None listed
Conditions
Brief summary
An observational cross-sectional multi-centre multi-level study design evaluating the organisational and departmental quality management, clinical management processes, and patient outcomes associated with perineal and obstetric anal sphincter injury (OASIS) trauma, at three health services across six maternity units, assessing: 1. Quality of care governance, practice and culture for each maternity unit organisation, using a set of modified Quality Management System and departmental pathway assessment instruments. 2. Clinical treatment processes by auditing medical records of all women diagnosed with OASIS, 5% of women having vaginal deliveries not diagnosed with OASIS and those undertaking the (Patient Measures of Safety) PMOS will be conducted comparing content and quality of clinical documentation and management against the institution’s evidence-based guidelines including conduct of a comprehensive perineal assessment. 3. Safety culture and clinical leadership, and pathways using a staff survey 4. Raw and risk-adjusted OASIS incidence rates, analysing perinatal data routinely collected through the Birthing Outcome System, compared between the six maternity units. 5. Women’s understanding of perineal injury risk and perception of safety using an antenatal and postnatal patient survey
Interventions
The rate and outcomes of Obstetric Anal Sphincter injury will be observed in relation to the quality of care measures.
Both patients and staff will be participants. Prospectively both participants groups will be complete de-identified questionnaires. Staff complete a one-off questionnaire with patients completing an antenatal and postnatal questionnaire. Retrospectively, de-identified patient data and clinical care information will be collected from medical records from 2017/18 in each recruitm
The rate and outcomes of Obstetric Anal Sphincter injury will be observed in relation to the quality of care measures. Both patients and staff will be participants. Prospectively both participants groups will be complete de-identified questionnaires. Staff complete a one-off questionnaire with patients completing an antenatal and postnatal questionnaire. Retrospectively, de-identified patient data and clinical care information will be collected from medical records from 2017/18 in each recruitment hospital site/ward.
Sponsors
Monash Partners Acadeimic Health Science Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For each of the participant groups, each participant must meet all of the following criteria to be enrolled in this study: Quality manager - formally appointed Quality Manager, or another professional in charge of managing aspects of quality, in the maternity unit. Clinicians o Any midwives or doctors who perform clinical duties on the labour ward/birth suite at least once per week during the survey period. Patients o For the clinical outcomes audit: Having a live birth vaginally at the respective maternity unit between February 20137- February 2018, identified through the Birthing Outcomes System (BOS). o For the clinical management audit: Having a live birth vaginally at the respective maternity unit between February 2017- February 2018 with a gestational age 37-42 weeks, singleton pregnancy, and cephalic presentation. o For the Childbirth Education and Patient Measures of Organisational Safety (PMOS) questionnaire. Aged 18 or over, gestational age at birth 37-42 weeks, primigravida, singleton pregnancy with a cephalic presentation.
Exclusion criteria
For those activities requiring individual feedback, participants who do not meet the inclusion criteria, and/or for the questionnaires are non-English speaking and requiring an interpreter, without the capacity to give informed consent (suffering from dementia, delirium or confusion), or suffering from physical or emotional distress (e.g. in pain, having recently received bad news), will be excluded from the study.
Outcome results
None listed