Transition to Home (TtH) After Preterm Birth: Pilot Testing an Advanced Practice Nurse (APN)-Led Model of Transitional Care
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Study burden
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Preterm infants with congenital heart malformations and other congenital problems evident at birth
研究组 & 干预措施
APN-led Intervention
Intervention 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
干预措施: music therapy (Behavioral)
APN-led Intervention
Intervention 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
干预措施: neonatologists (Behavioral)
APN-led Intervention
Intervention 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
干预措施: psychological support (Behavioral)
APN-led Intervention
Intervention 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
干预措施: lactation consultant (Behavioral)
APN-led Intervention
Intervention 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
干预措施: physiotherapeutic interventions (Behavioral)
APN-led Intervention
Intervention 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
干预措施: social workers (Behavioral)
APN-led Intervention
Intervention 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
干预措施: other health care professionals (Behavioral)
APN-led Intervention
Intervention 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
干预措施: interprofessional roundtable meetings (Behavioral)
APN-led Intervention
Intervention 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
干预措施: Advanced practice nurses' interventions (Behavioral)
Control, Standard Care
Control group receiving standard care
结局指标
主要结局
Study burden
时间窗: Once 6 month after discharge
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.
Parent-child interaction
时间窗: Once 6 month after discharge
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.
Parent depressive symptoms
时间窗: From birth until 6 months after discharge (at 5 time points)
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.
Parent anxiety
时间窗: From birth until 6 months after discharge (at 5 time points)
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.
Parent Posttraumatic Stress Disorder
时间窗: From birth until 6 months after discharge (at 5 time points)
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.
Parenting stress
时间窗: From birth until 6 months after discharge (at 5 time points)
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.
Parent self-efficacy
时间窗: From birth until 6 months after discharge (at 5 time points)
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.
Infant growth status
时间窗: From birth until 6 months after discharge
Growth Status including weight in kg, height in cm and head circumference in cm will be continuously assessed from medical records.
Infant behaviour
时间窗: Once 6 month after discharge
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).
Quality of life
时间窗: From birth until 6 months after discharge (at 3 time points)
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.
Sleep patterns
时间窗: From birth until 6 months after discharge
Sleep patterns will be continuously assessed from medical records.
Self-regulation abilities
时间窗: From birth until 6 months after discharge
Self-regulation abilities will be continuously assessed from medical records.
次要结局
- Model evaluation(6 Month)
- Cost analysis(6 Month)
- Infant Nutrition Management and feeding behaviour(From birth until 6 months after discharge)