PRogram In Support of Moms (PRISM): Phase 2
February 17, 2017
Eilean Attwood, MD
Baystate Medical Center, 759 Chestnut Street, Springfield, MA
The primary goal of this study is to refine, evaluate, and disseminate a new low-cost and sustainable
stepped care program for Obstetrics/Gynecology (Ob/Gyn) clinics that will improve perinatal womens' treatment rates and outcomes. We propose to compare two active interventions, enhanced usual care (access to MCPAP for Moms) vs. PRISM in a cluster randomized controlled trial (RCT) in which we will randomize 12 Ob/Gyn clinics to either PRISM or enhanced usual care. We will compare differences in depression severity and treatment participation among 300 depressed women (n=150 per group) that receive care from PRISM or enhanced usual care clinics.
- Prenatal care providers and support staff including physicians, advanced practice nurses, nurses, patient care assistants, social workers, office research staff, administrative support staff, and others serving women at Wesson Women’s Clinic and Pioneer Women's Health. Provider and staff subjects will participate in either PRISM or Enhanced Usual Care, depending on what Wesson Women’s Clinic and Pioneer Women's Health is assigned to. Wesson Women’s Clinic and Pioneer Women's Health will be randomly assigned to either the PRISM group or the Enhanced Usual care group.
- Women subjects will be enrolled to participate if they meet the following inclusion criteria:
- Age 18-55 years
- English speaking, able to communicate in written and spoken English
- >4 weeks gestational age (GA) until 4 months postpartum
- Edinburgh Postnatal Depression Scale score (EPDS) ≥10
- Cognitively able to participate in informed verbal consent
- Provider and staff subjects will be excluded from the study if they are not a prenatal care provider or support person as indicated above from either Wesson Women’s Clinic or Pioneer Women's Health.
- Women subjects will be excluded from the study for any of the following:
- Lack of verbal and written English fluency
- Under age 18 or over age 55
- Substance use disorder (as determined by substance use disorder questions in4P’s)
- Screen positive for bipolar disorder via the MDQ (Mood Disorder Questionnaire)
As part of this study, you will be asked to answer survey questions over the phone, up to 5 times throughout your pregnancy. Each phone interview will take <60 minutes of your time. We will
also be asking you questions about your baby’s health. All interviews will be audiotaped using a
digital recorder attached to the telephone to quality check data that will be collected during the
interviews. We will keep in contact with you by phone or mail in between assessments so we can
ask about and keep track of any changes in your contact information.