Research AppraisalRandomised Controlled Trial

Implementation of a clinical decision support tool for postpartum depression: protocol for a prospective randomised clinical trial

BMJ openJoly, Rochelle, Gossey, Travis J, Daoud, Anna K et al.18 May 2026DOI

Clinical Snapshot

50CEBM
Evidence: ModerateRandomised Controlled Trial

PICO Framework

P — PopulationPregnant individuals and postpartum patients receiving care at Weill Cornell Medicine clinics
I — InterventionClinical decision support (CDS) tool for postpartum depression risk prediction and management
C — ComparatorUsual care without CDS tool
O — OutcomesPrimary: acceptability, appropriateness, and feasibility of CDS tool. Secondary: mental health service utilisation, EQ-5D quality of life scores, Edinburgh Postnatal Depression Scale scores, and perceived social support

Bottom Line

This protocol describes a cluster-randomised trial testing a clinical decision support tool for postpartum depression at Weill Cornell Medicine. While addressing the important problem of underdiagnosed perinatal mental health disorders, the protocol lacks sufficient methodological detail for comprehensive appraisal. The study design appropriately uses cluster randomisation to prevent contamination, but blinding is not feasible. Primary outcomes focus on implementation metrics (acceptability, appropriateness, feasibility) rather than clinical effectiveness, which is appropriate for a pilot study. The intervention leverages electronic health records for risk prediction, potentially offering scalable solutions for early identification and intervention. However, generalisability may be limited to well-resourced health systems with advanced EHR capabilities. The study addresses a significant gap in perinatal mental health care, where up to 20% of women experience mood disorders that often go undiagnosed. Success could inform broader implementation of technology-assisted screening and intervention strategies.

Evidence: Moderate

Key Findings

  • P Value: Not applicable - protocol paper

  • Effect Size: Not applicable - protocol paper

  • Primary Outcome: Acceptability, appropriateness, and feasibility of CDS tool (protocol stage - no results)

  • Nnt Or Sensitivity: Not specified in protocol

  • Confidence Interval: Not applicable - protocol paper

Clinical Application

Requires sophisticated EHR integration and clinician training; may be challenging in resource-limited settings Relevant to Australian maternity services using digital health records; aligns with National Perinatal Mental Health Guidelines and potential integration with My Health Record system Pregnant and postpartum women in tertiary care settings with electronic health record systems

Abstract

INTRODUCTION: Perinatal mood and anxiety disorders affect more than one in five pregnant individuals. Despite the large percentage of individuals impacted by mood disorders, they continue to remain underdiagnosed and undertreated. Recent interventions such as risk prediction modelling offer opportunities to predict patients at risk prior to symptom onset. Leveraging technology platforms such as electronic health records allow for timely diagnosis and intervention. To date, there are no established clinical decision support (CDS) tools. We hypothesise that subjects who use a CDS aid will find them acceptable, appropriate and feasible. METHODS AND ANALYSIS: We will conduct a pilot randomised clinical trial at three Weill Cornell Medicine clinics with randomisation at the clinician level. Patients in the control arm will receive usual care, while those in the intervention arm will receive CDS. The primary implementation outcomes are the acceptability, appropriateness and feasibility. The effectiveness outcomes are mental health service utilisation, EuroQol 5 Dimensions questionnaire (EQ-5D), Edinburgh Postnatal Depression Scale and social support measured by the perceived support scale. We hypothesise that stakeholders will find the CDS acceptable, and the intervention arm will have lower mental health service needs compared with control. ETHICS AND DISSEMINATION: This study has been approved by the Weill Cornell Medicine Internal Review Board. IRB Protocol# 23-07026254. TRIAL REGISTRATION NUMBER: NCT06818734.

References

  1. 1.Joly, R., Gossey, T. J., Daoud, A. K., & Zhang, Y. (2026). Implementation of a clinical decision support tool for postpartum depression: protocol for a prospective randomised clinical trial. BMJ Open. https://doi.org/10.1136/bmjopen-2025-114571
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