PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)

NCT05265195 | Unknown

• 1 other identifier: B01416
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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. 1.To gain understanding of current UK-wide antenatal optimisation practices for infants born at periviable gestations.
2. 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. 3.To develop a set of parent and clinician derived recommendations to improve pre-delivery periviable decision-making conversations.
4. 4.Literature Review of literature related to how and what information is presented to parents facing periviable labour by healthcare professionals.
5. 5.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.
6. 6.National Evaluation of current periviable management practices across the UK. This will benchmark and expose variation in current practice.
7. 7.Analysis of pre-delivery periviable conversations.
8. 8.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.
9. 9.Parent survey of parent-assessed long-term outcomes for periviable delivery survivors.

Conditions

Periviable Infants; Extreme Prematurity; Communication

Keywords

Periviable Infant; Extreme Prematurity; Delivery Room Management; Communication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Semi-structured Interviews

Interviews will be conducted with parents and clinicians regarding their experiences of periviable counselling conversations. The interviews aim to identify key priorities and topic themes for the pre-delivery conversation for both parents and the clinicians, as these are hypothesised to differ between the groups. * Thematic analysis of transcribed semi-structured interviews with 20 parents and 20 clinicians. * The recruited parents will encompass a mixture of parent experiences: those with a surviving periviable child, parents whose baby died in delivery room and parents whose baby died in the neonatal unit.

Other: Mixed Methods study

National evaluation of current periviable management practices across the UK.

Review of periviable deliveries and antenatal management practices in the United Kingdom for infants where the decision is for active care at delivery.

Other: Mixed Methods study

Recording and thematic analysis of periviable decision-making conversations

* Recruiting parents who have presented in periviable labour to Manchester Foundation Trust sites. * Aiming to audio record 20 conversations discussing management options and potential outcomes between healthcare professionals and parents. * Thematic analysis will be undertake to determine key topics and priorities for parents and clinicians (these may well differ), time taken to discuss each topic, order topics presented, management options offered or requested, and discussion of comfort care.

Other: Mixed Methods study

Comparison of recorded and simulated periviable decision-making conversations

* Recruit 20 senior clinicians from mixture of obstetric and neonatal specialities. * Clinician will participate in a standardised simulated discussion with two parents (played by actors) who have presented in periviable labour. * Simulated conversations will be audio recorded and transcribed. * Analysis will be performed for structure and topics included in this simulated conversation. Comparison will be undertaken comparing the conversational architecture of the simulated conversations with the recorded real conversations (recorded in the above phase of this study).

Other: Mixed Methods study

Focus Groups with parents and clinicians

* Parent focus groups to consolidate and stratify key priority themes for periviable counselling and development of parent resources. * Clinician focus groups to discuss experiences with training in this area and preferences for future training methods/resources. * Parents will be recruited from parental advisory groups and local baby groups. * Aiming to run 5x focus groups with maximum 8 participants in each group.

Other: Mixed Methods study

Parental survey of long-term outcomes

* Survey will be distributed to all parents of surviving periviable deliveries at St Mary's Manchester over the last 2 - 10 years. * Parents will be asked to complete the survey at home giving their views on their child's strengths, difficulties, development and social interactions. * The survey also asks parents for their views on what they remember they were told before they delivered and, in light of their experiences, what would they recommend clinicians include in pre-delivery periviable conversations with future parents. * The survey will be sent to all eligible parents, which equates to 220 surviving infants. All returned surveys will be analysed.

Other: Mixed Methods study

Interventions

Mixed Methods study OTHER

Mixed Methods study

Comparison of recorded and simulated periviable decision-making conversations; Focus Groups with parents and clinicians; National evaluation of current periviable management practices across the UK.; Parental survey of long-term outcomes; Recording and thematic analysis of periviable decision-making conversations; Semi-structured Interviews

Eligibility Criteria

• Age: 22 Weeks - 24 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Infants born at periviable gestation. For this study periviability is defined as 22+0 - 24+6 weeks gestation.

You may not qualify if:

• Infants \<22+0 or \>24+6 weeks gestation.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jennifer Peterson, MBChB

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajit Mahaveer, MBBS

CONTACT

0161 701 2700; ajit.mahaveer@mft.nhs.uk

Karen Dockery

CONTACT

0161 701 2700; karen.dockery@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 3, 2022
• Study Start: May 31, 2022
• Primary Completion: September 30, 2024
• Study Completion: January 30, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)