Clinical trial NCT05265195: PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)
Official title: PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Periviable Infants
Extreme Prematurity
Communication
Keywords: Periviable Infant
Extreme Prematurity
Delivery Room Management
Communication
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-03-03
Enrollment: 340
Sex: ALL
Minimum age (years): 22
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit a mixture of participants at various stages of the study:

* Parents who have experienced a periviable labour,
* Clinicians (Obstetricians, Midwives and Neonatologists) with experience of managing periviable deliveries.

Brief summary: 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.

Detailed description: 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.

Research Objectives:

1. To benchmark current UK-wide antenatal optimisation intervention rates for periviable infants where active care has been deemed appropriate.
2. To record and perform thematic analysis of periviable decision-making conversations between parents and healthcare professionals.
3. To determine, then consolidate and stratify, key priority themes for periviable decision-making conversations using parent and clinician derived recommendations and avenues for dissemination.

Research Plan

1. Literature Review: Meta-synthesis of literature related to current pre-delivery periviable decision-making conversations and frameworks.
2. Semi-structured interviews:

   Aim: This study phase will 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. Semi-structured interviews will be conducted with 20 parents who have delivered a periviable baby and have experienced a range of outcomes after birth. There will also be interviews with 20 clinicians (equal split between obstetricians and neonatologists). Thematic analysis of the transcribed interviews will be performed to determine similarities and differences in parent and clinician experiences and priorities during pre-delivery periviable decision-making conversations.
3. National evaluation of current periviable management practices across the UK. Aim: This study phase will benchmark current periviable practices across the UK, evaluating the extent to which antenatal optimisation interventions (such as antenatal steroids) are utilised for periviable infants where active care was instigated after birth.
4. Recording and thematic analysis of periviable decision-making conversations. Aim: This study phase would involve recording real pre-delivery periviable decision-making conversations between clinicians and parents and analysing these for topics discussed, relative time spent on each topic and which management options at delivery were offered. Parents would be invited to participate in a follow-up interview 6 months later to evaluate if the pre-delivery conversation prepared them for the events that followed over their neonatal journey. This would aid evaluation of which conversations were helpful to parents and the structure of those helpful conversations could be used to inform better practice in the future.
5. Parent focus groups to consolidate and stratify key priority themes for periviable decision-making conversation and development of parent resources.

   Aim: This study phase will produce an evidence-based and parent-derived consensus of essential and desirable topic themes for inclusion in pre-delivery periviable decision-making conversations. These defined topic areas will provide a basis for future development of healthcare professional training curricula and the development of a parent information resource about periviable birth.
6. Parent survey of parent-assessed long-term outcomes for periviable delivery survivors.

Outcome:

This study will result in a set of evidence-based, prioritised topics for inclusion in periviable discussions between healthcare professional and parent. The study will also conclude with a set of recommendations for how to improve periviable discussion practices. The study results can be used as an evidence-basis to inform policy around periviable birth discussions and to develop clinician education curricula focused on translating the study results into improved everyday clinical practice.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Jennifer Peterson, MBChB
role: PRINCIPAL_INVESTIGATOR
References: