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.

Opioid overdose counseling and prescribing of naloxone in rural community pharmacies: A pilot study.

INTRODUCTION: Fatal overdoses from opioids increased four-fold from 1999 to 2009, and they are now the leading cause of death among Americans under 50. Legislation has been passed by every state to increase access to naloxone but dispensing by community pharmacies remains low. OBJECTIVES: The objective of this study was to pilot test a proactive opioid overdose counseling intervention and a passive naloxone intervention, and the implementation strategies developed to support their delivery, in rural community pharmacies on relevant implementation outcomes. METHODS: The interventions, implementation strategies, and the overall pilot study approach were developed in a collaborative partnership with a regional supermarket pharmacy chain. They selected 2 rural pharmacies to participate in the pilot study and 2 non-intervention pharmacies to serve as comparison sites. Two interventions were pilot tested in the 2 intervention pharmacies: 1)a proactive opioid overdose counseling intervention and 2) a passive naloxone intervention. An explanatory sequential mixed-methods design was utilized to evaluate adoption, feasibility, acceptability, and appropriateness outcomes after the 3-month observation period. RESULTS: Between the 2 intervention pharmacies, 130 patients received the opioid overdose counseling intervention. 44 (33.8%) were prescribed and dispensed naloxone. Zero naloxone prescriptions were written or dispensed at the comparison pharmacies. Interviews with pharmacy staff found the interventions to be feasible, acceptable, and appropriate in their settings. CONCLUSION: This small scale pilot study in partnership with a regional supermarket pharmacy chain had positive results with a third of patients who received the opioid overdose counseling intervention being dispensed naloxone. However, the majority of patients did not receive naloxone indicating additional revisions to the intervention components and/or implementation strategies are needed to improve the overall impact of the interventions.

Perceptions of HPV vaccination and pharmacist-physician collaboration models to improve HPV vaccination rates.

BACKGROUND: Human Papillomavirus (HPV) is the most common sexually transmitted disease in the United States (US), with 12 cancer causing strains. Vaccination rates in the southern US fall below the national average. Pharmacists provide an opportunity to improve vaccination rates. OBJECTIVES: The objectives of this study were to 1) identify barriers and facilitators to providing the HPV vaccine and Vaccines for Children (VFC) program participation in pharmacies and clinics, and 2) assess pharmacy staff, clinic staff, and parent perceptions of 3 collaboration models to improve HPV vaccination. METHODS: A developmental formative evaluation was conducted with pharmacy staff, primary care clinic staff, and parents of adolescent children. Interview guides were informed by the Consolidated Framework for Implementation Research (CFIR). Barriers and facilitators to HPV vaccination and VFC participation were explored. Additionally, acceptability of 3 collaboration models were explored: 1) a shared-responsibility model in which a physician provides the first dose of HPV vaccine with the second provided in the pharmacy, 2) a pharmacy-based model in which a clinic refers patients to the pharmacy to receive both doses, and 3) an insourced model in which pharmacists schedule days to provide the vaccine in the collaborating clinic. RESULTS: Twenty-nine interviews were conducted between August 2019 and June 2020. Both pharmacy and clinic staff had positive views toward the HPV vaccine and vaccinations in general. Pharmacists and physicians reported parental awareness and education as a barrier to HPV vaccination. Counseling about HPV vaccine was reported as being more time-consuming because of the stigma associated with the vaccine. Parents were willing to have their children vaccinated for HPV in the pharmacy but desired their child's physician be involved in the immunization process. The shared-responsibility model was the most favored of the 3 collaboration models. CONCLUSION: Perceptions of the HPV vaccine and vaccination in pharmacies were positive. Collaboration between clinics and pharmacies to improve HPV vaccination rates is viewed positively by pharmacy staff, clinic staff, and parents. This study will guide implementation of pharmacist-physician collaborative models to improve vaccination through pharmacy participation in the VFC program and HPV vaccination.

Improving HPV vaccination using implementation strategies in community pharmacies: Pilot study protocol.

BACKGROUND: Nearly 80 million people in the United States have contracted the Human Papillomavirus (HPV), and it is currently the most common sexually transmitted disease. Each year approximately 14 million people are newly infected. OBJECTIVE(S): This study will address increasing the HPV vaccination rates by initiating a research agenda focusing on how best to utilize community pharmacies as Vaccines For Children (VFC) vaccination sites. Community pharmacies are highly accessible when compared to traditional vaccination sites due to extended evening and weekend business hours, no copays for visits, and no appointment required to speak with a pharmacist. METHODS: We will conduct a Developmental Formative Evaluation using semi-structured interviews with key informants (pharmacists, pharmacy managers, technicians) from 5 Harps pharmacies to identify barriers and facilitators to community pharmacies' provision of HPV vaccine through a mixed methods design with pharmacy staff members and local physicians. We will follow that by selecting a pharmacist-physician collaborative model and identify implementation strategies through an Evidence Based Quality Improvement (EBQI) process with key stakeholders. This will be followed by piloting the selected pharmacist-physician collaborative model and implementation strategies in two Harps pharmacies (1 rural, 1 urban) on relevant implementation outcomes. PROJECT IMPACT: This study will examine the current model of HPV vaccinations and how to improve HPV vaccination rates among adolescents by utilizing community pharmacy services.

Communication between pharmacists and primary care physicians in the midst of a U.S. opioid crisis.

BACKGROUND: Effective communication between prescribers of opioids and community pharmacists can contribute to maximizing appropriate pain management and reducing opioid misuse and diversion. While much of the education and training available on reducing opioid misuse and diversion stresses the importance of interprofessional communication between prescribers and pharmacists, few studies have been explored those communication patterns directly. OBJECTIVE: The objectives of this manuscript are to present and explore key emergent themes from a qualitative study around the nature, frequency, and content of communication between primary care physicians (PCPs) and pharmacists focusing on opioids. METHODS: Interviews were conducted with 48 PCPs and 60 community pharmacists across four states in the U.S.: Washington, Idaho, Kentucky and Arkansas. RESULTS: Convergent results from both samples indicated that the content of communication usually centers on questions of dosing, timing of the prescription, and/or evidence of potential misuse/diversion. When communication was focused on relaying information about a patient and/or clarifying questions around the prescription, it appeared positive for both parties. Results also indicated that close physical proximity between PCPs and dispensing pharmacists contributed to more positive and useful communication, especially when the clinics and pharmacies were part of the same healthcare system. Many pharmacists reported hesitancy in "questioning" a physician's judgement, which appeared related to commonly held beliefs of both pharmacists and physicians about the respective roles of each in providing patient care. Pharmacists reported difficulty in reaching PCPs for discussion, while PCPs reported it was easy to reach pharmacists. CONCLUSIONS: Physician and pharmacist communication around opioids can be mutually beneficial. When prescribers and pharmacists are co-located, higher levels of trust and teamwork are reported, which in turn seems to be related to more open and positive communication. Additional research is needed to identify interventions to increase mutually-valued communication that improves the quality of decision-making around opioids.

Reliability and validity of the substance abuse outcomes module.

OBJECTIVE: The study sought to determine the validity and reliability of the Substance Abuse Outcomes Module (SAOM), a self-report tool designed to assess patient characteristics, process of care, and outcomes of care, using a minimum amount of information, in order to improve treatment. METHODS: A longitudinal field test (baseline and three-month follow-up) compared the SAOM to seven other research instruments in the assessment of 100 substance-abusing patients who were entering a new treatment episode. Quota samples of patients were drawn from two private inpatient substance abuse treatment facilities and an outpatient methadone clinic. The study's primary outcome measures were diagnostic accuracy, internal and test-retest reliability of key constructs, concurrent and predictive validity, and sensitivity to change. Cronbach's alpha coefficients were calculated to examine internal consistency and reliability. Intraclass correlation coefficients and kappa coefficients were used to examine test-retest reliability. Concurrent validity of outcomes measures was examined with Pearson or Spearman correlation coefficients and chi square and kappa statistics. Changes between baseline and follow-up were examined as a function of case-mix measures with ordinary least-squares multiple regression. Sensitivity to change was examined by calculating effect size scores. RESULTS: The SAOM had high internal consistency and a high level of agreement with research diagnoses at baseline and follow-up. The SAOM was found to be highly reliable, to have very strong validity, and to be sensitive to clinical change. CONCLUSIONS: The SAOM appears to be a reasonably reliable and valid self-report instrument when used to monitor substance abuse treatment among patients with a primary substance use diagnosis.