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出境医 / 临床实验 / Online Training for Addressing Perinatal Depression

Online Training for Addressing Perinatal Depression

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
Mood Disorders Anxiety Disorders Behavioral: Virtual implementation protocol Behavioral: e-learning toolkit Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Online Training for Addressing Perinatal Depression
Actual Study Start Date : August 17, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022
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 :
  1. Change in rates of screening for bipolar disorder during the 1st or 2nd half of pregnancy. [ Time Frame: 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 :
  1. Change in rates of screening for anxiety disorder during the 1st or 2nd half of pregnancy [ Time Frame: 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.

  2. Change in Providers' quality of care for perinatal mood and anxiety disorders [ Time Frame: 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:
  1. Change in Provider Self-Reported rate of Screening [ Time Frame: Baseline, 1 month and 13 months ]
    Providers are given a questionnaire to estimate their frequency of screening for perinatal mood and anxiety disorders.

  2. Change in Provider Subject Matter Knowledge acquisition and retention [ Time Frame: 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.

  3. Change in Provider attitudes and beliefs related to perinatal mood and anxiety disorders [ Time Frame: Baseline, 1 month and 13 months ]
    Providers are given a questionnaire to evaluate their attitudes and believes related to perinatal mood and anxiety disorders.

  4. Training satisfaction and usability [ Time Frame: 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts
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Contact: Padma Sankaran, MA 508-856-8505 Padma.sankaran@umassmed.edu
Contact: Melissa Maslin, MEd Melissa.Maslin@umassmed.edu

Locations
Layout table for location information
United States, Massachusetts
Montachusett Women's Health - UMass Memorial Health Alliance Recruiting
Leominster, Massachusetts, United States, 01453
Contact: Betty Ann Cirillo, MD    978-466-4550      
Sponsors and Collaborators
University of Massachusetts, Worcester
Praxis, Inc.
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE May 28, 2021
First Posted Date  ICMJE June 9, 2021
Last Update Posted Date September 30, 2021
Actual Study Start Date  ICMJE August 17, 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021) 		Change in rates of screening for bipolar disorder during the 1st or 2nd half of pregnancy. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • Change in rates of screening for anxiety disorder during the 1st or 2nd half of pregnancy [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 2, 2021)
  • Change in Provider Self-Reported rate of Screening [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Online Training for Addressing Perinatal Depression
Official Title  ICMJE Online Training for Addressing Perinatal Depression
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Mood Disorders
  • Anxiety Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Virtual implementation protocol
    • Behavioral: e-learning toolkit
  • 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.
    Intervention: Behavioral: e-learning toolkit
  • 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.
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2021) 		45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Padma Sankaran, MA 508-856-8505 Padma.sankaran@umassmed.edu
Contact: Melissa Maslin, MEd Melissa.Maslin@umassmed.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04919967
Other Study ID Numbers  ICMJE H00017480
R42MH113381 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data sharing is via the National Institute of Mental Health (NIMH) Data Archive (NDA) (https://ndar.nih.gov/), specifically the National Database for Clinical Trials Related to Mental Illness (NDCT).
Time Frame: Data will be deposited into the NDCT repository as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier. We will adhere to the NIH Data Sharing Policy and Implementation Guidance.
Access Criteria:

The data will be deposited and made available through NDCT, which is an NIH-funded repository, and that these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary studies related to perinatal mental health.

Final research data and data communication will be available to researchers under an appropriate data sharing agreement that provides for: (1) use of data only for research purposes (and not to identify any individual participant); (2) securing the data using appropriate measures; (3) not redistributing the data; (4) destroying or returning the data after analyses are completed; (5) not using the data for commercial purposes; and (6) proper acknowledgement of the data source.

All data products can be transferred to approved investigators by secure encrypted transfer using the secure managed data transfer server, MoveIt DMZ (Ipswitch File Transfer Inc.).
Responsible Party Nancy Byatt, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE
  • Praxis, Inc.
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
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
PRS Account University of Massachusetts, Worcester
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP