Online Training for Addressing Perinatal Depression

NCT04919967 | Completed

• 2 other identifiers: H00017480R42MH113381
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders; Anxiety Disorders

Keywords

Detection; Screening; Treatment; Depression; Anxiety; mood disorders; perinatal; maternity care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Other Outcomes (4)

• Change in Provider Self-Reported rate of Screening

  Baseline, 1 month and 13 months

• Change in Provider Subject Matter Knowledge acquisition and retention

  Baseline, 1 month and 13 months

• Change in Provider attitudes and beliefs related to perinatal mood and anxiety disorders

  Baseline, 1 month and 13 months

Study Arms (3)

Virtual implementation protocol

EXPERIMENTAL

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; Behavioral: e-learning toolkit

E-learning/toolkit alone

ACTIVE COMPARATOR

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

Treatment as usual

NO INTERVENTION

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.

Interventions

Virtual implementation protocol BEHAVIORAL

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.

Virtual implementation protocol

e-learning toolkit BEHAVIORAL

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.

E-learning/toolkit alone; Virtual implementation protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Praxis, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Montachusett Women's Health - UMass Memorial Health Alliance

Leominster, Massachusetts, 01453, United States

Location

Related Publications (7)

• 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(Suppl 4):S248-57. doi: 10.1542/peds.2015-4410F.

  PMID: 27251871 BACKGROUND

• 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.

  PMID: 30134941 BACKGROUND

• 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.

  PMID: 28994626 BACKGROUND

• 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.

  PMID: 27079994 BACKGROUND

• 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.

  PMID: 22853820 BACKGROUND

• 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. doi: 10.1177/002204260903900208.

  PMID: 20617124 BACKGROUND

• 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.

  PMID: 31331292 BACKGROUND

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Lifeline for Families Center & Lifeline for Moms Program;Associate Professor of Psychiatry, Obstetrics & Gynecology and Population & Quantitative Health Sciences

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 9, 2021
• Study Start: August 17, 2021
• Primary Completion: May 31, 2023
• Study Completion: June 1, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• 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.).

Locations

US (1)