CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
Virtual implementation protocol +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04919967
NCT04919967N/ACompleted

Online Training for Addressing Perinatal Depression

University of Massachusetts, Worcester·interventional·Posted Jun 9, 2021·Updated Jun 5, 2023

In Brief

A clinical study evaluating Virtual implementation protocol and e-learning toolkit for Mood Disorders and Anxiety Disorders. Completed, enrolled 140 participants across 1 site.

Detailed Summary

The study team is developing an e-learning course to train obstetric providers to address perinatal mood and anxiety disorders. The study team will conduct a formative evaluation of the e-learning course with 10 obstetric providers and revise/refine the course based on feedback and then conduct a summative evaluation using a cluster Randomized Controlled Trial (RCT). The three-arm cluster RCT will evaluate the effectiveness of 1) a virtual implementation protocol and e-learning/toolkit as compared to 2) e-learning/toolkit alone as compared to 3) treatment-as-usual. Effectiveness will be evaluated based on rates and quality of care for perinatal mood and anxiety disorders. Using 2:2:1 randomization, the study team will randomize a minimum of 15 to a maximum of 25 obstetric practices into three groups: (1) virtual implementation protocol plus e-learning/toolkit (n=6 to 10); (2) e-learning/toolkit alone (n=6 to 10); and (3) treatment-as-usual (n=3 to 5), which will yield a maximum of 1000 patient charts evaluated for care received from obstetric providers in the randomized practices. Charts from 40 patients per practice will be evaluated at 3 different time points.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 9, 2021
Enrollment StartAug 17, 2021
Primary CompletionMay 31, 2023
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.1 years ago

Interventions

Virtual implementation protocolbehavioral

Participants assigned to the virtual implementation protocol plus e-learning/toolkit group will take the e-learning course and also receive additional assistance through Virtual Implementation support. The Virtual Implementation strategy will be provided through virtual assistance, training, and toolkits to help obstetric practices integrate perinatal mental health and obstetric care and is delivered over 2-3 months and includes two 1-hour virtual implementation e-meetings. Implementation will occur within the practice where a champion is identified who establishes a quality improvement team to implement the practice's change plan to achieve their goals of addressing perinatal mental health conditions.

e-learning toolkitbehavioral

A toolkit given to obstetric care providers to enhance knowledge about and screening for perinatal mood and anxiety disorders. Participants assigned to the e-learning/toolkit alone group will take an e-learning course.This four-part online learning course aims to help obstetric care practitioners address perinatal mental health conditions such as depression, anxiety, PTSD and bipolar disorder.