Development and validation of a machine learning algorithm for predicting the risk of postpartum depression among pregnant women.
Yiye Zhang, Shuojia Wang, Alison Hermann...
https://pubmed.ncbi.nlm.nih.gov/33035748/Actively Recruiting
Led by Weill Medical College of Cornell University · Updated on 2026-07-30
160
Participants Needed
4
Research Sites
N/A
Total Duration
This trial evaluates a clinical decision support CDS tool designed to help healthcare providers identify and manage patients at risk of developing postpartum depression PPD. The study aims to assess whether this tool is acceptable, feasible, and improves the use of mental health services for women during and after pregnancy. It is a randomized clinical trial involving pregnant women and is sponsored by Weill Medical College of Cornell University. Participants are divided into two groups one receiving usual care and the other receiving care assisted by the CDS tool. The CDS tool alerts clinicians only if patients are at high risk of PPD, providing risk scores, risk factors, and recommended actions including referrals and educational resources. Clinicians then decide how to manage care, which may include referrals to nutrition or behavioral health services or no action. The control group receives standard care without CDS alerts. During the study, participants and clinicians are monitored for the tools acceptability, appropriateness, and feasibility at one and three months after initiating its use. Researchers will track mental health service use by counting mental health visits within the same time frames. The study will last from July 2026 to December 2026, with outcomes measured via questionnaires and service usage data to understand if the CDS improves care for postpartum depression.
CONDITIONS
Implementation of a Clinical Decision Support Tool for Postpartum Depression
R
Rochelle Joly, MD
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Weill Medical College of Cornell University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Care with CDS Tool for Clinicians | Usual Care (No CDS Tool) |
|---|---|---|
| What it is | A digital CDS tool using AI algorithms alerts clinicians to patients with high risk for postpartum depression. It provides a risk score, highlights relevant risk factors, and suggests anticipatory actions with integrated order sets. Clinicians retain decision-making authority after receiving CDS suggestions. | Routine postpartum care where clinicians do not receive CDS alerts or risk stratification. Management follows clinic standards, including possible referrals and education, but is not influenced by AI-driven risk scores. |
| Role in trial | The investigational arm receiving CDS support aims to evaluate whether AI-driven risk alerts and management recommendations improve acceptability and feasibility in postpartum depression care. | Comparator arm representing usual care, used to assess the impact of CDS tool introduction compared to routine clinical management. |
| Important limitations | The success of the CDS tool depends on clinician adoption, integration into workflow, and accuracy of AI risk prediction. Outcomes may vary if clinicians disregard or override CDS alerts. CDS recommendations are not a substitute for clinical judgement and may be limited by available patient data. | Routine care may miss patients at high risk for postpartum depression if screening is inconsistent or if clinicians lack timely risk information. Access to behavioral resources and patient follow-up may be suboptimal without systematic alerts. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 3 months
Participants receive either usual care or care aided by the clinical decision support tool, which alerts clinicians if the patient is at high risk of postpartum depression and suggests management options.
Regular clinical visits as part of routine care
Duration - Up to 3 months after treatment begins
Researchers assess the acceptability, appropriateness, and feasibility of the tool and track use of mental health services at one and three months after starting the intervention.
1 to 2 follow-up assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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Lead Sponsor