Clinical trial NCT04879797: Reducing Racial Disparities in Severe Maternal Morbidity
Official title: Reducing Racial Disparities in SMM: Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Death
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Baystate Medical Center
name: Beth Israel Medical Center
name: Boston Medical Center
name: UMass Memorial Health
name: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Brigham and Women's Hospital
First posted: 2021-05-10
Enrollment: 1538
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid type 1 implementation
Primary purpose: PREVENTION

Brief summary: There is a paucity of research examining the intersection of race, ethnicity, maternal safety bundles, doulas, and maternal outcomes in Black women at increased risk of severe maternal morbidity and mortality. The proposed mixed-methods study is the first systematic investigation of pregnancy complications and outcomes among Black women with whom maternal safety bundles are being implemented including racial disparities, hemorrhage, and hypertension. Additionally, through the analysis of secondary state level data, this study will examine perinatal care, maternal outcomes, and healthcare utilization of Black women at increased risk of severe maternal morbidity and mortality compared with non-Latino white women. Finally, through individual interviews with Black women and focus groups with obstetric health providers and doulas, the study will examine disparities and improve care by creating and disseminating a set of practice recommendations for maternity care for Black women at increased risk of morbidity and mortality.

Research has not yet examined the intersection of race/ethnicity, doulas, and quality improvement (QI) interventions, such as maternal safety bundles, on reducing SMM and mortality among non-Hispanic Black (NHB) women. The overall goal of this mixed-methods study is to use analysis of existing big data and the evaluation of two interventions to ultimately develop targeted recommendations for addressing these inequities. Our approach leverages multiple data sources to study maternal outcomes and access to care during the prenatal, birth, and postpartum periods in order to identify commonalities among women who experienced SMM and use those findings to create a risk profile of women who are more likely to experience SMM; examine the implementation of maternal safety bundles on SMM and MM outcomes for women up to 1 year postpartum (Intervention 1); gather in-depth data from obstetric care providers on factors that support or hinder safety bundle implementation (Intervention 1); and gather in-depth data from individual women and doulas on facilitators of barriers to the use of doulas to improve care and address inequities (Intervention 2).

Detailed description: Background / Literature Review / Rationale for the study:

Black women experience stark disparities in pregnancy complications and outcomes compared to White women. Recognizing, tracking and understanding patterns of severe maternal morbidity (SMM) and associated inequities by race/ethnicity, along with developing and carrying out interventions to improve the quality of maternal care, are essential to reducing SMM and thereby maternal mortality. To date, there has been little research specifically aimed at understanding whether the maternal health inequities as experienced by Black women can be ameliorated through an integrated care model that includes engagement of providers in the planning and implementation of maternal safety bundles or engaging mothers in prenatal, birth and postpartum support from community doulas. The investigators will use the Health Impact Pyramid and CFIR Framework (Consolidated Framework for Implementation) to develop, implement and assess the effectiveness of such a system in reducing disparities in SMM and mortality. The data sources for this study will include state-level and hospital-specific discharge data collected as part of the Alliance for Innovation on Maternal Health (AIM) project and the Pregnancy to Early Life Longitudinal (PELL) data system, which focuses on population-level data needed to examine health inequities among racial and ethnic minorities in Massachusetts. In addition to these existing data sources, the investigators intend to establish a data collection tool to assess doula services as well as analyze qualitative data from interviews with Black women, and focus groups with obstetrical care providers and doulas to explore the effect of implementing safety bundles and incorporating doula-provided services into prenatal, birth and postpartum care.

Eligibility criteria: Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures • Inclusion criteria: Births at the five participating hospital sites for Intervention 1, collecting data one year prior to, during and one year after the study period.

PREM PROM (Patient Reported Experience Measure ( PREM) Patient Reported Outcome Measure (PROM) Surveys for Intervention I

• Inclusion criteria for Pre- and post- surveys for Maternal Safety Bundles Implementation: Birthing individuals who have delivered six weeks to one year prior to the interview at the five participating sites in Intervention 1

Focus groups for Intervention I

• Inclusion criteria: Obstetrical care providers including nurses, midwives, family practitioners, attending obstetricians and trainee obstetricians employed at the five participating hospital sites will be invited to participate in focus groups.

Intervention II (Community doula support) Severe Maternal Mortality (SMM) 21 Outcome Measures • Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program. The study will include in the intervention arm 340 pregnant women who (1) live in the state of MA, (2) identify as Black or African American, (3) are offered doula care by either their provider or their payer-based navigation program and (4) deliver at one of the four delivering hospitals (Beth Israel Lahey, Boston Medical Center, St. Elizabeth's Medical Center, and Baystate Medical Center). Concurrently, the 340 birthing individuals who were offered doula care in the intervention arm will be matched with birthing individuals who identify as Black or African American, have a live birth, and deliver at one of four hospitals and have similar demographics such as age, comorbidities, payer status, etc.

Focus groups for Intervention II • Inclusion criteria: Persons who practice or identify as community doulas and work with clients who deliver in the state of Massachusetts and have assisted a client in pregnancy, birth, or postpartum within the past 12 months prior to the focus group discussion; obstetrical care provider including nurses, midwives, family medicine practitioners, attending obstetricians, and obstetricians employed at the four participating hospital sites as well as community doula programmatic staff who are employed at participating hospitals sites, or participating community doula organizations, or payers

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II

• Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program.

Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures

• Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention I

• Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

Focus groups for Intervention I

• Exclusion criteria: Staff who have contact with patients but do not identify in the provider types listed in the inclusion criteria

Intervention II (Community doula support) SMM 21 Outcome Measures • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

Focus groups for Intervention II • Exclusion criteria: Staff who have contact with clients but do not identify in the provider types listed in the inclusion criteria

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II

• Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the four participating hospitals

Primary outcomes:
measure: Patient experience - Respect
timeFrame: 6 -12 weeks postpartum
measure: Patient experience - Autonomy
timeFrame: 6 -12 weeks postpartum
measure: Severe maternal morbidity (SMM) 20
timeFrame: At delivery
measure: Cesarean Birth
timeFrame: At delivery
measure: Severe maternal morbidity (SMM) 21
timeFrame: At delivery
Secondary outcomes:
measure: Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate
timeFrame: At delivery
measure: Severe Maternal Morbidity among Hemorrhage Cases
timeFrame: Monthly up to 6 months
measure: Severe Maternal Morbidity (excluding cases with only a transfusion code) among Hemorrhage Cases.
timeFrame: Monthly up to 6 months
measure: Process Measure for Obstetric Hemorrhage - Unit Drills
timeFrame: Monthly up to 6 months
measure: Process Measure for Obstetric Hemorrhage - Provider Education
timeFrame: Monthly up to 6 months
measure: Process Measure for Obstetric Hemorrhage - Nursing Education
timeFrame: Monthly up to 6 months
measure: Process Measure for Obstetric Hemorrhage - Risk Assessment
timeFrame: Monthly up to 6 months
measure: Process Measure for Obstetric Hemorrhage - Quantified Blood Loss Measurement Utilization
timeFrame: Monthly up to 6 months
measure: Structure Measure for Obstetric Hemorrhage - Patient, Family & Staff Support System
timeFrame: Monthly up to 6 months
measure: Structure Measure for Obstetric Hemorrhage - Debriefs System
timeFrame: Monthly up to 6 months
measure: Structure Measure for Obstetric Hemorrhage - Multidisciplinary Case Reviews
timeFrame: Monthly up to 6 months
measure: Structure Measure for Obstetric Hemorrhage - Hemorrhage Cart
timeFrame: Monthly up to 6 months
measure: Structure Measure for Obstetric Hemorrhage - Unit Policy and Procedure
timeFrame: Monthly up to 6 months
measure: Structure Measure for Obstetric Hemorrhage - EHR Integration
timeFrame: Monthly up to 6 months
measure: Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity (excluding transfusion codes) among Preeclampsia Cases
timeFrame: Monthly up to 6 months
measure: Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity among Preeclampsia Cases
timeFrame: Monthly up to 6 months
measure: Process Measure for Severe Hypertension/Preeclampsia - Treatment of Severe HTN
timeFrame: Monthly up to 6 months
measure: SMM 20 by Race and Ethnicity
timeFrame: Monthly up to 2 years
measure: SMM 21 by Race and Ethnicity
timeFrame: Monthly up to 2 years
measure: Process Measure for Severe Hypertension/Preeclampsia - Unit Drills
timeFrame: Monthly up to 6 months
measure: Process Measure for Severe Hypertension/Preeclampsia - Provider Education
timeFrame: Monthly up to 6 months
measure: Process Measure for Severe Hypertension/Preeclampsia - Nursing Education
timeFrame: Monthly up to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Ndidiamaka Amutah Onukagha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes KG, Sousa MH, Cecatti JG. Skin Color and Maternal Near Miss: Exploring a Demographic and Health Survey in Brazil. Rev Bras Ginecol Obstet. 2017 May;39(5):209-216. doi: 10.1055/s-0037-1603498. Epub 2017 May 22.
citation: Thomas MP, Ammann G, Brazier E, Noyes P, Maybank A. Doula Services Within a Healthy Start Program: Increasing Access for an Underserved Population. Matern Child Health J. 2017 Dec;21(Suppl 1):59-64. doi: 10.1007/s10995-017-2402-0.
citation: Burns JJ, Livingston R, Amin R. The Proximity of Spatial Clusters of Low Birth Weight and Risk Factors: Defining a Neighborhood for Focused Interventions. Matern Child Health J. 2020 Aug;24(8):1065-1072. doi: 10.1007/s10995-020-02946-y.
citation: Elkafrawi D, Sisti G, Araji S, Khoury A, Miller J, Rodriguez Echevarria B. Risk Factors for Neonatal/Maternal Morbidity and Mortality in African American Women with Placental Abruption. Medicina (Kaunas). 2020 Apr 13;56(4):174. doi: 10.3390/medicina56040174.
citation: Ferranti EP, Frediani JK, Mitchell R, Fernandes J, Li S, Jones DP, Corwin E, Dunlop AL. Early Pregnancy Serum Metabolite Profiles Associated with Hypertensive Disorders of Pregnancy in African American Women: A Pilot Study. J Pregnancy. 2020 Feb 19;2020:1515321. doi: 10.1155/2020/1515321. eCollection 2020.
citation: Gyamfi-Bannerman C, Srinivas SK, Wright JD, Goffman D, Siddiq Z, D'Alton ME, Friedman AM. Postpartum hemorrhage outcomes and race. Am J Obstet Gynecol. 2018 Aug;219(2):185.e1-185.e10. doi: 10.1016/j.ajog.2018.04.052. Epub 2018 May 9.
citation: Wallace ME, Crear-Perry J, Green C, Felker-Kantor E, Theall K. Privilege and deprivation in Detroit: infant mortality and the Index of Concentration at the Extremes. Int J Epidemiol. 2019 Feb 1;48(1):207-216. doi: 10.1093/ije/dyy149.
citation: Ratnasiri AWG, Parry SS, Arief VN, DeLacy IH, Lakshminrusimha S, Halliday LA, DiLibero RJ, Basford KE. Temporal trends, patterns, and predictors of preterm birth in California from 2007 to 2016, based on the obstetric estimate of gestational age. Matern Health Neonatol Perinatol. 2018 Dec 12;4:25. doi: 10.1186/s40748-018-0094-0. eCollection 2018.
citation: Howell EA, Egorova NN, Balbierz A, Zeitlin J, Hebert PL. Site of delivery contribution to black-white severe maternal morbidity disparity. Am J Obstet Gynecol. 2016 Aug;215(2):143-52. doi: 10.1016/j.ajog.2016.05.007. Epub 2016 May 12.
citation: Gillespie SL, Christian LM, Alston AD, Salsberry PJ. Childhood stress and birth timing among African American women: Cortisol as biological mediator. Psychoneuroendocrinology. 2017 Oct;84:32-41. doi: 10.1016/j.psyneuen.2017.06.009. Epub 2017 Jun 15.
citation: Small MJ, James AH, Kershaw T, Thames B, Gunatilake R, Brown H. Near-miss maternal mortality: cardiac dysfunction as the principal cause of obstetric intensive care unit admissions. Obstet Gynecol. 2012 Feb;119(2 Pt 1):250-5. doi: 10.1097/AOG.0b013e31824265c7.
citation: Hans SL, Edwards RC, Zhang Y. Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):105-113. doi: 10.1007/s10995-018-2537-7.
citation: Poon LC, Kametas NA, Chelemen T, Leal A, Nicolaides KH. Maternal risk factors for hypertensive disorders in pregnancy: a multivariate approach. J Hum Hypertens. 2010 Feb;24(2):104-10. doi: 10.1038/jhh.2009.45. Epub 2009 Jun 11.
citation: Mehta PK, Kieltyka L, Bachhuber MA, Smiles D, Wallace M, Zapata A, Gee RE. Racial Inequities in Preventable Pregnancy-Related Deaths in Louisiana, 2011-2016. Obstet Gynecol. 2020 Feb;135(2):276-283. doi: 10.1097/AOG.0000000000003591.
citation: Bernet P, Gumus G, Vishwasrao S. Maternal Mortality and Public Health Programs: Evidence from Florida. Milbank Q. 2020 Mar;98(1):150-171. doi: 10.1111/1468-0009.12442. Epub 2020 Jan 14.
citation: Murthy NC, Black C, Kahn KE, Ding H, Ball S, Fink RV, Devlin R, D'Angelo D, Fiebelkorn AP. Tetanus, Diphtheria, and Acellular Pertussis and Influenza Vaccinations among Women With a Live Birth, Internet Panel Survey, 2017-2018. Infect Dis (Auckl). 2020 Feb 10;13:1178633720904099. doi: 10.1177/1178633720904099. eCollection 2020.
citation: Murugappan G, Li S, Lathi RB, Baker VL, Luke B, Eisenberg ML. Increased risk of severe maternal morbidity among infertile women: analysis of US claims data. Am J Obstet Gynecol. 2020 Sep;223(3):404.e1-404.e20. doi: 10.1016/j.ajog.2020.02.027. Epub 2020 Feb 27.
citation: Howell EA, Janevic T, Blum J, Zeitlin J, Egorova NN, Balbierz A, Hebert PL. Double Disadvantage in Delivery Hospital for Black and Hispanic Women and High-Risk Infants. Matern Child Health J. 2020 Jun;24(6):687-693. doi: 10.1007/s10995-020-02911-9.
citation: Lyons AB, Peacock A, McKenzie SA, Jacobsen G, Naik HB, Shi VY, Hamzavi IH, Hsiao JL. Evaluation of Hidradenitis Suppurativa Disease Course During Pregnancy and Postpartum. JAMA Dermatol. 2020 Jun 1;156(6):681-685. doi: 10.1001/jamadermatol.2020.0777.
citation: Feinstein L, McWhorter KL, Gaston SA, Troxel WM, Sharkey KM, Jackson CL. Racial/ethnic disparities in sleep duration and sleep disturbances among pregnant and non-pregnant women in the United States. J Sleep Res. 2020 Oct;29(5):e13000. doi: 10.1111/jsr.13000. Epub 2020 Feb 29.
citation: Cesar JA, Camerini AV, Paulitsch RG, Terlan RJ. Non-performance of serological tests for syphilis during prenatal care: prevalence and associated factors. Rev Bras Epidemiol. 2020 Feb 21;23:e200012. doi: 10.1590/1980-549720200012. eCollection 2020. English, Portuguese.
citation: Daw JR, Kolenic GE, Dalton VK, Zivin K, Winkelman T, Kozhimannil KB, Admon LK. Racial and Ethnic Disparities in Perinatal Insurance Coverage. Obstet Gynecol. 2020 Apr;135(4):917-924. doi: 10.1097/AOG.0000000000003728.
citation: Zhou X, McQueen DB, Schufreider A, Lee SM, Uhler ML, Feinberg EC. Black recipients of oocyte donation experience lower live birth rates compared with White recipients. Reprod Biomed Online. 2020 May;40(5):668-673. doi: 10.1016/j.rbmo.2020.01.008. Epub 2020 Jan 23.
citation: Meeks JR, Bambhroliya AB, Alex KM, Sheth SA, Savitz SI, Miller EC, McCullough LD, Vahidy FS. Association of Primary Intracerebral Hemorrhage With Pregnancy and the Postpartum Period. JAMA Netw Open. 2020 Apr 1;3(4):e202769. doi: 10.1001/jamanetworkopen.2020.2769.
citation: Lundeen EA, Park S, Woo Baidal JA, Sharma AJ, Blanck HM. Sugar-Sweetened Beverage Intake Among Pregnant and Non-pregnant Women of Reproductive Age. Matern Child Health J. 2020 Jun;24(6):709-717. doi: 10.1007/s10995-020-02918-2.