Culturally Engaged REcovery: MOms Connected Through Native CommunitY (CEREMONY)

Culturally Engaged REcovery - MOms Connected Through Native CommunitY (CEREMONY)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Substance Use Disorders (SUD); Cultural Adaptation; Maternal Morbidity and Mortality

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.

• Study Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Valerie Joseph Regulatory Coordinator; Phone Number: 801-587-2249; Email: valerie.joseph@hsc.utah.edu
• Study Contact Backup: Name: Priscilla Blosser; Phone Number: 801-213-6117; Email: priscilla.blosser@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84111
      • Sacred Circle Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CEREMONY; Any Native individuals seeking treatment in the integrated perinatal SUD clinical program specifically created for Native mothers may opt to enroll in prospective data collection during their time in the program
Contemporary comparison cohort; Utah Population Database will be queried for individuals who could have met criteria for prospective data collection but did not participate in the SUD clinical program. The outcomes of these individuals (administrative data only) will be compared to individuals taking part in the SUD program for Native pregnant people who agree to have their data collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum engagement in care	Completion of a postpartum follow up visit within 8 weeks of delivery	From enrollment until 12 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication for opioid use disorder	Any prescription of suboxone or methadone for individuals with OUD, and the length of time the prescription is kept current	Enrollment through 1 year postpartum

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Michelle Debbink, MD PhD, University of Utah; Principal Investigator: Adam Gordon, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Substance Use Disorder; Prenatal care; Native and Indigenous Health; Culturally adapted care
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 00177269; U54HD113169 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sovereignty is of critical importance when working with Native communities. Particularly with recent data breaches in Utah related to Native individuals' health data, a clear and strictly adhered-to data management policy is critical. The memorandum of understanding between the University of Utah and Sacred Circle includes a data sovereignty plan, which includes a statement that data is owned by the Tribal entity. Data will be deidentified before sharing on a need to know basis, on the agreement that once the data analysis is complete, the data will be returned to the Tribal entity or destroyed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No