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The PIPA Project: examining the effectiveness of integrated psychosocial assessment during pregnancy

The PIPA Project: a comparative effectiveness trial of integrated psychosocial assessment in the perinatal period

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000932369
Acronym
PIPA
Enrollment
1300
Registered
2017-06-27
Start date
2015-01-01
Completion date
2018-06-30
Last updated
2017-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Studies examining psychosocial and depression assessment programs in maternity settings have not adequately considered the context in which psychosocial assessment occurs or how broader components of integrated care, including clinician decision-making aids, may optimise program delivery and its cost-effectiveness. There is also limited evidence relating to the diagnostic accuracy of symptom-based screening measures used in this context. The Perinatal Integrated Psychosocial Assessment (PIPA) Project was developed to address these knowledge gaps. The PIPA Project will provide evidence relating to the clinical- and cost- effectiveness of psychosocial assessment integrated with electronic clinician decision making prompts, and referral options that are tailored to the woman’s psychosocial risk, in the maternity care setting. It will also address research recommendations from the Australian (2011) and NICE (2015) Clinical Practice Guidelines.

Interventions

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

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.

Sponsors

Perinatal & Women's Mental Health Unit, St John of God Burwood Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 9, 2026