Implementation of a Clinical Decision Support Tool for Postpartum Depression

Not Applicable

Not yet recruiting

• Conditions: Postpartum Depression

• Registration Number: NCT06818734
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-07-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Appropriateness as measured by Appropriateness Measure (IAM).	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.
Feasibility as measured by Feasibility of Intervention Measure (FIM).	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.
Mental Health service utilization as measured by number of mental health visits	one month and three month	Mental health service utilization includes presentations to ED or inpatient admission for mental health related reasons.
Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT).	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

Trial Locations

Locations (3)

Ob GYN Lower Manhattan 156 William street, New York City; 🇺🇸 New York, New York, United States

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

Weill Cornell Medicine- Women's Health practice 505 East 70th street, New York City; 🇺🇸 New York, New York, United States