Family Centred Healthcare - Zero Separation and Couplet Care

Sponsor
Copenhagen University Hospital, Hvidovre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05236023
Collaborator
University of Copenhagen (Other)
556
1
2
42.6
13.1

Study Details

Study Description

Brief Summary

Today mother and infant are routinely separated directly after birth if there is a need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus, there is a need of change in organizing the treatment and care in a way that minimizes separation.

The aim is to develop and test an intervention program that aims to improve treatment and care of sick mother-infant dyads. Further, to examine whether non-separated and couplet cared families' experiences a better admission course, improved health, and improved bonding in the family.

The study has a prospective non-blinded quasi-experimental design and consist of 4 sub-studies. First an intervention will be developed, implemented and evaluated. The intervention will take place at the Neonatal Intensive Care Unit at Hvidovre Hospital. The nurses will as a part of the intervention be educated to take care of both mother and infant and carry out the intervention. The second study is quantitative and aims to investigate the effect of zero separation and couplet care on specific health related outcomes. Data is collected through patient records and questionnaires. As a part of the second study a cost-effectiveness analysis will be carried out. The third study examines families' experiences with zero separation and couplet care through in-depth family interviews. Subsequently in the fourth study healthcare professionals will be interviewed about their experiences with zero separation and couplet care.

Nine families with experiences from the Neonatal Intensive Care Unit and the Maternity Unit participates as co-creators in the project, as their experiences and ideas will provide an added value to the project.

This study contribute with a new perspective on how to organize the treatment and care of a newborn family in a Neonatal Intensive Care Unit. The study will be the first to examine zero separation and couplet care within sick mother-infant dyads. The study will provide knowledge about how an intervention consisting of zero separation and couplet care can be feasible and acceptable, and what kind of effect and impact it will provide. It is expected that the study as a whole may impact and profile clinical nursing, as well as benefitting public health.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Zero separation and couplet care
N/A

Detailed Description

"There is no such thing as a baby, there is a baby and someone".

Approximately 10% of all newborn infants are admitted to a neonatal intensive care unit (NICU) for medical reasons and care, due to sickness related to birth or because of preterm delivery, defined as a live birth occurring before 37 weeks of gestation. In Denmark, around 60,000 infants are born per year. Having a sick or preterm infant is stressful and a considerable challenge for parents and in this context anxiety, depression and stress is often reported. Many mothers to infants born sick or premature have extended need of postpartum care and treatment and will because of this be separated from their newborn infant and admitted to the maternity unit (MU). Depending on the circumstances it can be hours or days before mother and infant are reunited. Mothers reports separation from their infant as one of the highest sources of stress. The first hours of an infant's life are of special importance, when the transition from the intra - to extra-uterine life takes place, as instability in this period may cause a cascade of negative effects. Early separation is found to have negative effects on interaction, child development and aggression level, respectively. The findings support the presence of a "early sensitive period" for both mother and infant. On the other hand, there is evidence of benefits from skin-to-skin contact immediately after birth as it improves growth and thermal control in the infant, breastfeeding initiation and duration, and the physiological bonding between mother and infant. The World Health Organization recommends infants and mothers, even with confirmed Covid19, to practice skin-to-skin contact as it supports health and wellbeing in the family. However, today mother and infant are still routinely separated directly after birth if there is need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus, there is a need of a change in organizing the treatment and care of mother-infant dyads in a way that minimizes separation - with a goal of zero-separation. New healthcare models are necessary, and these should include the care of the family. Family centred care (FCC) has been a central philosophy of care for many years in paediatric healthcare and zero-separation can be obtained by FCC supplemented with a couplet care model, meaning that mother and infant are being treated as an inseparable unit, with care of both the sick postpartum mother and the sick infant in the same room, by the same nurse. Zero separation and couplet care has been successfully examined in Sweden and Canada, with positive reaction from parents, professionals, and the organization; however, they have primarily studied the concept in relatively well infants and mothers. Thus, there is a need of providing scientific knowledge on treatment and care for severe sick mother-infant dyads. Furthermore, there is a need of knowledge about how an intervention, consisting of the concepts of zero separation and couplet care can be feasible, acceptable, and sustainable, from the point of view of both families, professionals, and the healthcare organization. System changes, educational changes and substantial adjustment is needed, to ensure effective and safe care of both mother and infant.

Copenhagen University Hospital Amager Hvidovre (AHH) is the largest national delivery hospital in Denmark and has about 7,000 deliveries a year, approximately 12% of total annual Danish births. The NICU at AHH has around 1,000 admissions yearly with a wide range, from premature infants above gestational age 28 weeks and sick infants after birth. The mean admission in NICU are 7.1 days with a range from 24 hours to three months.The NICU will move into new facilities in 2023, with 23 family rooms where all mothers with mild to severe treatment-requiring conditions will be couplet care for by nurses, which will be innovative and unique compared to present national and international treatment and care models, where mother and infant is separated.

The aim of this project is to develop and test an intervention program that aims to improve treatment and care of sick mother-infant dyads. Further, to examine whether non-separated and couplet cared families' experiences a better admission course, improved health, and improved bonding in the family.

The aim of the project will be achieved by answering the following research questions:
  1. How is the fidelity and acceptability of an educational - and family focused nursing intervention to support zero separation and couplet care?

  2. How does the intervention of zero separation and couplet care affect admission, family centred care and family health and wellbeing?

  3. How do families experience zero separation and couplet care in a Neonatal Intensive Care Unit?

  4. How do healthcare professionals experience zero separation and couplet care from a family centred perspective?

The project has a prospective non-blinded quasi-experimental design with two comparable groups: A control group and an intervention group. Based on the assumption that the primary outcome admission days will reduce from 7.1 to 6.0 days after zero-separation and couplet care are introduced, a total of 556 dyads will be included (278 in each group). Data on the control group will be collected in 2022/2023 prior education of staff and launch of the intervention. The control group consist of admitted families in NICU, who has a treatment-requiring condition meeting the same criteria as the intervention group.

Study 1

The intervention with zero separation and couplet care will start ultimo 2023 followed by a process evaluation. To gain the needed competencies to treat and care mother-infant dyads, considerable education of staff is required. The nurses (n=40) will as a part of the intervention be educated to take of both mother and infant and carry out the intervention of zero separation and couplet care. The education program consists of four components - with the purpose of increasing knowledge and competencies to treat and care the mother-infant dyads coordinated and secure:

  1. Postpartum care workshop

  2. Bed-side training

  3. Family nursing workshop

  4. Intensively family nursing course

To assess the fidelity and acceptability of the intervention a process evaluation will be carried out through two field studies with observational data and ethnographic interviews. By combining field observations and interviews it will be possible to access the explicit knowledge that health professionals and families communicates verbally, and the implicit knowledge about the intervention of zero separation and couplet care.

The intervention program and process evaluation comprise of knowledge gathered from prior literature, clinical practice, and the beneath listed components:

Family-focused nursing The theoretical framework in the project is the philosophy of FCC, that fundamentally is about supporting and respecting the family's participation in their infant's care.To embrace FCC healthcare professionals needs to have knowledge, commitment, and positive attitudes towards it, before it can be successful integrated in the organization.

Co-designing Nine families with experiences from a NICU and MU participates as co-designers in the project. They are engaged as experts in the design, development, testing and evaluation of the intervention. The families are selected based on their (1) admission course; (2) ability to reflect on their personal experience and use it on the behalf of the admitted families; and (3) knowledge of the NICU environment and care practices.

Sub-study 2 The effect of the intervention is measured by patient records and danish validated questionnaires. Data from the control group will be gathered prior launch of intervention, and data from the intervention group will be gathered 18 months after the control group, when the intervention has taken place. Data from the questionnaires will be collected at discharge and a follow up assessment will be made four months after discharge in each group.

Hypotheses The intervention of zero separation and couplet care

  • Leads to decreased admission days

  • Improves FCC provided by nurses

  • Increases skin-to-skin contact between mother and infant

  • Improves infant growth

  • Improves respiratory stabilization

  • Improves breastfeeding success

  • Improves family function and psychological health

Continuous outcomes will be analyzed by two-sample t-test or linear regression model and categorical outcomes will be analyzed by qui-squared, fishers exact or logistic regression model. Potential confounders will be selected a priori and will be included and evaluated in the models. Descriptive statistic and statistical analysis will be performed in STATA.

Cost-effectiveness analysis Information about specific economic outcomes will be collected in a period of two weeks two times: 1) before the intervention and in the end of the intervention. The following outcomes will be examined: In-NICU hospital bed days, readmission, staff, analgesic use, donor milk, and the need of respiratory support for infant.

Sub-study 3 A qualitative phenomenological approach with in-depth family interviews will be conducted in 2024, using a semi-structured interview guide founded in a structured literature search. The interviews will de digitally recorded and held at the hospital or at the family's home according to their preferences and will be facilitated by the PhD student. A qualitative methodological approach employing Giorgi's phenomenological method will be used to analyse data.

Sub-study 4 Data will be collected in 2025 from four interdisciplinary qualitative focus group interviews with 8 healthcare professionals in each consisting of both nurses and physician. The focus groups interview will be digitally recorded, and will take place at the hospital facilitated by the PhD student and the main supervisor. A deductive content analysis will be used, due to theoretical framework of zero separation, couplet care and FCC. It is a beneficial analysis for testing concepts, theories, and hypotheses in a new context.

Ethics Participating families and healthcare professionals will be informed about the purpose of the project and will receive oral and written information about the project prior to participation. According to the Declaration of Helsinki data will be handled confidently and when publishing the participants will be anonymized and written informed content will be obtained from all participants. The project will be reported to 'Videnscenter for dataanmeldelser' through Pacticus. Data are collected in REDcap and personally identifiable data will be stored in a hospital servers logged drive. Further, the regional Committee on Health Research Ethics is contacted about the duty to notify the project to the committee.

Perspective This study contribute with a new perspective on how to organize the treatment and care of a newborn family in a Neonatal Intensive Care Unit. The study will be the first to examine zero separation and couplet care within sick mother-infant dyads. The study will provide knowledge about how an intervention consisting of zero separation and couplet care can be feasible and acceptable, and what kind of effect and impact it will provide. It is expected that the study as a whole may impact and profile clinical nursing, as well as benefitting public health.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
556 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Zero Separation and Couplet Care of Sick Treatment-requiring Mother-infant Dyads - Family Centred Healthcare
Actual Study Start Date :
Jun 14, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

Group receiving care as usual before the intervention takes place

Experimental: Intervention group

Group receiving a new model of care based on zero separation and couplet care

Behavioral: Zero separation and couplet care
A planned four component education program delivered to nurses as competence development to take care of the sick mother-infant dyads, and to carry out the intervention of zero separation and couplet care at the Neonatal Intensive Care Unit.

Outcome Measures

Primary Outcome Measures

  1. Admission days [At discharge assessed up to 6 months]

    Number of admission days

Secondary Outcome Measures

  1. Couplet cared dyads [Assessed each months in a period of 12 months.]

    Number of couplet cared mother-infant dyads

  2. Physical united [Postpartum within 24 hours of admission]

    Hours from birth to mother-infant are physical united

  3. Skin-to-skin contact [Hours on day 2-4 of the admission period]

    Hours of skin-to-skin contact

  4. Family conversation [Assessed each month in a period of 12 months]

    Number of family conversation

  5. Weight loss [From admission and up to 21 days]

    Maximum weight loss in percent (infant)

  6. Birth weight [From admission and up to 21 days]

    Number of days to regain birth weight (infant)

  7. Respiratory support [At discharge up to 60 days.]

    Number of days with respiratory support (infant)

  8. Breast tension [Within 14 days of admission]

    Number of days until mothers first breast tension

  9. Milk volume [Milk volume on day 6 of the admission period]

    Milk volume (mother)

  10. Sufficient milk production [Within 3 months of admission]

    Number of days to sufficient milk production (Mother)

  11. Family centered care scale [At discharge assessed up to 6 months and four months after discharge]

    Family Centered Nursing Scale consists of seven statements that focus on the way nurses work and whether the nurses' work is performed in accordance with the principles of Family Centered Nursing. 7 items using a 5 point scale from not at all important to very important.

  12. Family centred care for parents [At discharge assessed up to 6 months and four months after discharge]

    This instrument is a self-report questionnaire that directs respondents to rate which activities they perceive to be necessary for FCC (necessary practice) and to self-report on which activities they believe to be currently present in their practice (current practice). 20 items rates on a 4 point scale from never to always.

  13. Parental Stress Scale [At discharge assessed up to 6 months and four months after discharge]

    Measures parental stress, 18 items, The item statements are rated for agreement by parents using a 5-point response scale (1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree)

  14. PedsQL family impact scale [At discharge assessed up to 6 months and four months after discharge]

    PedsQL™ Family Impact Module was designed to measure the impact of pediatric chronic health conditions on parents and the family. The PedsQL™ Family Impact Module measures parent selfreported physical, emotional, social, and cognitive functioning, communication, and worry. 24 items, rates on a five point scale from never to almost.

  15. Family functioning questionnaire [At discharge assessed up to 6 months and four months after discharge]

    The Iceland-Expressive Family Functioning Questionnaire, 17 items, rates on a five point cale from almost never to almost always

  16. SF-12 [At discharge assessed up to 6 months and four months after discharge]

    SF-12 is an international instrument, often used to assess health results and health related quality of life. 12 items with different rates in each; Yes and no, from all the time to never, all the time and not at all.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Mothers with a treatment-requiring condition such as preeclampsia, bleeding, psychological diagnoses, discontinued milk production and infection.

  • Infant from gestational age 28 weeks with a treatment-requiring condition such as respiratory distress syndrome (with respiratory support including mechanical ventilation), hyperbilirubinemia, infection, and low blood sugar.

Exclusion Criteria:
  • Healthy mothers who does not need care and treatment, and has an infant admitted at NICU.

  • Mothers who are admitted at an adult intensive care unit due to severe sickness (severe preeclampsia with spasm, severe bleeding of 4-5 liter, and severe HELLP syndrome) - counting one-two mothers a year

Contacts and Locations

Locations

Site City State Country Postal Code
1 Copenhagen University Hospital Hvidovre Hvidovre Denmark 2650

Sponsors and Collaborators

  • Copenhagen University Hospital, Hvidovre
  • University of Copenhagen

Investigators

  • Study Chair: Anne Brødsgaard, Copenhagen University Hospital, Hvidovre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michella Runge Kjøbeløv Bjerregaard, Principal investigator, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT05236023
Other Study ID Numbers:
  • P-2021-872
First Posted:
Feb 11, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michella Runge Kjøbeløv Bjerregaard, Principal investigator, Copenhagen University Hospital, Hvidovre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022