Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.

Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).

Optimizing Patient Engagement in Treatment for Opioid Use Disorder: Primary Care Team Perspectives on Influencing Factors.

BACKGROUND: Opioid use disorder (OUD) care engagement rates in primary care (PC) settings are often low. Little is known about PC team experiences when delivering OUD treatment and potential factors that influence their capacity to engage patients in treatment. Exploring PC team experiences may inform needed supports that can optimize OUD care delivery and improve outcomes for patients with OUD. OBJECTIVE: We explored multidisciplinary PC team perspectives on barriers and facilitators to engaging patients in OUD treatment. DESIGN: Qualitative study using in-depth interviews. PARTICIPANTS: Primary care clinical teams. APPROACH: We conducted semi-structured interviews (n = 35) with PC team members involved in OUD care delivery, recruited using a combination of criterion and maximal variation sampling. Data collection and analysis were informed by existing theoretical literature about patient engagement, specifically that patient engagement is influenced by factors across individual (patient, provider), interpersonal (patient-provider), and health system domains. Interviews were professionally transcribed and doubled-coded using a coding schema based on the interview guide while allowing for emergent codes. Coding was iteratively reviewed using a constant comparison approach to identify themes and verified with participants and the full study team. KEY RESULTS: Analysis identified five themes that impact PC team ability to engage patients effectively, including limited patient contact (e.g., phone, text) in between visits, varying levels of provider confidence to navigate OUD treatment discussions, structural factors (e.g., schedules, productivity goals) that limited provider time, the role of team-based approaches in lessening discouragement and feelings of burnout, and lack of shared organizational vision for reducing harms from OUD. CONCLUSIONS: While the capacity of PC teams to engage patients in OUD care is influenced across multiple levels, some of the most promising opportunities may involve addressing system-level factors that limit PC team time and collaboration and promoting organizational alignment on goals for OUD treatment.

Digital education about delirium for health care professional students: a mixed methods systematic review.

BACKGROUND: Competence in delirium care begins with pre-registration education for health care professionals. Although a common complication for hospitalised patients, delirium is avoidable and reversible. Delirium requires early recognition in person-centred care. Students need to learn how to identify and effectively care for 'at risk' patients. AIM: To identify and examine literature on how pre-registration health care professional students are prepared to recognise, assess, and deliver interventions to prevent delirium in practice, using digital/web based educational interventions. METHOD: Mixed methods systematic review with narrative synthesis. A protocol was registered with PROSPERO. The review questions and search strategy were guided by the Population, Phenomena of Interest, Context (PICo) framework. The PRISMA framework guided the screening, data extraction and analysis. Database searches (MEDLINE, Web of Science, Embase, CINAHL, Cochrane Central Register of Controlled Trials, PsycINFO & Scopus) were undertaken in April 2023 for publications from 2012 to 2023. Covidence software [30] was used to extract and manage the data. Quality appraisal was guided by the Crowe Critical Appraisal Tool (CCAT) [31]. FINDINGS: Ten papers were included: mixed methods (2), qualitative (1) and quantitative (7). Medical students were the most studied group (n = 5), followed by student nurses (n = 4) and mixed nursing and medical students (n = 1). Length of learning experience varied from 12 min virtual reality (VR) to a two-week 'geriatrics' elective. Learning was enhanced by player autonomy, engagement, safety, applicability, choices, multiple perspectives and moral reasoning opportunities. DISCUSSION: Digital programmes should be visually appealing, interactive with opportunities for practice and timely appropriate feedback.

Co-design and mixed methods evaluation of an interdisciplinary digital resource for undergraduate health profession students to improve the prevention, recognition, and management of delirium in Ireland: a study protocol.

BACKGROUND: Delirium is a common symptom of acute illness which is potentially avoidable with early recognition and intervention. Despite being a growing concern globally, delirium remains underdiagnosed and poorly reported, with limited understanding of effective delirium education for undergraduate health profession students. Digital resources could be an effective approach to improving professional knowledge of delirium, but studies utilising these with more than one profession are limited, and no evidence-based, interdisciplinary, digital delirium education resources are reported. This study aims to co-design and evaluate a digital resource for undergraduate health profession students across the island of Ireland to improve their ability to prevent, recognise, and manage delirium alongside interdisciplinary colleagues. METHODS: Utilising a logic model, three workstreams have been identified. Workstream 1 will comprise three phases: (1) a systematic review identifying the format, methods, and content of existing digital delirium education interventions for health profession students, and their effect on knowledge, self-efficacy, and behavioural change; (2) focus groups with health profession students to determine awareness and experiences of delirium care; and (3) a Delphi survey informed by findings from the systematic review, focus groups, and input from the research team and expert reference group to identify resource priorities. Workstream 2 will involve the co-design of the digital resource through workshops (n = 4) with key stakeholders, including health profession students, professionals, and individuals with lived experience of delirium. Lastly, Workstream 3 will involve a mixed methods evaluation of the digital resource. Outcomes include changes to delirium knowledge and self-efficacy towards delirium care, and health profession students experience of using the resource. DISCUSSION: Given the dearth of interdisciplinary educational resources on delirium for health profession students, a co-designed, interprofessional, digital education resource will be well-positioned to shape undergraduate delirium education. This research may enhance delirium education and the self-efficacy of future health professionals in providing delirium care, thereby improving practice and patients' experiences and outcomes. TRIAL REGISTRATION: Not applicable.

Integrating Routine Screening for Opioid Use Disorder into Primary Care Settings: Experiences from a National Cohort of Clinics.

BACKGROUND: The U.S. Preventive Services Task Force recommends routine population-based screening for drug use, yet screening for opioid use disorder (OUD) in primary care occurs rarely, and little is known about barriers primary care teams face. OBJECTIVE: As part of a multisite randomized trial to provide OUD and behavioral health treatment using the Collaborative Care Model, we supported 10 primary care clinics in implementing routine OUD screening and conducted formative evaluation to characterize early implementation experiences. DESIGN: Qualitative formative evaluation. APPROACH: Formative evaluation included taking detailed observation notes at implementation meetings with individual clinics and debriefings with external facilitators. Observation notes were analyzed weekly using a Rapid Assessment Process guided by the Consolidated Framework for Implementation Research, with iterative feedback from the study team. After clinics launched OUD screening, we conducted structured fidelity assessments via group interviews with each site to evaluate clinic experiences with routine OUD screening. Data from observation and structured fidelity assessments were combined into a matrix to compare across clinics and identify cross-cutting barriers and promising implementation strategies. KEY RESULTS: While all clinics had the goal of implementing population-based OUD screening, barriers were experienced across intervention, individual, and clinic setting domains, with compounding effects for telehealth visits. Seven themes emerged characterizing barriers, including (1) challenges identifying who to screen, (2) complexity of the screening tool, (3) staff discomfort and/or hesitancies, (4) workflow barriers that decreased screening follow-up, (5) staffing shortages and turnover, (6) discouragement from low screening yield, and (7) stigma. Promising implementation strategies included utilizing a more universal screening approach, health information technology (HIT), audit and feedback, and repeated staff trainings. CONCLUSIONS: Integrating population-based OUD screening in primary care is challenging but may be made feasible via implementation strategies and tailored practice facilitation that standardize workflows via HIT, decrease stigma, and increase staff confidence regarding OUD.

Impact of a Multicomponent Educational Intervention on Community Pharmacy-Based Naloxone Services Implementation: A Pragmatic Randomized Controlled Trial.

BACKGROUND: Despite US naloxone access laws, community pharmacists lack training and confidence in providing naloxone. OBJECTIVE: To assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as naloxone prescriptions dispensed. METHODS: A 3-month pragmatic randomized controlled trial was conducted from December 2018 to March 2019. Alabama community pharmacists were recruited by mail, email, phone, and fax and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly reminders only). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3), including naloxone knowledge (%correct); perceived barriers, attitudes, confidence, and intention regarding naloxone services implementation (7-point Likert-type scale; 1 = strongly disagree, 7 = strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention from T1 to T3 were assessed using 2-way mixed analysis of variance and adjusted analyses were conducted using generalized estimating equations with negative binomial distribution to assess associations between variables. RESULTS: Of 55 participants (n = 27 intervention, n = 28 control), most were female (80.3%), white (80.6%), in independently owned pharmacies (39.1%). Increases in mean [SD] confidence (5.52 [1.03]-6.16 [0.74], P < 0.0005) and intention (5.35 [1.51]-6.10 [0.96], P = 0.023) occurred from pre- to post-program within the intervention group and were statistically significant compared with control (confidence P = 0.016, intention P = 0.014). Confidence (exp(ß) = 1.46, P = 0.031) and perceived barriers (exp(ß) = 0.75, P = 0.022) were associated with number of naloxone prescriptions dispensed. CONCLUSION AND RELEVANCE: The Empowering Community Pharmacists program improved community pharmacists' confidence and intention regarding naloxone services implementation. Other states can adapt program elements according to their laws. CLINICALTRIALS.GOV IDENTIFIER: NCT05093309.

Reaching late adopters: factors influencing COVID-19 vaccination of Marshallese and Hispanic adults.

BACKGROUND: Marshallese and Hispanic communities in the United States have been disproportionately affected by COVID-19. Identifying strategies to reach late vaccine adopters is critical for ongoing and future vaccination efforts. We utilized a community-engaged approach that leveraged an existing community-based participatory research collaborative of an academic healthcare organization and Marshallese and Hispanic faith-based organizations (FBO) to host vaccination events. METHODS: Bilingual Marshallese and Hispanic study staff conducted informal interviews with 55 participants during the 15-minute post-vaccination observation period and formal semi-structured interviews with Marshallese (n = 5) and Hispanic (n = 4) adults post-event to assess the implementation of community vaccine events at FBOs, with a focus on factors associated with the decision to attend and be vaccinated. Formal interview transcripts were analyzed using thematic template coding categorized with the socio-ecological model (SEM). Informal interview notes were coded via rapid content analysis and used for data triangulation. RESULTS: Participants discussed similar factors influencing attitudes and behaviors toward receiving the COVID-19 vaccine. Themes included: (1) intrapersonal - myths and misconceptions, (2) interpersonal - protecting family and family decision-making, (3) community - trust of community location of events and influence of FBO members and leaders, (4) institutional - trust in a healthcare organization and bilingual staff, and (5) policy. Participants noted the advantages of vaccination delivery at FBOs, contributing to their decision to attend and get vaccinated. CONCLUSIONS: The following strategies may improve vaccine-related attitudes and behaviors of Marshallese and Hispanic communities not only for the COVID-19 vaccine but also for other preventive vaccinations: 1) interpersonal-level - develop culturally-focused vaccine campaigns targeting the family units, 2) community-level - host vaccination events at convenient and/or trusted locations, such as FBOs, and engage community and/or FBO formal or lay leaders as vaccine ambassadors or champions, and 3) institutional-level - foster trust and a long-term relationship with the healthcare organization and provide bilingual staff at vaccination events. Future research would be beneficial to investigate the effects of replicating these strategies to support vaccine uptake among Marshallese and Hispanic communities.

Implementation of group cognitive processing therapy in correction centers: Anticipated determinants from formative evaluation.

Nearly all people in prison have experienced trauma, and many meet the criteria for posttraumatic stress disorder (PTSD). Untreated PTSD increases the risk of substance use problems after release, contributing to a well-documented cycle of trauma, addiction, and incarceration. However, evidence-based, trauma-focused therapy for PTSD is rarely offered in prisons, and there is little research that can guide implementation efforts. In preparation for an effectiveness-implementation hybrid II pilot trial examining group-delivered cognitive processing therapy (CPT) in prisons, we conducted a formative evaluation using interviews structured according to the consolidated framework for implementation research (i.e., CFIR). Participants were correction center leadership, treatment staff, health care staff, and security staff (n = 22) and incarcerated persons (n = 14; 57.1% female). We found that CPT was highly compatible with residents' needs and the centers' available resources, culture, existing programs, and current workflow. CPT was also acceptable to all stakeholders. Potential barriers were the lower relative priority for CPT compared with programs that are reinforced at the system level, limited staff time to deliver CPT, limited staff knowledge about PTSD, and center features that could distract from CPT groups and/or training or be countertherapeutic. Taken together, CPT is a promising trauma-focused therapy for corrections, but these findings underscore the importance of identifying and matching potential barriers to effective implementation strategies a priori and work in the policy arena to promote sustainability.

Advancing health equity: A qualitative study assessing barriers and facilitators of implementing hereditary breast and ovarian cancer risk screening tools in community-based organizations.

Genetic counseling and testing (GCT) inform cancer management for persons at risk for hereditary breast and ovarian cancer (HBOC). Community-based organizations (CBOs) may play a role in identifying at-risk Latinx individuals to connect them to GCT but data are lacking. Two academic centers and their four CBO partners planned to implement a validated questionnaire for HBOC risk screening ("HBOC risk screening tool"). This study aimed to assess CBO's preferences for HBOC risk screening tools, as well as the barriers and facilitators anticipated for future implementation. Pre-implementation focus groups were conducted with CBO's staff. Discussions centered on current practices to identify and refer at-risk patients. During the discussion, staff were asked to select one out of five validated HBOC risk screening tools to implement and to discuss anticipated barriers/facilitators for implementation. The four focus groups were coded and qualitative analyzed following the Consolidated Framework for Implementation Research (CFIR) and Health Equity domains. All CBOs chose the Family History Screen 7 (FHS-7). Participants (N = 35) highlighted how the FHS-7 was easy to adapt to better fit the target population and changing guidelines. They had positive attitudes toward implementing the screening tool, stressed how the culture of the organization positioned them to reach the target population, and noted barriers in different CFIR domains (e.g., low knowledge about HBOC and GCT referrals; scarce available resources). Participants pointed to barriers related to health equity domains including limited access to GCT and follow-up care for uninsured and underinsured populations, challenges obtaining accurate family history, and immigration-related barriers. CBOs highlighted the importance of partnering with other stakeholders to overcome barriers. Findings emphasize the need to develop multi-level implementation strategies to overcome barriers and leverage facilitators. This study can inform the development of implementation toolkits for CBOs to implement HBOC screening tools to advance health equity.

Substance Use Disorder Treatment Programs during a Health Crisis: Response to the COVID-19 Pandemic and Future Implications.

Background: The COVID-19 pandemic rapidly changed how substance use disorder (SUD) treatment services are delivered. In this qualitative study, we examined what changes SUD treatment programs in Arkansas implemented in response to the pandemic, what factors influenced their ability to implement these changes, and their reflections, outlook, and future recommendations. Methods: Between May and August 2020, we conducted semi-structured phone interviews with 29 leaders at 21 SUD programs throughout Arkansas. Interview questions focused on what changes programs implemented in response to the pandemic, barriers and facilitators to implementation, and future outlook. Interviews were thematically analyzed. Results: Programs implemented similar infection control practices, including COVID-19 screening at entry, masks, hand hygiene, and social distancing. Residential programs discontinued outside visitations and capped admissions, and outpatient programs implemented telehealth services. Clients generally responded well to the changes, however many experienced difficulties (e.g., anxiety, lack of access to telehealth). While programs welcomed additional financial support (e.g., CARES act) and looser regulatory restrictions (e.g., telehealth use), many struggled economically due to lower demand and insufficient reimbursement. Programs varied in leadership and staff responses to the pandemic, and in their capacity to implement the changes (e.g., facilities, staffing). Finally, interviewees acknowledged they were unprepared for the pandemic and were uncertain about the future. Conclusions: The insights from the COVID-19 pandemic and SUD programs' responses helps researchers, policymakers and practitioners understand what has happened during the pandemic, how to prepare for future crises, and how to build more resilient SUD and public health systems.

Community pharmacist-provided opioid intervention frequencies and barriers.

BACKGROUND: Community pharmacists are well-positioned to engage in opioid-related harm reduction activities (i.e., opioid interventions). However, several barriers to providing these interventions have been identified. Comparing the frequencies of opioid interventions and identifying which barriers are perceived to have the highest impact in providing interventions will yield valuable information for increasing opioid use disorder (OUD) care access within pharmacies. OBJECTIVES: To (1) characterize the frequency of 9 opioid interventions in community practice settings and (2) assess community pharmacists' perceptions of what impact 15 key barriers have on providing opioid interventions. METHODS: This was a multi-state, cross-sectional, and descriptive survey study. Opioid interventions evaluated included prevention (e.g., OUD screening) and treatment (e.g., OUD resource referral); barriers encompassed confidence and knowledge, work environment, provider interactions, and patient interactions. Respondents were recruited from 3 community pharmacy practice-based research networks in the Midwest and South regions of the US. Recruitment and telephone survey administration occurred between December 2021 and March 2022. Descriptive statistics were computed and open-ended items were reviewed to identify common themes. RESULTS: Sixty-nine of 559 pharmacists contacted (12.3%) completed the survey. All opioid interventions were reported to be provided less frequently than indicated in practice. Screening and referral interventions were provided least frequently, at 1.2 and 1.6 times on average, respectively, to the last 10 patients for which respondents felt each intervention was needed. Patient refusal, minimal or no reimbursement, inadequate staffing and time, and negative patient reactions were identified as the highest-impact barriers to providing opioid interventions. Approximately 26% of respondents agreed or strongly agreed that pharmacy school adequately prepared them to provide opioid interventions in practice. CONCLUSION: Prioritizing the resolution of pharmacy work environment barriers will support pharmacists in routinely providing opioid interventions. Changes in Doctor of Pharmacy curricula and continuing education are also indicated to further prepare pharmacists to engage in opioid-related harm reduction.

Comprehensive medication management by pharmacists via telehealth in rural primary care: is it feasible and effective?

INTRODUCTION: Patients with uncontrolled diabetes living in rural communities experience many challenges, including lack of access to needed medication management services. Telepharmacy has been identified as a promising approach for addressing this gap. This presentation describes early insights into the implementation of a Comprehensive Medication Management (CMM) service in seven rural primary care clinics in North Carolina and Arkansas (USA). The CMM service involved two pharmacists meeting remotely with patients in their homes to identify and resolve Medication Therapy Problems (MTPs). STUDY DESIGN: This exploratory mixed methods study uses a pre-post design. Data sources include surveys, qualitative interviews, administrative data, and medical records (eg MTPs, hemoglobin A1Cs) collected as part of the first 3 months of a 1-year implementation period. METHODS: Lessons learned were identified through qualitative interviews with six clinic liaisons, review of pharmacists' observations, and open-ended survey questions with clinic staff and providers. Early service effectiveness was informed by MTP resolution rates and changes in patients' A1C levels. RESULTS: Key insights centered on the perceived benefits of the service for patients and clinics, the importance of patient engagement, access to implementation strategies (eg workflows and technical assistance calls), and the need to adapt the CMM service and implementation strategies to local context. The MTP resolution rate averaged 88% across pharmacists. There was a significant decrease in A1Cs in participating patients as a result of the service. CONCLUSION: Although preliminary, these results support the value of a pharmacist-led medication optimization service through remote delivery for complex patients with uncontrolled diabetes.

RURAL-CP: a rural community pharmacy practice-based research network in the USA.

INTRODUCTION: To strengthen and demonstrate the ability of rural pharmacists to address their communities' health needs, we developed the first multi-state rural community pharmacy practice-based research network (PBRN) in the USA called the Rural Research Alliance of Community Pharmacies (RURAL-CP). Our objective is to describe the process for developing RURAL-CP and discuss challenges to creating a PBRN during the pandemic. METHODS: We conducted a literature review of community pharmacy PBRNs and met with expert consultants to gain insight into PBRN best practices. We obtained funding to hire a postdoctoral research associate, conducted site visits, and administered a baseline survey, which assessed many aspects of the pharmacy, including staffing, services, and organizational climate. Pharmacy site visits were initially conducted in-person but were later adapted to a virtual format due to the pandemic. RESULTS: RURAL-CP is now a PBRN registered with the Agency for Healthcare Research and Quality within the USA. Currently, 95 pharmacies across five southeastern states are enrolled. Conducting site visits was critical for developing rapport, demonstrating our commitment to engage with pharmacy staff, and appreciating the needs of each pharmacy. RURAL-CP pharmacists' main research priority was expanding reimbursable pharmacy services, especially for diabetes patients. Since enrollment, network pharmacists have participated in two COVID-19 surveys. DISCUSSION: RURAL-CP has been instrumental in identifying rural pharmacists' research priorities. COVID-19 provided an early test of the network infrastructure, which allowed us to quickly assess COVID-19 training and resource needs. We are refining policies and infrastructure to support future implementation research with network pharmacies.

Design, Synthesis, and Preliminary Evaluation of [68Ga]Ga-NOTA-Insulin as a PET Probe in an Alzheimer's Disease Mouse Model.

Aberrant insulin signaling has been considered one of the risk factors for the development of Alzheimer's disease (AD) and has drawn considerable attention from the research community to further study its role in AD pathophysiology. Herein, we describe the development of an insulin-based novel positron emission tomography (PET) probe, [68Ga]Ga-NOTA-insulin, to noninvasively study the role of insulin in AD. The developed PET probe [68Ga]Ga-NOTA-insulin showed a significantly higher uptake (0.396 ± 0.055 SUV) in the AD mouse brain compared to the normal (0.140 ± 0.027 SUV) mouse brain at 5 min post injection and also showed a similar trend at 10, 15, and 20 min post injection. In addition, [68Ga]Ga-NOTA-insulin was found to have a differential uptake in various brain regions at 30 min post injection. Among the brain regions, the cortex, thalamus, brain stem, and cerebellum showed a significantly higher standard uptake value (SUV) of [68Ga]Ga-NOTA-insulin in AD mice as compared to normal mice. The inhibition of the insulin receptor (IR) with an insulin receptor antagonist peptide (S961) in normal mice showed a similar brain uptake profile of [68Ga]Ga-NOTA-insulin as it was observed in the AD case, suggesting nonfunctional IR in AD and the presence of an alternative insulin uptake route in the absence of a functional IR. The Gjedde-Patlak graphical analysis was also performed to predict the input rate of [68Ga]Ga-NOTA-insulin into the brain using MicroPET imaging data and supported the in vivo results. The [68Ga]Ga-NOTA-insulin PET probe was successfully synthesized and evaluated in a mouse model of AD in comparison with [18F]AV1451 and [11C]PIB to noninvasively study the role of insulin in AD pathophysiology.

Rural community pharmacists' ability and interest in administering COVID-19 vaccines in the Southern United States.

BACKGROUND: Community pharmacists are often the most accessible health professional in rural areas, which makes them well positioned to increase vaccine access in their communities. This study sought to document rural pharmacists' ability to and interest in administering coronavirus disease 2019 (COVID-19) vaccinations. METHODS: A sample of community pharmacists participating in a rural community pharmacy practice-based research network in the United States completed an online survey that assessed (1) demographic characteristics, (2) previous COVID-19 vaccine training, and (3) ability to administer COVID-19 vaccines. Data were collected between late December 2020 and mid-February 2021. Descriptive statistics and correlations were calculated. RESULTS: A total of 69 of 106 pharmacists completed the survey (response rate = 65%). Approximately half of pharmacists were ready (52%) or actively taking steps (39%) to provide COVID-19 vaccines in the next 6 months. Pharmacies had a median of 2 staff members who were authorized to administer COVID-19 vaccines. Almost half (46%) estimated they could administer more than 30 vaccinations per day. Most pharmacies could store vaccines at standard refrigeration (90%) and freezing (83%) levels needed for thawed and premixed vaccines, respectively. Most pharmacists planned to access COVID-19 vaccines through an agreement with a state or local public health entity (48%) or by ordering through group purchasing organizations (46%). Only 23% of pharmacists had received any COVID-19 vaccine training, and only 48% very much wanted to get the vaccine themselves. Several variables, including pharmacy type and pharmacists' vaccine attitudes and previous COVID-19 training, were significantly associated (P < 0.05) with the anticipated number of COVID-19 vaccines pharmacies could administer daily. CONCLUSION: Even early in the nation's COVID-19 vaccine rollout, most rural pharmacies were interested in and preparing to administer COVID-19 vaccines. Few rural pharmacists had received COVID-19 training, and many expressed some hesitancy to receive the vaccine themselves. The number of vaccines pharmacists could administer varied with pharmacy and pharmacist characteristics.

Emergency Department Nurses' Perceptions of Patient Substance Use, Impact on Sexual Assault Care, and Access to Follow-up Behavioral Health Resources.

INTRODUCTION: Patients may present to the emergency department for sexual assault care under the influence of drugs or alcohol. However, many emergency nurses are not prepared to meet their unique needs or aware of follow-up behavioral health resources. The purpose of this study was to (1) summarize current resources provided to patients and processes for referral to behavioral health services after sexual assault care, (2) explore emergency nurses' attitudes and behaviors toward patient substance use, and (3) explore nurses' perceptions of adjunct mobile health interventions for follow-up behavioral health care and describe anticipated barriers to use. METHODS: Fifteen emergency nurses participated in semi-structured qualitative interviews. RESULTS: Participants had mixed perceptions of patient intoxication during sexual assault care. They felt that conversations about substance use may be more appropriate after the ED visit. Participants recognized the opportunity to connect ED patients with substance use treatment or prevention resources but perceived that there are few local service providers. Most participants were not referring patients with substance use issues to behavioral health services after sexual assault care and said that their emergency departments did not have processes for referral to these services. Acceptability of mobile health for follow-up behavioral health care was high, but participants had concerns for patient privacy and internet access. Participants gave recommendations to improve referral practices and patient engagement with mobile health interventions. DISCUSSION: This study highlights the need for emergency nurses to consider patient intoxication during sexual assault care and opportunities to connect patients with resources post-assault.

Approaches for Implementing App-Based Digital Treatments for Drug Use Disorders Into Primary Care: A Qualitative, User-Centered Design Study of Patient Perspectives.

BACKGROUND: Digital interventions, such as websites and smartphone apps, can be effective in treating drug use disorders (DUDs). However, their implementation in primary care is hindered, in part, by a lack of knowledge on how patients might like these treatments delivered to them. OBJECTIVE: This study aims to increase the understanding of how patients with DUDs prefer to receive app-based treatments to inform the implementation of these treatments in primary care. METHODS: The methods of user-centered design were combined with qualitative research methods to inform the design of workflows for offering app-based treatments in primary care. Adult patients (n=14) with past-year cannabis, stimulant, or opioid use disorder from 5 primary care clinics of Kaiser Permanente Washington in the Seattle area participated in this study. Semistructured interviews were recorded, transcribed, and analyzed using qualitative template analysis. The coding scheme included deductive codes based on interview topics, which primarily focused on workflow design. Inductive codes emerged from the data. RESULTS: Participants wanted to learn about apps during visits where drug use was discussed and felt that app-related conversations should be incorporated into the existing care whenever possible, as opposed to creating new health care visits to facilitate the use of the app. Nearly all participants preferred receiving clinician support for using apps over using them without support. They desired a trusting, supportive relationship with a clinician who could guide them as they used the app. Participants wanted follow-up support via phone calls or secure messaging because these modes of communication were perceived as a convenient and low burden (eg, no copays or appointment travel). CONCLUSIONS: A user-centered implementation of treatment apps for DUDs in primary care will require health systems to design workflows that account for patients' needs for structure, support in and outside of visits, and desire for convenience.

Classifying intervention modifications in the community pharmacy context: A demonstration study.

OBJECTIVES: The objectives of this study were to apply the Stirman and colleagues' framework to identify modifications made to a motivational interviewing (MI)-based intervention for medication nonadherence and to determine whether the locally modified intervention affected expected patient medication adherence outcomes in community pharmacies. METHODS: Pharmacists at 4 pharmacies were trained to provide a brief MI intervention to 50 patients per pharmacy who were nonadherent to antihypertensive medications. The training included a 3-hour online course in MI and in-pharmacy training on patient identification and documentation. Semistructured interviews were conducted to determine modifications to the patient identification processes, MI interventions, and documentation of interventions. Directed content analysis was guided by the Stirman and colleagues' framework. Preintervention and 6 months postintervention adherence rates for the patients who received the intervention were calculated. Paired samples t tests were used to assess the impact of the intervention on adherence rates. RESULTS: Modifications were made to the context of the intervention (e.g., via telephone instead of in-pharmacy). Additionally, content modifications included "loosening the structure" (e.g., reordering intervention steps), "drifting or departing" (e.g., too busy to attempt), "adding elements" (e.g., reminder cards), and "repeating elements" (e.g., patient identification). There were statistically significant improvements in adherence from preintervention to 6 months postintervention (74.1% to 84.5%; P < 0.05) at each pharmacy regardless of the modifications applied. CONCLUSION: Modifications made during intervention implementation were classified using Stirman and colleagues' framework. Despite the modifications, adherence rates improved and were consistent with expectations based on prior studies of similar interventions. These findings support previous implementation research on adaptability and suggest that the ability to tailor, modify, or refine an intervention to meet the needs of the provider or setting may allow for intervention success. Future research on the impact of specific modifications will help determine which are detrimental or beneficial to patient outcomes and sustainability of services.

Development and implementation of a collaboration between a patient-centered medical home and community pharmacy.

OBJECTIVES: This study aimed to describe the development and implementation strategies used in the collaboration between a patient-centered medical home (PCMH) and a grocery pharmacy chain and to evaluate the effectiveness of a community pharmacist's clinical integration in reducing hemoglobin A1c levels at clinic and patient levels. SETTING: The Kroger Co and Catholic Health Initiative St. Vincent. PRACTICE DESCRIPTION: The Kroger Co is a large grocery store that operates 27 pharmacies in the state of Arkansas, with 20 locations in the central Arkansas area. PCMH is part of a large health system in central Arkansas with 10 primary-care clinics in the area. PRACTICE INNOVATION: With the transition to value-based payment models, pharmacists are being utilized in settings outside of the pharmacy. This project demonstrates a partnership between a community pharmacy and PCMH. The community pharmacist spent 20 h/week in the PCMH providing medication therapy and disease state management services. Services were focused on patients with uncontrolled diabetes. EVALUATION: Descriptive statistics were used to describe the distribution of the pharmacists' time. A patient-level pre-post analysis of the mean changes in hemoglobin A1c (HbA1c) was conducted for patients who interacted directly with the pharmacist. A clinic-level analysis was conducted to evaluate changes in HbA1c compared to that in a nonequivalent control group using a standard quality measure. RESULTS: In total, 312 individual patients interacted with the pharmacist. Of those patients, 228 had diabetes. A total of 111 patients underwent pre-post HbA1c analysis. In those patients, there was a statistically significant reduction in mean HbA1c . There was no difference in clinic-level results between the intervention and control locations. CONCLUSION: Collaboration between a community pharmacy and PCMH is feasible and may improve patient care. Future research should include pharmacy-based visits and development of a process for improved communication.

Scoping implementation science for the beginner: locating yourself on the "subway line" of translational research.

BACKGROUND: Beginners to the discipline of implementation science often struggle to determine whether their research questions "count" as implementation science. MAIN TEXT: In this paper, three implementation scientists share a heuristic tool to help investigators determine where their research questions fall in the translational research continuum. They use a "subway model" that envisions a journey to implementation research with stops along the way at efficacy and effectiveness research. CONCLUSIONS: A series of structured questions about intervention efficacy, effectiveness, and implementation can help guide researchers to select research questions and appropriate study designs along the spectrum of translational research.