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

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ClinicalTrials.gov Identifier: NCT06035640
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
East Kent Hospitals University NHS Foundation Trust

Study Description
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Brief 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


Condition or disease Intervention/treatment
Communication Other: Interview

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences (The ShAPE Study)
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026
Groups and Cohorts
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Intervention Details:
  • Other: Interview
    Participants will be engaged in a semi-structured interview.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will recruit parents of infants who have received care on a Neonatal Unit within the past 2years. Given the nature of interventions being studied, these are most likely to be (but not limited to) premature infants.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035640


Contacts
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Contact: Daniel Keen 01233633331 danielkeen@nhs.net
Contact: Vimal Vasu 01233633331 vimal.vasu@nhs.net

Locations
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United Kingdom
William Harvey Hospital Recruiting
Ashford, Kent, United Kingdom, TN24 0LZ
Contact: Daniel Keen    01233633331    danielkeen@nhs.net   
Contact: Vimal Vasu    01233633331    vimal.vasu@nhs.net   
Sponsors and Collaborators
East Kent Hospitals University NHS Foundation Trust
More Information
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Responsible Party: East Kent Hospitals University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT06035640    
Other Study ID Numbers: 2022/CTU2/NEONAT
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by East Kent Hospitals University NHS Foundation Trust:
Neonatal Care
Shared Decision Making