Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.

BACKGROUND: The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients. METHODS: Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0-mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate. CONCLUSIONS: IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.

Follow-up approaches to a health literacy intervention to increase colorectal cancer screening in rural community clinics: A randomized controlled trial.

BACKGROUND: Significant disparities exist in colorectal cancer (CRC) screening rates among those of low socioeconomic status, with fewer years of education, lacking health insurance, or living in rural areas. METHODS: A randomized controlled trial was conducted to compare the effectiveness of 2 follow-up approaches to a health literacy intervention to improve CRC screening: automated telephone call or personal call. Patients aged 50 to 75 years residing in 4 rural community clinics in Louisiana were given a structured interview that assessed demographic, health literacy and CRC screening barriers, knowledge, and attitudes. All were given health literacy-informed CRC education, a patient-friendly CRC screening pamphlet, simplified fecal immunochemical test (FIT) instructions, and a FIT kit, and a "teach-back" method was used to confirm understanding. Patients were randomized to 1 of 2 telephone follow-up arms. If they did not mail their FIT kit within 4 weeks, they received a reminder call and were called again at 8 weeks if the test still was not received. RESULTS: A total of 620 patients were enrolled. Approximately 55% were female, 66% were African American, and 40% had limited literacy. The overall FIT completion rate was 68%: 69.2% in the automated telephone call arm and 67% in the personal call arm. Greater than one-half of the patients (range, 58%-60%) returned the FIT kit without receiving a telephone call. There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%. CONCLUSIONS: Providing FIT kits and literacy-appropriate education at regularly scheduled clinic visits with a follow-up telephone call when needed was found to increase CRC screening among low-income, rural patients. The lower cost automated call was just as effective as the personal call.

Health-care Worker Engagement in Federally Qualified Health Centers and Associations with Confidence in Making Health-care Recommendations: Evidence from the Louisiana Community Engagement Alliance.

Throughout the coronavirus disease 2019 (COVID-19) pandemic, there have been numerous demands on primary care practices and providers affecting work engagement and burnout, which can affect health-care delivery and patient outcomes. We determined potentially modifiable factors associated with work engagement among employees of federally qualified health centers (FQHCs) throughout Louisiana. Resilient coping, spirituality, and social support were associated with being engaged at work. FQHC employees perceiving a more chaotic work environment and those with depressive or anxiety symptoms were less likely to be engaged at work. Being engaged was associated with confidence in COVID-19 vaccine recommendation for adults.

Demographic Determinants and Geographical Variability of COVID-19 Vaccine Hesitancy in Underserved Communities: Cross-sectional Study.

BACKGROUND: COVID-19 hospitalizations and deaths disproportionately affect underserved and minority populations, emphasizing that vaccine hesitancy can be an especially important public health risk factor in these populations. OBJECTIVE: This study aims to characterize COVID-19 vaccine hesitancy in underserved diverse populations. METHODS: The Minority and Rural Coronavirus Insights Study (MRCIS) recruited a convenience sample of adults (age≥18, N=3735) from federally qualified health centers (FQHCs) in California, the Midwest (Illinois/Ohio), Florida, and Louisiana and collected baseline data in November 2020-April 2021. Vaccine hesitancy status was defined as a response of "no" or "undecided" to the question "Would you get a coronavirus vaccine if it was available?" ("yes" categorized as not hesitant). Cross-sectional descriptive analyses and logistic regression models examined vaccine hesitancy prevalence by age, gender, race/ethnicity, and geography. The expected vaccine hesitancy estimates for the general population were calculated for the study counties using published county-level data. Crude associations with demographic characteristics within each region were assessed using the chi-square test. The main effect model included age, gender, race/ethnicity, and geographical region to estimate adjusted odds ratios (ORs) and 95% CIs. Interactions between geography and each demographic characteristic were evaluated in separate models. RESULTS: The strongest vaccine hesitancy variability was by geographic region: California, 27.8% (range 25.0%-30.6%); the Midwest, 31.4% (range 27.3%-35.4%); Louisiana, 59.1% (range 56.1%-62.1%); and Florida, 67.3% (range 64.3%-70.2%). The expected estimates for the general population were lower: 9.7% (California), 15.3% (Midwest), 18.2% (Florida), and 27.0% (Louisiana). The demographic patterns also varied by geography. An inverted U-shaped age pattern was found, with the highest prevalence among ages 25-34 years in Florida (n=88, 80.0%,) and Louisiana (n=54, 79.4%; P<.05). Females were more hesitant than males in the Midwest (n= 110, 36.4% vs n= 48, 23.5%), Florida (n=458, 71.6% vs n=195, 59.3%), and Louisiana (n= 425, 66.5% vs. n=172, 46.5%; P<.05). Racial/ethnic differences were found in California, with the highest prevalence among non-Hispanic Black participants (n=86, 45.5%), and in Florida, with the highest among Hispanic (n=567, 69.3%) participants (P<.05), but not in the Midwest and Louisiana. The main effect model confirmed the U-shaped association with age: strongest association with age 25-34 years (OR 2.29, 95% CI 1.74-3.01). Statistical interactions of gender and race/ethnicity with the region were significant, following the pattern found by the crude analysis. Compared to males in California, the associations with the female gender were strongest in Florida (OR=7.88, 95% CI 5.96-10.41) and Louisiana (OR=6.09, 95% CI 4.55-8.14). Compared to non-Hispanic White participants in California, the strongest associations were found with being Hispanic in Florida (OR=11.18, 95% CI 7.01-17.85) and Black in Louisiana (OR=8.94, 95% CI 5.53-14.47). However, the strongest race/ethnicity variability was observed within California and Florida: the ORs varied 4.6- and 2-fold between racial/ethnic groups in these regions, respectively. CONCLUSIONS: These findings highlight the role of local contextual factors in driving vaccine hesitancy and its demographic patterns.

COVID-19 vaccination likelihood among federally qualified health center patients: Lessons learned for future health crises.

BACKGROUND: To prepare for rollout of a COVID-19 vaccine in fall 2020, there was an urgent need to understand barriers to ensuring equitable access and addressing vaccine skepticism and resistance. This study aimed to understand the association between trusted sources of COVID-19 information and likelihood of vaccination during that time, focusing on lessons learned to prepare for future public health crises. METHODS: From December 2020-March 2021, we surveyed a probability-based, cross-sectional sample of 955 patients across seven federally qualified health centers (FQHCs) serving predominantly low-income, Black and White populations in southeastern Louisiana. Vaccination likelihood was measured on a 7-point scale; "very likely to vaccinate" was defined as score=7. Trust in healthcare provider was measured with a single survey item. High trust in personal contacts, government, and media, respectively, were defined as the highest tertiles of summative scores of trust items. Weighted multivariable logistic regression estimated adjusted odds ratios (aOR) and 95% confidence intervals (CI) for being very likely to vaccinate. RESULTS: Participants were 56% Black, 64% women, mean age 44.6 years; 33% were very likely to vaccinate. High trust in healthcare provider (aOR=4.14, 95% CI 2.26-7.57) and government sources (aOR=3.23, 95% CI 1.98-5.28) were associated with being very likely to vaccinate. CONCLUSIONS: During initial COVID-19 vaccination rollout, trust in healthcare providers and government sources of COVID-19 information was associated with likelihood to vaccinate in FQHC patients. To inform public health planning for future crises, we highlight lessons learned for translating community-relevant insights into direct action to reach those most impacted.

The Minority and Rural Coronavirus Insights Study: Design and Baseline Characteristics of a Minority Cohort.

The Minority and Rural Coronavirus Insights Study (MRCIS) is an ongoing prospective cohort study examining health disparities associated with SARS-CoV-2 infection among medically underserved populations. This report describes procedures implemented to establish the MRCIS cohort and examines the factors associated with the molecular and serological assessment of SARS-CoV-2 infection status at participant enrollment. Participants were recruited from 5 geographically dispersed federally qualified health centers between November 2020 and April 2021. At baseline, participants completed a detailed demographic survey and biological samples were collected for testing. SARS-CoV-2 infection status was determined based on the combined molecular and serological test results. Chi-squared and logistic regression analyses were conducted to examine associations between sociodemographic factors, COVID-19 safety measures, existing comorbidities, and SARS-CoV-2 infection status. The final cohort included 3238 participants. The mean age of participants was 50.2 ± 15.8 years. Most participants identified as female (60.0%), heterosexual or straight (93.0%), White (47.6%), and Hispanic or Latino (49.1%). Approximately 26.1% of participants had at least one positive SARS-CoV-2 test result. The main effect model included age, sex, and race/ethnicity. Compared with adults ≥65 years, participants in all other age groups had ∼2 times increased odds of a positive SARS-CoV-2 test result. In addition, racial/ethnic minorities had ∼2 times increased odds of a positive SARS-CoV-2 infection status compared with non-Hispanic Whites. A unique cohort of a traditionally medically underserved minority population was established. Significant racial and ethnic disparities in SARS-CoV-2 infection status at baseline were discovered.

Experiences and Beliefs of Low-Income Patients With Hypertension in Louisiana and Mississippi During the COVID-19 Pandemic.

Background The coronavirus disease 2019 (COVID-19) pandemic disproportionately affects individuals with hypertension and health disparities. Methods and Results We assessed the experiences and beliefs of low-income and minority patients with hypertension during the COVID-19 pandemic. Participants (N=587) from the IMPACTS-BP (Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control) study completed a telephone survey in May and June of 2020. Participants were 65.1% Black and 59.7% female, and 57.7% reported an income below the federal poverty level. Overall, 2.7% tested positive and 15.3% had lost a family member or friend to COVID-19. These experiences were significantly more common in Black (3.9% and 19.4%, respectively) than in non-Black participants (0.5% and 7.8%, respectively). In addition, 14.5% lost a job and 15.9% reported food shortages during the pandemic. Most participants complied with stay-at-home orders (98.3%), social distancing (97.8%), and always wearing a mask outside their home (74.6%). Participants also reported high access to needed health care (94.7%) and prescription medications (97.6%). Furthermore, 95.7% of respondents reported that they continued to take their regular dosage of antihypertensive medications. Among the 44.5% of participants receiving a healthcare appointment by telehealth, 96.6% got the help they needed, and 80.8% reported that the appointment quality was as good as or better than in-person visits. Finally, 88.9% were willing to return to their primary care clinic. Conclusions These data suggest that low-income patients, especially Black patients, were negatively impacted by COVID-19. However, most patients were able to access needed healthcare services and were willing to return to their primary care clinic for hypertension management. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03483662.

Closing the Loop on Electronic Referrals: A Quality Improvement Initiative Using the Care Coordination Model.

Primary care providers refer nearly one-third of their patients to specialty care services. Despite provider recommendations, approximately 1 in 4 referrals are never completed. Incomplete referral rates are higher among vulnerable and medically underserved individuals. Sixty-seven percent of federally qualified community health centers report difficulty obtaining specialty care appointments and incomplete referral rates as high as 73%. Effective electronic referral processes can improve health outcomes, reduce waste, and mitigate risks. Using the Care Coordination Model as its framework, this quality improvement initiative implemented evidence-based interventions aimed at improving patient support and organizational accountability for electronic referrals.

Repeat Annual Colorectal Cancer Screening in Rural Community Clinics: A Randomized Clinical Trial to Evaluate Outreach Strategies to Sustain Screening.

PURPOSE: The majority of colorectal cancer (CRC) research using the fecal immunochemical test (FIT) has studied short-term screening results in predominantly urban areas. The purpose of this study was to evaluate the effectiveness of 2 outreach strategies embedded in a health literacy intervention on repeat CRC screening in rural community clinics. METHODS: A 2-arm randomized controlled trial was conducted in 4 rural clinics in Louisiana. During a regularly scheduled clinic visit, participants ages 50-75 received a FIT kit and brief educational intervention. Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned. In year 2, materials were mailed, and follow-up calls were conducted as in year 1. The primary outcome was repeat FIT-the return of the FIT kit in both years. PARTICIPANTS: Of 568 eligible participants, 55% were female, 67% were African American, and 39% had low health literacy. FINDINGS: Repeat FIT rates were 36.5% for those receiving the automated call and 33.6% for those receiving a personal call (P = .30). No annual FITs were returned in 30% of participants, while only 1 FIT was returned by 35% of participants (31% only year 1 and 4% only year 2). CONCLUSION: Sustaining CRC screening with FIT is challenging in rural clinics. A lower cost automated call was just as effective as the personal call in promoting repeat annual screening. However, more intensive strategies are needed to improve long-term FIT screening among rural participants.