RecruitingACTRN12617000932369

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


Sponsor

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

Enrollment

1,300 participants

Start Date

Jan 1, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new system for assessing the emotional and mental health of pregnant women at their antenatal (pregnancy) checkups. Many women experience depression, anxiety, or other emotional challenges during pregnancy, but these are often missed. The PIPA program uses a built-in electronic decision tool to help midwives and doctors know how to respond to a woman's emotional needs and connect her with the right support. The study aims to find out whether this approach is more effective and cost-efficient than standard care. You may be eligible if: - You are 16 years old or older - You are pregnant and receiving antenatal care at one of the participating hospitals - OR you are a healthcare provider responsible for doing psychosocial assessments or mental health care for pregnant women at a participating site You may NOT be eligible if: - There are no specific exclusion criteria for this study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Royal Hospital for Women - Randwick

NSW, Australia

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ACTRN12617000932369