Implementation of a Clinical Decision Support Tool for Postpartum Depression

NCT ID: NCT06818734

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention: CDS support , clinician

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.

Group Type EXPERIMENTAL

Clinical Decision Support Tool

Intervention Type 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.

No intervention: Patients

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention: Patients

Group Type EXPERIMENTAL

Clinical Decision Support Tool

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yiye Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Center for Community Health: 515 6th street (3rd floor)

Brooklyn, New York, United States

Site Status

Ob GYN Lower Manhattan 156 William street, New York City

New York, New York, United States

Site Status

Weill Cornell Medicine- Women's Health practice 505 East 70th street, New York City

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Rochelle Joly, MD

Role: CONTACT

646-962-4222

Facility Contacts

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Tracy Grossman, MD

Role: primary

Jessica Miller

Role: backup

718-499-2273

Szilvia Nagy, MD

Role: primary

Rochelle Joly, MD

Role: primary

References

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Krause N, Borawski-Clark E. Social class differences in social support among older adults. Gerontologist. 1995 Aug;35(4):498-508. doi: 10.1093/geront/35.4.498.

Reference Type BACKGROUND
PMID: 7557520 (View on PubMed)

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

Reference Type BACKGROUND
PMID: 11491192 (View on PubMed)

Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

Zhang Y, Wang S, Hermann A, Joly R, Pathak J. Development and validation of a machine learning algorithm for predicting the risk of postpartum depression among pregnant women. J Affect Disord. 2021 Jan 15;279:1-8. doi: 10.1016/j.jad.2020.09.113. Epub 2020 Sep 30.

Reference Type BACKGROUND
PMID: 33035748 (View on PubMed)

Wang S, Pathak J, Zhang Y. Using Electronic Health Records and Machine Learning to Predict Postpartum Depression. Stud Health Technol Inform. 2019 Aug 21;264:888-892. doi: 10.3233/SHTI190351.

Reference Type BACKGROUND
PMID: 31438052 (View on PubMed)

Venkatesh KK, Nadel H, Blewett D, Freeman MP, Kaimal AJ, Riley LE. Implementation of universal screening for depression during pregnancy: feasibility and impact on obstetric care. Am J Obstet Gynecol. 2016 Oct;215(4):517.e1-8. doi: 10.1016/j.ajog.2016.05.024. Epub 2016 May 20.

Reference Type BACKGROUND
PMID: 27210067 (View on PubMed)

Dunkel Schetter C, Tanner L. Anxiety, depression and stress in pregnancy: implications for mothers, children, research, and practice. Curr Opin Psychiatry. 2012 Mar;25(2):141-8. doi: 10.1097/YCO.0b013e3283503680.

Reference Type BACKGROUND
PMID: 22262028 (View on PubMed)

Cox EQ, Sowa NA, Meltzer-Brody SE, Gaynes BN. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016 Sep;77(9):1189-1200. doi: 10.4088/JCP.15r10174.

Reference Type BACKGROUND
PMID: 27780317 (View on PubMed)

Werner E, Miller M, Osborne LM, Kuzava S, Monk C. Preventing postpartum depression: review and recommendations. Arch Womens Ment Health. 2015 Feb;18(1):41-60. doi: 10.1007/s00737-014-0475-y. Epub 2014 Nov 25.

Reference Type BACKGROUND
PMID: 25422150 (View on PubMed)

Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.

Reference Type BACKGROUND
PMID: 24314113 (View on PubMed)

Other Identifiers

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24-03027259

Identifier Type: -

Identifier Source: org_study_id

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