Addressing COVID-19 vaccine hesitancy in rural community pharmacies: a protocol for a stepped wedge randomized clinical trial.

BACKGROUND: Uptake of COVID-19 vaccines remains problematically low in the USA, especially in rural areas. COVID-19 vaccine hesitancy is associated with lower uptake, which translates to higher susceptibility to SARS-CoV-2 variants in communities where vaccination coverage is low. Because community pharmacists are among the most accessible and trusted health professionals in rural areas, this randomized clinical trial will examine implementation strategies to support rural pharmacists in delivering an adapted evidence-based intervention to reduce COVID-19 vaccine hesitancy. METHODS: We will use an incomplete stepped wedge trial design in which we will randomize 30 rural pharmacies (unit of analysis) to determine the effectiveness and incremental cost-effectiveness of a standard implementation approach (consisting of online training that describes the vaccine hesitancy intervention, live webinar, and resource website) compared to adding on a virtual facilitation approach (provided by a trained facilitator in support of the delivery of the vaccine hesitancy counseling intervention by pharmacists). The intervention (ASORT) has been adapted from an evidence-based vaccine communication intervention for HPV vaccines through a partnership with rural pharmacies in a practice-based research network in seven southern US states. ASORT teaches pharmacists how to identify persons eligible for COVID-19 vaccination (including a booster), solicit and address vaccine concerns in a non-confrontational way, recommend the vaccine, and repeat the steps later if needed. The primary trial outcome is fidelity to the ASORT intervention, which will be determined through ratings of recordings of pharmacists delivering the intervention. The secondary outcome is the effectiveness of the intervention, determined by rates of patients who agree to be vaccinated after receiving the intervention. Other secondary outcomes include feasibility, acceptability, adoption, reach, and cost. Cost-effectiveness and budget impact analyses will be conducted to maximize the potential for future dissemination and sustainability. Mixed methods will provide triangulation, expansion, and explanation of quantitative findings. DISCUSSION: This trial contributes to a growing evidence base on vaccine hesitancy interventions and virtual-only facilitation of evidenced-based practices in community health settings. The trial will provide the first estimate of the relative value of different implementation strategies in pharmacy settings. TRIAL REGISTRATION: NCT05926544 (clinicaltrials.gov); 07/03/2023.

Post-acute Ambulatory Care Service Use Among Patients Discharged Home After Stroke or TIA: The Cluster-randomized COMPASS Study.

BACKGROUND AND OBJECTIVES: We examined transitional care management within 90 days and 1 year following discharge home among acute stroke and transient ischemic attack patients from the Comprehensive Post-Acute Stroke Services (COMPASS) Study, a cluster-randomized pragmatic trial of early supported discharge conducted in 41 hospitals (40 hospital units) in North Carolina, United States. METHODS: Data for 2262 of the total 6024 (37.6%; 1069 intervention and 1193 usual care) COMPASS patients were linked with the Centers for Medicare and Medicaid Services fee-for-service Medicare claims. Time to the first ambulatory care visit was examined using Cox proportional hazard models adjusted for patient characteristics not included in the randomization protocol. RESULTS: Only 6% of the patients [mean (SD) age 74.9 (10.2) years, 52.1% women, 80.3% White)] did not have an ambulatory care visit within 90 days postdischarge. Mean time (SD) to first ambulatory care visit was 12.0 (26.0) and 16.3 (35.1) days in intervention and usual care arms, respectively, with the majority of visits in both study arms to primary care providers. The COMPASS intervention resulted in a 27% greater use of ambulatory care services within 1 year postdischarge, relative to usual care [HR=1.27 (95% CI: 1.14-1.41)]. The use of transitional care billing codes was significantly greater in the intervention arm as compared with usual care [OR=1.87 (95% CI: 1.54-2.27)]. DISCUSSION: The COMPASS intervention, which was aimed at improving stroke post-acute care, was associated with an increase in the use of ambulatory care services by stroke and transient ischemic attack patients discharged home and an increased use of transitional care billing codes by ambulatory providers.

A non-randomized pilot study to test the feasibility of treating chronic pain and opioid prescription use in rural areas with acceptance and commitment therapy (T-PACT).

Chronic non-cancer pain (CNCP) involves one-third of the US population, and prescription opioids contribute to the opioid epidemic. The Centers for Disease Control and Prevention emphasizes maximizing non-opioid treatment, but many rural populations cannot access alternative therapies. Clinical and Translational Science Award hubs across four rural states performed a multi-site, single-arm intervention feasibility study testing methods and procedures of implementing a behavioral intervention, acceptance and commitment therapy, in primary care CNCP patients on chronic opioids. Using the CONSORT extension for feasibility studies, we describe lessons learned in recruiting/retaining participants, intervention implementation, data measurement, and multi-site procedures. Results inform a future definitive trial and potentially others conducting rural trials.

Race-Specific Patterns of Treatment Intensification Among Hypertensive Patients Using Home Blood Pressure Monitoring: Analysis Using Defined Daily Doses in the Heart Healthy Lenoir Study.

BACKGROUND: Racial disparities in blood pressure (BP) control persist, but whether differences by race in antihypertensive medication intensification (AMI) contribute is unknown. OBJECTIVE: To compare AMI by race for patients with elevated home BP readings. METHODS: This prospective cohort study followed adult patients from 6 rural primary care practices who used home BP monitoring (HBPM) and recorded/reported values. For providers, AMI was encouraged when mean HBPM systolic blood pressure (SBP) values were ⩾135 mm Hg; patients received phone-based coaching on HBPM technique and sharing HBPM findings. AMI was assessed between baseline and 12 months using defined daily dose (DDD) and summed to create a total antihypertensive DDD value. RESULTS: A total of 217 patients (mean age = 61.4 ± 10.2 years; 66% female; 57% black) provided usable HBPM data. Among 90 (41%) intensification-eligible hypertensive patients (ie, mean HBPM SBP values for 6-months ⩾135 mm Hg), mean total antihypertensive DDD was increased in 61% at 12 months. Blacks had significantly higher mean DDD at baseline and 12 months, but intensification (+0.72 vs +0.65; P = 0.83) was similar by race. However, intensification was greater in males than females (+1.1 vs +0.39; P = 0.031). Reduction in mean SBP following intensification was greater in white versus black patients (-8.2 vs -3.9 mm Hg; P = 0.14). Conclusion/Relevance: Treatment intensification in HBPM users was similar by race, differed significantly by gender, and may produce a greater response in white patients. Differential AMI in HBPM users does not appear to contribute to persistent racial disparities in BP control.

Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.

Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. TRIAL REGISTRATION NUMBER: NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.

Organizational Leadership and Adaptive Reserve in Blood Pressure Control: The Heart Health NOW Study.

PURPOSE: Our purpose was to assess whether a practice's adaptive reserve and high leadership capability in quality improvement are associated with population blood pressure control. METHODS: We divided practices into quartiles of blood pressure control performance and considered the top quartile as the benchmark for comparison. Using abstracted clinical data from electronic health records, we performed a cross-sectional study to assess the association of top quartile hypertension control and (1) the baseline practice adaptive reserve (PAR) scores and (2) baseline practice leadership scores, using modified Poisson regression models adjusting for practice-level characteristics. RESULTS: Among 181 practices, 46 were in the top quartile, which averaged 68% or better blood pressure control. Practices with higher PAR scores compared with lower PAR scores were not more likely to reside in the top quartile of performance (prevalence ratio [PR] = 1.92 for highest quartile; 95% CI, 0.9-4.1). Similarly, high quality improvement leadership capability compared with lower capability did not predict better blood pressure control performance (PR = 0.94; 95% CI, 0.57-1.56). Practices with higher proportions of commercially insured patients were more likely than practices with lower proportions of commercially insured patients to have top quartile performance (37% vs 26%, P =.002), whereas lower proportions of the uninsured (8% vs 14%, P =.055) were associated with better performance. CONCLUSIONS: Our findings show that adaptive reserve and leadership capability in quality improvement implementation are not statistically associated with achieving top quartile practice-level hypertension control at baseline in the Heart Health NOW project. Our findings, however, may be limited by a lack of patient-related factors and small sample size to preclude strong conclusions.

Perceived Social Standing, Medication Nonadherence, and Systolic Blood Pressure in the Rural South.

PURPOSE: Little is known about how perceived social standing versus traditional socioeconomic characteristics influence medication adherence and blood pressure (BP) among African American and white patients with hypertension in the rural southeastern United States. METHODS: Perceived social standing, socioeconomic characteristics, self-reported antihypertensive medication adherence, and BP were measured at baseline in a cohort of rural African American and white patients (n = 495) with uncontrolled hypertension attending primary care practices. Multivariate models examined the relationship of perceived social standing and socioeconomic indicators with medication adherence and systolic BP. FINDINGS: Medication nonadherence was reported by 40% of patients. Younger age [ß = 0.20; P = .001], African American race [ß = -0.30; P = .03], and lower perceived social standing [ß = 0.08; P = .002] but not sex or traditional socioeconomic characteristics including education and household income, were significantly associated with lower medication adherence. Race-specific analyses revealed that this pattern was limited to African Americans and not observed in whites. In stepwise modeling, older age [ß = 0.57, P = .001], African American race [ß = 4.4; P = .03], and lower medication adherence [ß = -1.7, P = .01] but not gender, education, or household income, were significantly associated with higher systolic BP. CONCLUSIONS: Lower perceived social standing and age, but not traditional socioeconomic characteristics, were significantly associated with lower medication adherence in African Americans. Lower medication adherence was associated with higher systolic BP. These findings suggest the need for tailored, culturally relevant medication adherence interventions in rural communities.

Comparing traditional and participatory dissemination of a shared decision making intervention (ADAPT-NC): a cluster randomized trial.

BACKGROUND: Asthma is a common disease that affects people of all ages and has significant morbidity and mortality. Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and care delivery methods such as shared decision making (SDM) into clinical practice. METHODS/DESIGN: This non-blinded study will randomize 30 primary care clinics in NC stratified by four PBRNs. We will test dissemination across these practices using a facilitator-led participatory approach to dissemination (FLOW), a novel method of participatory dissemination involving key principles of community-based participatory research, and a more typical "lunch and learn" dissemination method. Specifically, we will use cluster randomization to assign each of the 30 practices to one of three arms: (1) control, no dissemination; (2) traditional dissemination, one didactic session a year and distribution of educational material; and (3) FLOW dissemination. We hypothesize that at the unit of randomization, the clinic, patients in the FLOW dissemination arm will be more likely to share in their treatment decisions compared to patients in the traditional dissemination or control arms. All outcomes will be measured at the level of the clinic. Adoption of the SDM approach will be evaluated by 1) asthma exacerbations, 2) level of patient involvement in the decision making process, and 3) qualitative assessments from patients and providers. TRIAL REGISTRATION: The trial was registered on January 27, 2014 through the United States National Institutes of Health's ClinicalTrials.gov NCT02047929 and funded by the Patient-Centered Outcomes Research Institute (PCORI).

The Heart Healthy Lenoir project--an intervention to reduce disparities in hypertension control: study protocol.

BACKGROUND: Racial disparities in blood pressure control are well established; however the impact of low health literacy (LHL) on blood pressure has garnered less attention. Office based interventions that are created with iterative patient, practice and community stakeholder input and are rolled out incrementally, may help address these disparities in hypertension control. This paper describes our study protocol. METHODS/DESIGN: Using a community based participatory research (CBPR) approach, we designed and implemented a cohort study that includes both a practice level and patient level intervention to enhance the care and support of patients with hypertension in primary care practices in a rural region of eastern North Carolina. The study is divided into a formative phase and an ongoing 2.5 year implementation phase. Our main care enhancement activities include the integration of a community health coach, using home blood pressure monitoring in clinical decision making, standardizing care delivery processes, and working to improve medication adherence. Main outcomes include overall blood pressure change, the differential change in blood pressure by race (African American vs. White) and health literacy level (low vs. higher health literacy). DISCUSSION: Using a community based participatory approach in primary care practice settings has helped to engage patients and practice staff and providers in the research effort and in making practice changes to support hypertension care. Practices have engaged at varying levels, but progress has been made in implementing and iteratively improving upon the interventions to date. TRIAL REGISTRATION: ClinicalTrials.gov NCT01425515.

How eight primary care practices initiated and maintained quality monitoring and reporting.

BACKGROUND: Primary care medical practices increasingly are asked by payers, employers, and government agencies to report quality data, but the process of doing so is not well delineated. METHODS: Providers and office staff in a diverse sample of eight primary care practices in North Carolina comprised this study population. Interviews were conducted and self-administered questionnaires were disseminated in practices that were successfully reporting data to one or more of 4 reporting programs. Our measures included responses to open-ended and Likert scale questions about experiences and potential facilitators and barriers, as well as subscales of the Practice Assessment tool and the Culture of Group Practices instrument. RESULTS: Study practices had stronger change histories, higher information and quality emphases, and lower business emphases than historical comparison practices. Motivation to participate, a leader who catalyzes the process, and establishment of new systems characterized successful practices. Staff time, information technology challenges, and resistance from some providers were common barriers. Practices achieve a sustainability state when numerous barriers have been successfully overcome and tangible results achieved from the process. CONCLUSIONS: Implementing and sustaining quality reporting requires a complex set of motivators, facilitators, and strategies to overcome inherent barriers that can present themselves in practices that seek to implement changes in this direction.

Establishing worksite wellness programs for North Carolina government employees, 2008.

BACKGROUND: State employee health plans sometimes provide worksite wellness programs to reduce the prevalence of chronic diseases among their members, but few offer the comprehensive range of interventions recommended by the Task Force on Community Preventive Services. COMMUNITY CONTEXT: North Carolina's State Health Plan for Teachers and State Employees provides health coverage for approximately 665,000 state employees, teachers, retirees, and dependents. Health claims indicate that the prevalence of having at least 1 chronic disease or of being obese is approximately 32% among state employees. METHODS: The State Health Plan created a partnership with North Carolina's Division of Public Health, Office of State Personnel, and other key state agencies to identify bureaucratic obstacles to providing worksite wellness programs for state employees and to develop a state policy to address them. The Division of Public Health established a model worksite program to guide development of the worksite wellness policy and pilot wellness interventions. OUTCOME: The state's first worksite wellness policy created an employee wellness infrastructure in state government and addressed administrative barriers to allow effective worksite wellness interventions. For example, the policy led to pilot implementation of a subsidized worksite weight management program. Positive results of the program helped generate legislative support to expand the weight management program throughout state government. INTERPRETATION: Strong interagency partnership is essential to guide worksite wellness policy and program development in state government. State health plans, public health agencies, and personnel agencies each play a role in that partnership.