NCT06818734 · Weill Medical College of Cornell University
Implementation of a Clinical Decision Support Tool for Postpartum Depression
(CDS)
What this study is about
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).
View original scientific description
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).
Interventions
OTHER
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.
Primary outcome measures
Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT).
Time frame: 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
Appropriateness as measured by Appropriateness Measure (IAM).
Time frame: 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).
Time frame: 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
Time frame: one month and three month
Mental health service utilization includes presentations to ED or inpatient admission for mental health related reasons.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Brooklyn, New York
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations