Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04919967
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2021-05-28
Brief Title:
Online Training for Addressing Perinatal Depression
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Online Training for Addressing Perinatal Depression
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 reviserefine 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-learningtoolkit as compared to 2 e-learningtoolkit 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 221 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-learningtoolkit n6 to 10 2 e-learningtoolkit alone n6 to 10 and 3 treatment-as-usual n3 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-learningtoolkit in comparison to the e-learningtoolkit 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 221 randomization we will randomize 15 - 25 obstetric practices into three groups 1 virtual implementation protocol plus e-learningtoolkit n6 - 10 2 e-learningtoolkit alone n6 - 10 and 3 treatment-as-usual n3 - 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-learningtoolkit and e-learningtoolkit alone group will also complete a usability and satisfaction survey post-test All practices will also be asked to facilitate a medical record reviewchart abstraction of a total of 120 patient files 40 pre-pandemic and 40 post pandemic first wave and 40 post e-learningimplementation
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-learningtoolkit and e-learningtoolkit alone group will also complete a usability and satisfaction survey post-test All practices will also be asked to facilitate a medical record reviewchart abstraction of a total of 120 patient files 40 pre-pandemic and 40 post pandemic first wave and 40 post e-learningimplementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R42MH113381 | NIH | None | httpsreporternihgovquickSearchR42MH113381 |