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

NCT ID: NCT06035640

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Communication

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Interview

Participants will be engaged in a semi-structured interview.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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East Kent Hospitals University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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William Harvey Hospital

Ashford, Kent, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Daniel Keen

Role: CONTACT

01233633331

Vimal Vasu

Role: CONTACT

01233633331

Facility Contacts

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Daniel Keen

Role: primary

01233633331

Vimal Vasu

Role: backup

01233633331

Other Identifiers

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2022/CTU2/NEONAT

Identifier Type: -

Identifier Source: org_study_id

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