Clinical trial NCT03460496: Transition to Home (TtH) After Preterm Birth
Official title: Transition to Home (TtH) After Preterm Birth: Pilot Testing an Advanced Practice Nurse (APN)-Led Model of Transitional Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Keywords: preterm infants
transition to home
advanced practice nurse
cost-analysis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Bern University of Applied Sciences
First posted: 2018-03-09
Enrollment: 36
Sex: ALL
Minimum age (years): 24
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An advanced practice nurse (APN)-led Intervention which focuses on improving parental mental health and well-being, on infant growth and development and on lowering overall costs.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: In The investigators' model, 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 be supported by specialized neonatology nurses; together, they will form the Advanced Nursing Practice Team (ANP Team). Currently, 4 APNs are in training for the project.

The most important tasks of the APN are listed below:

* at birth and during initial hospitalization: first contact of the APN with the family, followed by regular visits, consultations, and educational training for and coordination with other services like lactation consultant, psychologist, social support etc. The APN will conduct family interviews at regular intervals, consult with and train parents on predefined topics in a structured manner while closely collaborating with nursing and medical staff. The APN will take a family-centred approach to making joint decisions. The APN will coordinate health care providers, encourage information flow and collaboration between the professionals as well as organize and manage regular interprofessional exchanges.
* discharge from the hospital: the APN will plan the comprehensive discharge together with parents and the interprofessional team.
* at home: the APN will make systematic follow-up after discharge. The APN will also offer telephone support for requests and answer parent's questions. They will also make follow-up home visits to assess the situation, including assessing physical and mental well-being of parents and infants. The APN will evaluate the interventions the family requested, discuss them with the family, and initiate further services if they are necessary.
* end of the 6 month period: towards the end of the period, the APN will determine, with the parents and other professionals, if the family needs further support, and which specialist would be most appropriate to continue the collaboration with the family.

The role of the interprofessional team:

Within the new model of transitional care, some interprofessional interventions were augmented or adapted.These will be available to families in the intervention group:

Outpatient care by the neonatologist for families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician; Standardized psychological support to re-establish emotional stability, improve the ability of parents to cope with the situation and to prevent parental and family adaptive disorders and child developmental disorders; More frequent and standardized involvement of lactation consultant; Standardized involvement of physiotherapy and social workers; Outpatient music therapy.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Preterm infants with congenital heart malformations and other congenital problems evident at birth

Primary outcomes:
measure: Parent-child interaction
timeFrame: Once 6 month after discharge
measure: Parent depressive symptoms
timeFrame: From birth until 6 months after discharge (at 5 time points)
measure: Parent anxiety
timeFrame: From birth until 6 months after discharge (at 5 time points)
measure: Parent Posttraumatic Stress Disorder
timeFrame: From birth until 6 months after discharge (at 5 time points)
measure: Parenting stress
timeFrame: From birth until 6 months after discharge (at 5 time points)
measure: Parent self-efficacy
timeFrame: From birth until 6 months after discharge (at 5 time points)
measure: Infant growth status
timeFrame: From birth until 6 months after discharge
measure: Infant behaviour
timeFrame: Once 6 month after discharge
measure: Quality of life
timeFrame: From birth until 6 months after discharge (at 3 time points)
measure: Study burden
timeFrame: Once 6 month after discharge
measure: Sleep patterns
timeFrame: From birth until 6 months after discharge
measure: Self-regulation abilities
timeFrame: From birth until 6 months after discharge
Secondary outcomes:
measure: Model evaluation
timeFrame: 6 Month
measure: Cost analysis
timeFrame: 6 Month
measure: Infant Nutrition Management and feeding behaviour
timeFrame: From birth until 6 months after discharge
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsklinik für Kinderheilkunde Neonatologie Inselspital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Mathias Nelle, PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern University of Applied Sciences
name: Eva Cignacco, PD
role: PRINCIPAL_INVESTIGATOR
References: