NCT04919967

Online Training for Addressing Perinatal Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objective of this cluster RCT is to evaluate the effectiveness of adding an implementation protocol to the e-learning/toolkit in comparison to the e-learning/toolkit alone in comparison to treatment-as-usual among a maximum of 1000 patients receiving care from 15 - 25 obstetric practices regarding the rates and quality of care for perinatal mood and anxiety disorders. Using 2:2:1 randomization, we will randomize 15 - 25 obstetric practices into three groups: (1) virtual implementation protocol plus e-learning/toolkit (n=6 - 10); (2) e-learning/toolkit alone (n=6 - 10); and (3) treatment-as-usual (n=3 - 5). The study team will conduct a baseline practice and provider assessment which will inform restricted randomization based on existing approaches to screening for perinatal mood and anxiety disorders and the clinical care of perinatal women who screen positive. Pre- and post-intervention data will be obtained through individual provider surveys to evaluate perinatal mood and anxiety disorder care practices, knowledge, and attitudes. Rates and quality of care for perinatal mood and anxiety disorders will be assessed pre- and post- using our established approach and tool to evaluate practice readiness to evaluate and address perinatal mood and anxiety disorders (Masters et al., submitted). Our tool quantifies the extent to which assessment, treatment, monitoring, and transfer of care for perinatal mood and anxiety disorders is documented in patient medical records and provides benchmarks to measure the extent to which obstetric practices successfully integrate perinatal mental health care into their workflow over time. Records will be reviewed from the initiation of prenatal care through postpartum care for given pregnancies, for all abstracted charts. Participants in all phases of the project will complete the following: (1) a demographic questionnaire (pre-), (2) a knowledge test (pre- ,post- and final post assessment), (3) a practices and attitudes survey (pre-, post- and final post assessment), and (4) chart abstraction (pre- and post-) . The participants in the virtual implementation protocol plus e-learning/toolkit and e-learning/toolkit alone group will also complete a usability and satisfaction survey (post-test). All practices will also be asked to facilitate a medical record review/chart abstraction of a total of 120 patient files, 40 pre-pandemic and 40 post pandemic first wave and 40 post e-learning/implementation.

Conditions

• Mood Disorders
• Anxiety Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Virtual implementation protocol	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.
BEHAVIORAL	e-learning toolkit	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.

Timeline

• Start date: 2021-08-17
• Primary completion: 2023-05-31
• Completion: 2023-06-01
• First posted: 2021-06-09
• Last updated: 2023-06-05

Locations

1 site across 1 country: United States