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Completed

NCT Number: NCT06035640

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

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

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

William Harvey Hospital

Ashford, Kent, TN24 0LZ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Participants will be engaged in a semi-structured interview.

Primary outcomes

  1. 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.

    Time frame: 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.

    We aim to identify common themes that highlight aspects of the decision making process, which are the most important to parents.

Secondary outcomes

  1. 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?

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

East Kent Hospitals University NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: ShAPE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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