An interventional study of Clinical Decision Support Tool in Postpartum Depression, sponsored by Weill Medical College of Cornell University. Recruiting at 4 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Supportive care
This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD).
The goal of this randomized clinical trial is to assess the implementation of a clinical decision support (CDS) tool. The tool is designed to assist providers in managing patients at risk of developing of postpartum depression.
Investigators hypothesize that this tool will be acceptable and feasible for use and improve the use of mental health services for postpartum depression.
Patients in the control arm will receive usual care, while those in the intervention arm will receive CDS.
Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Clinicians in the intervention arm will refer patients based on the CDS.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's planned enrollment of 160 is above the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinician eligibility:
Clinicians in the intervention arm will refer patients based on the CDS.The CDS will alert clinicians only if patients have high risk of developing PPD, and provide clinicians with risk score, risk factors, and anticipatory actions with an order set to assist with ordering. Clinicians will make the ultimate clinical judgement after receiving CDS aid, including taking no actions towards PPD prevention. Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions.
Other: Clinical Decision Support Tool
The CDS will alert clinicians only if patients have high risk of developing PPD. Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions.
Other: Clinical Decision Support Tool
The CDS in and AI algorithm that will alert clinicians only if patients have high risk of developing PPD, and provide clinicians with risk score, risk factors, and anticipatory actions with an order set to assist with ordering. Clinicians will make the ultimate clinical judgement after receiving CDS aid, including taking no actions towards PPD prevention. Clinicians will manage patients per usual care, including initiating PPD prevention such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Clinicians in the intervention arm will refer patients based on the CDS.
Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT).
UTAUT has five constructs: performance expectation, effort expectation, social influence, facilitating conditions, and behavioral intention. The performance expectation construct in UTAUT is the CDS's ability to identify patients at risk of PPD that clinicians agree with. For each construct, responses will be sought in the 7-point Likert scale, setting 1 as 'strongly disagree', 2 as 'disagree', to 7 as 'strongly agree'. We will average the acceptability survey responses at the end of the study for each of the 5 UTAUT constructs to create a binary variable. An average score of 5 or above will be considered acceptance and non-acceptance otherwise
Time frame: One month after initiation of tool use and three months after use.
Appropriateness as measured by Appropriateness Measure (IAM).
IAM is a 4-item measure to assess the appropriateness of the intervention, respectively, with excellent usability. IAM is to be answered by participants in 5-point response scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree.
Time frame: One month after initiation of tool use and three months after use.
Feasibility as measured by Feasibility of Intervention Measure (FIM).
FIM is a 4-item measure to assess the feasibility of the intervention, respectively, with excellent usability. FIM is to be answered by participants in 5-point response scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree.
Time frame: One month after initiation of tool use and three months after use.
Mental Health service utilization as measured by number of mental health visits
Mental health service utilization includes presentations to ED or inpatient admission for mental health related reasons.
Time frame: one month and three month
Plan to share: Yes — The study protocol with the statistical analysis plan will be available following publication.
Supporting information: Study protocol, Sap, Icf
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Weill Medical College of Cornell University