Anxiety Disorders Clinical Trial
Official title:
Online Training for Addressing Perinatal Depression
Verified date | June 2023 |
Source | University of Massachusetts, Worcester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | June 1, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montachusett Women's Health - UMass Memorial Health Alliance | Leominster | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | National Institute of Mental Health (NIMH), Praxis, Inc. |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Provider Self-Reported rate of Screening | Providers are given a questionnaire to estimate their frequency of screening for perinatal mood and anxiety disorders. | Baseline, 1 month and 13 months | |
Other | Change in Provider Subject Matter Knowledge acquisition and retention | Providers are given a multiple-choice assessment to gauge provider knowledge about perinatal mood and anxiety disorders at baseline, and then provider knowledge about the subject matter post-training (at 1 month) and then retention of knowledge at 13 months. | Baseline, 1 month and 13 months | |
Other | Change in Provider attitudes and beliefs related to perinatal mood and anxiety disorders | Providers are given a questionnaire to evaluate their attitudes and believes related to perinatal mood and anxiety disorders. | Baseline, 1 month and 13 months | |
Other | Training satisfaction and usability | Providers are asked about their opinions of usability and satisfaction with the training course.
Providers are asked to provide a score on a scale of their opinion, with 0 being unusable and [5] being very useable. |
1 month | |
Primary | Change in rates of screening for bipolar disorder during the 1st or 2nd half of pregnancy. | Occurrence of bipolar screening will be assessed from medical records using an established tool that evaluates practice readiness to evaluate and address perinatal mood and anxiety disorders. The extent to which screening for bipolar disorder is documented in patient medical records will be quantified. Medical records will be reviewed from the initiation of prenatal care through postpartum care for given pregnancies. | Baseline and 13 months post baseline | |
Secondary | Change in rates of screening for anxiety disorder during the 1st or 2nd half of pregnancy | Occurrence of anxiety screening will be assessed from medical records using an established tool that evaluates practice readiness to evaluate and address perinatal mood and anxiety disorders. The extent to which screening for anxiety disorder is documented in patient medical records will be quantified. Medical records will be reviewed from the initiation of prenatal care through postpartum care for given pregnancies. | Baseline and 13 months post baseline | |
Secondary | Change in Providers' quality of care for perinatal mood and anxiety disorders | The documented care received by patients for perinatal mood and anxiety disorders will be measured from medical records using an established tool which rates five components in the care pathway of perinatal mood and anxiety disorders: detection, assessment, treatment initiation, follow-up & monitoring and ongoing care. Each component makes up 20% of the overall score for provider documentation/quality of care in addressing perinatal mood and anxiety disorders. | Baseline and 13 months |
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