PRogram In Support of Moms (PRISM): A Pilot Study (PRISM-Pilot)
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|ClinicalTrials.gov Identifier: NCT02935504|
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Depression||Behavioral: PRogram In Support of Moms (PRISM) Behavioral: MCPAP for Moms||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Program In Support of Moms PRISM
PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.
Behavioral: PRogram In Support of Moms (PRISM)
PRISM Intervention Provider and staff training Webinar Delivered in person Engage providers - Registered Nurses (RN) and Patient Care Assistants (PCA) and ensure they attend:
Toolkit Care coordination Psychiatric consultation Implementation support
Active Comparator: MCPAP for Moms
Consists of access to psychiatric consultation and resources and referrals through MCPAP for Moms - MCPAP for Moms is available free of charge to all Ob/Gyn practices in Massachusetts.
Behavioral: MCPAP for Moms
MCPAP for Moms Provider and staff training Delivered via web RN and PCA admin staff recommended to attend 30-60 minute presentation on perinatal depression Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns Access to one-time face-face evaluation with patient by a MCPAP for Moms psychiatrist for assessment and treatment recommendations for Ob/Gyn provider Access to Provider Toolkit which includes assessment and treatment protocols (available at www.mcpapformoms.org) Resource provision/referrals
- Depression Severity [ Time Frame: Baseline to 10-35 weeks follow-up ]To compare changes in depression severity as measured by Edinburgh Postnatal Depression Scale (EPDS) from baseline to follow-up (10-35 weeks) among pregnant and postpartum women in PRISM versus MCPAP for Moms.
- Provider Fidelity [ Time Frame: Baseline to 1 year follow-up (post intervention) ]To determine change in knowledge, attitudes, and practices as measured by S-KAP toward depression screening and treatment from baseline (pre implementation) to 1 year follow-up (post implementation) among providers in PRISM versus MCPAP for Moms practices.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935504
|Principal Investigator:||Nancy Byatt, DO, MS, MBA||• UMass Memorial Medical Center/UMass Medical School|