficacy Scale (GSE): A self-administered scale that assesses a general sense of perceived self-efficacy. Self-efficacy as it relates to parenting is addressed by including items in the participant questionnaire related to parenting. Responses are made on a 4-point scale. Sum up the responses to all 10 items to yield the final composite score with a range from 10 to 40. There are no sub-scales and no recoding is required. There is no cut-off score, therefore individuals are not categorized as high or low self-efficacious. The GSE score can be correlated with other traits such as anxiety, and depression.
  • Parenting stress [ Time Frame: At 18-months corrected age ]
    A 36-item scale, captures general parenting stress and three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Responses 1, 2, 3, 7, 8, 9 and 11 are summed for Defensive Responding. Subscale scores are calculated by summing response items 1-12 for Parental Distress, items 13 - 24 for Parent-Child Dysfunctional Interaction, and items 25 - 36 for Difficult Child. Total Stress score is calculated by summing the raw scores of the subscales. Raw scores are converted to T scores and percentiles. Normal range for scores is within the 16th to 84th percentiles. Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.
  • Maternal-reported toddler sleep [ Time Frame: At 18-months corrected age ]
    Extended Brief Infant Sleep Questionnaire
  • Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times). [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases
  • State Anxiety [ Time Frame: At 18-months corrected age ]
    Two sub-scales: 1) long-standing quality of trait anxiety (20 items), and 2) the temporary condition of state anxiety (20 items). Items are rated on a 4-point scale. Item scores are added to obtain subtest total scores. Scoring is reversed for anxiety-absent items (19/40 items). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the state anxiety scale. Normative values are available in the manual. Trait anxiety was collected previously in the FICare cRCT (NCT02879799) therefore, only state anxiety will be collected at 18 months.
  • Depression [ Time Frame: At 18-months corrected age ]
    Centre for Epidemiologic Studies Depression Scale Revised (CESD-R): This scale is a 20 item self-report measure of depression. A 5-point Likert scale measures symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition: (1) Sadness; (2) Loss of Interest; (3) Appetite; (4) Sleep; (5) Thinking/Concentration; (6) Guilt; (7) Tired; (8) Movement; and (9) Suicidal Ideation. The total score is calculated as a sum of responses to all 20 questions. The range of possible scores is between 0 and 60. Internal consistency (0.92) was high, and the CESD-R is highly correlated with the score for the original CESD (Pearson correlation coefficient 0.89), the latter of which has an internal consistency of 0.85 - 0.90, and test-retest reliability of 0.45 - 0.70.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Cluster Randomized Controlled Trial of FICare at 18 Months
Official Title  ICMJE Child Developmental Health, Maternal Psychosocial Distress, and Health System Costs at 18 Months Corrected Age: Effectiveness of a Cluster Randomized Controlled Trial of Family Integrated Care in Level II NICUs
Brief Summary In Alberta, one in every twelve babies is born preterm. Compared with their full term counterparts, preterm infants who survive are at higher risk for respiratory problems, jaundice, infections, feeding problems, behavioural problems, and neuro-developmental disabilities, including cognitive delays, and visual and hearing impairments. As a result, parents must leave their preterm babies in the hospital to fully develop enough to care for them at home. When it is time for discharge, parents are often unprepared to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The aim of this novel health services study is to assess the longer-term outcomes and costs, to 18 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). A cluster randomized controlled trial (cRCT) of FICare is currently in progress. 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. The FICare cRCT evaluates outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.
Detailed Description

Each year, about 15 million of the world's infants are born preterm (<37 weeks gestation), and this number is increasing. In Alberta, the preterm birth rate was 8.43% in 2015, representing 4,749 infants. Alberta has the highest rate of preterm birth among the Canadian provinces, which can be attributed, in part, to delayed child bearing and assisted reproduction. Approximately 20% of all preterm infants are born at <32 weeks GA and require care in a Level III NICU. The remaining 80% are moderate and late preterm infants, which comprises 6.6% of all live births. As gestational age (GA) decreases, the risk of chronic health problems and developmental delays increases. Compared to their full term counterparts, moderate and late preterm infants (born at 32 weeks and zero days [32 0/7] to 36 weeks and six days [36 6/7] GA) are at higher risk for poor health (e.g., increased hospitalizations, respiratory morbidities, and growth and feeding problems) and developmental outcomes (e.g., neurodevelopmental disabilities and cognitive delays, communication and language impairments, and school-related problems). Results of recent studies also indicate that moderate and late preterm infants are at greater risk of experiencing social-emotional problems. In Alberta, preterm infants represent the largest proportion of expenditures of all pediatric health care utilization at 8.45%, with a cost of approximately $35 million per year. The costs associated with preterm infants are greater than for term infants because of longer hospital stays following birth, increased resource utilization, hospital readmissions, and the need for additional health, education, and social services. Financial consequences for families of preterm infants are associated with reduced work force participation and lost earnings, specialized nutritional requirements, and learning and development supports for the child. In addition, there are unquantifiable costs associated with psychological distress, marital and family distress, and social isolation.

The aim of this novel health services research proposal is to assess the longer-term outcomes and costs, to 18 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) (clinicaltrials.gov ID: NCT02879799), the investigators are 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. Unless otherwise indicated, infant ages are corrected for prematurity. For the cRCT, investigators hypothesized that FICare would reduce length of NICU stay by 10%, reduce infant morbidities (e.g., nosocomial infections, respiratory support, feeding problems), increase breastmilk 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 (follow-up). With current funding, investigators can evaluate outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

The investigators hypothesize that compared to standard care in a Level II NICU, FICare will: (1) improve global development of moderate and late preterm infants at 18 months (primary outcome); (2) improve infant social and emotional development; (3) reduce the frequency of child emergency department visits, hospital readmission rates, and physician visits additional to recommended health surveillance visits; (4) improve child growth trajectories; (5) decrease use of antibiotic prescriptions; (6) increase maternal confidence in caring for their child; (7) decrease maternal psychosocial distress; (8) improve maternal-reported toddler sleep, and (9) decrease public healthcare payer costs.

There is currently no standardized timeline for follow-up of infants born prematurely. Evidence suggests that 18 months is ideal for follow-up because there is decreased inter-individual variability in child development, and social-emotional outcomes can be more accurately assessed. After 18 months, environmental factors may exert a stronger influence on infant development, potentially diluting the ability to directly measure the effect of FICare. Eighteen months is the age at which Canadian Neonatal Follow-Up Network data are collected for infants admitted to a Level III NICU, which will enable comparisons of some outcomes with infants in the Level II NICU FICare Alberta cRCT. There are no plans for further follow-up past 18 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Premature Birth
Intervention  ICMJE Other: 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.
Other Name: FICare
Study Arms  ICMJE
  • Experimental: FICare Intervention Group
    Study participants received Family Integrated Care (intervention) while their infant(s) was/were admitted to a Level II NICU.
    Intervention: Other: Family Integrated Care
  • No Intervention: FICare Control Group
    Study participants received standard care while their infant(s) was/were admitted to a Level II NICU.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
422
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Level II NICU cluster controlled trial (cRCT). 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03337659
Other Study ID Numbers  ICMJE CIP-150740
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Discussions are underway to draft a data deposition agreement with Secondary Analyses to Generate Evidence (SAGE).
Responsible Party Karen Benzies, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • University of Toronto
  • University of Alberta
  • Alberta Health Services
Investigators  ICMJE
Principal Investigator: Abhay Lodha, MD University of Calgary
Principal Investigator: Khalid Aziz, MD University of Alberta
Principal Investigator: Vibhuti Shah, MD University of Toronto
PRS Account University of Calgary
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP