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临床试验/NCT04919967
NCT04919967已完成不适用

Online Training for Addressing Perinatal Depression

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Change in rates of screening for bipolar disorder during the 1st or 2nd half of pregnancy.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

Change in rates of screening for bipolar disorder during the 1st or 2nd half of pregnancy.

时间窗: Baseline and 13 months post baseline

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.

次要结局

  • Change in rates of screening for anxiety disorder during the 1st or 2nd half of pregnancy(Baseline and 13 months post baseline)
  • Change in Providers' quality of care for perinatal mood and anxiety disorders(Baseline and 13 months)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Byatt

Executive Director, Lifeline for Families Center & Lifeline for Moms Program;Associate Professor of Psychiatry, Obstetrics & Gynecology and Population & Quantitative Health Sciences

University of Massachusetts, Worcester

研究点 (2)

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