The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.
The US maternal mortality ratio is the highest among developed nations at 26.4 maternal deaths per 100,000 livebirths. Among the states, Georgia has the second highest maternal mortality (66.3 per 100,000), with a 60% higher rate for black vs white women (95.6 vs 59.7 per 100,000). Nearly 100 times more common than maternal mortality is severe maternal morbidity (SMM), defined as unexpected outcomes of labor and delivery that result in short- and long-term deleterious health consequences. Maternal mortality and SMM are highest among women who are black, publicly insured or uninsured, and deliver in safety-net hospitals. In Georgia, 66% of maternal deaths occur to women insured by Medicaid at delivery and the majority of deaths and SMM occur postpartum, a time during which healthcare visits are poorly attended and oftentimes inaccessible. The Georgia Maternal Mortality Review Committee concluded that two-thirds of maternal deaths are preventable, with chronic health conditions, obesity, delays in accessing and fragmentation of care as key contributors. As solutions, it recommends improved prenatal and postpartum follow-up and case management, control of chronic health conditions, and extension of Medicaid coverage beyond 60 days postpartum. While the postpartum period represents a crucial window of opportunity for promoting women's current and future health, up to 40% of US women do not attend postpartum visits due to structural barriers (e.g., lack of insurance, transportation or childcare) social barriers (e.g., medical mistrust and poor patient-provider relationships) or low perceived utility of postpartum care. Moreover, the lowest rates of postpartum care utilization are concentrated among women with the highest rates of pregnancy complications and chronic conditions (e.g., women who are uninsured or Medicaid-insured, low-income, and non-Hispanic black). Timely and adequate use of postpartum care is especially important for women with diabetes or hypertensive disease as these conditions are associated with increased risk for postpartum morbidity and mortality and cardiovascular disease later in life. The researchers of this study plan to conduct an intervention study to assess the effect of a woman-centered, comprehensive postpartum care system on postpartum visit attendance and follow-up care among medically underserved women with chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity or hypertensive disorder of pregnancy (HDP). Because implementing and sustaining a comprehensive postpartum care system in a health disparities population requires a thorough understanding of patient preferences regarding the structural and process elements of care, methods of provider-patient communication, and strategies for addressing social and contextual barriers to care the researchers will use in-depth interviews to inform the intervention design and then assess health outcomes and satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
320
The intervention consists of a comprehensive postpartum care system that integrates American College of Obstetrician and Gynecologist's (ACOG) postpartum care guidelines together with American College of Cardiology and American Heart Association (ACC/AHA) guidelines for the prevention of cardiovascular disease in women, as well as patient preferences for care coordination and communication. The system consists of: 1) a tailored postpartum care plan that is collaboratively developed with patient and provider input and addresses both social and medical needs; 2) an electronic medical record (EMR) based tool for documenting the plan and monitoring postpartum care; and 3) a postpartum follow-up phone call at 1 week postpartum.
Grady Memorial Hospital
Atlanta, Georgia, United States
Number of Participants Attending a Comprehensive Postpartum Visit
The postpartum visit occurs between 4 and 12 weeks after delivery and meets specific, defined as a preventive care visit with an obstetric care provider (e.g., obstetrician-gynecologist, certified nurse midwife, or primary care provider with additional training relevant to postpartum care) that included an assessment of assessing multiple aspects of physical and mental health. Comprehensive postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
Time frame: 12 weeks after delivery
Number of Participants Attending Any Postpartum Visit
Any type of outpatient postpartum visit between 4 and 12 weeks after delivery other than visits to urgent care and/or emergency departments. Postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
Time frame: 12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Ordered
Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records.
Time frame: 12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Performed
Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records.
Time frame: 12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered
Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records, among enrolled participants diagnosed with gestational diabetes or diabetes mellitus.
Time frame: 12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Screening Was Performed
Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records, among enrolled participants diagnosed with gestational diabetes or diabetes mellitus.
Time frame: 12 weeks after delivery
Number of Participants Receiving Postpartum Hypertension Screening
Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records.
Time frame: 12 weeks after delivery
Number of Participants With Hypertension Receiving Postpartum Hypertension Screening
Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records, among enrolled participants diagnosed with hypertensive disorders of pregnancy or chronic hypertension.
Time frame: 12 weeks after delivery
Number of Participants Using Contraception 12 Weeks After Delivery
The number of participants using contraception is evaluated via patient self-report survey.
Time frame: 12 weeks after delivery
Number of Participants Using Contraception 14 Months After Delivery
The number of participants using contraception is evaluated via patient self-report survey.
Time frame: 14 months after delivery
Number of Participants Using Medication 12 Weeks After Delivery
The number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction.
Time frame: 12 weeks after delivery
Number of Participants Using Medication 14 Months After Delivery
The number of participants using prescription medication for chronic conditions will be evaluated via medical record abstraction.
Time frame: 14 months after delivery
Number of Participants With Ongoing Pregnancy Complications at 12 Weeks After Delivery
The number of participants with diagnoses of severe maternal morbidity since the birth of their baby, identified from medical records using International Classification of Diseases diagnosis and any procedure codes from readmissions following the delivery.
Time frame: 12 weeks after delivery
Number of Participants With Ongoing Pregnancy Complications at 14 Months After Delivery
The number of participants with diagnoses of severe maternal morbidity since the birth of their baby, identified from medical records using International Classification of Diseases diagnosis and any procedure codes from readmissions following the delivery.
Time frame: 14 months after delivery
Number of Participants Readmitted to the Hospital at 12 Weeks After Delivery
The number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.
Time frame: 12 weeks after delivery
Number of Participants Readmitted to the Hospital at 14 Months After Delivery
The number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.
Time frame: 14 months after delivery
Perceived Risk of Severe Maternal Morbidity (SMM)
Future severe maternal morbidity risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a serious pregnancy complication during a future pregnancy compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Time frame: 12 weeks after delivery
Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery
Future cardiovascular disease risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a heart attack or stroke compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Time frame: 12 weeks after delivery
Perceived Risk of Cardiovascular Disease at 14 Month After Delivery
Future cardiovascular disease risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a heart attack or stroke compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Time frame: 14 months after delivery
Number of Participants Using Primary Care
The number of participants planning to attend, or have already attended, a visit with a primary care provider will be evaluated via medical record abstraction 14 months after delivery.
Time frame: 14 months after delivery
Number of Participants Using Specialty Care
The number of participants planning to attend, or having already attended, a visit with a specialty health care will be evaluated via medical record abstraction 14 months after delivery.
Time frame: 14 months after delivery
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery
Depressive symptoms are assessed with the Edinburgh Postnatal Depression Scale (EPDS). The EPDS includes 10-items asking participants about symptoms of depression that they have experienced in the past 7 days. Responses are given on a 4-point scale where 0 corresponds with the least amount of symptoms and 3 corresponds with the highest amount of symptoms. Total scores range from 0 to 30 with higher scores indicating increased symptoms of depression. Scores of 13 or greater indicate that the respondent is likely suffering from depression.
Time frame: 12 weeks after delivery
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 14 Months After Delivery
Depressive symptoms are assessed with the Edinburgh Postnatal Depression Scale (EPDS). The EPDS includes 10-items asking participants about symptoms of depression that they have experienced in the past 7 days. Responses are given on a 4-point scale where 0 corresponds with the least amount of symptoms and 3 corresponds with the highest amount of symptoms. Total scores range from 0 to 30 with higher scores indicating increased symptoms of depression. Scores of 13 or greater indicate that the respondent is likely suffering from depression.
Time frame: 14 months after delivery
Satisfaction With Postpartum Care
Satisfaction with the postpartum checkup is assessed by asking those participants who reported completing a postpartum visit if they were satisfied with the wait time, amount of time with healthcare providers, advice given, and respect shown to each individual as a person. Responses are given as "yes" or "no". The count of participants reporting satisfaction with each separate item is assessed.
Time frame: 12 weeks after delivery
Satisfaction With Provider at Postpartum Care Visit
Satisfaction with the healthcare provider at the postpartum care visit is assessed with 4 items. Responses are given on a 5-point scale where 1 = poor and 5 = excellent. Each item is scored separately and higher scores indicate greater satisfaction with the healthcare provider.
Time frame: 12 weeks after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Participants are asked to self-rate their perception of their physical health and mental health since delivery as "excellent", "very good", "good", "fair", "declined" or "poor". The number of participants endorsing each category of health is presented.
Time frame: 12 weeks after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery
Participants are asked to self-rate their perception of their physical health and mental health since delivery as "excellent", "very good", "good", "fair", "declined" or "poor". The number of participants endorsing each category of health is presented.
Time frame: 14 months after delivery
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