Transition to Home (TtH) After Preterm Birth
1 other identifier
interventional
36
1 country
1
Brief Summary
Preterm birth is associated with significant and often life-long developmental, emotional and financial burdens. Preterm infants face several challenges that continue late into life, including developmental delays, social, and behavioural problems and poor academic performance. Parents also suffer considerable emotional and physical stress which in turn can have a negative impact on the child's development. In Switzerland, during the transition from hospital to home, there are not many interventions intended to improve mental health outcomes in parents or to promote positive parenting to improve developmental outcomes for the preterm infant. There are also few interventions to reduce associated health care costs. In order to improve parent and preterm infant outcomes, reduce hospital stay in the neonatal intensive care unit (NICU), lower readmission rates, and avoid unnecessary use of primary care resources a unique, new model of transitional care was developed. The new 'Transition to Home' (TtH) model makes use of well-tested, successful methods of post-discharge care. The investigators' study will evaluate the organizational and financial feasibility and cost effectiveness of the TtH model for infants born preterm by measuring the impact of an Advanced Practice Nurse (APN)-led intervention at the Children's University Hospital Bern. The intervention focuses on improving parental mental health and well-being, on infant growth and development, and on lowering overall costs. The investigators will gather data and then adapt and test the model within a longitudinal interventional comparative effectiveness study, and prepare it for other Cantons in Switzerland to implement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 3, 2019
April 1, 2019
1.2 years
January 23, 2018
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Parent-child interaction
Parent-child interaction is assessed with the CARE-Index. Three-minute video recordings made in the home setting will be coded by a certified blinded independent coder. The coding procedure focuses on seven aspects of adult and infant behavior. Each aspect of behavior is evaluated separately, for adult and infant, then the scores are summed to generate seven scale scores. For the adult, these are sensitivity, control, and unresponsiveness. For infants they are cooperativeness, compulsiveness, difficultness, and passivity. The scores on these scales range from 0-14, with zero sensitivity being dangerously insensitive, 7 being normally sensitive, and 14 being outstandingly sensitive. On the adult sensitivity scale, scores of 5-6 suggest the need for parental education, 3-4 suggests the need for parenting intervention, and 0-2 suggests the need for psychotherapy for the parent.
Once 6 month after discharge
Parent depressive symptoms
Depressive symptoms will be assessed with the short version of the 'Allgemeine Depressionsskala' (ADS-K), rated on a 4-point Likert-type scale. The sum score is dichotomized for binary analyses.
From birth until 6 months after discharge (at 5 time points)
Parent anxiety
Parental anxiety will be assessed with State-Trait Anxiety Inventory (STAI), to measure State Anxiety, and Trait Anxiety. Responses are scored on 4-point forced-choice Likert-type scales.
From birth until 6 months after discharge (at 5 time points)
Parent Posttraumatic Stress Disorder
PTSD-Checklist (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms over the past month. Items are rated on a 5-point Likert Scale ranging from 0 (not at all) - 4 (extremely). Items are summed to provide a total severity score (range = 0-80). At total score of 33 or higher indicates the presence of a posttraumatic stress disorder.
From birth until 6 months after discharge (at 5 time points)
Parenting stress
Parenting stress will be measured with the Parenting Stress Index Short Form (PSI-SF), a self-reporting questionnaire that contains 36 items rated on a 5-point Likert Scale (strongly agree to strongly disagree). Overall parenting stress is indicated by the total stress score. Parents report their level of agreement with 36 items that fall into three subscales (12 items each subscale): Parental distress, parent-child dysfunctional interaction and difficult child. The PSI-SF includes a defensive responding scale (seven items from the Parental Distress scale) that indicates the degree to which the parent might be attempting to deny or minimize problems. The raw scores will need to be converted into percentile scores. For each sub-scale a score which falls between the 15th and 80th percentile is considered typical. High scores are those at or above the 85th percentile considering high parenting stress.
From birth until 6 months after discharge (at 5 time points)
Parent self-efficacy
Tool to measure parenting self-efficacy (TOPSE) is an instrument of 48 statements that encompasses eight dimensions of parenting. The german version of the TOPSE, was reduced to 30 items that encompass five dimensions of parenting (emotion and affection, empathy and understanding, pressures, self-acceptance and learning and knowledge). The items are rated on an 11-point Likert scale.
From birth until 6 months after discharge (at 5 time points)
Infant growth status
Growth Status including weight in kg, height in cm and head circumference in cm will be continuously assessed from medical records.
From birth until 6 months after discharge
Infant behaviour
Infant temperament, behaviour and self-regulation abilities will be measured used the Infant Behavior Questionnaire-Revised (IBQ-R) short-form at the end of the 6-month study period. IBQ-R consists of 91 items that span 14 scales (Activity Level, Approach, Cuddliness, Distress to Limitations, Duration of Orienting, Falling Reactivity, Fear, High Intensity Pleasure, Low Intensity Pleasure, Perceptual Sensitivity, Sadness, Smiling and Laughter, Soothability and Vocal Reactivity).
Once 6 month after discharge
Quality of life
Quality of life will be assessed with the Visual Analog Scale (VAS). Parents will mark a spot along a line from 1 indicating worst possible quality of life to 10 indicating best possible quality of life.
From birth until 6 months after discharge (at 3 time points)
Study burden
Will be evaluated at the end of the study period with a Visual Analog Scale (VAS). Parents will mark a spot along a line from 0 indicating no study burden to 10 indicating highest possible study burden. The VAS will be part of the 6-month questionnaire.
Once 6 month after discharge
Sleep patterns
Sleep patterns will be continuously assessed from medical records.
From birth until 6 months after discharge
Self-regulation abilities
Self-regulation abilities will be continuously assessed from medical records.
From birth until 6 months after discharge
Secondary Outcomes (3)
Model evaluation
6 Month
Cost analysis
6 Month
Infant Nutrition Management and feeding behaviour
From birth until 6 months after discharge
Study Arms (2)
APN-led Intervention
EXPERIMENTALIntervention group being provided with the interventions described below. * Advanced practice nurses' interventions * Neonatologists: neonatal outpatient consultation * psychological support * lactation consultant * physiotherapeutic interventions * collaboration with social workers * music therapy * close collaboration with other health care professionals * interprofessional roundtable meetings
Control, Standard Care
NO INTERVENTIONControl group receiving standard care
Interventions
will continue to be contact persons for the APN, even after hospital discharge, and will be available for 3 fixed outpatient consultations with the APN and families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician.
Psychological support will be standard for all families. In a first consultation, psychologist and family will decide about long-term psychological support. They will have at least 3 follow-up consultations during hospital stay and one before discharge; specific psychological interventions will be provided. The aim of the interventions is to re-establish emotional stability and improve the ability of parents to cope with the situation, to prevent parental and family adaptive disorders and child developmental disorders. Support focus on screening for psychological disorders. Techniques include family-centred, holistic interventions (e.g. activating parental resources and coping, crisis intervention, stabilization techniques etc.). Parents will receive outpatient psychological support.
during hospitalization, the lactation consultant will be involved more frequently than during standard care. Breastfeeding support will take a structured approach and will be performed in close collaboration with both parents. The main aims of structured breastfeeding support are strengthen parent-child bonding. Infants will be breastfed according to their needs. Parents will become competent in meeting their child's nutritional needs. After discharge, parents may schedule outpatient breastfeeding consultations.
physiotherapeutic interventions will also be structured. The physiotherapist will make an assessment during hospitalization, and decide which physiotherapeutic interventions are necessary. Each family will learn how to handle their premature child in everyday life, based on the child's developmental stage, in a single consultation.
social workers will closely collaborate with the APN within the transitional model. They will be involved with every family and will assist the APN in establishing a network with social and medical services within and outside the clinic. They will also support families in coping with daily life and with their integration into society, family and work. Furthermore, they will give advice on social security issues and on asserting claims as well as clarify financial possibilities.
music therapy with premature infants and their parents creates a new dimension of contact, and helps stabilize the child and supports their development through music. It also reduces the anxiety of parents, and enhances self-efficacy and makes them more sensitive to their child 74,75, thus enhancing the parent-child relationship. In standard care, music therapy is offered only during hospitalization. In the new model of care, after NICU discharge, the program will offer 10 follow-up sessions at the family's home or in the music therapists' private practice.
the APN will contact and involve other health care professionals, like the family's paediatrician, the outpatient midwife, the community health care nurse or the mother and father counselling as soon as need becomes evident. The APN will help set up meetings between health care professionals and the family, and will keep them up-to-date on the family's situation.
interprofessional roundtable meetings with health care professionals involved in the care of a specific family will be held every two weeks. The meeting is aimed at developing consensus on the best possible support in the care of preterm infants and their families. Parents will be invited to participate in these meetings, led by the APN. The meeting will focus on two family situations, and then determine and initiate supportive interventions in collaboration with the parents.
The APN will participate in comprehensively planning individual discharge, coordinating services, consulting with other healthcare professionals, assessing needs on a case by case basis, and coaching the family from birth to 6 months after discharge from the NICU. The APN will provide the Newborn Behavioral Observation (NBO), an infant-centred and family-focused method for building relationships, to parents and children, during and after hospitalization. The NBO helps sensitize parents to their infant's competencies and capabilities, teaching them to read their infant's signals and understand their behaviours. It promotes positive interactions between parent and preterm infant. The APN will also offer telephone support and follow-up Visits at home after discharge.
Eligibility Criteria
You may qualify if:
- Families of preterm infants (between 24 0/7 weeks and 34 6/7 weeks of gestation) born and hospitalized in the University Hospital Bern
- Infants will need to be discharged directly from the Neonatology department, and their parents must reside in Canton Bern, and speak German, French or English.
- For multiple births, all infants will be followed.
- Written informed consent by the parents
You may not qualify if:
- Preterm infants with congenital heart malformations and other congenital problems evident at birth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinik für Kinderheilkunde Neonatologie Inselspital
Bern, 3010, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathias Nelle, PD
Insel Gruppe AG, University Hospital Bern
- PRINCIPAL INVESTIGATOR
Eva Cignacco, PD
Bern University of Applied Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2018
First Posted
March 9, 2018
Study Start
February 1, 2018
Primary Completion
April 30, 2019
Study Completion
December 31, 2019
Last Updated
April 3, 2019
Record last verified: 2019-04