Consent and enrollment process: achieving high enrollment rates for obstetric research.

AIM: The aim was to study the development, design, and implementation of a patient consent and enrollment initiative to identify strategies that enhanced participation. BACKGROUND: Consent and enrollment of patients, especially pregnant women, remains a challenge in healthcare research. Although many barriers have been identified, strategies to consistently improve consent and enrollment are less defined. METHODS: A case study was conducted on a consent and enrollment approach aimed at optimizing participation of mothers who delivered their infants from July 1, 2010 through June 30, 2013. Data were gathered through practitioner interviews, focus groups, and documentation review for each year of the study. RESULTS: A total of 19,236 mothers enrolled, representing an 85% enrollment rate at the five study sites. Enrollment rates improved over time with increased nursing engagement in patient recruitment, site specific adaptations and patient education strategies. CONCLUSIONS: Nursing's active role in implementation and rapid feedback loop of a multifaceted consent and enrollment program showed promise.

Recruitment of asthmatic ethnic minorities into a methacholine research study: factors influencing participation.

BACKGROUND: How to recruit minority participants into research studies has been an issue since 1993, when NIH funding guidelines required minorities to be included as research participants. OBJECTIVE: The purpose of this analysis was to determine what factors affected recruitment of asthmatic minorities into a large bronchoconstrictor study involving African-Americans, Hispanics/Mexican Americans, Asian/Pacific Islanders, and whites with mild asthma (forced expiratory volume in the first second of expiration > or = 70%). METHODS: Ethnic minorities were recruited for 3 years. Recruitment strategies included physician and clinic referrals, newspaper ads, posters in health care settings, asthma databases, and electronic resources. FINDINGS: After 3 years, the total number of referrals was 650, with 50 from medical doctor clinic settings and 600 from all of the other resources. The inclusion/exclusion criteria were clearly listed, but only 64.5% (419/650) of respondents met inclusion criteria. Of these, only 31.9% (134/419) [corrected] met pulmonary function testing criteria. Only 5, or 1% of the 50 medical doctor clinic referrals met inclusion criteria--1 participated. A total of 106, or 82.8%, completed all of the study procedures; for 87.7% of participants this was their first research experience. Hispanics/Mexican Americans accounted for only 14.8% of the total recruitment responses. CONCLUSION: We believe our recruitment strategies did encourage ethnic minorities to participate, but the inclusion criteria of a positive methacholine response proved to be a study enrollment barrier.

Ethnic differences in methacholine responsiveness and word descriptors in African Americans, Hispanic-Mexican Americans, Asian-Pacific Islanders, and Whites with mild asthma.

OBJECTIVE: There is little asthma research that compares ethnic differences in airway responsiveness and word descriptors among African Americans, Hispanic-Mexican Americans, Asian-Pacific Islanders, and Whites. Thus, identifying ethnic differences in symptom descriptors and airway responsiveness may improve health outcomes by educating health professionals about treatment decisions that are culturally and ethnically sensitive. METHODS: Specific Inclusion criteria-forced expiratory volume in one second (FEV(1)) >or= 70% predicted normal; provocative concentration causing a 30% fall in FEV(1) (PC(30))

Disproportionate Preterm Delivery Among Black Women: a State-Level Analysis.

Preterm delivery occurs at extraordinarily higher rates among Black women than among women of any other race or ethnicity. For those children who survive, many face a lifetime of health and developmental challenges as well as difficulties in school and life. Previous studies have provided substantive evidence that the preterm delivery disparity experienced by Black women is associated with ongoing distress caused by racism. Our study examines rates of preterm delivery for Black women in the USA to determine the level of risk associated with living in specific states. Using a logistic regression model, we examined the impact of the delivery state, controlling for known clinical, economic, and demographic risk factors. We found that 32 of the 35 states included in our analysis were associated with a statistically significantly increased risk of preterm delivery among Black women, as compared to the state with the lowest preterm delivery rate for Black women. These findings allowed us to organize states into a continuum of preterm delivery risk. Because of the harmful effects of preterm delivery and its disproportionate impact among Black women and infants, we recommend that a measure of preterm delivery be included in any state plan to assess, intervene in, and monitor racial disparities.

Sustaining and spreading quality improvement: Decreasing intrapartum malpractice risk.

BACKGROUND: Malpractice liability is an ongoing problem in obstetrics. However, developing, sustaining, and spreading effective interventions is challenging. The aim of this study is to examine the spread and sustainability of a multilevel integrated practice and coordinated communication model 66 months after its original implementation. METHODS: Data on labor and delivery patients from 37 hospitals (5 beta sites and 32 expansion sites) were analyzed for the 81-month time period from January 2010 through September 2016. RESULTS: High-risk occurrence rates per 1000 live births decreased by over 70% at both beta and expansion sites. The likelihood of a high-risk occurrence was statistically significantly lower during the final study period than in the preintervention period at both beta sites (odds ratio [OR] = 0.218; p < .0001) and expansion sites (OR = 0.288; p < .001). CONCLUSION: The multilevel integrated practice and coordinated communication model was successfully spread and sustained. Key elements contributing to this success included developing and maintaining evidence-based guidelines, ensuring leadership buy-in and support, collecting and reporting performance measures, holding teams accountable, providing training, and ensuring transparent communication.

Population-Based Risk Factors for Shoulder Dystocia.

OBJECTIVE: To re-examine the risk factors for shoulder dystocia given the increasing rates of obesity and diabetes in pregnant women. DESIGN: Retrospective observational study. SETTING: Five hospitals located in Wisconsin, Florida, Maryland, Michigan, and Alabama. PARTICIPANTS: We evaluated 19,236 births that occurred between April 1, 2011, and July 25, 2013. METHODS: Data were collected from electronic medical records and used to evaluate the risk of shoulder dystocia. Data were analyzed using a generalized linear mixed model, which controlled for clustering due to site. RESULTS: When insulin was prescribed, gestational diabetes was associated with an increased risk of shoulder dystocia (odds ratio = 2.10, 95% confidence interval [1.01, 4.37]); however, no similar association was found with regard to gestational diabetes treated with glycemic agents or through diet. Use of epidural anesthesia was associated with an increased risk for shoulder dystocia (odds ratio = 3.47, 95% confidence interval [2.72, 4.42]). Being Black or Hispanic, being covered by Medicaid or having no insurance, infant gestational age of 41 weeks or greater, and chronic diabetes were other significant risk factors. CONCLUSION: With the changing characteristics of pregnant women, labor and birth clinicians care for more pregnant women who have an increased risk for shoulder dystocia. Our findings may help prospectively identify women with the greatest risk.

Changing Labor and Delivery Practice: Focus on Achieving Practice and Documentation Standardization with the Goal of Improving Neonatal Outcomes.

OBJECTIVE: To establish multifactorial shoulder dystocia response and management protocol to promote sustainable practice change. DATA SOURCES/STUDY SETTING: Primary data collection was conducted over 3 years. Implementation of the protocol spanned 13 months. Data collection occurred at five sites, which were chosen for their diversity in both patient mix and geographical location. STUDY DESIGN: Case study evaluation methodology was used to examine clinician engagement and protocol adoption. DATA COLLECTION METHODS: The training completion for all practice engagement team activities was collected by the site project manager and entered into a flat file. Data from the labor and delivery notes, medical records, and interviews with labor and delivery teams were gathered and analyzed by the senior investigator. PRINCIPAL FINDINGS: In the first year, there was a threefold increase in shoulder dystocia reporting, which continued in years 2 and 3. In the first year, 96 percent of clinicians completed all training elements and in subsequent years, 98 percent completed the follow-up training. Overall teams reached a 99 percent adoption rate of the shoulder dystocia protocol. CONCLUSIONS: System and site management teams implemented a standardized shoulder dystocia protocol that fostered effective teamwork and obstetric team readiness for managing shoulder dystocia emergencies.