Implementation of a Clinical Decision Support Tool for Postpartum Depression

NCT06818734 | Not Yet Recruiting

• 1 other identifier: 24-03027259
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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).

Conditions

Postpartum Depression

Keywords

Clinical decision support tool

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  one month and three month

Study Arms (3)

Intervention: CDS support , clinician

EXPERIMENTAL

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

No intervention: Patients

NO INTERVENTION

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.

Intervention: Patients

EXPERIMENTAL

Other: Clinical Decision Support Tool

Interventions

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.

Intervention: CDS support , clinician; Intervention: Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• does not have internet access
• Clinician eligibility:
• If they manage patients in the three clinics as a board-certified OBGYN clinician.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (3)

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

Brooklyn, New York, 11215, United States

Location

Ob GYN Lower Manhattan 156 William street, New York City

New York, New York, 10038, United States

Location

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

New York, New York, 10065, United States

Location

Related Publications (10)

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  PMID: 11491192 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

• 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.

  PMID: 33035748 BACKGROUND

• 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.

  PMID: 31438052 BACKGROUND

• 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.

  PMID: 27210067 BACKGROUND

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  PMID: 22262028 BACKGROUND

• 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.

  PMID: 27780317 BACKGROUND

• 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.

  PMID: 25422150 BACKGROUND

• 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.

  PMID: 24314113 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Yiye Zhang, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rochelle Joly, MD

CONTACT

646-962-4222; roj9069@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available once published.
• Access Criteria: Anyone who subscribes to the journal, or has access online will be able to review the data.

Locations

US (3)