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Am J Manag Care. 2020;26(6):e198-e201. https://doi.org/10.37765/ajmc.2020.43496 Takeaway Points * Despite the Medicare Diabetes Prevention Program (MDPP) now being a covered benefit, there is inadequate supplier availability to reach the estimated 29.5 million Medicare beneficiaries with prediabetes. * Severe shortages of MDPP providers in US states/territories with the largest populations of racial/ethnic minority beneficiaries merit particular attention to address health disparities. * Insufficient reimbursement relative to costs for suppliers may largely account for limited availability. METHODS We conducted a descriptive analysis of MDPP access using data extracted from the CMS registry of MDPP suppliers as of July 2019,10 more than a year after CMS enacted the covered benefit.1 We examined the number of MDPP suppliers and their respective site locations. Because a single supplier can offer the MDPP at multiple sites, site availability was a primary indicator of access. [...]we calculated the percentage of organizations as of July 2019 that offer the in-person NDPP and are listed in the CDC's recognition program,11 a prerequisite to MDPP designation.1 RESULTS There are 126 unique supplier organizations that offer the MDPP across 601 sites. Yet even if all 601 sites currently in the United States were well distributed across California and each had an annual capacity to enroll 500 participants, only 10% of California's beneficiaries with prediabetes would have MDPP access within a year. [...]there are notable access gaps in states/territories with the largest populations of Hispanic, African American, or Native American beneficiaries, suggesting that the MDPP will encounter barriers to better addressing existing health disparities.

The delivery of Intensive Behavioral Therapy (IBT) for obesity by primary care providers (PCPs) has been covered by Medicare to support elderly individuals with obesity (BMI > 30 kg/m2) in managing their weight since 2011 for individual therapy and 2015 for group therapy. We conducted a cohort study of PCPs in an attempt to understand patterns of uptake of IBT for obesity services among PCPs serving the Medicare population across the U.S. We used the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data from 2013 to 2019 to identify all PCPs who served more than 10 Medicare beneficiaries in each of the seven-year period to form a longitudinal panel. The procedure codes G0447 and G0473 were used to identify PCPs who provided IBT; and the characteristics of these providers were compared by the IBT-uptake status. Of the 537,754 eligible PCPs who served Medicare patients in any of the seven years, only 1.2% were found to be IBT service providers in at least one year from 2013 through 2019 (246 always users, 1,358 early adopters, and 4,563 late adopters). IBT providers shared a few common characteristics: they were more likely to be male, internal medicine providers, saw a higher number of Medicare beneficiaries, and practiced in the South and Northeast regions. Having higher proportion of patients with hyperlipidemia was associated with higher likelihood of a provider being an IBT-user. Very few PCPs continuously billed IBT services for Medicare patients with obesity. Further investigation is needed to mitigate barriers to the uptake of IBT services among PCPs.

Background Children with medical complexity (CMC) often rely upon the use of multiple medications to sustain quality of life and control substantial symptom burden. Pediatric polypharmacy (≥ 5 concurrent medications) is prevalent and increases the risk of medication-related problems (MRPs). Although MRPs are associated with pediatric morbidity and healthcare utilization, polypharmacy is infrequently assessed during routine clinical care for CMC. The aim of this randomized controlled trial is to determine if a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention reduces MRP counts, as well as the secondary outcomes of symptom burden and acute healthcare utilization. Methods This is a hybrid type 2 randomized controlled trial assessing the effectiveness of pMTM compared to usual care in a large, patient-centered medical home for CMC. Eligible patients include all children ages 2–18 years old, with ≥ 1 complex chronic condition, and with ≥ 5 active medications, as well as their English-speaking primary caregivers. Child participants and their primary parental caregivers will be randomized to pMTM or usual care before a non-acute primary care visit and followed for 90 days. Using generalized linear models, the overall effectiveness of the intervention will be evaluated using total MRP counts at 90 days following pMTM intervention or usual care visit. Following attrition, a total of 296 CMC will contribute measurements at 90 days, which provides > 90% power to detect a clinically significant 1.0 reduction in total MRPs with an alpha level of 0.05. Secondary outcomes include Parent-Reported Outcomes of Symptoms (PRO-Sx) symptom burden scores and acute healthcare visit counts. Program replication costs will be assessed using time-driven activity-based scoring. Discussion This pMTM trial aims to test hypotheses that a patient-centered medication optimization intervention delivered by pediatric pharmacists will result in lower MRP counts, stable or improved symptom burdens, and fewer cumulative acute healthcare encounters at 90 days following pMTM compared to usual care. The results of this trial will be used to quantify medication-related outcomes, safety, and value for a high-utilization group of CMC, and outcomes may elucidate the role of integrated pharmacist services as a key component of outpatient complex care programs for this priority pediatric population. Trial Registration This trial was prospectively registered at clinicaltrials.gov (NCT05761847) on Feb 25, 2023.

Background Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation. Methods A stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed. Discussion The effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice. Trial registration ClinicalTrials.gov NCT04678752 . Registered on December 21, 2020.

Background Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. Methods This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. Discussion Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. Trial registration ClinicalTrials.gov, NCT03590041 . Registered on 5 July 2018.

Background As the field of implementation science wrestles with the need for system decision-makers to anticipate the budget impact of implementing new programs, there has been a push to report implementation costs more transparently. For this purpose, the method of time-driven activity-based costing (TDABC) has been heralded as a pragmatic advance. However, a recent TDABC review found that conventional methods for estimating staff time remain resource-intensive and called for simpler alternatives. Our objective was to conceptually compare conventional and emerging TDABC approaches to measuring staff time. Methods Our environmental scan of TDABC methods identified several categories of approaches for staff time estimation; across these categories, staff time was converted to cost as a pro-rated fraction of salary/benefits. Conventional approaches used a process map to identify each step of program delivery and estimated the staff time used at each step in one of 3 ways: (a) uniform estimates of time needed for commonly occurring tasks (self-report), (b) retrospective “time diary” (self-report), or (c) periodic direct observation. In contrast, novel semi-automated electronic health record (EHR) approaches “nudge” staff to self-report time for specific process map step(s)—serving as a contemporaneous time diary. Also, novel EHR-based automated approaches include timestamps to track specific steps in a process map. We compared the utility of these TDABC approach categories according to the 5 R’s model that measures domains of interest to system decision-makers: relevance, rapidity, rigor, resources, and replicability, and include two illustrative case examples. Results The 3 conventional TDABC staff time estimation methods are highly relevant to settings but have limited rapidity, variable rigor, are rather resource-intensive, and have varying replicability. In contrast to conventional TDABC methods, the semi-automated and automated EHR-based approaches have high rapidity, similar rigor, similar replicability, and are less resource-intensive, but have varying relevance to settings. Conclusions This synthesis and evaluation of conventional and emerging methods for staff time estimation by TDABC provides the field of implementation science with options beyond the current approaches. The field remains pressed to innovatively and pragmatically measure costs of program delivery that rate favorably across all of the 5 R’s domains.

After publication of our article [1] the authors have notified us that the title for Figure 1 was incorrectly captioned.After publication of our article [1] the authors have notified us that the title for Figure 1 was incorrectly captioned.

Background:Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov.Objective:This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment.Methods:This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery.Results:This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024.Conclusions:This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country.Trial Registration:ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499.International Registered Report Identifier (IRRID):PRR1-10.2196/15499

Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. Pragmatic cluster randomized trial. A total of 1060 adults with type 2 diabetes in 22 primary care practices. Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NCT03590041.

Organizational health literacy (OHL) is the degree to which health care organizations implement strategies to make it easier for patients to understand health information, navigate the health care system, engage in the health care process, and manage their health. Although resources exist to guide OHL-related quality improvement (QI) initiatives, little work has been done to establish measures that organizations can use to monitor their improvement efforts. We sought to identify and evaluate existing OHL-related QI measures. To complement prior efforts to develop measures based on patient-reported data, we sought to identify measures computed from clinical, administrative, QI, or staff-reported data. Our goal was to develop a set of measures that experts agree are valuable for informing OHL-related QI activities. We used four methods to identify relevant measures computed from clinical, administrative, QI, or staff-reported data. We convened a Technical Expert Panel, published a request for measures, conducted a literature review, and interviewed 20 organizations working to improve OHL. From the comprehensive list of measures identified, we selected a set of high-priority measures for review by a second expert panel. Using a modified Delphi review process, panelists rated measures on four evaluation criteria, participated in a teleconference to discuss areas of disagreement among panelists, and rerated all measures. Across all methods, we identified 233 measures. Seventy measures underwent Delphi Panel review. For 22 measures, there was consensus among panelists that the measures were useful, meaningful, feasible, and had face validity. Five additional measures received strong ratings for usefulness, meaningfulness, and face validity, but failed to show consensus among panelists regarding feasibility. We identified OHL-related QI measures that have the support of experts in the field. Although additional measure development and testing is recommended, the Consensus OHL QI Measures are appropriate for immediate use. . The health care system is complex. Health care organizations can make things easier for patients by making changes to improve communication and to help patients find their way around, become engaged in the health care process, and manage their health. We identify 22 measures that organizations can use to monitor their efforts to improve communication with and support for patients.