Communication Clinical Trial
— ALLIANCEOfficial title:
PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)
NCT number | NCT05265195 |
Other study ID # | B01416 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2022 |
Est. completion date | January 30, 2025 |
Background: There is significant variation in how clinicians currently present information to parents in periviable labour. Whilst each conversation with an individual set of parents will vary, the current level of variation is extreme. In collaborative discussions with the neonatal parental advisory group whilst designing this project, parents reported numerous experiences of significant variation in practice between clinicians in relation to periviable delivery management. There is a pressing issue of injustice here as the hospital or clinician the parent presents to in labour should not restrict their access to information and options for management at delivery. Parents should be empowered and engaged in making an individualised decision for their infant. However, this is not possible if information is not accurately presented to them. There is a gap in knowledge about what information is vital to include in periviable decision-making conversations between parents and healthcare professionals. This study aims to address this important gap in knowledge. Research Question: How can information sharing and decision-making conversations between healthcare professionals and parents prior to periviable birth be improved? Research Aims: 1. To gain understanding of current UK-wide antenatal optimisation practices for infants born at periviable gestations. 2. To establish an evidence-based conversational structure for pre-delivery periviable decision-making discussions, and a prioritised set of key discussion topics derived from parental consensus and clinician input. 3. To develop a set of parent and clinician derived recommendations to improve pre-delivery periviable decision-making conversations. Methodology: The study would progress along the following structure: 1. Literature Review of literature related to how and what information is presented to parents facing periviable labour by healthcare professionals. 2. Semi-structured interviews with clinicians and parents. The aim will be to determine an evidence-based set of priorities for each group and identify the differences in priorities and barriers that exist in communication between parents and clinicians. 3. National Evaluation of current periviable management practices across the UK. This will benchmark and expose variation in current practice. 4. Analysis of pre-delivery periviable conversations. 5. Focus groups with parents and clinicians to consolidate and stratify key priority themes for periviable decision-making conversations and assess acceptability of developing parent-centred periviable delivery resources. 6. Parent survey of parent-assessed long-term outcomes for periviable delivery survivors. Impact and Dissemination: This study will investigate the key topic areas and conversational structure of pre-delivery periviable decision-making conversations, aiming to provide evidence-based recommendations for improvement.
Status | Recruiting |
Enrollment | 340 |
Est. completion date | January 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Weeks to 24 Weeks |
Eligibility | Inclusion Criteria: - Infants born at periviable gestation. For this study periviability is defined as 22+0 - 24+6 weeks gestation. Exclusion Criteria: - Infants <22+0 or >24+6 weeks gestation. Specific inclusion and exclusion criteria apply to each phase of the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Manchester University NHS Foundation Trust | Manchester |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measures of current periviable delivery management: content of topics discussed in pre-delivery conversations and national rates of antenatal steroid and magnesium sulphate administration and place of birth. | 3 years |
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