Online Training for Addressing Perinatal Depression
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Virtual implementation protocol 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. |
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.
|
| Active Comparator: E-learning/toolkit alone Participants assigned to the e-learning/toolkit alone group will only complete the e-learning course/receive the e-learning toolkit. |
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.
|
| No Intervention: Treatment as usual 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. |
Outcome Measures
Primary Outcome Measures
- Change in rates of screening for bipolar disorder during the 1st or 2nd half of pregnancy. [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.
Secondary Outcome Measures
- Change in rates of screening for anxiety disorder during the 1st or 2nd half of pregnancy [Baseline and 13 months post baseline]
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.
- Change in Providers' quality of care for perinatal mood and anxiety disorders [Baseline and 13 months]
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.
Other Outcome Measures
- Change in Provider Self-Reported rate of Screening [Baseline, 1 month and 13 months]
Providers are given a questionnaire to estimate their frequency of screening for perinatal mood and anxiety disorders.
- Change in Provider Subject Matter Knowledge acquisition and retention [Baseline, 1 month and 13 months]
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.
- Change in Provider attitudes and beliefs related to perinatal mood and anxiety disorders [Baseline, 1 month and 13 months]
Providers are given a questionnaire to evaluate their attitudes and believes related to perinatal mood and anxiety disorders.
- Training satisfaction and usability [1 month]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montachusett Women's Health - UMass Memorial Health Alliance | Leominster | Massachusetts | United States | 01453 |
Sponsors and Collaborators
- University of Massachusetts, Worcester
- Praxis, Inc.
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Nancy Byatt, DO, MS, MBA, FACLP, University of Massachusetts Medical School/UMass Memorial Health
- Principal Investigator: Tiffany Moore Simas, MD, MPH, MEd, FACOG, University of Massachusetts Medical School/UMass Memorial Health
Study Documents (Full-Text)
None provided.More Information
Publications
- Byatt N, Moore Simas TA, Biebel K, Sankaran P, Pbert L, Weinreb L, Ziedonis D, Allison J. PRogram In Support of Moms (PRISM): a pilot group randomized controlled trial of two approaches to improving depression among perinatal women. J Psychosom Obstet Gynaecol. 2018 Dec;39(4):297-306. doi: 10.1080/0167482X.2017.1383380. Epub 2017 Oct 10.
- Byatt N, Pbert L, Hosein S, Swartz HA, Weinreb L, Allison J, Ziedonis D. PRogram In Support of Moms (PRISM): Development and Beta Testing. Psychiatr Serv. 2016 Aug 1;67(8):824-6. doi: 10.1176/appi.ps.201600049. Epub 2016 Apr 15.
- Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012 Aug 1;13:120. doi: 10.1186/1745-6215-13-120. Review.
- Johnson JE, Wiltsey-Stirman S, Sikorskii A, Miller T, King A, Blume JL, Pham X, Moore Simas TA, Poleshuck E, Weinberg R, Zlotnick C. Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women. Implement Sci. 2018 Aug 22;13(1):115. doi: 10.1186/s13012-018-0807-9.
- McLaughlin TJ, Aupont O, Kozinetz CA, Hubble D, Moore-Simas TA, Davis D, Park C, Brenner R, Sepavich D, Felice M, Caviness C, Downs T, Selwyn BJ, Forman MR. Multilevel Provider-Based Sampling for Recruitment of Pregnant Women and Mother-Newborn Dyads. Pediatrics. 2016 Jun;137 Suppl 4:S248-57. doi: 10.1542/peds.2015-4410F.
- Moore Simas TA, Brenckle L, Sankaran P, Masters GA, Person S, Weinreb L, Ko JY, Robbins CL, Allison J, Byatt N. The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings. BMC Pregnancy Childbirth. 2019 Jul 22;19(1):256. doi: 10.1186/s12884-019-2387-3.
- Tajima B, Guydish J, Delucchi K, Passalacqua E, Chan M, Moore M. Staff Knowledge, Attitudes, and Practices Regarding Nicotine Dependence Differ by Setting. J Drug Issues. 2009;39(2):365-384.
- H00017480
- R42MH113381