Pathways to Perinatal Mental Health Equity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,270
- Locations
- 1
- Primary Endpoint
- Change in depression score as measured by either Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9)
Study Overview
Brief Summary
Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, "Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.
Detailed Description
Mental health conditions are now the leading cause of death during pregnancy and the postpartum period (the perinatal period) in the United States. One in five individuals who are pregnant or one year or less postpartum experience a mood or anxiety disorder. Despite these risks and the availability of evidence-based treatments for mood and anxiety disorders that occur during this time, most do not receive adequate treatment, if any at all. Gaps in care loom largest for individuals who are Black or African American, Hispanic or Latino, American Indian or Alaska Native, or Native Hawaiian or other Pacific Islander. Thus, it is recommended that, in order to detect and address perinatal mood and anxiety disorders and related social inequities, screening be implemented in both healthcare and community settings.
In response, the study team has developed approaches for addressing mood and anxiety disorders in both healthcare and community settings caring for pregnant and postpartum individuals. These programs have been adopted across the United States. The study's community partner, Postpartum Support International (PSI), developed a national Peer Support Program that pairs individuals in need of support with a trained volunteer who has also experienced and fully recovered from a perinatal mood and anxiety disorder.
The study's research partner, UMass Chan, developed:
- A statewide program that offers support to patients and their medical professionals to help them both address mental health during pregnancy and the postpartum period.
- A national network of similar statewide programs to coordinate their efforts across the United States.
- A comprehensive approach to help obstetric care settings address mental health concerns among their patients.
Despite the benefits of these programs, investigators have learned that none of them is sufficient to address mental health challenges on their own.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for perinatal care setting team members:
- •Be employed by a participating perinatal care setting in a clinical role (including as an obstetrician-gynecologist, midwife, nurse practitioner, a nurse, a navigator, or administrative staff member who implemented the respective intervention during the study period).
- •Be 18 years of age or older
- •Provide verbal consent prior to the focus group or interview
- •Be proficient in English
- •Inclusion Criteria for peer mentors:
- •Have completed PSI training to be a peer mentor
- •Be 18 years of age or older
- •Provide verbal consent prior to the focus group or interview
- •Be proficient in English
- •Inclusion Criteria for perinatal individuals:
- •Have received perinatal care at a study partnering perinatal care setting during the study period
- •Be 18 years of age or older
- •Provide verbal consent prior to the focus group or interview
- •Be proficient in English or Spanish
Exclusion Criteria
- •An individual who does not meet the inclusion criteria listed above will be excluded from participation in this study. There are no additional exclusion criteria.
Arms & Interventions
Healthcare-Community Partnership approach
The Healthcare-Community Partnership approach will include the PRISM model plus PSI Peer Support specialists.
Intervention: Program in Support of Moms (PRISM) (Behavioral)
Healthcare-Community Partnership approach
The Healthcare-Community Partnership approach will include the PRISM model plus PSI Peer Support specialists.
Intervention: PSI Peer Support (Behavioral)
Healthcare system approach
The Healthcare system approach will include the PRogram In Support of Moms (PRISM) model alone.
Intervention: Program in Support of Moms (PRISM) (Behavioral)
Outcomes
Primary Outcomes
Change in depression score as measured by either Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9)
Time Frame: Baseline to up to 13 months postpartum
Perinatal individual depressive symptoms will be determined from their medical charts, through the screening questionnaire used by their care setting. The screener may be the Edinburgh Postnatal Depression Scale (EPDS) or the Patient Health Questionnaire-9 (PHQ-9). The 10-item EPDS is the most widely used measure of perinatal depression symptoms. The 9-item PHQ-9 is the most widely-used measure of depression symptoms across the lifespan and the second most widely used measure during the perinatal period.
Proportion of perinatal individuals with evidence of initiation of treatment/support in their medical chart
Time Frame: Baseline to up to 13 months postpartum
Perinatal individual initiation of treatment/support will be determined by their medical charts' indication that they have received treatment or support. Treatment or support is defined as one initial mental health assessment or treatment visit, peer support encounter, or currently on medication for depression or anxiety. Perinatal individuals will receive a score of 1 if they initiated treatment or support or a score of 0 if they did not initiate treatment or support. This outcome refers to the % of perinatal individuals who received treatment or support.
Change in perinatal individual depression symptoms as measured by Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9)
Time Frame: Baseline to up to 13 months postpartum
Perinatal individual depressive symptoms will be determined from their medical charts, through the screening questionnaire used by their care setting. The screener may be the Edinburgh Postnatal Depression Scale (EPDS) or the Patient Health Questionnaire-9 (PHQ-9). The 10-item EPDS is the most widely used measure of perinatal depression symptoms. The 9-item PHQ-9 is the most widely-used measure of depression symptoms across the lifespan and the second most widely used measure during the perinatal period.
Secondary Outcomes
- Perinatal individual anxiety symptoms(Baseline to up to 13 months postpartum)
- Change in perinatal individual anxiety symptoms as measured by Generalized Anxiety Disorder Scale (GAD-7)(Baseline to up to 13 months postpartum)
- Proportion of perinatal individuals with evidence of initiation of treatment/support in their medical chart(Baseline to up to 13 months postpartum)
Investigators
Nancy Byatt
Principal Investigator
University of Massachusetts, Worcester