VOICE Study in China 'Towards a Partnership Between Parents of Very Premature Infants and Healthcare Professionals'

Parents Clinical Trial

— VOICE  

Official title:

VOICE: Values, Opportunities, Integration, Control and Evaluation: Towards a Partnership Between Parents of Very Premature Infants and Healthcare Professionals in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05385198
• Other study ID #: HN06
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2022
• Source: Hunan Children's Hospital
• Contact: Yan Zhuang
• Phone: +86-177-0843-9719
• Email: 121427059[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Admission to a Neonatal Intensive Care Unit (NICU) is associated with significant levels of parental stress and anxiety. Parents are often uncertain to perform care giving activities and might feel uncertain to fulfill the desirable parental role during NICU admission. Furthermore, transition of the NICU to another unit or hospital is stressful for parents often related to poor information and communication. A VOICE program is developed aiming to increase the empowerment of parents, to improve partnership between parents of very premature infants and healthcare professionals.

Aim: To conduct a feasibility RCT study to evaluate the implementation and the effect of the VOICE program on parental stress and anxiety in the NICU.

Methods:

Design is a feasibility RCT to test the procedures, compliance, determine sample size, estimating recruitment and retention, and to get first insight in the effects of the VOICE program on the outcome measures.

VOICE will be implemented as a structured empowerment and partnership program for parents from admission of the infant to the NICU till the first visit to the out-patient clinic. The program exists of five structured and focused meetings, following the acronym VOICE (Values, Opportunities, Integration, Control and Evaluation). These interdisciplinary meetings with parents aim to increase the involvement of parents in the care and decision making of participants' infant in the NICU. The primary outcome measures will be parental stress and anxiety measured by the Chinese version of the Hospital Anxiety and Depression scale (HADS) and the Edinburgh Postnatal Depression Scale (Chinese version). The secondary outcome measures will be parent satisfaction with care measured by the Empowerment of Parents in the Intensive Care (EMPATHIC-30) scale, length-of-stay in the NICU, hours of parental visitation and activities, compliance of NICU staff to the VOICE program.

An embedded qualitative study will be designed to explore the experiences of parents and NICU staff about the implemented VOICE program. Individual interviews with parents and focus groups sessions with NICU staff will be conduction. This will help to identify methodological issues such as recruitment and retention and any enablers and barriers to the intervention which may impede the future RCT.

Description:

BACKGROUND AND RATIONAL Preterm birth and admission at the Neonatal Intensive Care Unit (NICU) can be stressful and traumatic events both for parents and infants.

Infants born very premature are usually admitted to a NICU. A multidisciplinary dedicated team takes care of these infants and parents. Admission to a NICU is essential if the infant requires additional life support for their vital functions after birth. NICU admission is associated with high rates of impaired development of the infants, and parents or families often experience significant disruption, stress and anxiety during NICU admission and beyond.

Depending the diagnostic criteria, 6.8-16.5% of the mothers suffers of post-partum depression. Elevated stress levels and depressive symptoms are present upon NICU admission. Besides the normal stress of parenthood, parental distress is related to different factors such as physical and emotional isolation from the infant, a lack of control, adapting the idea of having a sick infant and the stress of the NICU environment.

During admission, support of nurses and doctors is important; when perception of nursing support is decreasing, mothers' depressive symptoms are increasing. Stress is known to negatively influence the parent-child relationship. Schappin concluded that stress decreases by better quality of care and stress in parents of premature infants is higher in comparison with term infants. Counseling parents in taking care of their infants is therefore very important.

The quality of care in the first weeks has a impact on parental stress. For optimal development of the infant, parents need to be involved in the total care process at the NICU. Creating an environment, both physical and emotional, in which involvement of parents is crucial in the care for their infant, increases outcome and decreases parental stress. In addition, maternal visits are positive associated with decreased length-of-stay and rates of behavioral and emotional problems. The main predictors of lower maternal NICU visitation were the number of potential traumatic events, maternal anxiety and number of children at home.

A program was developed called VOICE: Values, Opportunities, Integration, Control and Evaluation. The program exists of 5 structured meetings in congruence with the acronym VOICE: structural interdisciplinary meetings with parents to inform and communicate with parents and to support them in decision-making and care of their infant. The aim of this VOICE program is to decrease the level of parental stress in parents. To increase the parental involvement in decision-making and care, investigators aim to implement the VOICE program and test its feasibility and impact on parents.

AIM AND OBJECTIVES The aim of the feasibility RCT is to evaluate the implementation and the effect of the VOICE program on parental stress and anxiety in the NICU.

Specifically, the objectives are:

1. To determine the feasibility of delivering the VOICE program intervention to parents of infants GA <32 weeks admitted to the NICU A feasibility study will be conducted to collect process, resource, management and scientific data to inform the design of a larger multi-center RCT. The proposed outcome measures will be related to stress, anxiety, parent satisfaction, NICU length-of-stay, hours of parental visitation and their activities, compliance of NICU staff to the VOICE program.

2. To explore the implementation of the VOICE program intervention with parents and healthcare professionals.

A qualitative study will explore experiences of parents who will be participating in the feasibility study and the NICU staff carrying out the intervention. This will provide information on methodological issues such as recruitment/retention, and enablers/barriers of the intervention.

METHODS Design Design of the study is a feasibility study. Since the VOICE program is a complex intervention, the MRC-framework for developing and testing complex interventions will be followed. The process from development through to implementation of a complex intervention may take a wide range of different forms.

In the developmental phase, the VOICE intervention was developed from the available evidence and experts in this field, including parents. All involved healthcare professionals have been trained. After the developmental phase, the current 'step' in this MRC framework is the feasibility and piloting phase. The study will be a mixed-method study. Specifically, the feasibility study will be conducted with RCT design and an embedded qualitative design.

Setting The NICU of the Hunan Children's Hospital is a tertiary neonatal center providing high quality care and treatment. Infants above 24 weeks gestational age (GA) are admitted and treated in this NICU. More than 5000 newborns are admitted annually. Of these infants, around 350 are born very premature, with a GA <32 weeks. These very premature infants need long-term intensive care treatment with a mean length-of-stay of 35 days. The NICU has meanwhile implemented successfully family-centered care and parent are allowed to visit their infants and become more involved in the care.

Sample size As this is a feasibility study the sample size has been determined pragmatically to address the study objectives. Investigators aim to include parents (father and/or mother) of 30 infants in the intervention group and parents of 30 infants in the standard care group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parents of infants born < 32 weeks GA

• Parents of infants admitted to NICU within 7days after birth

• Parents speaking and writing Chinese.

Exclusion Criteria:

• Parent of infants with an expected NICU length-of-stay less than 4 weeks

• Parents of infants having a major life-threatening congenital anomaly

• Parents of infants with a critical illness and unlikely to survive

• Parents with an inability to participate (health, family, social, or language issues that might inhibit their ability to collaborate with the NICU staff

Related Conditions & MeSH terms

• Emotional Stress
• Family Centered Care
• Infant ALL
• Neonatal Intensive Care
• Parents
• Premature Birth

Intervention

Behavioral:
• VOICE care
I phase:build a relationship with parents and where the Values of the parents and NICU staff is shared. II phase: discuss with the parents the Opportunities the parents can have to be more involved in the care of their baby. III phase: Integration of the involvement of the parents in the care of their baby. The experiences of parents need to be shared with the NICU staff. Any raising issue about the involvement of care by the parents can be discussed and see if improvement is needed. IV phase:Control of the knowledge about the care of their baby before going home and if the parents have any issues which need to be arranged before discharge. V phase:Evaluation. During this conversation the overall experiences of the parents will be discussed and if there are any further questions related to the care of their baby at home will be explored and discussed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Children's Hospital

References & Publications (21)

Alkozei A, McMahon E, Lahav A. Stress levels and depressive symptoms in NICU mothers in the early postpartum period. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1738-43. doi: 10.3109/14767058.2014.942626. Epub 2014 Jul 30. — View Citation

Ayers S, Joseph S, McKenzie-McHarg K, Slade P, Wijma K. Post-traumatic stress disorder following childbirth: current issues and recommendations for future research. J Psychosom Obstet Gynaecol. 2008 Dec;29(4):240-50. doi: 10.1080/01674820802034631. — View Citation

Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. — View Citation

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655. — View Citation

Davis L, Edwards H, Mohay H, Wollin J. The impact of very premature birth on the psychological health of mothers. Early Hum Dev. 2003 Aug;73(1-2):61-70. — View Citation

Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. eCollection 2016. — View Citation

Engelhard IM, van den Hout MA, Schouten EG. Neuroticism and low educational level predict the risk of posttraumatic stress disorder in women after miscarriage or stillbirth. Gen Hosp Psychiatry. 2006 Sep-Oct;28(5):414-7. — View Citation

Engelhard IM, van Rij M, Boullart I, Ekhart TH, Spaanderman ME, van den Hout MA, Peeters LL. Posttraumatic stress disorder after pre-eclampsia: an exploratory study. Gen Hosp Psychiatry. 2002 Jul-Aug;24(4):260-4. — View Citation

Gonya J, Martin E, McClead R, Nelin L, Shepherd E. Empowerment programme for parents of extremely premature infants significantly reduced length of stay and readmission rates. Acta Paediatr. 2014 Jul;103(7):727-31. doi: 10.1111/apa.12669. — View Citation

Greene MM, Rossman B, Patra K, Kratovil A, Khan S, Meier PP. Maternal psychological distress and visitation to the neonatal intensive care unit. Acta Paediatr. 2015 Jul;104(7):e306-13. doi: 10.1111/apa.12975. Epub 2015 Feb 27. — View Citation

Helder OK, Verweij JC, van Staa A. Transition from neonatal intensive care unit to special care nurseries: experiences of parents and nurses. Pediatr Crit Care Med. 2012 May;13(3):305-11. doi: 10.1097/PCC.0b013e3182257a39. — View Citation

Jiang S, Warre R, Qiu X, O'Brien K, Lee SK. Parents as practitioners in preterm care. Early Hum Dev. 2014 Nov;90(11):781-5. doi: 10.1016/j.earlhumdev.2014.08.019. Epub 2014 Sep 20. Review. — View Citation

Koren, P. E., DeChillo, N., & Friesen, B. J. (1992). Measuring empowerment in families whose children have emotional disabilities: A brief questionnaire. Rehabilitation Psychology, 37(4), 305-321.

Latour JM, Duivenvoorden HJ, Hazelzet JA, van Goudoever JB. Development and validation of a neonatal intensive care parent satisfaction instrument. Pediatr Crit Care Med. 2012 Sep;13(5):554-9. doi: 10.1097/PCC.0b013e318238b80a. — View Citation

Latour JM, Hazelzet JA, Duivenvoorden HJ, van Goudoever JB. Perceptions of parents, nurses, and physicians on neonatal intensive care practices. J Pediatr. 2010 Aug;157(2):215-220.e3. doi: 10.1016/j.jpeds.2010.02.009. Epub 2010 Mar 31. — View Citation

Melnyk BM, Feinstein NF. Reducing hospital expenditures with the COPE (Creating Opportunities for Parent Empowerment) program for parents and premature infants: an analysis of direct healthcare neonatal intensive care unit costs and savings. Nurs Adm Q. 2009 Jan-Mar;33(1):32-7. doi: 10.1097/01.NAQ.0000343346.47795.13. — View Citation

O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0. — View Citation

Schappin R, Wijnroks L, Uniken Venema MM, Jongmans MJ. Rethinking stress in parents of preterm infants: a meta-analysis. PLoS One. 2013;8(2):e54992. doi: 10.1371/journal.pone.0054992. Epub 2013 Feb 6. — View Citation

Stowe ZN, Nemeroff CB. Women at risk for postpartum-onset major depression. Am J Obstet Gynecol. 1995 Aug;173(2):639-45. Review. — View Citation

Weis J, Zoffmann V, Egerod I. Improved nurse-parent communication in neonatal intensive care unit: evaluation and adjustment of an implementation strategy. J Clin Nurs. 2014 Dec;23(23-24):3478-89. doi: 10.1111/jocn.12599. Epub 2014 Apr 3. — View Citation

White T , Matthey S , Boyd K , et al. Postnatal depression and post-traumatic stress after childbirth: Prevalence, course and co-occurrence[J]. Journal of Reproductive & Infant Psychology, 2006, 24(2):107-120.

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Hospital Anxiety and Depression before and after intervention	Hospital Anxiety and Depression scale is a 14-item scale measuring hospital anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Each subscale has a score ranging from 0 to 21. Items are rated on a 4-point Likert scale, ranging from 0-3, generating a scale range of 0-42 points, with higher scores representing greater symptom severity. Score of 0-7 indicates normal levels of anxiety and depression; 8-10 indicate borderline abnormal anxiety and depression levels, and 11-21 suggest abnormal levels of anxiety and depression.	Time Frame of measurement : T1 = Baseline pre-intervention (first week of admission) , T2 = After intervention (4 weeks after discharge)
Secondary	Postnatal Depression	Edinburgh Postnatal Depression Scale usually be completed in less than 5 minutes. Responses are scored 0, 1, 2, or 3 according to increased severity of the symptom. The total score is determined by adding together the scores for each of the 10 items. Cut-off scores ranged from 9 to 13 points and with higher scores representing greater symptom severity.	Measure time point: After invervention(4 weeks after discharge)
Secondary	Parent satisfaction	Parent satisfaction measured by the Empowerment of Parents in the Intensive Care (EMPATHIC-30) scale.The EMPATHIC-30 consist of 30 statement measuring parent satisfaction and experience. The scores of the statement are on a scale of 1-6 (from certainly yes to certainly no). Scores are presented in mean and SD values on statement level and domain level. Higher scores represent greater satisfaction.	Measure time point: After invervention(4 weeks after discharge)
Secondary	Length-of-stay in the NICU	The length-of-stay in the NICU will be collected.	Measure time point: After invervention(4 weeks after discharge)
Secondary	Hours of parental daily visitation and their activities	The number of hours of parental visitation and their activities will be collected.	Daily during intervention
Secondary	Weight gain during hospitalization	Weight at admission and weight at discharge will be collected.	T1 = at admission ,T2 = at discharge