Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences (ShAPE)
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| ClinicalTrials.gov Identifier: NCT06035640 |
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Recruitment Status :
Recruiting
First Posted : September 13, 2023
Last Update Posted : April 3, 2024
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| Tracking Information | |||||||||
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| First Submitted Date | February 15, 2023 | ||||||||
| First Posted Date | September 13, 2023 | ||||||||
| Last Update Posted Date | April 3, 2024 | ||||||||
| Actual Study Start Date | January 1, 2023 | ||||||||
| Estimated Primary Completion Date | January 2026 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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.
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences | ||||||||
| Official Title | Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences (The ShAPE Study) | ||||||||
| 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 |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | Communication | ||||||||
| Intervention | Other: Interview
Participants will be engaged in a semi-structured interview.
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
30 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 2026 | ||||||||
| Estimated Primary Completion Date | January 2026 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT06035640 | ||||||||
| Other Study ID Numbers | 2022/CTU2/NEONAT | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | East Kent Hospitals University NHS Foundation Trust | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | East Kent Hospitals University NHS Foundation Trust | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | East Kent Hospitals University NHS Foundation Trust | ||||||||
| Verification Date | April 2024 | ||||||||