Clinical trial NCT06818734: Implementation of a Clinical Decision Support Tool for Postpartum Depression
Official title: Implementation of a Clinical Decision Support Tool for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Depression
Keywords: Clinical decision support tool
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT).
timeFrame: One month after initiation of tool use and three months after use.
measure: Appropriateness as measured by Appropriateness Measure (IAM).
timeFrame: One month after initiation of tool use and three months after use.
measure: Feasibility as measured by Feasibility of Intervention Measure (FIM).
timeFrame: One month after initiation of tool use and three months after use.
measure: Mental Health service utilization as measured by number of mental health visits
timeFrame: one month and three month
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Center for Community Health: 515 6th street (3rd floor)
state: New York
city: New York
country: United States
facility: Ob GYN Lower Manhattan 156 William street, New York City
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine- Women's Health practice 505 East 70th street, New York City
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Yiye Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
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