Clinical Decision Support Tool for Postpartum Depression

(CDS Trial)

Not yet recruiting at 2 trial locations

Overseen By Rochelle Joly, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: No internet access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool in electronic health records designed to help doctors identify women at risk of developing postpartum depression (PPD) after childbirth. The goal is to determine if this Clinical Decision Support Tool can alert doctors to take early preventive steps against PPD. The trial includes two groups: one where doctors use the tool to guide their actions, and another where doctors provide usual care without the tool. The trial seeks pregnant women who are at least 20 weeks along and visiting certain clinics. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance postpartum care for future mothers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this clinical decision support tool is safe for use in detecting postpartum depression?

Research has shown that the Clinical Decision Support (CDS) Tool is safe for use in healthcare settings. This software program assists doctors by alerting them to patients who might be at risk of developing postpartum depression (PPD). As the CDS Tool is neither a medication nor a physical treatment, it does not directly affect patients physically.

The tool poses no risks to patients because it solely provides information to healthcare providers, aiding in better decision-making. In past uses, no reports of harm or negative effects have been linked to these digital support tools.

Overall, the CDS Tool is considered safe because it enhances the usual care process without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new Clinical Decision Support (CDS) tool designed to help clinicians identify and manage postpartum depression (PPD) risks early on. Unlike traditional approaches that might rely solely on clinical judgment or standard screening tools, this CDS tool provides clinicians with a risk score, specific risk factors, and suggested anticipatory actions. This targeted approach aims to enhance early intervention, potentially reducing the incidence or severity of PPD by offering timely, personalized support. By integrating into the clinician's workflow, the CDS tool could make it easier for healthcare providers to address PPD proactively, offering a more tailored approach than current standard practices.

What evidence suggests that this clinical decision support tool is effective for detecting postpartum depression?

Research has shown that special computer tools can help identify postpartum depression (PPD) by detecting those at higher risk. In this trial, one arm involves clinicians using a Clinical Decision Support (CDS) tool, integrated into electronic health records, to assist in identifying and managing patients at risk for PPD. These tools provide alerts, risk scores, and advice to clinicians. Studies have found that recognizing symptoms poses a significant challenge in diagnosing PPD, and these tools aim to help by raising awareness and understanding. Early results suggest that using these tools in healthcare settings helps identify at-risk patients, leading to timely care. This method may help healthcare providers manage and possibly prevent PPD by offering focused support and resources. ^{1 3 4 5 6}

Who Is on the Research Team?

Yiye Zhang, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals at least 20 weeks along, who are 18 years or older and visit one of the participating clinics. It's not for those who don't speak the language used in the study or lack internet access.

Inclusion Criteria

Being seen at one of the participating clinics

I am at least 20 weeks pregnant.

Exclusion Criteria

Does not speak inclusion

Does not have internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a clinical decision support tool to assist providers in managing patients at risk of developing postpartum depression

3 months

Ongoing monitoring through EHR

Follow-up

Participants are monitored for acceptability, appropriateness, and feasibility of the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Decision Support Tool

Trial Overview The study is testing a new tool within electronic health records designed to help healthcare providers identify patients at risk of postpartum depression before it develops.

How Is the Trial Designed?

Group I: Intervention: Patients Experimental Treatment 1 Intervention

Group II: Intervention: CDS support , clinician Experimental Treatment 1 Intervention

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 III: No intervention: Patients Active Control 1 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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Postmarketing safety evaluations of antidepressant drugs can benefit from data collected through systems like the FDA Adverse Event Reporting System and electronic medical records, which provide more extensive information than premarketing trials.

The study assesses the strengths and limitations of these data sources for pharmacovigilance, highlighting the need for consistent results and integration of evidence to improve drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients. Duan, R., Zhang, X., Du, J., et al.[2021]

The Assessment of Risk Tool (ART) developed by a New Zealand hospital significantly improved the identification of inpatients at high risk for adverse drug events (ADEs), leading to an increase in monthly medication reconciliations from 280 to 500 patients within 18 months of implementation.

During an 8-month period, the ART helped prioritize 765 high-risk patients for discharge services and successfully prevented 526 medication errors, including 174 that could have caused moderate to major harm, demonstrating its efficacy in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an electronic patient prioritization tool for clinical pharmacist interventions. Falconer, N., Nand, S., Liow, D., et al.[2022]

A practice-based training program for postpartum depression significantly improved diagnosis and treatment rates among mothers, with 34.5% of participants showing elevated depression scores, and those in the intervention group more likely to receive appropriate care.

Women in the intervention group reported lower levels of depressive symptoms at both 6 and 12 months postpartum, indicating that structured screening and management can lead to better long-term mental health outcomes for mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TRIPPD: a practice-based network effectiveness study of postpartum depression screening and management. Yawn, BP., Dietrich, AJ., Wollan, P., et al.[2021]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06818734?locStr=United+States&country=United+States&aggFilters=healthy%3Ay%2Cstatus%3Anot+rec+enr+unk&firstPost=2024-01-01_

Implementation of a Clinical Decision Support Tool for ... Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26669601/

Using clinical decision support as a means of ... A major barrier to the diagnosis of postpartum depression (PPD) includes symptom detection. The lack of awareness and understanding of PPD ...

4. trial.medpath.com trial.medpath.com/clinical-trial/1e97f9395d594ebf/nct06818734-clinical-decision-support-postpartum-depression

Implementation of a Clinical Decision Support Tool ... - MedPath This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at ris...

5. machaustralia.org machaustralia.org/projects/clinical-decision-support-integrated-with-e-screening-for-postnatal-depression/

Clinical Decision Support Integrated with e-Screening ... Postnatal depression screening is mainly conducted by time-poor Maternal & Child Health Nurses (MCHNs) who are not mental health specialists and receive limited ...

6. withpower.com withpower.com/trial/phase-depression-postpartum-6-2025-21236

Clinical Decision Support Tool for Postpartum Depression ... The CDS medical study, being run by Weill Medical College of Cornell University, needs participants to evaluate whether Clinical Decision Support Tool will ...