Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences

Communication Clinical Trial

— ShAPE  

Official title:

Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences (The ShAPE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035640
• Other study ID #: 2022/CTU2/NEONAT
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: East Kent Hospitals University NHS Foundation Trust
• Contact: Daniel Keen
• Phone: 01233633331
• Email: danielkeen[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1 in 7 infants born in the United Kingdom will require treatment on a Neonatal unit to treat conditions, which vary in there level of severity. Treatments and interventions aimed at supporting the unwell neonate have associated risks and the evidence underpinning them can range from limited to substantial. There is a degree of uncertainty in Neonatology, which can be very stressful for parents and clinicians alike. Parents need to be supported by the clinical team in making many complicated clinical decisions, a skill that requires robust communication of risks, benefits and alternatives.

In 2019 the British Association of Perinatal Medicine released a framework of care advocating Shared Decision Making (SDM) as the optimal process for making clinical decisions on neonatal units. This model builds upon the "informed decision" models by putting a greater emphasis on involving parents in key decisions regarding the treatment of their babies medical condition. Evidence has demonstrated that SDM can improve parental satisfaction and reduce anxiety and the likelihood of feeling regret.

In order to support parents in the SDM process, clinicians need to be able to provide impartial information encompassing the proposed intervention, intended benefit, potential risks and alternatives. Whilst clinicians may have preconceptions on the information that they think should be provided, there is limited evidence in the literature of what are the most important concepts and themes that parents would expect to be conveyed during the SDM process.

ShAPE is a qualitative study that aims to

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parent of an Infant who, whilst on a neonatal unit, has received either; a transfusion of blood products, pharmacotherapy for persistent ductus arteriosus or corticosteroid therapy for chronic lung disease

Exclusion Criteria:

• The infant must have received the above treatments within the last 6 months prior to interview AND have been discharged from neonatal care for at least 4 weeks

Related Conditions & MeSH terms

• Communication

Intervention

Other:
• Interview
Participants will be engaged in a semi-structured interview.

Locations

Country	Name	City	State
United Kingdom	William Harvey Hospital	Ashford	Kent

Sponsors (1)

Lead Sponsor	Collaborator
East Kent Hospitals University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What are the main communicative, environmental and informative factors that support the facilitation of effective shared decision making on the neonatal unit? We aim to identify common themes that highlight aspects of the decision making process.	We aim to identify common themes that highlight aspects of the decision making process, which are the most important to parents.	Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.
Secondary	How does the quality of the shared decision process, experienced by parents on neonatal units in the UK, impact their level of satisfaction with the care their infant received?	We aim to identify common themes that highlight aspects of the decision making process, which influence parent satisfaction with the care received by their infant.	Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.