Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000941167
Ethics application status
Approved
Date submitted
7/03/2019
Date registered
5/07/2019
Date last updated
5/07/2019
Date data sharing statement initially provided
5/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Victorian Obstetric Anal Sphincter Injury (OASIS) Quality of Care Improvement Project: (QCIP) Organisational, Departmental and Patient-level factors contributing to variation in OASIS rates
Scientific title
Victorian Obstetric Anal Sphincter Injury (OASIS) Quality of Care Improvement Project: (QCIP) Organisational, Departmental and Patient-level factors contributing to variation in OASIS rates
Secondary ID [1] 297650 0
None
Universal Trial Number (UTN)
U1111-1229-6821
Trial acronym
Victorian OASIS QCIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstetric Anal Sphincter Injury 311924 0
Condition category
Condition code
Reproductive Health and Childbirth 310511 310511 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 313883 0
Diagnosis / Prognosis
Intervention code [2] 313884 0
Early Detection / Screening
Comparator / control treatment
Health services will be compared against one another. There is no control group.
Control group
Active

Outcomes
Primary outcome [1] 319368 0
The primary composite outcome is to assess the association between quality of care and obstetric anal sphincter injury (OASI) rates as assessed by the:following instruments:

- Quality Management System Index
- Quality Management Compliance Index
- Clinical Quality Implementation Index
- Specialised Expertise and Responsibility instrument
- Evidence based organisation of pathway instrument
- Patient safety strategies instrument
-Safety Attitudes Questionnaire
- Leadership Effectiveness Scale questionnaire
- Clinical Practice questionnaire
- Patient measures of safety questionnaire
- Childbirth education questionnaire
Timepoint [1] 319368 0
Questionnaires are administered to staff and by external assessors over a 6-8 week survey period
Patients are recruited at 35-37 weeks with surveys administered at recruitment and within 2 weeks postpartum.
Primary outcome [2] 319369 0
Determination of compliance with OASI clinical practice guidelnes through a clinical documentation audit.
Timepoint [2] 319369 0
Clinical documentation audit of random sample of births between 2017 and 18.
Primary outcome [3] 319370 0
Comparison of risk-adjusted incidence rates of OASIS between maternity units using data recorded in the Birthing Outcome System.
Timepoint [3] 319370 0
Clinical audit of births recorded in the Birthing Outcome System between 2013 and 2018
Secondary outcome [1] 367916 0
The completeness and variation in clinical documentation of perineal and OASI management and will be measured through an audit of medical records.
Timepoint [1] 367916 0
Retrospective clinical documentation audit of births from 2017 to 2018.
Secondary outcome [2] 372150 0
Women’s exposure to antenatal education and understanding of perineal injury risk.
This will be assessed using a childbirth education questionnaire, designed and piloted for this study, administered at the time of recruitment and postnatally.
Timepoint [2] 372150 0
At recruitment (37-40 weeks) and postnatally

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis
We plan to conduct a series of statistical analyses with the aim of answering our primary research questions. This will include descriptive, bivariate and multivariate analysis along with multilevel modelling.

Descriptive statistics will be used to summarise the spread, frequencies or distributions of the variables of interest in our study. Bivariate analysis, testing for associations between variables, will be carried out along with multivariate modelling. Multivariate modelling will take the form of a multilevel or hierarchical model in the first instance; with hospitals as the level two unit and departments as level one. This type of regression will adjust for both hospital and department level covariates. Subject to the results of this modelling, the levels may be changed to have individual patient outcomes as level one or alternatively a single level model utilised. By employing multilevel methods investigators will be able to identify the amount of variation in outcomes attributed to the hospital and department level, as well as what factors contribute to this variation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
180
Accrual to date
109
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13323 0
Frankston Hospital - Frankston
Recruitment hospital [2] 13324 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 13325 0
Casey Hospital - Berwick
Recruitment hospital [4] 13326 0
Dandenong Hospital - Dandenong
Recruitment hospital [5] 13327 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 13328 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 25923 0
3199 - Frankston
Recruitment postcode(s) [2] 25924 0
3168 - Clayton
Recruitment postcode(s) [3] 25925 0
3806 - Berwick
Recruitment postcode(s) [4] 25926 0
3175 - Dandenong
Recruitment postcode(s) [5] 25927 0
3128 - Box Hill
Recruitment postcode(s) [6] 25928 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 302179 0
Government body
Name [1] 302179 0
Australian Government Department of Health
Country [1] 302179 0
Australia
Primary sponsor type
University
Name
Monash Partners Acadeimic Health Science Centre
Address
Monash Centre for Health Research and Implementation (MCHRI) building
43-51 Kanooka Grove
Clayton VIC 3168
Locked Bag 29
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 302021 0
University
Name [1] 302021 0
Monash University
Address [1] 302021 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country [1] 302021 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302861 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302861 0
Monash Research Office
26 Sports Walk,
Monash University
Wellington Road
Clayton VIC 3800
Ethics committee country [1] 302861 0
Australia
Date submitted for ethics approval [1] 302861 0
30/11/2017
Approval date [1] 302861 0
22/02/2018
Ethics approval number [1] 302861 0
RES-18-0000-039A

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58362 0
Prof Sue Evans
Address 58362 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 58362 0
Australia
Phone 58362 0
+61 3 9903 0017
Fax 58362 0
+61 3 9903 0556
Email 58362 0
[email protected]
Contact person for public queries
Name 58363 0
Dr Oliver Daly
Address 58363 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 58363 0
Australia
Phone 58363 0
+61 3 8345 1333
Fax 58363 0
+61 3 9903 0556
Email 58363 0
[email protected]
Contact person for scientific queries
Name 58364 0
Dr Oliver Daly
Address 58364 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 58364 0
Australia
Phone 58364 0
+61 3 8345 1333
Fax 58364 0
+61 3 9903 0556
Email 58364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics not provided for sharing sensitive participant and hospital data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.