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Previous studies indicate that suboptimal medication adherence may contribute to uncontrolled asthma. Global Initiative for Asthma (GINA) guidelines recommend treatment escalation to biologics for patients with uncontrolled asthma despite adherence to high-dose maintenance medication and who have eosinophilic/allergic biomarkers or require maintenance oral corticosteroids.This study aimed to describe the clinical status of patients with asthma escalated to biologic therapy.This retrospective claims database analysis enrolled US patients with asthma who were escalated to biologics between January 2016 and June 2020. Exacerbations, control status, GINA step, and maintenance medication adherence during the 12 months before biologic therapy initiation were analyzed. Asthma control was assessed using both the European Respiratory Society/American Thoracic Society (ERS/ATS) and Stempel criteria. Adherence was defined as the proportion of days covered (PDC) by maintenance medication claims.Of 1786 patients escalated to biologics, 506 were included for analysis. During the 12 months before escalation, 346 patients had confirmed exacerbations. Uncontrolled asthma status was estimated in 55% and 70% of patients (ERS/ATS and Stempel criteria, respectively). GINA step was inferred for 395 patients: 154 were at step 2, 11 at step 3, 104 at step 4, and 126 at step 5. Of 403 patients with maintenance medication claims, 63% had suboptimal maintenance medication adherence (PDC80%).In this study, most patients initiating biologic therapy had mild-to-moderate asthma or suboptimal maintenance medication adherence, possibly indicating inappropriate escalation. Incorporating objective medication adherence monitoring into existing guidelines may reduce inappropriate escalation to biologics.

The albuterol Digihaler (albuterol 90 μg/dose) transmits data wirelessly to a smart device application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. The Reliever Digihaler System (RDS) comprises the albuterol Digihaler, application, Digital Health Platform and Dashboard. This allows patients and health care professionals to review reliever inhaler usage and inhalation quality to aid clinical decision making.To demonstrate the effectiveness, as measured by change in asthma control, of the RDS compared with standard of care.In this 12-week study, participants aged 13 years or older with suboptimal asthma control (Asthma Control Test [ACT] score19) were randomized to use either RDS or standard of care albuterol reliever inhalers. The health care professionals were recommended at study start to check each participant's inhalation data (including inhalation quantity and quality parameters) 1 or more times per week. Primary outcome was the proportion of participants achieving clinically meaningful improvement in asthma control (ACT score ≥ 20 at week 12 and/or increase ≥ 3 units from baseline). Bayesian statistical analysis provided a posterior probability distribution for odds ratios with corresponding credible intervals.Participants using the RDS (n = 167) had an 85.3% probability of greater odds of clinically meaningful asthma control improvements than those using SoC (n = 166) after 3 months (mean odds ratio 1.33; 95% credible interval 0.813-2.050).In this study, participants using the RDS had greater odds of clinically meaningful improvements in asthma control versus SoC after 3 months. Further investigation of the potential of the RDS to help improve asthma management is warranted.

To assess the effects of eLongTermCare (eLTC), a telehealth program implemented by an integrated health system in 45 nursing homes across the Midwest, on the use of acute hospital services and total expenditures for Medicare residents.Minimum Data Set, Medicare fee-for-service claims, and enrollment data from 2013 to 2018.We used a longitudinal difference-in-differences design to estimate the changes in outcomes for treatment beneficiaries before and after participating in the eLTC program, relative to changes for the matched comparison beneficiaries over the same period. We measured outcomes over a 24-month follow-up period, including total Medicare spending, emergency department (ED) visits, hospitalizations, and the likelihood of readmission.Using administrative data, we identified treatment beneficiaries who stayed at participating nursing facilities during the program period and matched comparison beneficiaries with similar baseline characteristics from non-participating facilities in the same geographic locations.For long-term care residents, the eLTC program led to an estimated reduction of 73 ED visits per 1000 beneficiaries (p 0.01, 8.6% effect) over the two-year follow-up period. The estimated effects for this group were concentrated among beneficiaries who entered the nursing home after program startup, with sizable reductions in hospitalizations, ED visits, and spending. For skilled care residents, the program was associated with an estimated reduction of 85 ED visits per 1000 beneficiaries (p = 0.03, 9.7% effect), but had no discernible effect on their hospitalizations or total Medicare spending.Telehealth can be a valuable tool for nursing homes to enhance care coordination and provide timely access to care, leading to lower spending for nursing home residents. Future research needs to explore payment methods that encourage telehealth expansion in nursing homes.

Background Melphalan flufenamide (melflufen), an alkylating peptide-drug conjugate, plus dexamethasone showed clinical activity and manageable safety in the phase 2 HORIZON study. We aimed to determine whether melflufen plus dexamethasone would provide a progression-free survival benefit compared with pomalidomide plus dexamethasone in patients with previously treated multiple myeloma. Methods In this randomised, open-label, head-to-head, phase 3 study (OCEAN), adult patients (aged ≥18 years) were recruited from 108 university hospitals, specialist hospitals, and community-based centres in 21 countries across Europe, North America, and Asia. Eligible patients had an ECOG performance status of 0–2; must have had relapsed or refractory multiple myeloma, refractory to lenalidomide (within 18 months of randomisation) and to the last line of therapy; and have received two to four previous lines of therapy (including lenalidomide and a proteasome inhibitor). Patients were randomly assigned (1:1), stratified by age, number of previous lines of therapy, and International Staging System score, to either 28-day cycles of melflufen and dexamethasone (melflufen group) or pomalidomide and dexamethasone (pomalidomide group). All patients received dexamethasone 40 mg orally on days 1, 8, 15, and 22 of each cycle. In the melflufen group, patients received melflufen 40 mg intravenously over 30 min on day 1 of each cycle and in the pomalidomide group, patients received pomalidomide 4 mg orally daily on days 1 to 21 of each cycle. The primary endpoint was progression-free survival assessed by an independent review committee in the intention-to-treat (ITT) population. Safety was assessed in patients who received at least one dose of study medication. This study is registered with ClinicalTrials.gov, NCT03151811, and is ongoing. Findings Between June 12, 2017, and Sept 3, 2020, 246 patients were randomly assigned to the melflufen group (median age 68 years [IQR 60–72]; 107 [43%] were female) and 249 to the pomalidomide group (median age 68 years [IQR 61–72]; 109 [44%] were female). 474 patients received at least one dose of study drug (melflufen group n=228; pomalidomide group n=246; safety population). Data cutoff was Feb 3, 2021. Median progression-free survival was 6·8 months (95% CI 5·0–8·5; 165 [67%] of 246 patients had an event) in the melflufen group and 4·9 months (4·2–5·7; 190 [76%] of 249 patients had an event) in the pomalidomide group (hazard ratio [HR] 0·79, [95% CI 0·64–0·98]; p=0·032), at a median follow-up of 15·5 months (IQR 9·4–22·8) in the melflufen group and 16·3 months (10·1–23·2) in the pomalidomide group. Median overall survival was 19·8 months (95% CI 15·1–25·6) at a median follow-up of 19·8 months (IQR 12·0–25·0) in the melflufen group and 25·0 months (95% CI 18·1–31·9) in the pomalidomide group at a median follow-up of 18·6 months (IQR 11·8–23·7; HR 1·10 [95% CI 0·85–1·44]; p=0·47). The most common grade 3 or 4 treatment-emergent adverse events were thrombocytopenia (143 [63%] of 228 in the melflufen group vs 26 [11%] of 246 in the pomalidomide group), neutropenia (123 [54%] vs 102 [41%]), and anaemia (97 [43%] vs 44 [18%]). Serious treatment-emergent adverse events occurred in 95 (42%) patients in the melflufen group and 113 (46%) in the pomalidomide group, the most common of which were pneumonia (13 [6%] vs 21 [9%]), COVID-19 pneumonia (11 [5%] vs nine [4%]), and thrombocytopenia (nine [4%] vs three [1%]). 27 [12%] patients in the melflufen group and 32 [13%] in the pomalidomide group had fatal treatment-emergent adverse events. Fatal treatment-emergent adverse events were considered possibly treatment related in two patients in the melflufen group (one with acute myeloid leukaemia, one with pancytopenia and acute cardiac failure) and four patients in the pomalidomide group (two patients with pneumonia, one with myelodysplastic syndromes, one with COVID-19 pneumonia). Interpretation Melflufen plus dexamethasone showed superior progression-free survival than pomalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma., Oncopeptides AB

OBJECTIVES This study examines 14 independent and diverse health care interventions funded under the second round of Health Care Innovation Awards by CMS to determine if any organizational, model, or implementation features were strongly associated with the programs' estimated impacts on total expenditures, hospitalizations, or emergency department visits. STUDY DESIGN We estimated program impacts using awardee-specific difference-in-differences models based on Medicare and Medicaid enrollment and claims data for treatment and matched comparison groups from 2012 to 2018. METHODS We used 2 analytic approaches to identify program features associated with favorable impacts. The first method identified program characteristics that were common among programs that had estimated reductions in costs and service use and uncommon among those that did not. The second approach compared median impacts among awardees with a given distinguishing feature with median impacts among awardees that lacked the characteristic. RESULTS Of the 23 program features examined, 7 were associated with favorable estimated impacts: 3 intervention components (behavioral health, telehealth, and health information technology) and 4 program design and organizational characteristics (having prior experience implementing similar programs, targeting patients with substantial nonmedical needs in addition to medical problems, being focused on individual patient care rather than transforming provider practice, and using nonclinical staff as frontline providers of the intervention). CONCLUSIONS Innovative health care service delivery models with 2 or more of these 7 identified features were more likely than programs without them to reduce Medicare and Medicaid beneficiaries' needs for costly health care services.

Evaluation of public programs has undergone many changes over the past four decades since Peter Rossi coined his “Iron Law” of program evaluation: “The expected value of any net impact assessment of any large-scale social program is zero.” While that assessment may be somewhat overstated, the essence still holds. The failures far outnumber the successes, and the estimated favorable effects are rarely sizeable. Despite this grim assessment, much can be learned from “failed” experiments, and from ones that are successful in only some sites or subgroups. Advances in study design, statistical models, data, and how inferences are drawn from estimates have substantially improved our analyses and will continue to do so. However, the most actual learning about “what works” (and why, when, and where) is likely to come from gathering more detailed and comprehensive data on how the intervention was implemented and attempting to link that data to estimated impacts. Researchers need detailed data on the target population served, the content of the intervention, and the process by which it is delivered to participating service providers and individuals. Two examples presented here illustrate how researchers drew useful broader lessons from impact estimates for a set of related programs. Rossi posited three reasons most interventions fail—wrong question, wrong intervention, poor implementation. Speeding the accumulation of wisdom about how social programs can best help vulnerable populations will require that researchers work closely with program funders, developers, operators, and participants to gather and interpret these detailed data about program implementation.

Overdoses continue to increase in the US, but the contribution of methamphetamine use is understudied in rural communities.To estimate the prevalence of methamphetamine use and its correlates among people who use drugs (PWUD) in rural US communities and to determine whether methamphetamine use is associated with increased nonfatal overdoses.From January 2018 through March 2020, the National Rural Opioid Initiative conducted cross-sectional surveys of PWUD in rural communities in 10 states (Illinois, Kentucky, New Hampshire, Massachusetts, North Carolina, Ohio, Oregon, Vermont, West Virginia, and Wisconsin). Participants included rural PWUD who reported any past-30-day injection drug use or noninjection opioid use to get high. A modified chain-referral sampling strategy identified seeds who referred others using drugs. Data analysis was performed from May 2021 to January 2022.Use of methamphetamine alone, opioids alone, or both.Unweighted and weighted prevalence of methamphetamine use, any past-180-day nonfatal overdose, and number of lifetime nonfatal overdoses.Among the 3048 participants, 1737 (57%) were male, 2576 (85%) were White, and 225 (7.4%) were American Indian; the mean (SD) age was 36 (10) years. Most participants (1878 of 2970 participants with any opioid or methamphetamine use [63%]) reported co-use of methamphetamine and opioids, followed by opioids alone (702 participants [24%]), and methamphetamine alone (390 participants [13%]). The estimated unweighted prevalence of methamphetamine use was 80% (95% CI, 64%-90%), and the estimated weighted prevalence was 79% (95% CI, 57%-91%). Nonfatal overdose was greatest in people using both methamphetamine and opioids (395 of 2854 participants with nonmissing overdose data [22%]) vs opioids alone (99 participants [14%]) or methamphetamine alone (23 participants [6%]). Co-use of methamphetamine and opioids was associated with greater nonfatal overdose compared with opioid use alone (adjusted odds ratio, 1.45; 95% CI, 1.08-1.94; P = .01) and methamphetamine use alone (adjusted odds ratio, 3.26; 95% CI, 2.06-5.14; P .001). Those with co-use had a mean (SD) of 2.4 (4.2) (median [IQR], 1 [0-3]) lifetime overdoses compared with 1.7 (3.5) (median [IQR], 0 [0-2]) among those using opioids alone (adjusted rate ratio, 1.20; 95% CI, 1.01-1.43; P = .04), and 1.1 (2.9) (median [IQR], 0 [0-1]) among those using methamphetamine alone (adjusted rate ratio, 1.81; 95% CI, 1.45-2.27; P .001). Participants with co-use most often reported having tried and failed to access substance use treatment: 827 participants (44%) for both, 117 participants (30%) for methamphetamine alone, and 252 participants (36%) for opioids alone (χ22 = 33.8; P .001). Only 66 participants (17%) using methamphetamine alone had naloxone.These findings suggest that harm reduction and substance use disorder treatment interventions must address both methamphetamine and opioids to decrease overdose in rural communities.

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

BACKGROUND The extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of AUDs works or does not work, for whom, and under what circumstances. OBJECTIVE The primary aim is to detect the effectiveness of an mHealth intervention by assessing differences in self-reported risky drinking patterns and quality of life between participants in three study groups (self-monitored, peer-supported, and clinically integrated). The cost-effectiveness of each approach will also be assessed. METHODS This hybrid type 1 study is an unblinded patient-level randomized clinical trial testing the effects of using an evidence-based mHealth system on participants’ drinking patterns and quality of life. There are two groups of participants for this study: individuals receiving the intervention and health care professionals practicing in the broader health care environment. The intervention is a smartphone app that encourages users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. The primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life as well as app use from weekly and quarterly surveys. Cost measures include intervention and implementation costs. The cost per participant will be determined for each study arm, with intervention and implementation costs separated within each group. There will also be a qualitative assessment of health care professionals’ engagement with the app as well as their thoughts on participant experience with the app. RESULTS This protocol was approved by the Health Sciences Minimal Risk Institutional Review Board on November 18, 2019, with subsequent annual reviews. Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of November 17, 2021, is as follows: 357 participants were enrolled in the study for a planned enrollment of 546 participants. CONCLUSIONS The new knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for individuals with mild to moderate AUDs. The results of this study will guide policy makers and providers toward cost-effective ways to incorporate technology in health care and community settings. CLINICALTRIAL ClinicalTrials.gov NCT04011644; https://clinicaltrials.gov/ct2/show/NCT04011644 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/31109

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.

In the same way that discrete global grid systems (DGGS) are used to index data on the spherical Earth, they can aggregate point data, with their spherical polygons serving as bins. DGGS are particularly useful at multiple map scales because they are spatially hierarchical and exist on the sphere or ellipsoid, allowing large or small scale binning without projection distortion. We use DGGS in a free and open-source pedagogical tool for teaching students about the modifiable areal unit problem (MAUP). Our software application uses Dutton’s quaternary triangular mesh (QTM) to bin global data points geodesically with counts or measures of any theme at multiple levels. Users can interactively select the level to which the data are binned by the QTM, as well as translate the whole tessellation east or west so that points fall into and out of different bins. These two functions illustrate the scaling and zoning aspects of the MAUP with dynamically-drawn choropleths on the surface of a virtual globe that the user can zoom and rotate, allowing visualization at virtually any cartographic scale. Users may also select various quantile classifications to further explore issues in visualizing aggregate data. In addition to presenting this new tool, we highlight the importance, especially at smaller scales, of using geodesic point-in-polygon intersection detection, rather than the projected 2D methods typically used by geographic information systems.

Background: Policy makers seek to replace the “thumbs up–thumbs down” of conventional hypothesis testing with statements about the probability that program effects on key outcomes exceed policy-relevant thresholds. Objective: We develop a Bayesian model that addresses the shortcomings of a typical frequentist approach to estimating the effects of the Comprehensive Primary Care (CPC) initiative, a Centers for Medicare and Medicaid Services demonstration. We compare findings from the two approaches to illustrate the relative merits of introducing additional assumptions through Bayesian methods. Research design: We apply Bayesian and frequentist methods to estimate the effects of CPC on total Medicare expenditures per beneficiary per month for Medicare beneficiaries attributed to participating practices. Under both paradigms, we estimated program effects using difference-in-differences regressions comparing the change in Medicare expenditures between baseline and follow-up for Medicare patients attributed to 497 primary care practices participating in CPC to Medicare patients attributed to 908 propensity score-matched comparison practices. Results: Results from the Bayesian and frequentist models are comparable for the overall sample, but in regional subsamples, the Bayesian model produces more precise etimates that exhibit less variation over time. The Bayesian results also permit probabilistic inference about the magnitudes of effects, offering policy makers the ability to draw conclusions about practically meaningful thresholds. Conclusions: Carefully developed Bayesian models can enhance precision and plausibility and offer a more nuanced understanding of where and when program effects occur, without imposing undue assumptions. At the same time, these methods frame conclusions in flexible, intuitive terms that respond directly to policy makers’ needs.

BACKGROUND: The Centers for Medicare & Medicaid Services launched the 4-year Comprehensive Primary Care Initiative (CPC Classic) in 2012 and its 5-year successor, CPC Plus (CPC+), in 2017 to test whether improving primary care delivery in five areas—and providing practices with financial and technical support—reduced spending and improved quality. This is the first study to examine long-term effects of a primary care practice transformation model. OBJECTIVE: To test whether long-term primary care transformation—the 4-year CPC Classic and the first 2 years of its successor, CPC+—reduced hospitalizations, emergency department (ED) visits, and spending over 6 years. DESIGN: We used a difference-in-differences analysis to compare outcomes for beneficiaries attributed to CPC Classic practices with outcomes for beneficiaries attributed to comparison practices during the year before and 6 years after CPC Classic began. PARTICIPANTS: The study involved 565,674 Medicare fee-for-service beneficiaries attributed to 502 CPC Classic practices and 1,165,284 beneficiaries attributed to 908 comparison practices, with similar beneficiary-, practice-, and market-level characteristics as the CPC Classic practices. INTERVENTIONS: The interventions required primary care practices to improve 5 care areas and supported their transformation with substantially enhanced payment, data feedback, and learning support and, for CPC+, added health information technology support. MAIN MEASURES: Hospitalizations (all-cause), ED visits (outpatient and total), and Medicare Part A and B expenditures. KEY RESULTS: Relative to comparison practices, beneficiaries in intervention practices experienced slower growth in hospitalizations—3.1% less in year 5 and 3.5% less in year 6 (P < 0.01) and roughly 2% (P < 0.1) slower growth each year in total ED visits during years 3 through 6. Medicare Part A and B expenditures (excluding care management fees) did not change appreciably. CONCLUSIONS: The emergence of favorable effects on hospitalizations in years 5 and 6 suggests primary care transformation takes time to translate into lower hospitalizations. Longer tests of models are needed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-06952-w.

Objective: To explore second- and third-year student pharmacists’ perspectives on the design and use of a digital game to teach opioid medication safety. To explore the game-based learning approach to teach about appropriate drug use and pediatric education. Innovation: The lead author developed MedSMA℞T: Adventures in PharmaCity, an educational video game focused on adolescent opioid safety. Second- and third-year students in a Midwestern School of Pharmacy enrolled in an elective course focused on appropriate use of abused drugs, played the digital game during a classroom session on adolescent opioid misuse. Using a small group discussion guide, students summarized their reflections and perspectives on gameplay. Critical Analysis: Students retained fundamental messages of the game including opioid safety and identified that social interactions contribute to decision-making and consequences of opioid misuse. Student pharmacists found the game’s visual appearance engaging, dialogue amusing, and the settings and scenarios relatable. Feedback regarding game controls, environment, dialogue, instructions, and level summaries was provided by students to improve the game design and content. This project provides an example of a thoughtful approach to game-based learning in pharmacy classrooms with the purpose of enhancing student pharmacists’ knowledge about opioid safety education, communication, social collaboration, and critical-thinking. Next Steps: Future projects can further investigate student pharmacists’ preferences of using game-based active learning. Additionally, retention rates of students from joint lectures and game-based learning activities can be analyzed.

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 Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics. Methods/design The study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study’s primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study’s primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics. Discussion Systems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices. Trial registration NCT 04044521 (ClinicalTrials.gov). Registered 05 August 2019.

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.

OBJECTIVESThis study explored adolescents' perspectives on prescription opioids, opioid safety and misuse, and sources of opioid information.METHODSHigh school students participated in focus groups that elicited information about adolescent perspectives on prescription opioids and opioid safety. Demographic information was collected. Focus groups consisted of 5 to 8 student participants and 2 moderators. Focus groups were audio-recorded and professionally transcribed. Transcript content was thematically analyzed using NVivo.RESULTSA total of 54 high school students (59% female, 44% white, 44% Latino) participated in 8 focus groups. Participants ranged from ages 14 to 18 years and grades 9 to 12. Five major themes emerged: 1) perceptions of prescription opioids and misuse; 2) prevalence of prescription opioid misuse; 3) reasons for prescription opioid misuse; 4) consequences of prescription opioid misuse; and 5) sources of medication information. Participants identified examples of misuse and reasons for and consequences of teen opioid misuse, including mental and physical health challenges, peer and family influences, and addiction. Sources of opioid-related information included family, peers, online Web sites, and television shows.CONCLUSIONSAdolescents had some knowledge pertaining to prescription opioids, but they had misconceptions related to safety. Participants were aware of safety risks and negative consequences of misuse. Adolescents obtained medication information from various sources, including health care professionals, family and peers, and online sources. Educational efforts that target adolescents should provide opportunities for addressing misconceptions about safe and responsible use of medications.

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.

BACKGROUND Adolescents 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. OBJECTIVE This 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. METHODS The 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. RESULTS A 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. CONCLUSIONS We 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.

Background The extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of AUDs works or does not work, for whom, and under what circumstances. Objective The primary aim is to detect the effectiveness of an mHealth intervention by assessing differences in self-reported risky drinking patterns and quality of life between participants in three study groups (self-monitored, peer-supported, and clinically integrated). The cost-effectiveness of each approach will also be assessed. Methods This hybrid type 1 study is an unblinded patient-level randomized clinical trial testing the effects of using an evidence-based mHealth system on participants’ drinking patterns and quality of life. There are two groups of participants for this study: individuals receiving the intervention and health care professionals practicing in the broader health care environment. The intervention is a smartphone app that encourages users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. The primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life as well as app use from weekly and quarterly surveys. Cost measures include intervention and implementation costs. The cost per participant will be determined for each study arm, with intervention and implementation costs separated within each group. There will also be a qualitative assessment of health care professionals’ engagement with the app as well as their thoughts on participant experience with the app. Results This protocol was approved by the Health Sciences Minimal Risk Institutional Review Board on November 18, 2019, with subsequent annual reviews. Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of November 17, 2021, is as follows: 357 participants were enrolled in the study for a planned enrollment of 546 participants. Conclusions The new knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for individuals with mild to moderate AUDs. The results of this study will guide policy makers and providers toward cost-effective ways to incorporate technology in health care and community settings. Trial Registration ClinicalTrials.gov NCT04011644; https://clinicaltrials.gov/ct2/show/NCT04011644 International Registered Report Identifier (IRRID) DERR1-10.2196/31109