Online Training for Addressing Perinatal Depression

University of Massachusetts, Worcester

Status: Completed

Conditions: Anxiety Disorders; Mood Disorders

Treatments: Behavioral: e-learning toolkit; Behavioral: Virtual implementation protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04919967

R42MH113381 (U.S. NIH Grant/Contract)

H00017480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• licensed independent providers e.g. Ob/Gyn attendings and residents, family medicine, Maternal Fetal Medicine physicians (attending/fellow), certified nurse midwives, nurse practitioners, and physician assistants)

Exclusion criteria

• providers from the participating practices that are unable to consent,
• individuals who are not yet adults,
• prisoners
• non-English speaking participants in the study.

Pregnant women will not be excluded from participation in the study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

Virtual implementation protocol

Experimental group

Description:

Participants assigned to the virtual implementation protocol plus e-learning/toolkit group will take the e-learning course an also receive support through the Virtual Implementation Protocol.

Treatment:

Behavioral: e-learning toolkit

Behavioral: Virtual implementation protocol

E-learning/toolkit alone

Active Comparator group

Description:

Participants assigned to the e-learning/toolkit alone group will only complete the e-learning course/receive the e-learning toolkit.

Treatment:

Behavioral: e-learning toolkit

Treatment as usual

No Intervention group

Description:

Participants assigned to this group will not be provided any additional training or implementation assistance. They will be able to take trainings outside of study protocol if they would otherwise plan or want to do so. They will be offered the study-specific training and implementation assistance after they have completed the final study assessments.