TY - JOUR KW - Adult KW - Cluster Analysis KW - Depression/diagnosis/etiology/therapy KW - Depression, Postpartum/diagnosis/therapy KW - Female KW - Humans KW - Mental Health KW - Outcome Assessment, Health Care KW - Patient Participation KW - Perinatal Care/methods KW - Pregnancy KW - Pregnancy Complications/diagnosis/psychology/therapy KW - Psychological Techniques KW - Psychosocial Support Systems KW - Research Design KW - Depression KW - Implementation randomized controlled trial KW - integrated care KW - Intervention KW - methods KW - Perinatal KW - Postpartum KW - Protocol AU - T. A. Moore Simas AU - L. Brenckle AU - P. Sankaran AU - G. A. Masters AU - S. Person AU - L. Weinreb AU - J . Y. Ko AU - C. L. Robbins AU - J. Allison AU - N. Byatt A1 - AB - BACKGROUND: Perinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support. METHODS: This study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm. DISCUSSION: This manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016. AD - University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA. TiffanyA.MooreSimas@UMassMemorial.org.; Department of Obstetrics and Gynecology, University of Massachusetts Medical School, 119 Belmont Street, Worcester, MA, 01605, USA. TiffanyA.MooreSimas@UMassMemorial.org.; Department of Pediatrics, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA. TiffanyA.MooreSimas@UMassMemorial.org.; Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA. TiffanyA.MooreSimas@UMassMemorial.org.; Department of Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA. TiffanyA.MooreSimas@UMassMemorial.org.; Department of Obstetrics and Gynecology, UMass Memorial Health Care, 119 Belmont Street, Worcester, MA, 01605, USA. TiffanyA.MooreSimas@UMassMemorial.org.; Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.; Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.; University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.; University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.; Department of Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.; Department of Family Medicine and Community Health, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.; Fallon Health, Worcester, MA, USA.; Centers for Disease Control and Prevention, Atlanta, GA, USA.; U.S. Public Health Service, Comissioned Corps, Maryland, USA.; Centers for Disease Control and Prevention, Atlanta, GA, USA.; University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.; Department of Quantitative Health Sciences, University of Massachuse(TRUNCATED) BT - BMC pregnancy and childbirth C5 - Education & Workforce; Healthcare Disparities CP - 1 CY - England DO - 10.1186/s12884-019-2387-3 IS - 1 JF - BMC pregnancy and childbirth LA - eng M1 - Journal Article N2 - BACKGROUND: Perinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support. METHODS: This study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm. DISCUSSION: This manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016. PP - England PY - 2019 SN - 1471-2393; 1471-2393 T1 - 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 T2 - BMC pregnancy and childbirth TI - 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 U1 - Education & Workforce; Healthcare Disparities U2 - 31331292 U3 - 10.1186/s12884-019-2387-3 VL - 19 VO - 1471-2393; 1471-2393 Y1 - 2019 Y2 - Jul 22 ER -