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Introduction Skin and soft tissue infections (SSTIs) are among the leading causes of morbidity and mortality for people who inject drugs (PWID). Studies demonstrate that certain injection practices correlate with SSTI incidence among PWID. The opioid epidemic in the USA has particularly affected rural communities, where access to prevention and treatment presents unique challenges. This study aims to estimate unsafe injection practices among rural-dwelling PWID; assess treatments utilized for injection related SSTIs; and gather data to help reduce the overall risk of injection-related SSTIs. Methods Thirteen questions specific to SSTIs and injection practices were added to a larger study assessing unmet health care needs among PWID and were administered at six syringe exchange programs in rural Wisconsin between May and July 2019. SSTI history prevalence was estimated based on infections reported within one-year prior of response and was compared to self-reported demographics and injection practices. Results Eighty responses were collected and analyzed. Respondents were white (77.5%), males (60%), between the ages 30 and 39 (42.5%), and have a high school diploma or GED (38.75%). The majority of respondents (77.5%) reported no history of SSTI within the year prior to survey response. Females were over three times more likely to report SSTI history (OR = 3.07, p = 0.038) compared to males. Water sources for drug dilution (p = 0.093) and frequency of injecting on first attempt (p = 0.037), but not proper skin cleaning method (p = 0.378), were significantly associated with a history of SSTI. Injecting into skin (p = 0.038) or muscle (p = 0.001) was significantly associated with a history of SSTI. Injection into veins was not significantly associated with SSTI (p = 0.333). Conclusion Higher-risk injection practices were common among participants reporting a history of SSTIs in this rural sample. Studies exploring socio-demographic factors influencing risky injection practices and general barriers to safer injection practices to prevent SSTIs are warranted. Dissemination of education materials targeting SSTI prevention and intervention among PWID not in treatment is warranted.

BACKGROUND: Adolescents are affected by the opioid epidemic, but little is known about their attitudes toward opioids and preferences for opioid safety education. OBJECTIVES: This study explored adolescents’ awareness prescription opioid misuse, sources of medication information, and educational preferences. METHODS: An online survey explored adolescents’ understanding and perceptions of prescription opioids and opioid misuse and safety, medication information sources, and educational preferences. Eligible participants included students from three Wisconsin high schools who could speak and understand English. Participants were recruited through “backpack mail” and completed surveys online at school. Survey responses were compared across demographic information of study participants. Binary response items were compared across demographic strata by Fisher’s exact tests, and Likert responses were analyzed by Kruskal-Wallis tests. RESULTS: A total of 190 students (53% female, 53% White, 32% Hispanic) were surveyed. Most (83.5%) considered using someone else’s opioid medication to be misuse, 85.2% identified using opioids at a higher dose or frequency than prescribed as misuse, and 67.6% considered using an opioid prescription after its expiration date to be misuse. About 90% of students perceived that opioid misuse causes some, quite a bit, or a great deal of harm to a person’s physical and mental health and school ability. Many students were able to correctly identify examples and consequences of misuse, however 24.7% believed that flushing opioids down the drain was dangerous. The most common source for finding information about opioids was Google or other search engines (67.6%), followed by talking with parents (56.7%), talking with a doctor or nurse (54.9%), and online videos (42.3%). CONCLUSION: Adolescents have some opioid safety knowledge, but there is a clear opportunity to increase knowledge and understanding of risks. Adolescents could benefit from opioid safety education, particularly on safe storage and disposal, harms of misuse, and strategies for discouraging peer opioid misuse.

OBJECTIVES Although unhealthy substance use and addiction contribute to 1 in 4 deaths and are estimated to cost the US more than $740 billion annually, fewer than 12 hours of physician education over the 7 years of medical school and primary residency training specifically address alcohol and other drug-related issues. Addiction Medicine was formally recognized as a medical subspecialty in 2016 to address the need for physicians trained in prevention, treatment, and management of substance use. This study examines the characteristics of the Addiction Medicine fellowships in operation during this critical period in the subspecialty's development to identify needs and potential. METHODS This study is a cross-sectional survey of Addiction Medicine Fellowship Directors from 46 fellowships accredited as of 2017 (43 in the United States and 3 in Canada). The response rate was 100%. RESULTS Directors estimated significant growth in available fellowship slots between 2016 to 2017 and 2017 to 2018 (F = 49.584, P

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P

Misuse of prescription opioids and associated negative health outcomes is a leading public health crisis among adolescents in the US. Opioid prescription rates, misuse, and overdose deaths have increased among adolescents in the last twenty years. This commentary highlights trends in prescribing opioids and medication misuse among adolescents in the US and sheds light on reasons and motives for misuse of prescription opioids among adolescents. It discusses recent educational initiatives which promote medication safety, describes current practices, and recommends effective strategies to enhance prescription opioid safety among adolescents. Opportunities to enhance opioid medication safety among adolescents are frequently overlooked. A critical strategy to combat opioid misuse and overdose deaths among adolescents involves increasing awareness and knowledge about safe medication use.

Background A variety of digital intervention approaches have been investigated for asthma therapy during the past decade, with different levels of interactivity and personalization and a range of impacts on different outcome measurements. Objective To assess the effectiveness of digital interventions in asthma with regard to acceptability and outcomes and evaluate the potential of digital initiatives for monitoring or treating patients with asthma. Methods We evaluated digital interventions using a scoping review methodology through a literature search and review. Of 871 articles identified, 121 were evaluated to explore intervention characteristics, the perception and acceptability of digital interventions to patients and physicians, and effects on asthma outcomes. Interventions were categorized by their level of interactivity with the patient. Results Interventions featuring non-individualized content sent to patients appeared capable of promoting improved adherence to inhaled corticosteroids, but with no identified improvement in asthma burden; and data-gathering interventions appeared to have little effect on adherence or asthma burden. Evidence of improvement in both adherence and patients' impairment due to asthma were seen only with interactive interventions involving two-way responsive patient communication. Digital interventions were generally positively perceived by patients and physicians. Implementation was considered feasible, with certain preferences for design and features important to drive use. Conclusions Digital health interventions show substantial promise for asthma disease monitoring and personalization of treatment. To be successful, future interventions will need to include both inhaler device and software elements, combining accurate measurement of clinical parameters with careful consideration of ease of use, personalization, and patient engagement aspects.

Background The United States spends more than US $100 billion annually on the impact of medication misuse. Serious games are effective and innovative digital tools for educating patients about positive health behaviors. There are limited systematic reviews that examine the prevalence of serious games that incorporate medication use. Objective This systematic review aimed to identify (1) serious games intended to educate patients about medication adherence, education, and safety; (2) types of theoretical frameworks used to develop serious games for medication use; and (3) sampling frames for evaluating serious games on medication use. Methods PubMed, Scopus, and Web of Science databases were searched for literature about medication-based serious games for patients. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed for article selection. Results Using PRISMA guidelines, 953 publications and 749 unique titles were identified from PubMed, Scopus, and Web of Science. A total of 16 studies featuring 12 unique serious games were included with components of medication adherence, education, and safety, published from 2003 to 2019. Of the 12 games included, eight serious games were tested in adolescents, three games were tested in young adults, and one game was tested in adults. Most studies (n=11) used small sample sizes to test the usability of serious games. Theoretical frameworks identified in the 12 serious games included information, motivation, and behavior theory; social cognitive theory; precede-proceed model; middle-range theory of chronic illness; adult learning theory; experiential learning theory; and the theory of reasoned action. Existing reviews explore serious games focused on the management of specific disease states, such as HIV, diabetes, and asthma, and on the positive impact of serious game education in each respective disease state. Although other reviews target broad topics such as health care gamification and serious games to educate health care workers, no reviews focus solely on medication use. Serious games were mainly focused on improving adherence, whereas medication safety was not widely explored. Little is known about the efficacy and usability of medication-focused serious games often because of small and nonrepresentative sample sizes, which limit the generalizability of existing studies. Conclusions Limited studies exist on serious games for health that incorporate medication use. The findings from these studies focus on developing and testing serious games that teach patients about medication use and safety. Many of these studies do not apply a theoretical framework in the design and assessment of these games. In the future, serious game effectiveness could be improved by increasing study sample size and diversity of study participants, so that the results are generalizable to broader populations. Serious games should describe the extent of theoretical framework incorporated into game design and evaluate success by testing the player’s retention of learning objectives.

BackgroundAdolescents in North America are severely affected by the opioid crisis, yet there are limited educational resources for educating teens about prescription opioid safety and misuse. Empirical literature lacks evidence regarding teen education about prescription opioid safety through serious games and lacks conceptual models and frameworks to guide the process of game development for this purpose.ObjectiveThis study aims to conceptualize and design a serious game prototype to teach teens about prescription opioid safety and propose a conceptual framework for developing a serious game to educate youth about safe and responsible use of prescription opioids.MethodsThe initial steps of the project comprised of the formulation of an integrated conceptual framework that included factors from health behavior models and game development models. This was followed by the formal process of serious game development, which resulted in a game prototype. The assessment of the game prototype was done through group discussions, individual interviews, and questionnaires with adolescents following gameplay. Field notes were used to keep track of the responses from the group discussions. Content and thematic analyses were used to analyze field notes and responses to the open-ended questionnaire, which were then used to refine the game prototype.ResultsA total of 10 playtests with over 319 adolescents and emerging young adults (AYAs) in community settings such as middle schools, high schools, and colleges were conducted by the project team between March and June 2019. The AYAs provided feedback on the initial game prototype using questionnaires administered through Qualtrics or in-person on paper. Preliminary feedback suggested that the teens found the game objectives, outcomes, and design appealing. Overall, the game was perceived as realistic, and learning outcomes seemed achievable. Suggestions for improvement included the need for additional direction on gameplay, clearer instructions, concise dialog, and reduced technical problems in the gameplay.ConclusionsWe propose a conceptual framework for developing a serious game prototype to educate youth about prescription opioid safety. The project used a theory-driven conceptual framework for the development of a serious game targeting the prevention of adolescent opioid misuse and garnered preliminary feedback on the game to improve the quality of gameplay and the prototype. Feedback through informal assessments in community settings suggests that the youth and their families are interested in a game-based approach to learn about prescription opioid safety in homes and schools. The next steps include modifications to the game prototype based on feedback from the community, integration of learning analytics to track the in-game behaviors of players, and formal testing of the final prototype.

Aim: The aim of the current study was to investigate the relationship between escalating higher doses of psilocybin and the potential psilocybin occasioned positive subjective effects. Methods: Healthy participants ( n=12) were given three escalating doses of oral psilocybin (0.3 mg/kg; 0.45 mg/kg; 0.6 mg/kg) or (18.8–36.6 mg; 27.1–54.0 mg; 36.3–59.2 mg) a minimum of four weeks apart in a supervised setting. Blood and urine samples, vital signs, and electrocardiograms were obtained. Subjective effects were assessed using the Mystical Experience Questionnaire and Persisting Effects Questionnaire. Results: There was a significant linear dose-related response in Mystical Experience Questionnaire total score and the transcendence of time and space subscale, but not in the rate of a complete mystical experience. There was also a significant difference between dose 3 compared to dose 1 on the transcendence of time and space subscale, while no dose-related differences were found for Mystical Experience Questionnaire total scores or rate of a mystical experience. Persisting Effects Questionnaire positive composite scores 30 days after completion of the last dose were significantly higher than negative composite scores. Persisting Effects Questionnaire results revealed a moderate increase in sense of well-being or life satisfaction on average that was associated with the maximum Mystical Experience Questionnaire total score. Pharmacokinetic measures were associated with dose but not with Mystical Experience Questionnaire total scores or rate of a mystical experience. Conclusions: High doses of psilocybin elicited subjective effects at least as strong as the lower doses and resulted in positive persisting subjective effects 30 days after, indicating that a complete mystical experience was not a prerequisite for positive outcomes.

The Comprehensive Primary Care Initiative (CPC), a health care delivery model developed by the Centers for Medicare and Medicaid Services (CMS), tested whether multipayer support of 502 primary care practices across the country would improve primary care delivery, improve care quality, or reduce spending. We evaluated the initiative's effects on care delivery and outcomes for fee-for-service Medicare beneficiaries attributed to initiative practices, relative to those attributed to matched comparison practices. CPC practices reported improvements in primary care delivery, including care management for high-risk patients, enhanced access, and improved coordination of care transitions. The initiative slowed growth in emergency department visits by 2 percent in CPC practices, relative to comparison practices. However, it did not reduce Medicare spending enough to cover care management fees or appreciably improve physician or beneficiary experience or practice performance on a limited set of Medicare claims-based quality measures. As CMS and other payers increasingly use alternative payment models that reward quality and value, CPC provides important lessons about supporting practices in transforming care.

Background External change agents can play an essential role in healthcare organizational change efforts. This systematic review examines the role that external change agents have played within the context of multifaceted interventions designed to promote organizational change in healthcare—specifically, in primary care settings. Methods We searched PubMed, CINAHL, Cochrane, Web of Science, and Academic Search Premier Databases in July 2016 for randomized trials published (in English) between January 1, 2005 and June 30, 2016 in which external agents were part of multifaceted organizational change strategies. The review was conducted according to PRISMA guidelines. A total of 477 abstracts were identified and screened by 2 authors. Full text articles of 113 studies were reviewed. Twenty-one of these studies were selected for inclusion. Results Academic detailing (AD) is the most prevalently used organizational change strategy employed as part of multi-component implementation strategies. Out of 21 studies, nearly all studies integrate some form of audit and feedback into their interventions. Eleven studies that included practice facilitation into their intervention reported significant effects in one or more primary outcomes. Conclusions Our results demonstrate that practice facilitation with regular, tailored follow up is a powerful component of a successful organizational change strategy. Academic detailing alone or combined with audit and feedback alone is ineffective without intensive follow up. Provision of educational materials and use of audit and feedback are often integral components of multifaceted implementation strategies. However, we didn’t find examples where those relatively limited strategies were effective as standalone interventions. System-level support through technology (such as automated reminders or alerts) is potentially helpful, but must be carefully tailored to clinic needs.

Background This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named “systems consultation” aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. Methods We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Results Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: “I am more familiar with guidelines for safe opioid prescribing” and “My clinic’s workflow for opioid prescribing is easier.” At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. Conclusions The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. Trial registration ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015 Electronic supplementary material The online version of this article (10.1186/s13012-018-0713-1) contains supplementary material, which is available to authorized users.

Over 16 million Americans meet diagnostic criteria for alcohol use disorder (AUD), but only 7.8% of them receive formal treatment each year. Safe and effective pharmacological treatments for AUD exist; however, they are rarely prescribed. Therefore, we developed and pilot tested a multifaceted implementation intervention to improve consideration and receipt of effective pharmacologic treatments for AUD, focusing on primary care settings where patients have the most frequent contact with healthcare systems. The intervention included training of local providers to serve as champions and a website for primary care providers that included educational materials, a case-finding dashboard, and contact information for local and national clinical experts. We also mailed patients educational material about treatment options. The intervention was implemented at three large facilities of the Veterans Health Administration (VHA). An interrupted time series design, analyzed with segmented logistic regression, was used to evaluate the intervention's effects. The odds of a patient with AUD receiving one of the AUD medications was increasing throughout the pre-implementation period, and the rate of change (slope) increased significantly in the implementation period. Translating these numbers into percentages, at baseline 2.9% of patients filled a prescription for an AUD medication within 30days of a primary care visit. This increased to 3.8% by the end of the pre-implementation period (increasing 0.037% per month), and increased to 5.2% by the end of the implementation period (increasing 0.142% per month). However, the intervention effect was not significant when control sites were added, suggesting that improvement may have been driven by secular trends rather than solely by this intervention. Although the intervention was feasible, it was not effective. Continued analysis of process and implementation data including qualitative interviews with key stakeholders, may elucidate the reasons this intervention was not successful and ways to strengthen its effects.

BACKGROUND Injectable naltrexone for alcohol use disorders (AUDs) has been efficacious in several studies. It has not been (i) compared head-to-head with oral naltrexone or (ii) examined in the hospital setting as an intervention that might facilitate treatment attendance after hospital discharge. METHODS Fifty-four hospitalized veterans identified as having DSM-IV-TR alcohol dependence were randomized to receive (i) a 50 mg oral naltrexone plus a 30-day prescription or (ii) a 380 mg intramuscular naltrexone injection prior to discharge. Of 113 veteran inpatients deemed eligible based on screening criteria, 54 met final eligibility criteria and were enrolled and randomized. Baseline data included demographics, alcohol consumption, and comorbidity. Measures of treatment initiation and engagement and alcohol consumption were reassessed at 14- and 45-day follow-ups. RESULTS Thirty-five participants (64.8%) completed the entire study protocol (received a study medication and completed 14- and 45-day follow-ups). Among those who received a study medication (n = 45), 77.8% completed all follow-up interviews. This pilot study was not designed to have sufficient statistical power for hypothesis testing, and thus, as expected, there were no significant differences between groups in medication adherence (self-report of >80% of daily doses taken in oral group; receipt of second injection in the injection group), treatment engagement (at least treatment 3 visits in the 30 days postdischarge, and 2 or more visits per month in each of the 3 months following discharge) or alcohol consumption at 14 or at 45 days (p > 0.05). The median number of drinks among the entire cohort in the 2 weeks prior to hospitalization (128 drinks) was significantly higher than at day 14 (0 drinks, p

Objectives To test whether a care management program could replicate its success in an earlier trial and determine likely explanations for why it did not. Data Sources/Setting Medicare claims and nurse contact data for Medicare fee-for-service beneficiaries with chronic illnesses enrolled in the trial in eastern Pennsylvania (N = 483). Study Design A randomized trial with half of enrollees receiving intensive care management services and half receiving usual care. We developed and tested hypotheses for why impacts declined. Data Extraction All outcomes and covariates were derived from claims and the nurse contact data. Principal Findings From 2010 to 2014, the program did not reduce hospitalizations or generate Medicare savings to offset program fees that averaged $260 per beneficiary per month. These estimates are statistically different (p

Family-focused prevention programs have been shown to effectively reduce a range of negative behavioral health outcomes but have had limited reach. Three key barriers must be overcome to expand the reach of family-focused prevention programs and thereby achieve a significant public health impact. These barriers are (1) current social norms and perceptions of parenting programs; (2) concerns about the expertise and legitimacy of sponsoring organizations to offer parenting advice; and (3) a paucity of stable, sustainable funding mechanisms. Primary healthcare settings are well positioned to overcome these barriers. Recent changes within health care make primary care settings an increasingly favorable home for family-focused prevention and suggest possibilities for sustainable funding of family-focused prevention programs. This paper discusses the existing advantages of primary care settings and lays out a plan to move toward realizing the potential public health impact of family-focused prevention through widespread implementation in primary healthcare settings.

The 4-year, multipayer Comprehensive Primary Care Initiative was started in October 2012 to determine whether several forms of support would produce changes in care delivery that would improve the quality and reduce the costs of care at 497 primary care practices in seven regions across the United States. Support included the provision of care-management fees, the opportunity to earn shared savings, and the provision of data feedback and learning support.We tracked changes in the delivery of care by practices participating in the initiative and used difference-in-differences regressions to compare changes over the first 2 years of the initiative in Medicare expenditures, health care utilization, claims-based measures of quality, and patient experience for Medicare fee-for-service beneficiaries attributed to initiative practices and a group of matched comparison practices.During the first 2 years, initiative practices received a median of $115,000 per clinician in care-management fees. The practices reported improvements in approaches to the delivery of primary care in areas such as management of the care of high-risk patients and enhanced access to care. Changes in average monthly Medicare expenditures per beneficiary did not differ significantly between initiative and comparison practices when care-management fees were not taken into account (-$11; 95% confidence interval [CI], -$23 to $1; P=0.07; negative values indicate less growth in spending at initiative practices) or when these fees were taken into account ($7; 95% CI, -$5 to $19; P=0.27). The only significant differences in other measures were a 3% reduction in primary care visits for initiative practices relative to comparison practices (P0.001) and changes in two of the six domains of patient experience--discussion of decisions regarding medication with patients and the provision of support for patients taking care of their own health--both of which showed a small improvement in initiative practices relative to comparison practices (P=0.006 and P0.001, respectively).Midway through this 4-year intervention, practices participating in the initiative have reported progress in transforming the delivery of primary care. However, at this point these practices have not yet shown savings in expenditures for Medicare Parts A and B after accounting for care-management fees, nor have they shown an appreciable improvement in the quality of care or patient experience. (Funded by the Department of Health and Human Services, Centers for Medicare and Medicaid Services; ClinicalTrials.gov number, NCT02320591.).

Background Asthma exacerbation risk increases with worsening asthma control. Prevailing numerical control tools evaluate only current symptom impairment despite the importance of also assessing risk based on exacerbation history. An easy-to-use questionnaire addressing impairment and risk domains of control is needed. Objective To validate a composite asthma control tool that includes impairment and risk assessments (Asthma Impairment and Risk Questionnaire [AIRQ]). Methods Four-hundred forty-two patients aged ≥12 years with physician-diagnosed asthma who were followed in specialty practices completed 15 impairment and risk questions with dichotomized yes/no responses. Patients spanned all Global Initiative for Asthma severities and were classified as well-controlled, not well-controlled, or very poorly controlled according to a standard of Asthma Control Test (ACT) score plus prior-year exacerbations. Logistic regression analyses identified questions with the greatest predictive validity to discriminate among patients and determine cut points for these 3 classifications. Results The final AIRQ comprises 10 equally weighted yes/no impairment and risk questions. The final 10-item models yielded receiver operating characteristic curves of 0.94 to identify well-controlled versus not well-/very poorly controlled and 0.93 to identify well-/not well-controlled versus very poorly controlled asthma, as reflected by the ACT plus prior-year exacerbations standard. Cut points of 0-1, 2-4, and 5-10 best represented well-, not well-, and very poorly controlled asthma. Conclusions AIRQ is a rigorously validated composite measure designed to identify adults and adolescents with varying degrees of asthma control. Ongoing investigations will determine test-retest reliability, responsiveness to change, and predictive ability for future exacerbations.

Objective: To examine associations between Pain Catastrophizing Scale (PCS) scores and daily opioid dosage in traumatic injury patients. Design: This was a prospective cohort study with patient assessments at baseline and 1-month following discharge. Setting: Study visits were conducted at a Regional Level I Trauma Center and by phone at follow-up. Patients: Forty-nine injured inpatients completed baseline PCS. A subsample of 23 patients continued to take prescribed opioid medication at 1-month postdischarge and were included in the current analyses. Main Outcome measured: Associations between baseline PCS and morphine equivalent daily dose (MEDD) at 1-month follow-up. Results: Controlling for baseline MEDD, baseline PCS score was positively associated with MEDD at 1-month postdischarge ( β = 0.577 [0.399, 1.535]; p = 0.002; R 2 of PCS = 0.395). Conclusions : In the current sample of traumatic injury inpatients, findings indicated that a baseline measure of pain catastrophizing predicts ongoing opioid medication use and dosage at 1-month postdischarge from an inpatient trauma unit.

Background: Despite the near ubiquity of mobile phones, little research has been conducted on the implementation of mobile health (mHealth) apps to treat patients in primary care. Although primary care clinicians routinely treat chronic conditions such as asthma and diabetes, they rarely treat addiction, a common chronic condition. Instead, addiction is most often treated in the US health care system, if it is treated at all, in a separate behavioral health system. mHealth could help integrate addiction treatment in primary care. Objective: The objective of this paper was to report the effects of implementing an mHealth system for addiction in primary care on both patients and clinicians. Methods: In this implementation research trial, an evidence-based mHealth system named Seva was introduced sequentially over 36 months to a maximum of 100 patients with substance use disorders (SUDs) in each of three federally qualified health centers (FQHCs; primary care clinics that serve patients regardless of their ability to pay). This paper reports on patient and clinician outcomes organized according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Results: The outcomes according to the RE-AIM framework are as follows: Reach—Seva reached 8.31% (268/3226) of appropriate patients. Reach was limited by our ability to pay for phones and data plans for a maximum of 100 patients per clinic. Effectiveness—Patients who were given Seva had significant improvements in their risky drinking days (44% reduction, (0.7-1.25)/1.25, P=.04), illicit drug-use days (34% reduction, (2.14-3.22)/3.22, P=.01), quality of life, human immunodeficiency virus screening rates, and number of hospitalizations. Through Seva, patients also provided peer support to one another in ways that are novel in primary care settings. Adoption—Patients sustained high levels of Seva use—between 53% and 60% of the patients at the 3 sites accessed Seva during the last week of the 12-month implementation period. Among clinicians, use of the technology was less robust than use by patients, with only a handful of clinicians using Seva in each clinic and behavioral health providers making most referrals to Seva in 2 of the 3 clinics. Implementation—At 2 sites, implementation plans were realized successfully; they were delayed in the third. Maintenance—Use of Seva dropped when grant funding stopped paying for the mobile phones and data plans. Two of the 3 clinics wanted to maintain the use of Seva, but they struggled to find funding to support this. Conclusions: Implementing an mHealth system can improve care among primary care patients with SUDs, and patients using the system can support one another in their recovery. Among clinicians, however, implementation requires figuring out how information from the mHealth system will be used and making mHealth data available in the electronic health (eHealth) record. In addition, paying for an mHealth system remains a challenge.

BACKGROUND Performance feedback is central to data-driven models of quality improvement, but the use of claims-based data for feedback has received little attention. PURPOSE To examine the challenges, uses, and limitations of quarterly Medicare claims-based performance feedback reports generated for practices participating in the Comprehensive Primary Care (CPC) initiative from 2012 to 2015. METHODS Mixed methods study of nearly 500 CPC practices in seven regions, combining pilot testing; systematic monitoring; surveys; in-depth interviews; user feedback; and input from data feedback team. RESULTS Designing reports required addressing issues about timing, data completeness and reliability, variations in patient risk across practices, and use of benchmarks and metrics understandable to users. Practices' ability to use reports constructively depended on their experience, analytic resources, expectations, and perceptions about the role of primary care in improving reported outcomes. CONCLUSIONS Generating claims-based feedback reports that support practices' quality improvement efforts requires a significant investment of analytic expertise, time, resources, continuous improvement, and technical assistance. IMPLICATIONS Claims-based performance feedback can provide insight into patterns of patients' care across provider settings and opportunities for improvement, but practices need data from other sources to manage patients in real time or assess the short-term effects of specific changes in care delivery.

Background Opioid addiction and overdose are epidemic in the U.S. Victims of traumatic injury are at greater than average risk for opioid misuse and related complications. Potential risk screens and preventive interventions in this clinical population remain under-investigated. The current project seeks to develop and pilot the implementation of a screening tool for opioid risk at American College of Surgeons (ACS) Level I and Level II trauma centers. Methods The project began with an online survey, which was sent to Wisconsin trauma center medical directors and trauma coordinators for the purpose of gathering information on current substance use screening practices. Next, a focus group of trauma center staff was convened to discuss barriers and facilitators to screening, resources available and needed to support trauma patients with opioid use disorders, and measurable clinical observations that could indicate a patient’s potential risk for opioid misuse. Data from the surveys and focus group were combined to inform the data collection instruments that are currently being administered to patients recruited from the University of Wisconsin Hospital Trauma Inpatient and Orthopedic Surgery Services. Eligible and consenting patients complete standardized measures of socio-demographics, substance use history, opioid misuse risk, mental health, medical history, and injury and pain severity. Follow up visits at weeks 4, 12, and 24 after hospital discharge assess hypothesized risk factors for opioid addiction and opioid use disorder diagnosis. At the completion of patient data collection, a forward stepwise regression will identify factors of most significant risk of the development of opioid use disorder after traumatic injury. This modeling will inform the development of a novel opioid risk screening tool, which will undergo pilot implementation at 4 Wisconsin ACS Level I and Level II trauma centers, using an evidence-based implementation strategy with roots in systems engineering. Discussion Positive findings from the proposed work would lead to improved, standardized opioid risk screening practices among victims of traumatic injury. The ultimate goal of this and future work is to reduce the likelihood of opioid misuse, addiction, and related complications, such as overdose and death. Trial registration Clinicaltrials.gov registration number: NCT02861976. Date of registration: Feb 9, 2016

Psilocybin is a psychedelic tryptamine that has shown promise in recent clinical trials for the treatment of depression and substance use disorders. This open-label study of the pharmacokinetics of psilocybin was performed to describe the pharmacokinetics and safety profile of psilocybin in sequential, escalating oral doses of 0.3, 0.45, and 0.6 mg/kg in 12 healthy adults. Eligible healthy adults received 6–8 h of preparatory counseling in anticipation of the first dose of psilocybin. The escalating oral psilocybin doses were administered at approximately monthly intervals in a controlled setting and subjects were monitored for 24 h. Blood and urine samples were collected over 24 h and assayed by a validated liquid chromatography-tandem mass spectrometry (LC–MS/MS) assay for psilocybin and psilocin, the active metabolite. The pharmacokinetics of psilocin were determined using both compartmental (NONMEM) and noncompartmental (WinNonlin) methods. No psilocybin was found in plasma or urine, and renal clearance of intact psilocin accounted for less than 2% of the total clearance. The pharmacokinetics of psilocin were linear within the twofold range of doses, and the elimination half-life of psilocin was 3 h (standard deviation 1.1). An extended elimination phase in some subjects suggests hydrolysis of the psilocin glucuronide metabolite. Variation in psilocin clearance was not predicted by body weight, and no serious adverse events occurred in the subjects studied. The small amount of psilocin renally excreted suggests that no dose reduction is needed for subjects with mild–moderate renal impairment. Simulation of fixed doses using the pharmacokinetic parameters suggest that an oral dose of 25 mg should approximate the drug exposure of a 0.3 mg/kg oral dose of psilocybin. Although doses of 0.6 mg/kg are in excess of likely therapeutic doses, no serious physical or psychological events occurred during or within 30 days of any dose. NCT02163707.

Objective To identify the most robust methods for evaluating alternative payment models (APMs) in the emerging health care delivery system environment. Study Design (Approach) We assess the impact of widespread testing of alternative payment models on the ability to find credible comparison groups. We consider the applicability of factorial research designs for assessing the effects of these models. Principal Findings The widespread adoption of alternative payment models could effectively eliminate the possibility of comparing APM results with a “pure” control or comparison group unaffected by other interventions. In this new environment, factorial experiments have distinct advantages over the single-model experimental or quasi-experimental designs that have been the mainstay of recent tests of Medicare payment and delivery models. Conclusions The best prospects for producing definitive evidence of the effects of payment incentives for APMs include fractional factorial experiments that systematically vary requirements and payment provisions within a payment model.

Objective To describe the modified Patient-Centered Medical Home Assessment (M-PCMH-A) survey module developed to track primary care practices' care delivery approaches over time, assess whether its underlying factor structure is reliable, and produce factor scores that provide a more reliable summary measure of the practice's care delivery than would a simple average of question responses. Data sources/study setting Survey data collected from diverse practices participating in the Comprehensive Primary Care (CPC) initiative in 2012 (n = 497) and 2014 (n = 493) and matched comparison practices in 2014 (n = 423). Study design Confirmatory factor analysis. Data collection Thirty-eight questions organized in six domains: Access and Continuity of Care, Planned Care for Chronic Conditions and Preventive Care, Risk-Stratified Care Management, Patient and Caregiver Engagement, Coordination of Care across the Medical Neighborhood, and Continuous Data-Driven Improvement. Principal findings Confirmatory factor analysis suggested using seven factors (splitting one domain into two), reassigning two questions to different domain factors, and removing one question, resulting in high reliability, construct validity, and stability in all but one factor. The seven factors together formed a single higher-order factor summary measure. Factor scores guard against potential biases from equal weighting. Conclusions The M-PCMH-A can validly and reliably track primary care delivery across practices and over time using factors representing seven key components of care as well as an overall score. Researchers should calculate factor loadings for their specific data if possible, but average scores may be suitable if they cannot use factor analysis due to resource or sample constraints.

Background Peripheral blood stem cell (PBSC) mobilization is routinely undertaken prior to autologous stem cell transplantation (ASCT) in patients with multiple myeloma (MM). A number of studies have identified risk factors for poor PBSC mobilization, however, little data exists to correlate mobilization with disease-specific outcomes in this patient population. Prospective work in MM has demonstrated similar outcomes in a homogenous patient population. Methods In this single institution analysis, we retrospectively studied the impact of poor PBSC mobilization on progression free survival (PFS) and OS in MM patients undergoing PBSC mobilization. Poor mobilizers are defined as patients that collected 10 mcg/kg/day) and/or plerixafor can significantly improve mobilization and ASCT chances in this population. Discussion These data indicate that poor mobilization can be predictable and is associated with more aggressive disease biology and worse outcomes, warranting intensive post-ASCT management.

Millions of Americans need but don’t receive treatment for substance use, and evidence suggests that addiction-focused interventions on smart phones could support their recovery. There is little research on implementation of addiction-related interventions in primary care, particularly in Federally Qualified Health Centers (FQHCs) that provide primary care to underserved populations. We used mixed methods to examine three FQHCs’ implementation of Seva, a smart-phone app that offers patients online support/discussion, health-tracking, and tools for coping with cravings, and offers clinicians information about patients’ health tracking and relapses. We examined (a) clinicians’ initial perspectives about implementing Seva, and (b) the first year of implementation at Site 1. Prior to staggered implementation at three FQHCs (Midwest city in WI vs. rural town in MT vs. metropolitan NY), interviews, meetings, and focus groups were conducted with 53 clinicians to identify core themes of initial expectations about implementation. One year into implementation at Site 1, clinicians there were re-interviewed. Their reports were supplemented by quantitative data on clinician and patient use of Seva. Clinicians anticipated that Seva could help patients and make behavioral health appointments more efficient, but they were skeptical that physicians would engage with Seva (given high caseloads), and they were uncertain whether patients would use Seva. They were concerned about legal obligations for monitoring patients’ interactions online, including possible “cries for help” or inappropriate interactions. One year later at Site 1, behavioral health care providers, rather than physicians, had incorporated Seva into patient care, primarily by discussing it during appointments. Given workflow/load concerns, only a few key clinicians monitored health tracking/relapses and prompted outreach when needed; two researchers monitored the discussion board and alerted the clinic as needed. Clinician turnover/leave complicated this approach. Contrary to clinicians’ initial concerns, patients showed sustained, mutually supportive use of Seva, with few instances of misuse. Results suggest the value of (a) focusing implementation on behavioral health care providers rather than physicians, (b) assigning a few individuals (not necessarily clinicians) to monitor health tracking, relapses, and the discussion board, (c) anticipating turnover/leave and having designated replacements. Patients showed sustained, positive use of Seva. ClinicalTrials.gov ( NCT01963234 ).

Background Adoption of evidence-based practices takes place at a glacial place in healthcare. This research will pilot test an innovative implementation strategy – systems consultation –intended to speed the adoption of evidence-based practice in primary care. The strategy is based on tenets of systems engineering and has been extensively tested in addiction treatment. Three innovations have been included in the strategy – translation of a clinical practice guideline into a checklist-based implementation guide, the use of physician peer coaches (‘systems consultants’) to help clinics implement the guide, and a focus on reducing variation in practices across prescribers and clinics. The implementation strategy will be applied to improving opioid prescribing practices in primary care, which may help ultimately mitigate the increasing prevalence of opioid abuse and addiction. Methods/Design The pilot test will compare four intervention clinics to four control clinics in a matched-pairs design. A leading clinical guideline for opioid prescribing has been translated into a checklist-based implementation guide in a systematic process that involved experts who wrote the guideline in consultation with implementation experts and primary care physicians. Two physicians with expertise in family and addiction medicine are serving as the systems consultants. Each systems consultant will guide two intervention clinics, using two site visits and follow-up communication by phone and email, to implement the translated guideline. Mixed methods will be used to test the feasibility, acceptability, and preliminary effectiveness of the implementation strategy in an evaluation that meets standards for ‘fully developed use’ of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The clinic will be the primary unit of analysis. Discussion The systems consultation implementation strategy is intended to generalize to the adoption of other clinical guidelines. This pilot test is intended to prepare for a large randomized clinical trial that will test the strategy against other implementation strategies, such as audit/feedback and academic detailing, used to close the gap between knowledge and practice. The systems consultation approach has the potential to shorten the famously long time it takes to implement evidence-based practices and clinical guidelines in healthcare.

Background Only 7.8 % of individuals meeting diagnostic criteria for alcohol use disorder (AUD) receive treatment in a given year. Most individuals with AUDs are identified in primary care (PC) settings and referred to substance use disorders (SUD) clinics; however, only a minority of those referred attend treatment services. Safe and effective pharmacological treatments for AUD exist, but they are rarely prescribed by PC providers. The objective of this study is to refine, implement, and evaluate an intervention to integrate pharmacological AUD treatment options into PC settings. This paper provides a detailed description of the intervention design and the evaluation components. Methods/design Three large Veterans Health Administration (VHA) facilities are participating in the intervention. The intervention targets stakeholder groups with tailored strategies based on implementation theory and prior research identifying barriers to implementation of AUD pharmacotherapy. Local SUD providers and primary care mental health integration (PCMHI) providers are trained to serve as local implementation/clinical champions and receive external facilitation. PC providers receive access to consultation from local and national clinical champions, educational materials, and a dashboard of patients with AUD on their caseloads for case identification. Veterans with AUD diagnoses receive educational information in the mail just prior to a scheduled PC visit. Effectiveness of the intervention will be evaluated through an interrupted time series with matched controls to monitor change in facility level AUD pharmacotherapy prescribing rates. Following Stetler’s four-phase formative evaluation (FE) strategy, FE methods include (1) developmental FE (pre-implementation interviews with champions, PC providers, and Veterans), (2) implementation-focused FE (tracking attendance at facilitation meetings, academic detailing efforts by local champions, and patient dashboard utilization), (3) progress-focused FE (tracking rates of AUD pharmacotherapy prescribing and rates of referral to PCMHI and SUD specialty care), and (4) interpretive FE (post-implementation interviews with champions and PC providers). Analysis of FE data will be guided by the Consolidated Framework for Implementation Research (CFIR). Discussion If demonstrated to be successful, this implementation strategy will provide a replicable, feasible, and relative low-cost method for integrating AUD treatment services into PC settings, thereby increasing access to AUD treatment.

We tested the hypothesis that the neuropathologic outcome following recovery from incomplete ischemia is similar in normoglycemia and diabetes. Incomplete global ischemia was induced for 20 min in two groups of dogs: (a) normoglycemic, nondiabetic controls (n = 11) and (b) chronic (3 months), diabetic hyperglycemic subjects (n = 12). Animals were allowed to recover from surgery for 7 days after which they were perfusion-fixed for neuropathology. On paraffin processed tissue stained with hematoxylin and eosin (H&E), ischemic neurons were counted and the per cent of cell damage determined. All control animals survived for 7 days postischemia. Four of 12 diabetic animals survived for 7 days, with the remaining eight diabetic dogs dying within the first 3 days. On day 7, the percentage of neurons showing ischemic cell change in the four diabetic survivors and the 11 nondiabetic controls was similar in the cerebellum, CA1, superior temporal gyrus, and caudate. However, diabetic dogs that did not survive the 7-day recovery period showed cerebellar swelling, reduced Purkinje cell densities, and herniation. During the 3 months prior to ischemia, morning (10.7 ± 4.4 versus 11.2 ± 5.2 m M) and afternoon (8.8 ± 5.0 versus 9.4 ± 5.3 m M) blood glucose levels in the four surviving and eight nonsurviving diabetic animals, respectively, were similar. However, preischemic blood glucose was significantly elevated in animals that did not survive (7.8 ± 2.8 versus 15.8 ± 7.3 m M in survivors and nonsurvivors, respectively). This study shows that diabetic animals surviving 7 days postischemia and nondiabetic controls have similar neuropathology. However, diabetic animals in which glucose control deteriorated during the 24-h prior to ischemia did not survive, possibly due to severe hindbrain edema. These results show that in diabetes, blood glucose control immediately prior to incomplete global brain ischemia is an important determinant of morbidity and neuropathology.

Methods Community-recruited adults aged ≥ 50 years were randomized to one of three conditions: 8-week training in mindfulness meditation; matched 8-week training in moderate intensity sustained exercise; or wait-list observational control. The primary outcome was area-under-the-curve global illness severity over one cold and flu season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS24) to assess severity. Significance was set at p=0.025. Health care visits and days-of-missed-work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid.

In this study we measured the dimensions of the articular eminence before and after eminectomy in order to establish a guideline for the surgical reduction of this structure. Among the 38 cadaver half-heads studied, there was a range before reduction of 89° to 16° in the angle of the anterior slope of the fossa (the posterior incline of the eminence) relative to the Frankfort horizontal plane. The depth of the fossa ranged from 3 to 15 millimeters. After reduction was completed, the change in the angle of the slope ranged from 0° to 44°, and the change in the depth of the fossa ranged from 1 to 6 millimeters.