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Trial registered on ANZCTR


Registration number
ACTRN12617000932369
Ethics application status
Approved
Date submitted
2/06/2017
Date registered
27/06/2017
Date last updated
27/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PIPA Project: examining the effectiveness of integrated psychosocial assessment during pregnancy
Scientific title
The PIPA Project: a comparative effectiveness trial of integrated psychosocial assessment in the perinatal period
Secondary ID [1] 291292 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PIPA
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Antenatal depression 302254 0
Antenatal anxiety 303186 0
Antenatal psychosocial health 302253 0
Condition category
Condition code
Reproductive Health and Childbirth 301847 301847 0 0
Antenatal care
Mental Health 301848 301848 0 0
Depression
Mental Health 301849 301849 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PIPA model of care: Women who attend the participating site (a large maternity hospital in metropolitan Sydney) for their initial midwife-led antenatal booking-in visit during the Intervention arm of the study (the last 12 months of the trial) will receive the PIPA model of integrated psychosocial care.

The PIPA model of care comprises three key electronic elements:
1) Administration of the Antenatal Risk Questionnaire-Revised (ANRQ-R) questionnaire (covering a range of known psychosocial risk factors) and the EPDS (including four additional questions to aid more guided exploration of recent thoughts of self-harm among women who endorse EPDS question 10, by the midwife) with responses recorded in a state-wide administrative data platform (eMaternity);
2) A computer-based clinician decision-support algorithm, which generates the woman’s psychosocial risk profile and self-harm risk scores (based on the ANRQ-R and EPDS), summarises the presence/combinations of identified risk factors and articulates six psychosocial risk levels, ranging from No Risk to High Risk;
3) Immediate referral prompts for the midwife conducting the assessment: these clinician prompts are embedded within a local folder in eMaternity, and are tailored to the woman’s psychosocial risk profile and available hospital-based support services.

The ANRQ-R is a revised version of the validated ANRQ (Austin et al 2013). It adheres to the recommendations of Australian national perinatal mental health guidelines and the New South Wales SAFE START guidelines, in terms of the minimum core set of psychosocial variables that are assessed.

It is anticipated that the time required to complete the EPDS and ANRQ-R will be in line with the time required to complete the corresponding questions in Standard Care (EPDS and SAFE START psychosocial questions). Hence, no additional time has been allocated to the usual booking-in appointment during the Intervention arm of the study.
Intervention code [1] 297313 0
Early detection / Screening
Comparator / control treatment
Standard Care: Women who attend the participating site for their initial midwife-led antenatal booking-in visit during the first 12 months of the study will receive the care as usual (the NSW Health SAFE START model of care).

This model of care includes completion of the series of psychosocial questions provided in the SAFE START guidelines as well as the paper-based Edinburgh Perinatal Depression Scale (EPDS), which asks about symptoms of depression occurring in the previous seven days.
Control group
Active

Outcomes
Primary outcome [1] 301273 0
Primary Outcome (2) Clinical effectiveness: the proportion of ‘correct’ and ‘incorrect’ referrals from the initial psychosocial assessment in each model of care, measured by the consensus opinion of senior psychosocial clinicians at the weekly ‘triage’ and MCD meetings.

For the purposes of the PIPA Project, the following definitions will apply:

‘Correct’ referral: a clinically appropriate referral made by the midwife, as determined by the consensus opinion of senior psychosocial clinicians at the weekly ‘triage’ and Multidisciplinary Case Discussion (MCD) meetings.

‘Incorrect’ referral: a clinically inappropriate referral made by the midwife, as determined by the consensus opinion of senior psychosocial clinicians at the weekly ‘triage’ and MCD meetings.
Timepoint [1] 301273 0
Primary Outcome (2) Clinical effectiveness: Antenatal 'booking-in' appointment (approx. 12-16 weeks gestation)
Primary outcome [2] 301271 0
Primary Outcome (1) Clinical effectiveness: the proportion of women identified as ‘at risk’ and referred by the midwife conducting the initial psychosocial assessment to various on-site referral pathways, stratified by comparable levels of risk in each model of care, measured using data extracted from eMaternity (formerly ObstetriX).
Timepoint [2] 301271 0
Primary Outcome (1) Clinical effectiveness: Antenatal 'booking-in' appointment (approx. 12-16 weeks gestation)
Primary outcome [3] 301275 0
Primary Outcome (3) Cost-effectiveness: the cost per ‘correct’ and ‘incorrect’ referral made at the initial psychosocial assessment for each model of care, measured using data extracted from eMaternity (formerly ObstetriX) and activity-based costing methods.
Timepoint [3] 301275 0
Primary Outcome (3) Cost-effectiveness: Antenatal 'booking-in' appointment (approx. 12-16 weeks gestation) and activity-based data collection at the weekly triage and MCD meetings, throughout each 12 month phase.
Secondary outcome [1] 336308 0
Secondary Outcome (1) Psychometric properties of screening tools: the sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios of the EPDS, ‘Whooley’ depression questions, the Generalised Anxiety Disorder Scale [GAD-7] and its short form [GAD-2], and the Matthey Generic Mood Questionnaire (MGMQ) when used during pregnancy, measured using the Mini International Neuropsychiatric Interview v6.0 (MINI) as the gold standard (mood and anxiety disorder modules only).
Timepoint [1] 336308 0
Secondary Outcome (1) Psychometric properties of screening tools: 2 weeks after the initial booking-in appointment.
Secondary outcome [2] 332176 0
Primary Outcome (4) Cost-effectiveness: the incremental cost per ‘correct’ referral made and the incremental cost per ‘incorrect’ referral averted by the PIPA model compared to standard care, measured using data extracted from eMaternity (formerly ObstetriX) and activity-based costing methods.

Timepoint [2] 332176 0
Primary Outcome (4) Cost-effectiveness: Antenatal 'booking-in' appointment (approx. 12-16 weeks gestation) and activity-based data collection at the weekly triage and MCD meetings, throughout each 12 month phase.
Secondary outcome [3] 336023 0
Primary Outcome (7) Health care provider perspectives: the acceptability and perceived benefit of each model of care from the perspective of health care provider, measured using a survey, semi-structured interviews and focus groups (survey questions, and interview and focus group question guides, developed for this project).
Timepoint [3] 336023 0
Primary Outcome (7) Health care provider perspectives: survey or semi-structured interview completed once only, in the final six months of the data collection period for each model of care (subject to health care provider availability); focus groups convened approx. 3 months after the implementation of the PIPA model.
Secondary outcome [4] 336021 0
Primary Outcome (5) Cost-effectiveness: the budgetary implications of implementing the PIPA model at the participating site, based on number of women screened, measured using data extracted from eMaternity (formerly ObstetriX) and activity-based costing methods.
Timepoint [4] 336021 0
Primary Outcome (5) Cost-effectiveness: Antenatal 'booking-in' appointment (approx. 12-16 weeks gestation) and activity-based data collection at the weekly triage and MCD meetings, throughout each 12 month phase.
Secondary outcome [5] 336022 0
Primary Outcome (6) Consumer perspectives: the acceptability and perceived benefit of each model of care from the perspective of pregnant women, measured using a survey developed for this project.
Timepoint [5] 336022 0
Primary Outcome (6) Consumer perspectives: 2 weeks after the initial booking-in appointment

Eligibility
Key inclusion criteria
Women: Pregnant and attending the participating site for antenatal care.
Healthcare providers: responsible for conducting the psychosocial assessment or providing emotional and mental health care for women who attend the participating site for antenatal care.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a comparative-effectiveness study which will compare Standard Care to an alternative model of integrated psychosocial assessment (the PIPA model) sequentially over a 36 month period.

Women who attend the participating site for their antenatal 'booking-in' visit during the first 12 months of the trial will receive Standard Care.

Women who attend the participating site for their antenatal 'booking-in' visit during the last 12 months of the trial will receive the alternative PIPA model of care.

There will be an interval of approximately 12 months to allow for the implementation of a new state-wide administrative database, which will incorporate the PIPA model, and one month of staff training for the PIPA model. During this time, women attending the hospital will continue to receive Standard Care, though no study data will be collected.

Study definitions

For the purposes of the PIPA Project, the following definitions will apply:

Referral: will be defined as the initial referral made by the midwife to one or more of the on-site support options. NOTE: Referrals to services external to the participating site are outside the scope of data collection for the current project, as are referrals made at later antenatal appointments (i.e., not the initial booking-in appointment).

‘Correct’ referral: a clinically appropriate referral made by the midwife, as determined by the consensus opinion of senior psychosocial clinicians at the weekly ‘triage’ and Multidisciplinary Case Discussion (MCD) meetings.

‘Incorrect’ referral: a clinically inappropriate referral made by the midwife, as determined by the consensus opinion of senior psychosocial clinicians at the weekly ‘triage’ and MCD meetings.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary aims will be evaluated using a between-groups design. Clinical effectiveness and Consumer Perspectives will be analysed using chi-square and independent-samples t-tests (or Mann Whitney U tests, as appropriate). Chi-square analysis of subgroups of women based on risk status may also be explored. Clinically significant differences between the two models will be based upon obtaining at least medium effect sizes or absolute percentage differences of at least 15%. Focus group data will be analysed using inductive thematic content analysis consistent with an interpretive descriptive approach.

The cost-effectiveness analysis will be from the healthcare system perspective. The incremental costs and effects of Standard Care compared to the alternative PIPA model will be expressed as the incremental cost-effectiveness ratio (ICER). The ICER per ‘correct’ referral made and per ‘incorrect’ referral averted will be estimated using mean costs and effects and represented with 95% confidence intervals for the ICERs. Costs will be based in activity-based costing methods and will be presented in constant Australian dollars (AUD).

The secondary aims will be evaluated using a within group design. Receiver operator curve analyses will be conducted to calculate the area under the curve and sensitivity, specificity, positive and negative predictive values and positive and negative likelihood ratios negative likelihood ratios of each measure, using the M.I.N.I. as the gold standard (mood and anxiety disorder modules only).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
14/07/2018
Actual
Sample size
Target
1300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7974 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 15947 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 295759 0
Other Collaborative groups
Name [1] 295759 0
St John of God Health Care
Country [1] 295759 0
Australia
Primary sponsor type
Hospital
Name
Perinatal & Women's Mental Health Unit, St John of God Burwood Hospital
Address
13 Grantham St
Burwood
N.S.W. 2134
Country
Australia
Secondary sponsor category [1] 294603 0
None
Name [1] 294603 0
Address [1] 294603 0
Country [1] 294603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297057 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 297057 0
Ethics committee country [1] 297057 0
Australia
Date submitted for ethics approval [1] 297057 0
23/06/2014
Approval date [1] 297057 0
23/10/2014
Ethics approval number [1] 297057 0
14/117

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72834 0
Prof Marie-Paule Austin
Address 72834 0
Perinatal & Women's Mental Health Unit
St John of God Burwood Hospital
13 Grantham St
Burwood
N.S.W. 2134
Country 72834 0
Australia
Phone 72834 0
+61 2 9715 9224
Fax 72834 0
Email 72834 0
m.austin@unsw.edu.au
Contact person for public queries
Name 72835 0
Nicole Reilly
Address 72835 0
Perinatal & Women's Mental Health Unit
St John of God Burwood Hospital
13 Grantham St
Burwood
N.S.W. 2134
Country 72835 0
Australia
Phone 72835 0
+61 2 9715 9224
Fax 72835 0
Email 72835 0
n.reilly@unsw.edu.au
Contact person for scientific queries
Name 72836 0
Nicole Reilly
Address 72836 0
Perinatal & Women's Mental Health Unit
St John of God Burwood Hospital
13 Grantham St
Burwood
N.S.W. 2134
Country 72836 0
Australia
Phone 72836 0
+61 2 9715 9224
Fax 72836 0
Email 72836 0
n.reilly@unsw.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a comparative effectiveness trial of two models of perinatal integrated psychosocial assessment: The PIPA project.2017https://dx.doi.org/10.1186/s12884-017-1354-0
N.B. These documents automatically identified may not have been verified by the study sponsor.