Pathways to Perinatal Mental Health Equity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Massachusetts, Worcester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Program in Support of Moms (PRISM)

    Behavioral

    Program in Support of Moms (PRISM): a practice-level intervention with implementation support that helps obstetric practices integrate mental health care for perinatal individuals. To help obstetric practices implement pathways for screening, assessment, and a stepped intervention response for mental health problems and social determinants of health. PRISM offers training in trauma informed and equitable care, technical assistance, and implementation and change management support.

  • PSI Peer Support

    Behavioral

    Postpartum Support International (PSI) Peer Support: a service administered by PSI that pairs perinatal individuals with a volunteer peer mentor who provides support, psychoeducation, behavioral activation, and navigation services, which includes planning, goal setting, and practical tools to manage parenting and mental health symptoms.

Treatment groups

1,270 Participants
are divided into 2 treatment groups
Group A: Healthcare-Community Partnership approachActive comparator 2 interventions
Group B: Healthcare system approachActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in perinatal individual depression symptoms as measured by Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9)

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.

Time frame
Baseline to up to 13 months postpartum

Secondary outcomes

1

Change in perinatal individual anxiety symptoms as measured by Generalized Anxiety Disorder Scale (GAD-7)

Perinatal individual anxiety symptoms will be determined from their medical charts, through results of the Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 has seven items assessing anxiety severity and is validated in perinatal populations.

Time frame
Baseline to up to 13 months postpartum
2

Proportion of perinatal individuals with evidence of initiation of treatment/support in their medical chart

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 percentage of perinatal individuals who received treatment or support.

Time frame
Baseline to up to 13 months postpartum

Other outcomes

1

Perinatal individual screening, assessment, treatment, and follow-up

Whether perinatal individuals have received screening, assessment, treatment, and follow-up for mental health concerns will be determined from their medical charts. Receipt of screening and results (positive screen versus not) of screening will be determined from medical charts. Screeners will include Edinburgh Postpartum Depression Scale \[EPDS\], Nine-item Patient Health Questionnaire \[PHQ-9\], or Seven-item Generalized Anxiety Disorder scale \[GAD-7\]. Higher scores on these scales indicate higher symptom severity. Recognizing that a positive screen is not synonymous with a diagnosis, we will code mental health assessment (including administration and results of secondary screeners), as well as follow-up. Treatment follow-up will be defined as an average of ≥1 mental health service every month over 3 months or currently on medication for depression or anxiety during the study window.

Time frame
Baseline to up to 13 months postpartum
2

Perinatal Individuals Social Determinants of Health (SDOH) screening and referral

Perinatal Individuals' Social Determinants of Health (SDOH) screening and referral will be determined by review of their medical charts. Researchers will look for completion of the steps in the WE CARE process (screening, discussion with care professionals, and referral for unmet needs) and responses to the 12-item WE CARE screener.

Time frame
Baseline to up to 13 months postpartum
3

Workforce capacity and support for engaging in mental health care

Perinatal care setting staff and peer mentor capacity and support for engaging in mental health care will be measured by the Pathways survey. To develop the Pathways survey, we carefully reviewed questions and constructs from the Mini-Z Single-Item Burnout Scale, the Trauma-Informed System Change Instrument questionnaire, the Kaiser Family Foundation's National Survey of Physicians, and the Determinants of Implementation Behavior Questionnaire. Rather than focus on participants' behaviors (for which we will collect data from electronic medical records and PSI administrative databases), the survey emphasizes questions on participants' perspectives regarding motivation and capacity to deliver mental health care, beliefs about consequences, and trust. Higher scores on the Pathways survey indicate higher capacity and support for engaging in mental health care.

Time frame
Baseline to up to 2 years post-implementation

Sponsors and contacts

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University of Massachusetts, Worcester

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator