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NCT Number: NCT06818734

Implementation of a Clinical Decision Support Tool for Postpartum Depression

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).

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Community Health: 515 6th street (3rd floor), Brooklyn, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • being seen at one of participating clinics
  • pregnancy at 20 week gestation or more

Exclusion criteria

  • Does not speak inclusion
  • does not have internet access

Clinician eligibility:

  • If they manage patients in the three clinics as a board-certified OBGYN clinician.
  • No exclusion criteria apply for clinician based on their knowledge and experience in treating PPD

Treatment and study plan

Clinical Decision Support Tool

Other

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.

Primary outcomes

  1. Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT).

    Time frame: One month after initiation of tool use and three months after use.

    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

  2. Appropriateness as measured by Appropriateness Measure (IAM).

    Time frame: One month after initiation of tool use and three months after use.

    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.

  3. Feasibility as measured by Feasibility of Intervention Measure (FIM).

    Time frame: One month after initiation of tool use and three months after use.

    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.

  4. Mental Health service utilization as measured by number of mental health visits

    Time frame: one month and three month

    Mental health service utilization includes presentations to ED or inpatient admission for mental health related reasons.

Study contacts

Contact information is provided by the study sponsor or research team.

Rochelle Joly, MD

CONTACT

[email protected]

646-962-4222

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: CDS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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