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Background The opioid epidemic has prompted nationwide efforts to expand access to medications for opioid use disorder (MOUD). Primary care settings have been identified as a critical access point for patients who may benefit from MOUD treatments. Despite implementation efforts, there is limited understanding of how MOUD practice capability in primary care settings evolves over time or what factors influence clinic-level implementation trajectories. Methods We conducted a longitudinal study of 95 primary care clinics in California from 2019 to 2024. MOUD practice capability was measured using the Integrating Medications for Addiction Treatment in Primary Care (IMAT-PC) index across three timepoints. Using latent class growth analysis, we analyzed implementation growth trajectories and examined their associations with clinic characteristics and MOUD implementation outcomes (e.g., patient reach and provider adoption). Results Three distinct implementation trajectory classes emerged: elevated improving (41.0%), moderate improving (47.4%), and low improving (11.6%). All clinics demonstrated improvements in MOUD practice capability over time. Elevated improving clinics primarily consisted of smaller clinics (< 15,000 patients) and achieved significantly higher number of patients receiving MOUD compared to moderate ( p  = 0.03) and low improving clinics ( p  = 0.04). Clinics serving medically underserved populations disproportionately represented the low improving class ( p  < 0.01). Increase in the number of providers prescribing MOUD did not differ significantly across trajectory classes. Conclusions Although all clinics increased MOUD capability, we found significant associations between implementation trajectory classes and changes in patients receiving MOUD over time in primary care-based MOUD programs. Implementation supports may be more effective and efficient if selected and delivered based upon clinic contextual factors, particularly in resource-constrained and underserved settings.

Background Implementation costs—the combined costs of delivering expert support and participating in an implementation endeavor—are often omitted from economic evaluations. When included, delivery and participation costs are usually combined, even though these may be covered by different funders. We propose a pragmatic micro-costing approach that separates the delivery and participation costs as well as outlines practical considerations for measuring implementation costs. Methods Sixty-four specialty addiction treatment programs and primary care clinics participated in a stepped sequence of implementation strategies focused on improving access to buprenorphine and naltrexone for persons with opioid use disorder. The implementation strategies deployed were: audit and feedback (A&F), a two-day workshop, internal facilitation, and external facilitation. Our micro-costing approach separately measured the cost to deliver and participate in implementation strategies, as demonstrated through the A&F case example, which was the first of four implementation strategies deployed. We applied the following practical considerations to maximize the precision and accuracy of cost data: 1) Balance the frequency and length of cost survey, 2) Cost tracking training, 3) Regular survey reminders, 4) Tailor cost surveys, 5) Perform frequent cost data validation, 6) Iterative evaluation and refinement. Results In A&F, the implementation setup cost was $32,266, and the annual recurring costs were $4,231 per clinic. While the majority of the setup cost (99%) can be attributed to A&F delivery, over half of the annual recurring costs (63%) were attributed to clinic participation in A&F. Conclusions This micro-costing approach appears both pragmatic and meaningful. By understanding the total cost implications of implementation, decision-makers can better select the most suitable strategy based on the context, goals, and budget constraints to efficiently optimize the pace and desired outcome of an implementation endeavor. Trial registration The trial protocol is registered with ClinicalTrials.gov (NCT05343793).

Background In response to the US opioid epidemic, significant national campaigns have been launched to expand access to `opioid use disorder (MOUD). While adoption has increased in general medical care settings, specialty addiction programs have lagged in both reach and adoption. Elevating the quality of implementation strategy, research requires more precise methods in tailoring strategies rather than a one-size-fits-all-approach, documenting participant engagement and fidelity to the delivery of the strategy, and conducting an economic analysis to inform decision making and policy. Research has yet to incorporate all three of these recommendations to address the challenges of implementing and sustaining MOUD in specialty addiction programs. Methods This project seeks to recruit 72 specialty addiction programs in partnership with the Washington State Health Care Authority and employs a measurement-based stepped implementation-to-target approach within an adaptive trial design. Programs will be exposed to a sequence of implementation strategies of increasing intensity and cost: (1) enhanced monitoring and feedback (EMF), (2) 2-day workshop, and then, if outcome targets are not achieved, randomization to either internal facilitation or external facilitation. The study has three aims: (1) evaluate the sequential impact of implementation strategies on target outcomes, (2) examine contextual moderators and mediators of outcomes in response to the strategies, and (3) document and model costs per implementation strategy. Target outcomes are organized by the RE-AIM framework and the Addiction Care Cascade. Discussion This implementation project includes elements of a sequential multiple assignment randomized trial (SMART) design and a criterion-based design. An innovative and efficient approach, participating programs only receive the implementation strategies they need to achieve target outcomes. Findings have the potential to inform implementation research and provide key decision-makers with evidence on how to address the opioid epidemic at a systems level. Trial registration This trial was registered at ClinicalTrials.gov (NCT05343793) on April 25, 2022.

Objectives The aim of this study was to investigate the effects of anticoagulation with DOACs and warfarin on the characteristics of chronic subdural hematomas (CSDHs), specifically, the size of the hematomas, the presence of midline shift and the effect on consciousness levels, measured via the Glasgow Coma Scale (GCS). Methods A multi-centre retrospective case series analysis from January 2015 to May 2020 was conducted. Patients who were anticoagulated with DOACs and warfarin were of primary interest. The CSDH characteristics that were focussed on included the size of the CSDH, midline shift and GCS. Chi-squared analysis and independent t-tests were conducted for inter-variable analysis. Relative risk was also calculated. Results Two thousand, six hundred seventy-five patients across two tertiary neurosurgical units referred with CSDHs were included in the analysis. 1799 patients were male (67.3%), with a mean age of 78.5 years. 905 patients (33.8%) were on antithrombotic therapy, with 298 patients (11.1%) on warfarin and 203 patients (7.6%) on DOACs. There were statistically significant associations between the type of antithrombotic medication and both midline shift and size of the CSDH ( p  < 0.0001), but not GCS ( p  = 0.1956). No significant difference in relative risk (RR) for impaired GCS was found between DOACs and warfarin (1.158 vs 1.174 respectively). Relative risk analysis revealed a safer profile for DOACs, with a lower risk of developing a larger sized hematoma (RR 0.887 v 1.021) and a reduced likelihood of midline shift (RR 0.858 VS 0.938), which was supported by effect size analysis using odd’s ratios. Comparative risk analysis between DOACs and warfarin further demonstrated a higher risk of midline shift for patients on warfarin (RR 1.431), that trended towards statistical significance ( p  = 0.0511, 95% confidence interval 0.998–2.05). Conclusions For CSDH patients, DOACs may potentially be a safer method of anticoagulation as opposed to warfarin as they appear to be linked to the development of smaller sized hematomas and reduced midline shift, although there was no significant difference in GCS between the groups. These features are known to reduce the risk of needing neurosurgical intervention for CSDH. This is important in influencing the management of an increasingly ageing, multi-morbid population on increasing amounts of anticoagulation medication.

Background How communities impact patients taking medication for opioid use disorder (MOUD) has not been well-studied. Understanding the experience of MOUD providers allows us to better understand and measure community attitudes toward MOUD and identify strategies to increase support. Methods We deployed an explanatory sequential mixed methods design to analyze baseline data from the SITT-MAT clinical trial. Our quantitative instrument was seven Likert-scale questions asking about community attitudes toward MOUD analyzed through means, standard deviations, and principal components. The qualitative data were semi-structured interviews coded inductively using a thematic analysis. The quantitative and qualitative results were integrated to produce the findings. Results We surveyed staff from 20 specialty care addiction and primary care clinics in Washington state as part of a larger clinical trial. Eleven sites were also selected to complete an interview. Participating clinics were primarily specialty addiction treatment programs ( N  = 14, 70%), outpatient ( N  = 17, 85%), and/or located in urban areas ( N  = 12, 81%). In the survey, participants most agreed that relationships with other clinics help provide better care and least agreed that system-level policies mandate MOUD. In interviews, some staff described how reliable relationships with other clinics improved employee morale and patient care while others added that loose collaborations had fallen apart, leaving patients without the care they need. Interviewees described how insurer and government policies have made it difficult to expand their MOUD offerings. The interview data also indicated community attitudes on MOUD have improved over time with some clinics using direct outreach to garner support for MOUD. Conclusions Our results suggest that building local peer networks of clinics can improve staff morale and patient care in areas where community support for MOUD is low. Though system-level barriers to MOUD have been reduced, there is still room for improvement in simplifying reimbursements and funding for clinics looking to improve care. Our findings encourage further measurement of community attitudes toward MOUD and development of implementation strategies to build networks that support patients and clinics alike. Trial registration The data for this study is from the Stagewise Implementation-to-Target – Medications for Addiction Treatment clinical trial registered as NCT05343793 on April 25, 2022.

Background Successful implementation and sustainment of interventions is heavily influenced by context. Yet the complexity and dynamic nature of context make it challenging to connect and translate findings across implementation efforts. Existing methods to assess context are typically qualitative, limiting potential replicability and utility. Existing quantitative measures and the siloed nature of implementation efforts limit possibilities for data pooling and harmonization. The Inventory of Factors Affecting Successful Implementation and Sustainment (IFASIS) was developed to be a pragmatic, quantitative, organizational-level assessment of contextual factors. The intention is to characterize context with a measure that may enhance replication and reproducibility of findings beyond single implementation case studies. Here, we present the development and validation of the IFASIS. Methods A literature review was conducted to identify major concepts of established theories and frameworks to be retained. IFASIS data were examined in relation to implementation outcomes gathered from two studies. Psychometric validation efforts included content and face validity, reliability, internal consistency, and predictive and concurrent validity. Predictive validity was evaluated using generalized estimating equations (GEE) for longitudinal data on three implementation outcomes: reach, effectiveness, and implementation quality. Pragmatic properties were also evaluated. Results The IFASIS is a 27-item, team-based, instrument that quantitatively operationalizes context. Two rating scales capture current state and importance of each item to an organization. It demonstrated strong reliability, internal consistency, and predictive and concurrent validity. There were significant associations between higher IFASIS scores and improved implementation outcomes. A one-unit increase in total IFASIS score corresponded to a 160% increase in the number of patients receiving a medication (reach). IFASIS domains of factors outside the organization, factors within the organization, and factors about the intervention, and subscales of organizational readiness, community support, and recipient needs and values, were predictive of successful implementation outcomes. IFASIS scores were also significantly associated with measures of implementation quality. Conclusions The IFASIS is a psychometrically and pragmatically valid instrument to assess contextual factors in implementation endeavors. Its ability to predict key implementation outcomes and facilitate data pooling across projects suggests it can play an important role in advancing the field.

IntroductionVulnerable populations face significant challenges in navigating the care continuum, ranging from diagnosis of illness to linkage and retention in healthcare. Understanding how best to move individuals within these vulnerable populations across the care continuum is critical to improving their health. A large body of literature has focused on evaluation of implementation of various health-focused interventions in this population. However, we do not fully understand the unique challenges to implementing healthcare interventions for vulnerable populations. This study aims to examine the literature describing implementation of health service interventions among vulnerable populations to identify how implementations using the Consolidated Framework for Implementation Research are adapted. Findings from this review will be useful to implementation scientists to identify gaps in evidence and for adapting similar interventions in unique settings.Methods and analysisThis study protocol outlines a scoping review of the peer-reviewed and grey literature, using established approaches delineated in Arksey and O'Malley’s scoping review framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. Search strategies will be developed and refined by a medical librarian in collaboration with the research team. Searches will be conducted in electronic databases (CINAHL, Cochrane, PsychINFO, PubMed, Social Services Abstracts, Web of Science, Google and Google Scholar) and limited to studies published between 1 August 2009 and 1 June 2020. Additionally, hand searches will be conducted in three relevant journals—Implementation Science, Systematic Reviews and BMJ Open. English-language studies and reports meeting inclusion criteria will be screened independently by two reviewers and the final list will be abstracted and charted in duplicate.Ethics and disseminationThis is a review of the literature; ethics approval is not indicated. We will disseminate findings from this study in peer-reviewed journals as well as presentations to relevant stakeholders and conferences.

Background To combat the opioid epidemic in the USA, unprecedented federal funding has been directed to states and territories to expand access to prevention, overdose rescue, and medications for opioid use disorder (MOUD). Similar to other states, California rapidly allocated these funds to increase reach and adoption of MOUD in safety-net, primary care settings such as Federally Qualified Health Centers. Typical of current real-world implementation endeavors, a package of four implementation strategies was offered to all clinics. The present study examines (i) the pre-post effect of the package of strategies, (ii) whether/how this effect differed between new (start-up) versus more established (scale-up) MOUD practices, and (iii) the effect of clinic engagement with each of the four implementation strategies. Methods Forty-one primary care clinics were offered access to four implementation strategies: (1) Enhanced Monitoring and Feedback, (2) Learning Collaboratives, (3) External Facilitation, and (4) Didactic Webinars. Using linear mixed effects models, RE-AIM guided outcomes of reach, adoption, and implementation quality were assessed at baseline and at 9 months follow-up. Results Of the 41 clinics, 25 (61%) were at MOUD start-up and 16 (39%) were at scale-up phases. Pre-post difference was observed for the primary outcome of percent of patient prescribed MOUD (reach) ( β time = 3.99; 0.73 to 7.26; p = 0.02). The largest magnitude of change occurred in implementation quality (ES = 0.68; 95% CI = 0.66 to 0.70). Baseline MOUD capability moderated the change in reach (start-ups 22.60%, 95% CI = 16.05 to 29.15; scale-ups −4.63%, 95% CI = −7.87 to −1.38). Improvement in adoption and implementation quality were moderately associated with early prescriber engagement in Learning Collaboratives (adoption: ES = 0.61; 95% CI = 0.25 to 0.96; implementation quality: ES = 0.55; 95% CI = 0.41 to 0.69). Improvement in adoption was also associated with early prescriber engagement in Didactic Webinars (adoption: ES = 0.61; 95% CI = 0.20 to 1.05). Conclusions Rather than providing an all-clinics-get-all-components package of implementation strategies, these data suggest that it may be more efficient and effective to tailor the provision of implementation strategies based on the needs of clinic. Future implementation endeavors could benefit from (i) greater precision in the provision of implementation strategies based on contextual determinants, and (ii) the inclusion of strategies targeting engagement.

Background Rigorous implementation evaluations are needed to understand factors that influence implementation and sustainability of evidence-based interventions across contexts. In this study, we conducted a longitudinal, multi-methods, multi-site evaluation guided by the Dynamic Sustainability Framework (DSF). This evaluation focused on implementation of the Homeless Overdose Prevention—Expansion (HOPE), an opioid overdose education and naloxone distribution (OEND) trial in a permanent supportive housing program in the Veterans Health Administration (VA). Methods We used a multi-methods study design comprised of qualitative interviews and completion of a three-item survey. Semi-structured interviews were completed with Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) staff, site leaders, and site prescribers at four VA healthcare systems in the Western United States. Interviews were conducted at three timepoints: pre-implementation, implementation, and sustainment. Site staff also completed the Provider REport of Sustainment Scale (PRESS) during sustainment to provide more context for our interpretation of results. We analyzed interview data using rapid directed content analysis guided by DSF constructs and analyzed PRESS using descriptive statistics. Results We conducted 96 interviews with 67 unique individuals. Six determinants influenced the reciprocal fit of the intervention, practice setting, and ecological system across our study: (1) OEND for unstably housed veterans; (2) Staffing shortages and competing demands; (3) Training-related concerns; (4) Supervisor and leadership buy-in at site; (5) Social workers’ scope of practice; and (6) Cultural climate and saliency of OEND initiatives. Both planned and unplanned implementation strategies were optimized by different actors (i.e., the implementation team, target practitioners) in response to evolving determinants at all three DSF levels to maintain overall fit. Approaches taken to optimize fit depended on longitudinal data collection and evaluation of determinants at each phase. Conclusions Our approach is a theoretically driven example of capturing important determinants of implementation and sustainment of OEND in a high-risk setting. Despite the uniqueness of our study setting, our approach is generalizable and has the potential to promote sustainability of other public health interventions.