Collaborating to Improve Neonatal Care: ParentAl Participation on the NEonatal Ward—Study Protocol of the neoPARTNER Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patient Organisation Involvement
2.2. Design
2.3. Setting
2.4. Study Population
2.4.1. Inclusion Criteria
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- Infant requiring hospital admission directly (within 24 h) after birth;
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- Parent are 18 years or older;
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- Written, informed consent of both parents/legal guardians (compliant to the regulations of the Central Committee on Research Involving Human Subjects).
2.4.2. Exclusion Criteria
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- Infant’s hospital stay shorter than 7 days;
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- Infant with severe congenital or syndromal anomaly;
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- Infant with critical illness who is unlikely to survive;
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- Parents with current severe psychosocial problems;
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- Involvement of child protective services in the family;
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- Parents not able or not willing to fill out questionnaires in English or Dutch.
2.5. Procedures
- Education of parents:
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- Information on the hospital admission and care of an infant, including a digital application (NeoZorg application);
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- The possibility to keep track of (medical) information in a diary and/or digital application (NeoZorg application, see further);
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- Educational and thematic meetings (physical and/or digital) with other parents, led by either healthcare professionals (nurses, paediatricians and/or paramedic staff) or veteran parents.
- Education of healthcare professionals:
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- Comprehensive e-learning on FICare and FCR, developed by the research group. The e-learning comprises the following modules:
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- Theoretical background and historical context of FICare and FCR;
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- Implementing FCR in practical settings;
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- Coaching of parents by healthcare professionals;
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- Explanation of the existing (co-)interventions SFR and family-centred care;
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- Understanding the principles of FCR and shared decision-making.
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- Training in FICare principles: the research group has designed training materials for effective collaboration and communication with parents, parent participation and shared decision-making. These training materials draw from both existing literature and the valuable insights available on the Canadian website dedicated to FICare (www.familyintegratedcare.com, accessed on 22 May 2022).
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- The theory and practical application of FICare and FCR;
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- The role of healthcare professionals within the context of FICare;
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- Emphasizing shared decision-making.
- Psychosocial support:
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- Facilitating contact and peer support for parents with veteran parents, both during admission and after discharge;
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- Support by paramedical staff (e.g., psychologist, preverbal speech therapist, physiotherapist, social worker).
- Environment of the neonatal ward:
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- FICare whiteboard/communication board, at which parents can track for example their participation progress and information on their infant;
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- Facilities for skin-to-skin contact and expressing human milk on the ward;
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- 24/7 access to the ward;
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- Facilities to be (digitally) present during medical rounds (i.e., including video conference or telephone calls).
2.6. Control Treatment: Standard Neonatal Care without FCR
2.7. Interventional Treatment: Family-Centred Rounds Embedded in the FICare Principles
2.8. Primary Outcome
2.9. Secondary Outcomes
2.9.1. Infant Outcomes
2.9.2. Parental Outcomes
2.9.3. Outcomes at Cluster Level
2.9.4. Cost-Effectiveness
2.9.5. Biomarkers
2.10. Statistical Procedures
2.10.1. Sample Size Calculation
2.10.2. Statistical Analysis
3. Results
3.1. Trial Progress
3.2. Reporting and Publication
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Correction Statement
References
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Timing | Subject | Outcome | Tool/Unit |
---|---|---|---|
Admission 1 | Parents | Parental stress levels 2 | PSS:NICU [31,32] |
Depression | PROMIS [50,51] | ||
Anxiety | PROMIS [50,51] | ||
PTSD | PCL-5 [45,46,48] | ||
Infant | Baseline characteristics | N/A | |
Discharge | Parents | Demographics | General questionnaire |
Parental stress levels | PSS:NICU [31,32] | ||
SDM | SDM-Q-9 [36,37] | ||
SDM preference | CPS [39] | ||
Depression | PROMIS [50,51] | ||
Anxiety | PROMIS [50,51] | ||
PTSD | PCL-5 [45,46,48] | ||
Mothers | Human milk biofactors | See text | |
Infant | Breastfeeding rates | Index of breastfeeding [52,53] | |
Length of stay | days | ||
Growth | Weight gain velocity [54] | ||
Glucocorticoid receptor methylation rate in buccal mucosal cells | Mquant method [55] | ||
CA of 3 months of the infant | Parents | Follow-up characteristics | General questionnaire |
Depression | PROMIS [50,51] | ||
Anxiety | PROMIS [50,51] | ||
PTSD | PCL-5 [45,46,48] | ||
Hair cortisol | LC-MS/MS [56,57] | ||
Salivary cortisol | LC-MS/MS [56,57] | ||
Mothers | Human milk biofactors | See text | |
Infant | Glucocorticoid receptor methylation rate in buccal mucosal cells | Mquant method [55] | |
Salivary cortisol | LC-MS/MS [56,57] | ||
CA of 6 months of the infant | Parents | Follow-up characteristics | General questionnaire |
Depression | PROMIS [50,51] | ||
Anxiety | PROMIS [50,51] | ||
PTSD | PCL-5 [45,46,48] | ||
CA of 12 months of the infant | Infant | Neurodevelopment | ASQ [33,35] |
Medical costs | iMTA MCQ [58] | ||
Parents | Follow-up characteristics | General questionnaire | |
Productivity costs | iMTA PCQ [59] | ||
Medical costs | iMTA MCQ [58] | ||
Depression | PROMIS [50,51] | ||
Anxiety | PROMIS [50,51] | ||
PTSD | PCL-5 [45,46,48] |
Timing | Subject | Outcome | Tool/Unit |
---|---|---|---|
At start, halfway through and end of study | HCP | Demographics | General questionnaire |
Work engagement | UWES-9 [61] | ||
Autonomy | Subscale of JCQ [64] | ||
SDM | SDM-Q-Doc [37,60] | ||
Productivity costs | iMTA PCQ [59] | ||
Organisation | Work absence | Percentages of absenteeism | |
Parental presence at rounds | No. of parents present, no. of rounds | ||
Duration of rounds | Minutes |
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Hoeben, H.; Alferink, M.T.; van Kempen, A.A.M.W.; van Goudoever, J.B.; van Veenendaal, N.R.; van der Schoor, S.R.D.; on behalf of the neoPARTNER Study Group. Collaborating to Improve Neonatal Care: ParentAl Participation on the NEonatal Ward—Study Protocol of the neoPARTNER Study. Children 2023, 10, 1482. https://doi.org/10.3390/children10091482
Hoeben H, Alferink MT, van Kempen AAMW, van Goudoever JB, van Veenendaal NR, van der Schoor SRD, on behalf of the neoPARTNER Study Group. Collaborating to Improve Neonatal Care: ParentAl Participation on the NEonatal Ward—Study Protocol of the neoPARTNER Study. Children. 2023; 10(9):1482. https://doi.org/10.3390/children10091482
Chicago/Turabian StyleHoeben, Hannah, Milène T. Alferink, Anne A. M. W. van Kempen, Johannes B. van Goudoever, Nicole R. van Veenendaal, Sophie R. D. van der Schoor, and on behalf of the neoPARTNER Study Group. 2023. "Collaborating to Improve Neonatal Care: ParentAl Participation on the NEonatal Ward—Study Protocol of the neoPARTNER Study" Children 10, no. 9: 1482. https://doi.org/10.3390/children10091482