Clinical trial NCT06747442: Culturally Engaged REcovery: MOms Connected Through Native CommunitY
Official title: Culturally Engaged REcovery - MOms Connected Through Native CommunitY (CEREMONY)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Substance Use Disorders (SUD)
Pregnancy
Maternal Morbidity and Mortality
Cultural Adaptation
Keywords: Pregnancy
Prenatal care
Substance Use Disorder
Native and Indigenous Health
Culturally adapted care
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-12-24
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study compares the outcomes of two groups: 1) Native individuals who have decided to participate in a new clinical program for pregnant Native mothers with SUD (program cohort) who then also agree to have their data to collected prospectively; and 2) pregnant Native mothers with SUD identified through administrative data who did not participate in the clinical program. The study population as a whole consists of Native and Indigenous pregnant individuals with SUD in the state of Utah.

Brief summary: Pregnant and postpartum American Indian and Alaska Native people (Native mothers) face a more than two-fold higher risk of maternal mortality compared to non-Hispanic White mothers. Deaths related to substance use (SU) and mental health conditions are a leading cause of preventable maternal mortality, including among Native mothers, making these conditions a strong target for reducing maternal mortality and morbidity. The objective of our study is to 1) adapt evidence-based perinatal care models that integrate pregnancy and postpartum care with SU treatment and care to meet the needs of Native mothers, and 2) assess the implementation and efficacy of that model for participants with substance use disorder who identify as Native receiving prenatal care at Sacred Circle Healthcare in Salt Lake City, Utah.

Detailed description: Pregnant and postpartum American Indian and Alaska Native people (Native mothers) face a more than two-fold higher risk of maternal mortality compared to non-Hispanic White mothers. Deaths related to substance use (SU) and mental health conditions reflect a leading cause of preventable maternal mortality, including among Native mothers, making these conditions a strong target for reducing maternal mortality and morbidity. The Utah Maternal Mortality Review Committee (MMRC) has identified access to substance use disorder (SUD) treatment including medication for opioid use disorder (MOUD), mental health care, improved social support, decreased stigma against SUD, and care coordination, particularly in the postpartum period (when the majority of deaths occur) as actionable intervention points. The objective of our study, Culturally-Engaged REcovery - MOms connected through Native CommunitY (CEREMONY), is to adapt evidence-based perinatal care models that integrate pregnancy and postpartum care with SU/SUD treatment and care to meet the needs of Native mothers. With our partners at Sacred Circle Clinic, a federal Tribal Contract clinic operated by the Confederated Tribes of the Goshute Reservation, we are uniquely poised to respond to the expressed needs of Native mothers and stakeholders, who identified a lack of culturally-integrated SUD care as a significant gap in perinatal care for Native mothers. We will do this by building upon the strong, evidence-based foundation of our University of Utah integrated perinatal SUD clinic called Substance Use and Pregnancy - Recovery, Addiction, and Dependence (SUPeRAD). The SUPeRAD model directly addresses the actionable intervention points identified by the MMRC to prevent SUD-related maternal deaths, but is not specifically adapted to Native mothers' needs. The rationale for this study is that there is a critical knowledge gap in the adaptation and implementation of integrated perinatal SUD care specifically for Native mothers. The CEREMONY study will fill this gap by adapting the SUPeRAD clinic model to the needs of Native mothers using the validated ADAPT-ITT adaptation framework, informed by human centered design and community-based participatory research (Aim 1; not part of the observation trial submission described on this website); and then studying the adapted, culturally-integrated perinatal SUD care intervention at Sacred Circle Healthcare using a Hybrid Type 1 effectiveness-implementation study (Aim 2a\&b). The Hybrid Type 1 design will provide important, reliable data on the clinical effectiveness of culturally adapted perinatal SUD care for Native mothers (Aim 2a) while also producing novel data on the implementation process (Aim 2b). Successful completion of these Aims will provide implementation and training protocols that can be used to guide adaptation and implementation of culturally-adapted perinatal SUD care in other settings across the US.

Sacred Circle Healthcare will be implementing the new care model and offering it to all patients who identify as Native and having a substance use disorder. Within that group, the CEREMONY study will invite patients who meet study inclusion criteria to participate in the observational research study.

Participants enrolled prospectively will be compared to a historical cohort, with data pulled from the Utah Population Database, for our primary outcome. The historical cohort will be comprised on deidentified data from individuals over 18 years old with delivery of an infant greater than 20 weeks' gestation between 2020 and the most recent year of available data (approximately 2027-28) who had at least one visit with a Utah health provider before delivery and identify as American Indian/Alaska Native based on vital records or hospital records.

Eligibility criteria: CEREMONY Inclusion Criteria:

* English or Spanish speaking
* pregnant (verified by point of care urine pregnancy test)
* plan to carry the fetus to delivery
* identify as Indigenous, Native, Native American, American Indian or Alaska Native
* willing to grant a release of information to allow study staff to contact other health care institutions and treatment centers and collect information from the medical record, e.g., date of delivery, infant admission etc.

CEREMONY Exclusion Criteria:

* have a documented psychotic episode in the last 30 days
* be \>39 weeks of gestation
* be unable provide collateral contact information of at least 1 person
* be unable to provide reliable phone number
* plan to move within 3 months of delivery

Primary outcomes:
measure: Postpartum engagement in care
timeFrame: From enrollment until 12 weeks after delivery
Secondary outcomes:
measure: Medication for opioid use disorder
timeFrame: Enrollment through 1 year postpartum
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Sacred Circle Healthcare
state: Utah
Study officials:
affiliation: University of Utah
name: Michelle Debbink, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Adam Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References: