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Conducting research in primary care during the COVID-19 pandemic is hard, due to baseline stresses on primary care, which have been compounded by the pandemic. We acknowledge and validate primary care researchers' frustrations. Using our experience on over 15 individual projects during the pandemic we identify 3 key challenges to conducting primary care research: (1) practice delivery trickle-down effects, (2) limited/changing resources and procedures for research, and (3) a generally tense milieu in US society during the pandemic. We present strategies, informed by a set of questions, to help researchers decide how to address these challenges observed during our studies. In order to overcome and grow from these challenging times we encourage normalization and self-compassion, and encourage researchers and funders to embrace pragmatic and adaptive research designs as the circumstances with COVID-19 evolve over time. [ABSTRACT FROM AUTHOR]

Background: Interventions are often adapted; some adaptations may provoke more favorable outcomes, whereas some may not. A better understanding of the adaptations and their intended goals may elucidate which adaptations produce better outcomes. Improved methods are needed to better capture and characterize the impact of intervention adaptations.Methods: We used multiple data collection and analytic methods to characterize adaptations made by practices participating in a hybrid effectiveness-implementation study of a complex, multicomponent diabetes intervention. Data collection methods to identify adaptations included interviews, observations, and facilitator sessions resulting in transcripts, templated notes, and field notes. Adaptations gleaned from these sources were reduced and combined; then, their components were cataloged according to the framework for reporting adaptations and modifications to evidence-based interventions (FRAME). Analytic methods to characterize adaptations included a co-occurrence table, statistically based k-means clustering, and a taxonomic analysis.Results: We found that (1) different data collection methods elicited more overall adaptations, (2) multiple data collection methods provided understanding of the components of and reasons for adaptation, and (3) analytic methods revealed ways that adaptation components cluster together in unique patterns producing adaptation "types." These types may be useful for understanding how the "who, what, how, and why" of adaptations may fit together and for analyzing with outcome data to determine if the adaptations produce more favorable outcomes rather than by adaptation components individually.Conclusion: Adaptations were prevalent and discoverable through different methods. Enhancing methods to describe adaptations may better illuminate what works in providing improved intervention fit within context.Trial Registration: This trial is registered on clinicaltrials.gov under Trial number NCT03590041 , posted July 18, 2018. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Care management and care managers are becoming increasingly prevalent in primary care medical practice as a means of improving population health and reducing unnecessary care. Care managers are often involved in chronic disease management and associated transitional care. In this study, we examined the communication regarding chronic disease care within 24 primary care practices in Michigan and Colorado. We sought to answer the following questions: Do care managers play a key role in chronic disease management in the practice? Does the prominence of the care manager's connectivity within the practice's communication network vary by the type of care management structure implemented?Methods: Individual written surveys were given to all practice members in the participating practices. Survey questions assessed demographics as well as practice culture, quality improvement, care management activities, and communication regarding chronic disease care. Using social network analysis and other statistical methods, we analyzed the communication dynamics related to chronic disease care for each practice.Results: The structure of chronic disease communication varies greatly from practice to practice. Care managers who were embedded in the practice or co-located were more likely to be in the core of the communication network than were off-site care managers. These care managers also had higher in-degree centrality, indicating that they acted as a hub for communication with team members in many other roles.Discussion: Social network analysis provided a useful means of examining chronic disease communication in practice, and highlighted the central role of care managers in this communication when their role structure supported such communication. Structuring care managers as embedded team members within the practice has important implications for their role in chronic disease communication within primary care. [ABSTRACT FROM AUTHOR]

Context: Self-management, including diet, exercise, use of medications, and stress management, is essential for good outcomes in Type 2 Diabetes Mellitus (T2DM). Shared medical appointments (SMAs) are an avenue for primary care practices to support development of self-management, but implementation of SMAs is context dependent and often requires adaptations for each practice. Objective: To describe adaptations made by practices participating in the Invested in Diabetes (IID) project during implementation of SMAs. Study design and Analysis: IID is a pragmatic cluster-randomized, comparative effectiveness trial designed to compare two different approaches to delivery of diabetes shared medical appointments (SMAs). Key informant interviews with traditional qualitative thematic analysis, thematic analysis of coach notes and session observations; multi-step process to categorize adaptations using FRAME. Population studied: primary care team members involved in delivering SMAs including medical and behavioral health providers, health educators, coordinators. Intervention/Measurement: Semi-structured interview guide, session observation guide. Outcome measures: Emergent themes pertaining to adaptations made by participating practices Results: Four dominant themes emerged: 1) Adaptations are common in implementation of SMAs. 2) Implementation challenges can be improved or overcome through actively identifying those challenges and making changes in response. Specific challenges identified include recruitment and retention, physical space, staff involvement and turnover, and scheduling 3) Content changes in the classes were often planned and enacted to better address the contextual circumstances such as patient needs and culture. 4) Adaptation components tend to cluster together in certain types that may reveal ways to improve on desired implementation outcomes. Conclusions: SMA implementation in real-world primary care settings requires adaptations related to practice-specific contexts. Practices benefit from support to identify and address areas that need adaptation for successful implementation. [ABSTRACT FROM AUTHOR]

CONTEXT: Despite the fact that obesity is both treatable and preventable, treating the comorbidities, rather than obesity per se remains the mainstay of therapy. Objective: To evaluate the efficacy and implementation of a pragmatic approach to weight management in primary care that prioritizes treatment of weight rather than weight-related diseases (PATHWEIGH). Study design and ANALYSIS: PATHWEIGH is a hybrid type 1 cluster randomized stepped wedge clinical trial. Clinics were enrolled and randomized to three sequences using covariate constrained randomization. Descriptive statistics were used to summarize clinic and patient characteristics with t-tests, Wilcoxon rank sums or Fisher's exact tests used to compare groups. SETTING: Fifty-seven primary care clinics in rural, suburban and urban Colorado in a single healthcare system were utilized. Population studied: Patients age >18 years and body mass index (BMI) >25 kg/m2 who had a weight-prioritized visit (WPV) in the prior year were enrolled. A WPV was defined as a chief complaint or reason for visit that included "weight", ICD-10 codes for weight or use of an intake questionnaire for weight. Intervention: None. This abstract describes the baseline (pre-intervention) characteristics of the clinics and patients treated with standard-of-care (SOC) for weight management. Outcome measures: Baseline characteristics of the clinics and patients undergoing a WPV from March 17, 2020 - March 16, 2021. Results: 20,410 patients met these eligibility requirements representing 12% of patients >18 years and body mass index (BMI) >25 kg/m2 seen at the clinic during this baseline period. The three randomization sequences of 20, 18, and 19 sites were similar with an overall median age of 53 years (IQR: 39-65), 58% women, 76% non-Hispanic whites, 64% commercial insurance, and median BMI of 36 kg/m2 (IQR: 32-41). No sequence differences were seen for vital signs, relevant laboratory values, or numbers of comorbidities or medications that cause weight loss or weight gain. Referral for anything weight-related was low (<6%) and only 334 prescriptions of an anti-obesity medication were noted. Conclusions: Of patients >18 years and body mass index (BMI) >25 kg/m2 seen in the 57 primary care clinics, 12% had a weightprioritized visit during the baseline period. Despite most being commercially insured, referral to any weight-related service or prescription of anti-obesity medication was uncommon. [ABSTRACT FROM AUTHOR]

Background: Care management in primary care can be effective in helping patients with chronic disease improve their health status. Primary care practices, however, are often challenged with its implementation. Incorporating care management involves more than a simple physical process redesign to existing clinical care routines. It involves changes to who is working with patients, and consequently such things as who is making decisions, who is sharing patient information, and how. Studying the range of such changes in "knowledge work" during implementation requires a perspective and tools designed to do so. We used the macrocognition perspective, which is designed to understand how individuals think in dynamic, messy real-world environments such as care management implementation. To do so, we used cognitive task analysis to understand implementation in terms of such thinking as decision making, knowledge, and communication.Methods: Data collection involved semi-structured interviews and observations at baseline and at approximately 9 months into implementation at five practices in one physician-owned administratively connected group of practices in the state of Michigan, USA. Practices were intervention participants in a larger trial of chronic care model implementation. Data were transcribed, qualitatively coded and analyzed, initially using an editing approach and then a template approach with macrocognition as a guiding framework.Results: Seventy-four interviews and five observations were completed. There were differences in implementation success across the practices, and these differences in implementation success were well explained by macrocognition. Practices that used more macrocognition functions and used them more often were also more successful in care management implementation.Conclusions: Although care management can introduce many new changes into the delivery of primary care clinical practice, implementing it successfully as a new complex intervention is possible. Macrocognition is a useful perspective for illuminating the elements that facilitate new complex interventions with a view to addressing them during implementation planning. [ABSTRACT FROM AUTHOR]

Background: Care management in primary care can be effective in helping patients with chronic disease improve their health status, however, primary care practices are often challenged with implementation. Further, there are different ways to structure care management that may make implementation more or less successful. Normalization process theory (NPT) provides a means of understanding how a new complex intervention can become routine (normalized) in practice. In this study, we used NPT to understand how care management structure affected how well care management became routine in practice.Methods: Data collection involved semi-structured interviews and observations conducted at 25 practices in five physician organizations in Michigan, USA. Practices were selected to reflect variation in physician organizations, type of care management program, and degree of normalization. Data were transcribed, qualitatively coded and analyzed, initially using an editing approach and then a template approach with NPT as a guiding framework.Results: Seventy interviews and 25 observations were completed. Two key structures for care management organization emerged: practice-based care management where the care managers were embedded in the practice as part of the practice team; and centralized care management where the care managers worked independently of the practice work flow and was located outside the practice. There were differences in normalization of care management across practices. Practice-based care management was generally better normalized as compared to centralized care management. Differences in normalization were well explained by the NPT, and in particular the collective action construct. When care managers had multiple and flexible opportunities for communication (interactional workability), had the requisite knowledge, skills, and personal characteristics (skill set workability), and the organizational support and resources (contextual integration), a trusting professional relationship (relational integration) developed between practice providers and staff and the care manager. When any of these elements were missing, care management implementation appeared to be affected negatively.Conclusions: Although care management can introduce many new changes into delivery of clinical practice, implementing it successfully as a new complex intervention is possible. NPT can be helpful in explaining differences in implementing a new care management program with a view to addressing them during implementation planning. [ABSTRACT FROM AUTHOR]

Context: Integrating behavioral health care into primary care has increased access to care for patients with behavioral health needs. Within primary care there is a broad range of need, including traditional mental health diagnoses as well as support in disease management and health-related behavior change. Most BHPs report spending a majority of their clinical time addressing traditional mental health diagnoses. Objective: Understanding current BHP practice with traditional diagnoses as well as supporting health-related behavior change may illuminate new approaches that could be undertaken in primary care to improve patient outcomes. Study design and Analysis: Survey research using Qualtrics. Results were analyzed using simple statistics as well as simple correlations (chi-squared and Spearman's rank correlation). Setting: Practices participating in the State Innovation Model in Colorado, a CMS supported behavioral health integration project. Population: Behavioral health providers in participating practices. Instrument: Survey designed by project team to understand approaches BHPs use and range of treatments provided to patients. Outcome measures: Survey responses. Results: We received 79 BHP surveys representing 64 practices out of a total of 319 SIM practices. BHPs reported addressing healthrelated behaviors like diet, physical activity, and weight management with many patients who were referred to them strictly for mental health diagnoses. They expressed interest in working with patients in these areas and believe that the skills and techniques they use for traditional mental health diagnoses are effective for supporting behavior change. LCSWs are more likely to address behavior change than LMFTs and LACs. BHPs who have been in practice for longer also are more likely to address behavior change. There was no relationship between type of practice and BHPs intervention on behavior change, but BHPs in practices that had case managers or health coaches were more likely to report addressing behavior change. Health-related behavior change topics were more likely to be addressed in co-visits with providers. Conclusions: BHPs frequently address health related behavior whether that is the reason for referral or not and in general are interested in providing these services. Understanding how to formalize that in primary care may provide opportunities to better support patients with behavior change and subsequently improve health outcomes. [ABSTRACT FROM AUTHOR]

Context: Primary care practices can help patients address obesity through weight loss, however, there are many barriers to doing so. Objective: This study sought to examine current weight management services provided and factors associated with higher reported provision of services. Study design and Analysis: One time survey. We used descriptive statistics to summarize responses and linear regression with generalized estimating equations to assess the association between the clinician characteristics and the amount of weight management services provided. Setting/Population: Clinicians in 18 diverse primary care health system practices in Colorado. Instrument/Outcome measures: Survey assessing 19 weight management services (e.g. identifying obesity, educating, prescribing medications, etc.) to assess the amount and type of weight loss assistance provided and other factors that may be important. Results: The overall response rate was 65% (257/397). Of respondents, 28% were clinicians, 3% other providers, 47% clinical staff, and 21% administrative staff. On average, clinicians reported performing 70% (IQR: 60%-80%) of the services and when grouped into minimal, basic, and extensive types of services, the clinicians on average performed 87%, 78%, and 69% of them respectively. Factors associated with performing more services included perception of overall better practice culture (more team-ness, less chaos, more change culture) and perception of weight management implementation climate (support for, recognition and expectation to support weight loss) (p<0.05). Demographics, satisfaction with the practice's provision of weight loss services, importance of providing weight management, and clinician-specific joy at work and level of burnout were not associated with the number of services performed. Ninety-six percent of clinicians indicated interest in learning more about weight management, especially recommendations about diet and eating plans and organizing workflows to accommodate weight management. Conclusions: Practice-associated factors such as culture and implementation climate may be worth examining to understanding how to implement weight management in primary care. These data add to the growing knowledge base about overcoming challenges to address obesity in the US. [ABSTRACT FROM AUTHOR]

Objective Report lessons learned in an RCT of Stop My Smoking (SMS) USA, a mHealth smoking cessation program for young adult smokers. Methods 164 18–24-year-olds were recruited nationally, online in 2011. Program evaluation data were provided at 12-week post-Quit Day. Results (1) Inviting participants to complete a brief text messaging survey and then asking them to complete a longer online survey resulted in the highest response rate (89%). (2) The positive tone of program messages was the most commonly noted program strength. (3) Suggested improvements included more social connectivity and additional assistance overcoming stressful situations. (4) Half of intervention participants moved through the program linearly and half went through various paths that reflected multiple relapses. Suggestions to use pharmacotherapy resulted in 22% of heavy smokers to utilize it. Conclusion Participant feedback provided concrete ways in which this and other young adult-focused interventions can improve messaging and program features to be even more salient. Practice implications Future young adult mHealth interventions could: Integrate models that are flexible to different “paths” of behavior change; address stressful life events directly and comprehensively; integrate proactive messaging that promotes pharmacotherapy options; and use text messaging as a gateway to longer online surveys. [ABSTRACT FROM AUTHOR]

Data from high-income countries suggest that cell phone-based smoking cessation programs have the potential to affect cessation rates. There is a paucity of research, however, about the feasibility of cell phone-based smoking cessation programs in lower income countries that have higher smoking prevalence rates. A one-arm feasibility and acceptability pilot study of SMS Turkey, a text messaging-based smoking cessation program, was conducted in Ankara, the capital of Turkey. The authors recruited 75 daily smokers who were seriously thinking about quitting in the subsequent 30 days into the 6-week SMS Turkey program. Recruitment was completed in 4 months. Participant retention was high: Almost all (96%) completed the program, and 84% provided 12-week follow-up data. Most (89%) of the respondents who completed the 4-week follow-up measures (n = 38, 51%) said that the text messages were easy to understand and referred to what they were experiencing and feeling during the quitting process (78%). On the basis of intention to treat, 13% of participants (n = 10) reported, at 12-week follow-up, continuous abstinence since their quit date, confirmed by carbon monoxide readings. The cell phone text messaging-based smoking cessation intervention appears feasible and acceptable in Ankara, Turkey. [ABSTRACT FROM AUTHOR]

Introduction: To address the lack of smoking cessation programs available to young adults, Stop My Smoking (SMS) USA, a text messaging-based smoking cessation program, was developed and pilot tested.Methods: This was a two-arm randomized controlled trial with adaptive randomization (arms were balanced by sex and smoking level [heavy vs. light]), conducted nationally in the United States. One hundred sixty-four 18- to 25-year-old daily smokers who were seriously thinking about quitting in the next 30 days were randomized to either (a) the 6-week SMS USA intervention (n = 101) or (b) an attention-matched control group aimed at improving sleep and physical activity (n = 63). The main outcome measure was 3-month continuous abstinence, verified by a significant other. Participants but not researchers were blinded to study arm allocation.Results: Based upon intent-to-treat analyses, intervention participants (39%) were significantly more likely than control participants (21%) to have quit at 4 weeks postquit (adjusted odds ratio [aOR] = 3.33, 95% confidence interval [CI]: 1.48, 7.45). Findings were not sustained at 3 months postquit, although rates in the SMS USA group were favored (40% vs. 30%, respectively; aOR = 1.59, 95% CI: 0.78, 3.21). Subsequent analyses suggested that among intervention participants, SMS USA might be more influential for youth not currently enrolled in a higher education (p = .06).Conclusions: Consistent with pilot studies, the sample was underpowered. Data suggest, however, that the SMS USA program affects smoking cessation rates at 4 weeks postquit. More research is needed before conclusions can be made about long-term impact. Identifying profiles of users for whom the program may be particularly beneficial also will be important. [ABSTRACT FROM AUTHOR]

Introduction: To address the lack of smoking cessation programs available to young adults, Stop My Smoking (SMS) USA, a text messaging–based smoking cessation program, was developed and pilot tested. Methods: This was a two-arm randomized controlled trial with adaptive randomization (arms were balanced by sex and smoking level [heavy vs. light]), conducted nationally in the United States. One hundred sixty-four 18- to 25-year-old daily smokers who were seriously thinking about quitting in the next 30 days were randomized to either (a) the 6-week SMS USA intervention (n = 101) or (b) an attention-matched control group aimed at improving sleep and physical activity (n = 63). The main outcome measure was 3-month continuous abstinence, verified by a significant other. Participants but not researchers were blinded to study arm allocation. Results: Based upon intent-to-treat analyses, intervention participants (39%) were significantly more likely than control participants (21%) to have quit at 4 weeks postquit (adjusted odds ratio [aOR] = 3.33, 95% confidence interval [CI]: 1.48, 7.45). Findings were not sustained at 3 months postquit, although rates in the SMS USA group were favored (40% vs. 30%, respectively; aOR = 1.59, 95% CI: 0.78, 3.21). Subsequent analyses suggested that among intervention participants, SMS USA might be more influential for youth not currently enrolled in a higher education (p = .06). Conclusions: Consistent with pilot studies, the sample was underpowered. Data suggest, however, that the SMS USA program affects smoking cessation rates at 4 weeks postquit. More research is needed before conclusions can be made about long-term impact. Identifying profiles of users for whom the program may be particularly beneficial also will be important. [ABSTRACT FROM AUTHOR]

Smoking during pregnancy is the single most modifiable risk factor for poor birth outcomes, yet it remains prevalent among low-income women. This study examined factors associated with continued smoking and quitting among pregnant women. A total of 2,203 Medicaid-eligible pregnant women were screened at their first enhanced prenatal services visit for risk factors including demographics, health behaviors (smoking, alcohol and drug use), mental health (history of mental health disorders, current depressive symptoms), and stress. Smoking status was divided into non-smokers, quitters (quit smoking since learning of pregnancy), and continuing smokers. Descriptive statistics and logistic regression models were used to describe the sample and analyze relationships between smoking status and other characteristics. Overall, 57% were non-smokers, 17% quitters, and 26% continuing smokers. Approximately 18% had severe depressive symptoms, 53% had a high stress score, and 33% had a history of mental health problems. Younger women had lower odds of continued smoking as compared to both non-smokers (OR = 0.48, p < 0.01) and quitters (OR = 0.56, p < 0.05). Older women with less than a 12th grade education had higher odds of continued smoking (OR = 2.17, p < 0.01) and quitting (OR = 1.62, p < 0.05) as compared to non-smokers. Alcohol use (OR = 2.81, p < 0.05) and drug use before pregnancy (OR = 5.32, p < 0.01) predicted continued smoking compared to non-smoking. Women with a mental health history (OR = 1.81, p < 0.01) and high stress scores (OR = 1.39, p < 0.05) had higher odds of continued smoking compared to non-smokers. Mental health history, stress, demographics, current alcohol and past drug use are strongly related to continued smoking in this population. [ABSTRACT FROM AUTHOR]

The article discusses the importance of patient-centered medical homes (PCMHs) to health educators. Topics include an overview of the PCMH model, which is an approach to providing comprehensive care in a primary care setting, and the enhancement of primary care delivery as a result of health educators involvement in the implementation of the PCMH model.

Background: Referral of patients to smoking cessation telephone counseling (i.e., quitline) is an underutilized resource by primary care physicians. Previously, we conducted a randomized trial to determine the effectiveness of benchmarked feedback on clinician referrals to a quitline. Subsequently, we sought to understand the successful practices used by the high-referring clinicians, and the perceptions of the barriers of referring patients to a quitline among both high and non-referring clinicians in the trial. Methods: We conducted a qualitative sub-study with subjects from the randomized trial, comparing high- and non-referring clinicians. Structured interviews were conducted and two investigators employed a thematic analysis of the transcribed data. Themes and included categories were organized into a thematic framework to represent the main response sets. Results: As compared to non-referring clinicians, high-referring clinicians more often reported use of the quitline as a primary source of referral, an appreciation of the quitline as an additional resource, reduced barriers to use of the quitline referral process, and a greater personal motivation related to tobacco cessation. Time and competing demands were critical barriers to initiating smoking cessation treatment with patients for all clinicians. Clinicians reported that having one referral source, a referral coordinator, and reimbursement for tobacco counseling (as a billable code) would aid referral. Conclusion: Further research is needed to test the effectiveness of new approaches in improving the connection of patients with smoking cessation resources. [ABSTRACT FROM AUTHOR]

The article presents a study which evaluates the impact of comparative feedback compared to general reminders on practice-based referrals to a tobacco cessation quit line and estimated costs for project quit responses. With a group-randomized clinical trial, it was found out that comparative feedback on clinician referrals to quit-line service had a modest impact with limited increased costs.

Objectives: To examine the types and influences of health behavior goals self-selected by post hospitalized cardiac patients. Methods: Subjects participated in a trial assessing the effectiveness of a health behavior change program. Results: Nearly 95% of smokers and 89.7% of patients with elevated weights selected a smoking and/or dietary modification goal, respectively. Only 43.8% of physical activity goal patients started a rehabilitation program. Although no consistent relationships were found between patient characteristics and type of goal(s) selected, significant improvements in readiness to change levels occurred. Conclusions: Many patients can make health behavior progress consistent with behaviors needing Improvements by clinical criteria. [ABSTRACT FROM AUTHOR]

Background: 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. Objective: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. Design: Pragmatic cluster randomized trial. Participants: A total of 1060 adults with type 2 diabetes in 22 primary care practices. Interventions: 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). Main measures: 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. Key Results: 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. Conclusions: 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. NIH trial registry number: NCT03590041. [ABSTRACT FROM AUTHOR]

Background: There have been over 430 publications using the RE-AIM model for planning and evaluation of health programs and policies, as well as numerous applications of the model in grant proposals and national programs. Full use of the model includes use of qualitative methods to understand why and how results were obtained on different RE-AIM dimensions, however, recent reviews have revealed that qualitative methods have been used infrequently. Having quantitative and qualitative methods and results iteratively inform each other should enhance understanding and lessons learned.Methods: Because there have been few published examples of qualitative approaches and methods using RE-AIM for planning or assessment and no guidance on how qualitative approaches can inform these processes, we provide guidance on qualitative methods to address the RE-AIM model and its various dimensions. The intended audience is researchers interested in applying RE-AIM or similar implementation models, but the methods discussed should also be relevant to those in community or clinical settings.Results: We present directions for, examples of, and guidance on how qualitative methods can be used to address each of the five RE-AIM dimensions. Formative qualitative methods can be helpful in planning interventions and designing for dissemination. Summative qualitative methods are useful when used in an iterative, mixed methods approach for understanding how and why different patterns of results occur.Conclusions: In summary, qualitative and mixed methods approaches to RE-AIM help understand complex situations and results, why and how outcomes were obtained, and contextual factors not easily assessed using quantitative measures. [ABSTRACT FROM AUTHOR]

Shared medical appointments (SMAs) are an evidence-based approach to diabetes care in primary care settings, yet practices can struggle to ensure participation, especially among racial and ethnic minority and low-income patients. We conducted a multimethod evaluation of reach and attendance in the Invested in Diabetes study of the comparative effectiveness of two SMA delivery models (standardized and patient-driven) in two practice settings (federally qualified health centers [FQHCs] and clinics serving more commercially insured patients). Through this study, 22 practices reached 6.2% of patients with diabetes through SMAs over 3 years, with good attendance for both practice types and both SMA delivery models. FQHCs were especially successful at enrolling underserved populations and improved attendance with virtual SMAs. [ABSTRACT FROM AUTHOR]

Objective Skilled nursing facility rehabilitation is commonly required to address hospital-associated deconditioning among older adults with medical complexity. In skilled nursing facilities, standard-of-care rehabilitation focuses on low-intensity interventions, which are not designed to sufficiently challenge skeletal muscle and impart functional improvements. In contrast, a high-intensity resistance training approach (IntenSive Therapeutic Rehabilitation for Older NursinG homE Residents; i-STRONGER) in a single-site pilot study resulted in better physical function among patients in skilled nursing facilities. To extend this work, an effectiveness-implementation hybrid type 1 design, cluster-randomized trial will be conducted to compare patient outcomes between 16 skilled nursing facilities utilizing i-STRONGER principles and 16 Usual Care sites. Methods Clinicians at i-STRONGER sites will be trained to deliver i-STRONGER as a standard of care using an implementation package that includes a clinician training program. Clinicians at Usual Care sites will continue to provide usual care. Posttraining, changes in physical performance (eg, gait speed, Short Physical Performance Battery scores) from patients' admission to discharge will be collected over a period of 12 months. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework will be used to evaluate i-STRONGER effectiveness and factors underlying successful i-STRONGER implementation. Effectiveness will be evaluated by comparing changes in physical function between study arms. Reach (proportion of patients treated with i-STRONGER), adoption (proportion of clinicians utilizing i-STRONGER), implementation (i-STRONGER fidelity), and maintenance (i-STRONGER sustainment) will be concurrently quantified and informed by clinician surveys and focus groups. Impact This effectiveness-implementation hybrid type 1 cluster-randomized trial has the potential to shift rehabilitation care paradigms in a nationwide network of skilled nursing facilities, resulting in improved patient outcomes and functional independence. Furthermore, evaluation of the facilitators of, and barriers to, implementation of i-STRONGER in real-world clinical settings will critically inform future work evaluating and implementing best rehabilitation practices in skilled nursing facilities. [ABSTRACT FROM AUTHOR]

PURPOSE To describe the characteristics of patients and practice of clinicians during standard- of-care for weight management in a large, multiclinic health system before the implementation of PATHWEIGH, a pragmatic weight management intervention. METHODS We analyzed baseline characteristics of patients, clinicians, and clinics during standard-of-care for weight management before the implementation of PATHWEIGH, which will be evaluated for effectiveness and implementation in primary care using an effectiveness-implementation hybrid type-1 cluster randomized stepped-wedge clinical trial design. A total of 57 primary care clinics were enrolled and randomized to 3 sequences. Patients included in the analysis met the eligibility requirements of age ≥18 years and body mass index (BMI) ≥25 kg/m² and had a weight-prioritized visit (defined a priori) during the period March 17, 2020 to March 16, 2021. RESULTS A total of 12% of patients aged ≥18 years and with a BMI ≥25 kg/m² seen in the 57 practices during the baseline period (n = 20,383) had a weight-prioritized visit. The 3 randomization sequences of 20, 18, and 19 sites were similar, with an overall mean patient age of 52 (SD 16) years, 58% women, 76% non-Hispanic White patients, 64% with commercial insurance, and with a mean BMI of 37 (SD 7) kg/m². Documented referral for anything weight related was low (<6%), and 334 prescriptions of an antiobesity drug were noted. CONCLUSIONS Of patients aged ≥18 years and with a BMI ≥25 kg/m² in a large health system, 12% had a weight-prioritized visit during the baseline period. Despite most patients being commercially insured, referral to any weight-related service or prescription of antiobesity drug was uncommon. These results fortify the rationale for trying to improve weight management in primary care. [ABSTRACT FROM AUTHOR]

Background: Tobacco use, unhealthy diet, physical inactivity, and risky alcohol use are leading causes of preventable death. As there are many barriers that prevent primary care clinicians from effectively assisting patients with these behaviors, connecting patients with health behavior resources may reduce these unhealthy behaviors. Methods: A new adjunct role in primary care practice, the community health educator referral liaison (CHERL), was tested in 15 practices in three Michigan communities. All practices were advised how to access this liaison, and nine practices were randomly selected to receive support to develop a systematic referral process. Adult patients needing improvement in at least one of the four unhealthy behaviors were eligible for referral. The CHERL contacted referred patients by telephone; assessed health risks; provided health behavior–change counseling, referral to other resources, or both; and sent patient progress reports to referring clinicians. Data were collected from February 2006 through July 2007. Results: The CHERLs received 797 referrals over 8 months, a referral rate of 0%–2% per practice. Among referred patients, 55% enrolled, and 61% of those participated in multiple-session telephone counseling; 85% were referred to additional resources. Among patients enrolling, improvements (p<0.001) were reported at 6 months for BMI, dietary patterns, alcohol use, tobacco use, health status, and days of limited activity in the past month. Conclusions: The results of this study suggest that through relationships with practices, patients, and community resources, these liaisons successfully facilitated patients'' behavior change. The CHERL role may fill a gap in promoting healthy behaviors in primary care practices and merits further exploration. [Copyright &y& Elsevier]

Background: 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. Methods: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]

Background: Despite lung cancer being a leading cause of death in the United States and lung cancer screening (LCS) being a recommended service, many patients eligible for screening do not receive it. Research is needed to understand the challenges with implementing LCS in different settings. This study investigated multiple practice members and patient perspectives impacting rural primary care practices related to LCS uptake by eligible patients. Methods: This qualitative study involved primary care practice members in multiple roles (clinicians n = 9, clinical staff n = 12 and administrators n = 5) and their patients (n = 19) from 9 practices including federally qualified and rural health centers (n = 3), health system owned (n = 4) and private practices (n = 2). Interviews were conducted regarding the importance of and ability to complete the steps that may result in a patient receiving LCS. Data were analyzed using a thematic analysis with immersion crystallization then organized using the RE-AIM implementation science framework to illuminate and organize implementation issues. Results: Although all groups endorsed the importance of LCS, all also struggled with implementation challenges. Since assessing smoking history is part of the process to identify eligibility for LCS, we asked about these processes. We found that smoking assessment and assistance (including referral to services) were routine in the practices, but other steps in the LCS portion of determining eligibility and offering LCS were not. Lack of knowledge about screening and coverage, patient stigma, and resistance and practical considerations such as distance to LCS testing facilities complicated completion of LCS compared to screening for other types of cancer. Conclusions: Limited uptake of LCS results from a range of multiple interacting factors that cumulatively affect consistency and quality of implementation at the practice level. Future research should consider team-based approaches to conduct of LCS eligibility and shared decision making. [ABSTRACT FROM AUTHOR]

Background: Self-management is essential for good outcomes in type 2 diabetes and patients often benefit from self-management education. Shared medical appointments (SMAs) can increase self-efficacy for self management but are difficult for some primary care practices to implement. Understanding how practices adapt processes and delivery of SMAs for patients with type 2 diabetes may provide helpful strategies for other practices interested in implementing SMAs. Methods: The Invested in Diabetes study was a pragmatic cluster-randomized, comparative effectiveness trial designed to compare two different models of diabetes SMAs delivered in primary care. We used a multi-method approach guided by the FRAME to assess practices' experience with implementation, including any planned and unplanned adaptations. Data sources included interviews, practice observations and field notes from practice facilitator check-ins. Results: Several findings were identified from the data: 1) Modifications and adaptations are common in implementation of SMAs, 2) while most adaptations were fidelity-consistent supporting the core components of the intervention conditions as designed, some were not, 3) Adaptations were perceived to be necessary to help SMAs meet patient and practice needs and overcome implementation challenges, and 4) Content changes in the sessions were often planned and enacted to better address the contextual circumstances such as patient needs and culture. Discussion: Implementing SMAs in primary care can be challenging and adaptations of both implementation processes and content and delivery of SMAS for patients with type 2 diabetes were common in the Invested in Diabetes study. Recognizing the need for adaptations based on practice context prior to implementation may help improve fit and success with SMAs, but care needs to be given to ensure that adaptations do not weaken the impact of the intervention. Practices may be able to assess what might need to adapted for them to be successful prior to implementation but likely will continue to adapt after implementation. Conclusion: Adaptations were common in the Invested in Diabetes study. Practices may benefit from understanding common challenges in implementing SMAs and adapting processes and delivery based on their own context. Trial registration: This trial is registered on clinicaltrials.gov under Trial number NCT03590041, posted 18/07/2018. [ABSTRACT FROM AUTHOR]

Background: The real world implementation of chronic care management model varies greatly. One aspect of this variation is the delivery mode. Two contrasting strategies include provider-delivered care management (PDCM) and health plan-delivered care management (HPDCM).Objective: We aimed to compare the effectiveness of PDCM vs. HPDCM on improving clinical outcomes for patients with chronic diseases.Design: We used a quasi-experimental two-group pre-post design using the difference-in-differences method.Patients: Commercially insured patients, with any of the five chronic diseases-congestive heart failure, chronic obstructive pulmonary disease, coronary heart disease, diabetes, or asthma, who were outreached to and engaged in either PDCM or HPDCM were included in the study.Main Measures: Outreached patients were those who received an attempted or actual contact for enrollment in care management; and engaged patients were those who had one or more care management sessions/encounters with a care manager. Effectiveness measures included blood pressure, low density lipoprotein (LDL), weight loss, and hemoglobin A1c (for diabetic patients only). Primary endpoints were evaluated in the first year of follow-up.Key Results: A total of 4,000 patients were clustered in 165 practices (31 in PDCM and 134 in HPDCM). The PDCM approach demonstrated a statistically significant improvement in the proportion of outreached patients whose LDL was under control: the proportion of patients with LDL < 100 mg/dL increased by 3 % for the PDCM group (95 % CI: 1 % to 6 %) and 1 % for the HPDCM group (95 % CI: -2 % to 5 %). However, the 2 % difference in these improvements was not statistically significant (95 % CI: -2 % to 6 %). The HPDCM approach showed 3 % [95 % CI: 2 % to 6 %] improvement in overall diabetes care among outreached patients and significant reduction in obesity rates compared to PDCM (4 %, 95 % CI: 0.3 % to 8 %).Conclusions: Both care management delivery modes may be viable options for improving care for patients with chronic diseases. In this commercially insured population, neither PDCM nor HPDCM resulted in substantial improvement in patients' clinical indicators in the first year. Different care management strategies within the provider-delivered programs need further investigation. [ABSTRACT FROM AUTHOR]

Steps to develop or refine text messaging-based interventions are largely missing from the literature. Here, the authors describe steps in refining Stop My Smoking USA, a text messaging-based smoking cessation program for smokers 18-25 years old. Research activities included the following: needs assessment focus groups (n = 35); a content advisory team to affirm message acceptability (n = 10); and two beta tests to confirm technological feasibility (n = 12 and 28, respectively). Various recruitment strategies were tested to identify the optimal methods to reach young adult smokers ready to quit. Each stage of the refinement process yielded new insights, resulting in improved message content and tone, an effective recruitment strategy, and the identification and subsequent resolution of technology challenges. Findings suggest that young adults prefer messages that provide concrete behavioral strategies to overcome cravings, and which are positive in tone. Craigslist was the most efficient recruitment method and yielded a sample that was racially and economically diverse. Despite a successful beta test of initial technological feasibility, extensive problems were subsequently experienced in a beta test of the technological feasibility of the entire program. Iterative program refinement and adaptation on the basis of user input is necessary to ensure salience, while extensive field testing is required to ensure proper functioning of technology-based programs. [ABSTRACT FROM AUTHOR]

Background: Telephone counseling in chronic disease self-management is increasing, but has not been tested in studies that control for quality of medical care.Objective: To test the effectiveness of a six-session outpatient telephone-based counseling intervention to improve secondary prevention (behaviors, medication) in patients with acute coronary syndrome (ACS) following discharge from hospital, and impact on physical functioning and quality of life at 8 months post-discharge.Design: Patient-level randomized trial of hospital quality improvement (QI-only) versus quality improvement plus brief telephone coaching in three months post-hospitalization (QI-plus).Data: medical record, state vital records, patient surveys (baseline, three and eight months post-hospitalization).Analysis: pooled-time series generalized estimating equations to analyze repeated measures; intention-to-treat analysis.Participants: Seven hundred and nineteen patients admitted to one of five hospitals in two contiguous mid-Michigan communities enrolled; 525 completed baseline surveys.Measurements: We measured secondary prevention behaviors, physical functioning, and quality of life.Results: QI-plus patients showed higher self-reported physical activity (OR = 1.53; p = .01) during the first three months, with decline after active intervention was withdrawn. Smoking cessation and medication use were not different at 3 or 8 months; functional status and quality of life were not different at 8 months.Conclusions: Telephone coaching post-hospitalization for ACS was modestly effective in accomplishing short-term, but not long-term life-style behavior change. Previous positive results shown in primary care did not transfer to free-standing telephone counseling as an adjunct to care following hospitalization. [ABSTRACT FROM AUTHOR]

In 1996, with the release of the first report by the U.S. Surgeon General on physical activity and health, moderate physical activity was placed firmly on the U.S. public health agenda. Physical Activity and Health recommended moderate exercise five or more days per week or vigorous exercise three or more times per week, suggesting that Americans can be active simply by incorporating moderate activities like walking, cycling or yard-work into their daily routines. Within this context, urban planners and policy makers have recognized their potential role in shaping the urban built environment as one variable that might facilitate increased moderate physical activity among the American population. This article explores the explicit links that have been made between specific characteristics in the urban built environment and moderate physical activity. It also reviews current policy and procedures in Michigan that can influence change in urban development patterns as well as recent initiatives that have been introduced to promote moderate physical activity. Michigan is the focus since it is among the leading U.S. States in decentralization (with 60% of the population living in suburbs) and also in overweight and obesity prevalence (with over 60% of the population being either obese or overweight). [Copyright &y& Elsevier]

Background: Publication of results from the Women's Health Initiative study in July 2002 was a landmark event in biomedical science related to postmenopausal women. The purpose of this study was to describe the impact of new hormone therapy recommendations on patients' attitudes and decision-making in a primary care practice. Methods: A questionnaire including structured and open-ended questions was administered in a family practice office waiting room from August through October 2003. Rationale for taking or not taking hormone therapy was specifically sought. Women 50-70 years old attending for office visits were invited to participate. Data were analyzed qualitatively and with descriptive statistics. Chart review provided medication use rates for the entire practice cohort of which the sample was a subset. Results: Respondents (n = 127) were predominantly white and well educated, and were taking hormone therapy at a higher rate (38%) than the overall rate (26%) for women of the same age range in this practice. Belief patterns about hormone therapy were, in order of frequency, 'use is risky', 'vindication or prior beliefs', 'benefit to me outweighs risk', and 'unaware of new recommendations'. Twenty-eight out of 78 women continued hormones use after July 2002. Of 50 women who initially stopped hormone therapy after July 2002, 12 resumed use. Women who had stopped hormone therapy were a highly symptomatic group. Responses with emotional overtones such as worry, confusion, anger, and grief were common. Conclusion: Strategies for decision support about hormone therapy should explicitly take into account women's preferences about symptom relief and the trade-offs among relevant risks. Some women may need emotional support during transitions in hormone therapy use. [ABSTRACT FROM AUTHOR]

Purpose: Evidence supports treatment for opioid use disorder (OUD) with buprenorphine in primary care practices (PCPs). Barriers that slow implementation of this treatment include inadequately trained staff. This study aimed to increase the number of rural PCPs providing OUD treatment with buprenorphine. This evaluation describes the impact of a practice team training on the implementation and delivery of OUD treatment with buprenorphine in PCPs of rural Colorado.Methods: Implementing Technology and Medication Assisted Treatment Team Training in Rural Colorado (IT MATTTRs) was a multilevel implementation study that included a practice-focused intervention to improve awareness, adoption, and use of buprenorphine treatment for OUD. Participating PCP teams received the IT MATTTRs Practice Team Training and support. Practices' implementation of treatment components was assessed before and after training. Practice-reported and population-level data from the Prescription Drug Monitoring Program were obtained to describe changes in delivery of treatment after training.Results: Forty-two practices received team training. Practices reported an average of 4.7 treatment-related components in place at baseline compared with 13.0 at 12-month follow-up (F[2,56] = 31.17, P <.001). The proportion of participating practices providing or referring patients for treatment increased from 18.8% to 74.4%. The increase in number of people with a prescription for buprenorphine was significantly greater in the study region over a 4-year period compared with the rest of the state (Wald χ2 = 15.73, P <.001).Conclusions: The IT MATTTRs training for PCP teams in OUD treatment with buprenorphine addressed elements beyond clinician waiver training to make implementation feasible and effectively increased implementation and delivery of this treatment in rural Colorado. [ABSTRACT FROM AUTHOR]

Background: Obesity is of epidemic proportion in the USA but most people with obesity do not receive treatment. Objective: To explore the experience of providing obesity management among primary care clinicians and their team members involved with weight loss in primary care practices. The study's focus was on examining the use of the Medicare payment code for intensive behavioral therapy for obesity (IBT), but other obesity management services and payment mechanisms were also studied. Design/Participants: We conducted 85 interviews of clinicians (physician, advanced practice clinicians, registered dietitian, or other) practicing in primary care practices. Interviews gathered information about treatment approach to obesity, barriers, and facilitators to providing obesity care including the handling of billing and reimbursement (especially use of the IBT code), personal beliefs about the appropriateness of primary care providing weight loss services, and recommendations for improving weight management in primary care practice. The analysis was conducted using a grounded theory hermeneutic editing approach and the constant comparative method. Key Results: Seventy-five interviews were included in this analysis. We identified three primary themes: (1) clinicians and staff involved in obesity management in primary care believe that addressing obesity is an essential part of primary care services, (2) because providing obesity care can be challenging, many practices opt out of treatment, and (3) despite the challenges, many clinicians and others find treating obesity feasible, satisfying, and worthwhile. Conclusions: Treating obesity in primary care settings poses several challenges but can also be very satisfying and rewarding. To improve the ability of clinicians and practice members to treat obesity, important changes in payment, education, and work processes are necessary. [ABSTRACT FROM AUTHOR]

Objective: To fill the gap in knowledge on systematic differences between primary care practices (PCP) that do or do not provide intensive behavioral therapy (IBT) for obese Medicare patients. Methods: A mixed modality survey (paper and online) of primary care practices obtained from a random sample of Medicare databases and a convenience sample of practice-based research network practices. Key Results: A total of 287 practices responded to the survey, including 140 (7.4% response rate) from the random sample and 147 (response rate not estimable) from the convenience sample. We found differences between the IBT-using and non-using practices in practice ownership, patient populations, and participation in Accountable Care Organizations. The non-IBT-using practices, though not billing for IBT, did offer some other assistance with obesity for their patients. Among those who had billed for IBT, but stopped billing, the most commonly cited reason was billing difficulties. Many providers experienced denied claims due to billing complexities. Conclusions: Although the Centers for Medicare and Medicaid Services established payment codes for PCPs to deliver IBT for obesity in 2011, very few providers submitted fee-for-service claims for these services after almost 10 years. A survey completed by both a random and convenience sample of practices using and not using IBT for obesity payment codes revealed that billing for these services was problematic, and many providers that began using the codes discontinued using them over the past 7 years. [ABSTRACT FROM AUTHOR]

Outpatient palliative care offers an opportunity to improve the quality of life of Parkinson's disease (PD) patients and families. While there are efforts to improve clinicians' palliative care knowledge and skills, there is limited knowledge on patients and carepartners' knowledge and perceptions of palliative care. As part of a larger study on implementing outpatient palliative care, this study aimed to understand patients' and carepartners' knowledge and perceptions of palliative care, and their palliative care needs and preferences prior to the implementation. Using qualitative descriptive research design, we completed semi-structured interviews with 47 patients and carepartners prior to the project implementation. De-identified transcripts of interviews were coded and analyzed. Five themes were identified that describe patients' and carepartners' palliative care knowledge, perceptions, needs and preferences: (a) Patients and carepartners have varied knowledge and perceptions of palliative care (b) Non-motor symptoms are challenging for patients and carepartners , (c) Addressing patients' grief and emotional needs is important to patients and carepartners , (d) Carepartners want a place for emotional care, well-being, and strategizing and (e) Patients and carepartners desire anticipatory guidance and care planning. Study participants desired guidance to manage non-motor symptoms, support for patients' emotional needs and for carepartners, and for anticipatory guidance to guide future planning. Despite varied palliative care knowledge, PD patients and carepartners universally desire care that addresses their palliative care needs. Palliative care education and integration of palliative care approaches into standard care may facilitate increased acceptance of outpatient palliative care throughout the disease trajectory. • Patients and families want guidance on management of non-motor symptoms. • Patients want support for non-pathological emotional distress. • Carepartners need and want support and guidance. • PD families want anticipatory guidance about the future. • Palliative care education may improve acceptance among patients and families. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: The National Diabetes Prevention Program (NDPP) is a widely disseminated lifestyle intervention. Attendance is problematic, leading to suboptimal weight loss, especially among racial/ethnic minority participants. We conducted a novel "presession" protocol to improve engagement of diverse NDPP candidates, comparing NDPP participants who attended a presession to those who did not on attendance and weight loss outcomes.Design: Longitudinal cohort study.Setting: A safety net health-care system.Participants: A total of 1140 patients with diabetes risks (58.9% Hispanic, 19.8% non-Hispanic black, 61.8% low income).Intervention: The NDPP has been delivered in a Denver, Colorado health-care system since 2013. The program included 22 to 25 sessions over 1 year. Beginning September 2016, individuals were required to attend a presession before enrollment that focused on (1) increasing risk awareness, (2) motivational interviewing to participate in the NDPP, and (3) problem-solving around engagement barriers.Measures: Duration and intensity of NDPP attendance and weight loss.Analysis: Outcomes of 75 presession participants who enrolled in the NDPP were compared to 1065 prior participants using analysis of covariance and multivariable logistic regression.Results: Presession participants stayed in the NDPP 99.8 days longer ( P < .001) and attended 14.3% more sessions ( P < .001) on average than those without a presession. Presession participants lost 2.0% more weight ( P < .001) and were 3.5 times more likely to achieve the 5% weight loss target ( P < .001).Conclusion: Presessions may improve NDPP outcomes for individuals from diverse backgrounds. A full-scale trial is needed to determine whether presessions reliably improve NDPP effectiveness. [ABSTRACT FROM AUTHOR]

Care management (CM) is a promising team-based, patient-centered approach "designed to assist patients and their support systems in managing medical conditions more effectively." As little is known about its implementation, this article describes CM implementation and associated lessons from 12 Agency for Healthcare Research and Quality-sponsored projects. Two rounds of data collection resulted in project-specific narratives that were analyzed using an iterative approach analogous to framework analysis. Informants also participated as coauthors. Variation emerged across practices and over time regarding CM services provided, personnel delivering these services, target populations, and setting(s). Successful implementation was characterized by resource availability (both monetary and nonmonetary), identifying as well as training employees with the right technical expertise and interpersonal skills, and embedding CM within practices. Our findings facilitate future context-specific implementation of CM within medical homes. They also inform the development of medical home recognition programs that anticipate and allow for contextual variation. [ABSTRACT FROM AUTHOR]

Care management is becoming increasingly offered in the U.S. as a means of helping patients better manage their chronic diseases and possibly avoid worsening or exacerbations of their conditions, which can result in potentially avoidable and costly healthcare services. Since care management can be provided using different intervention methods and by different entities, we sought to compare different models of care management delivery on their long-term medical savings. Specifically, we compare health plan provided care management to provider delivered care management. Evaluation of the effectiveness of care management programs can be challenging because it can take time for patients to make recommended changes and then demonstrate healthcare savings associated with those changes. In this study, we modeled the unknown form of the time-varying program effects using a spline-based technique in the Bayesian framework, where the number and locations of knots were treated unknown and learned via reversible jump Markov chain Monte Carlo. We also addressed additional modeling challenges from features seen in our healthcare cost data such as highly right-skewed outcomes with non-constant variances and extra zeros. To provide a more robust analysis, we incorporated a follow-up period of up to 4 years that is longer than the most of the published studies on care management. The results of this work demonstrate that cost savings do accrue with specific models of care management. In particular, the embedded model of care management was significantly more effective than the health plan provided care management in controlling medical costs after 2 years of engagement, and the savings increased over time. This information should help policy makers and employer groups achieve a better understanding of the potential value of care management. [ABSTRACT FROM AUTHOR]

The U.S. Preventive Services Task Force (USPTF) recognizes that behaviors have a major impact on health and well-being. Currently, the USPSTF has 11 behavioral counseling intervention (BCI) recommendations. These BCIs can be delivered in a primary care setting or patients can be referred to other clinical or community programs. Unfortunately, many recommended BCIs are infrequently and ineffectually delivered, suggesting that more evidence is needed to understand which BCIs are feasible and referable. In response, the USPSTF convened an expert forum in 2013 to inform the evaluation of BCI feasibility. This manuscript reports on findings from the forum and proposes that researchers use several frameworks to help clinicians and the USPSTF evaluate which BCIs work under usual conditions. A key recommendation for BCI researchers is to use frameworks whose components can support dissemination and implementation efforts. These frameworks include the Template for Intervention Description and Replication (TIDieR), which helps describe the essential components of an intervention, and pragmatic frameworks like Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) or Pragmatic–Explanatory Continuum Indicator Summary (PRECIS), which help to report study design elements and outcomes. These frameworks can both guide the design of more-feasible BCIs and produce clearer feasibility evidence. Critical evidence gaps include a better understanding of which patients will benefit from a BCI, how flexible interventions can be without compromising effectiveness, required clinician expertise, necessary intervention intensity and follow-up, impact of patient and clinician intervention adherence, optimal conditions for BCI delivery, and how new care models will influence BCI feasibility. [ABSTRACT FROM AUTHOR]

Background: Addiction consultation services (ACS) provide evidence-based treatment to hospitalized patients with substance use disorders (SUD). Expansion of hospital-based addiction care may help to counteract the stigma that patients with SUD experience within the health care system. Stigma is among the most impactful barriers to seeking care and adhering to medical advice among people with SUD. We aimed to understand how the presence of an ACS affected patients' and hospital-based providers' experiences with stigma in the hospital setting.Methods: We conducted a qualitative study utilizing focus groups and key informant interviews with hospital-based providers (hospitalists and hospital-based nurses, social workers, pharmacists). We also conducted key informant interviews with patients who received care from an ACS during their hospitalization. An interprofessional team coded and analyzed transcripts using a thematic analysis approach to identify emergent themes.Results: Sixty-two hospital-based providers participated in six focus groups or eight interviews. Twenty patients participated in interviews. Four themes emerged relating to the experiences of stigma reported by hospital-based providers and hospitalized patients with SUD: (1) past experiences in the health care system propagate a cycle of stigmatization between hospital-based providers and patients; (2) documentation in medical charts unintentionally or intentionally perpetuates enacted stigma among hospital-based providers resulting in anticipated stigma among patients; (3) the presence of an ACS reduces enacted stigma among hospital-based providers through expanding the use of evidenced-based SUD treatment and reframing the SUD narrative; (4) ACS team members combat the effects of internalized stigma by promoting feelings of self-worth, self-efficacy, and mutual respect among patients with SUD.Conclusions: An ACS can facilitate destigmatization of hospitalized patients with SUD by incorporating evidence-based SUD treatment into routine hospital care, by providing and modeling compassionate care, and by reframing addiction as a chronic condition to be treated alongside other medical conditions. Future reductions of stigma in hospital settings may result from promoting greater use of evidence-based treatment for SUD and expanded education for health care providers on the use of non-stigmatizing language and medical terminology when documenting SUD in the medical chart. [ABSTRACT FROM AUTHOR]

Background: Smoking during pregnancy is one of the most modifiable risk factor for poor birth outcomes. This study assesses the prevalence and correlates of smoking during pregnancy. Methods: A questionnaire was applied to pregnant women in two urban clinics in Romania to assess smoking prevalence, attitudes and knowledge about smoking, and other risks poorly documented in Romania, such as depressive symptoms, stress and social support. The response rate was >80% and the valid sample comprised of 916 women. Descriptive statistics and logistic regressions were used to estimate the prevalence of smoking and other risk factors and to identify correlates of smoking during pregnancy. Results: Approximately 15% of the women continued smoking during pregnancy, and 26% of all women said they smoked prior to pregnancy, but quit upon finding out they were pregnant. Depressive symptoms and stress were not associated with smoking during pregnancy. Women with no social support had higher odds of continued smoking vs. non-smoking (OR = 2.3, P < 0.01), and vs. quitting (OR = 2.3, P < 0.05). Roma women had 5.2 times the odds (P < 0.01) of continued smoking vs. non-smoking. Lack of awareness about the benefits of quitting smoking and about the risks of smoking light cigarettes were associated with continued smoking during pregnancy. Conclusions: Smoking was common in a sample of Romanian pregnant women. Smoking cessation programs in Romania should include components to raise the awareness about the risks of smoking during pregnancy and the benefits of quitting at any time during pregnancy. More targeted interventions are needed in Roma communities. [ABSTRACT FROM AUTHOR]

PURPOSE In what ways is primary care practice-based research a facilitator of practice improvement vs a barrier to practice change? This article aims to alert investigators to the pitfalls they may face in undertaking the dual agenda of research and practice improvement. METHODS We derived examples of the relationship between the research and practice improvement goals of 17 Prescription for Health (P4H) grantees from verbal communications with the grantees, fi eld notes from interviews and site visits, and entries made by grantees to an online diary managed by the P4H Analysis Team. RESULTS An analysis of key themes identifi ed factors facilitating and impeding the dual goals of research and practice improvement. The requirements of conducting research mandated by institutional review boards, including patient enrollment and consent, often constituted barriers to practice improvement. The choice of practices in which to conduct research and improvement activities and the manner in which the practices are approached may affect the outcome of both research and practice improvement goals. Approaching practices with a time-limited project mentality can interfere with a process of permanent practice change. The RE-AIM construct (reach, effi cacy/effectiveness, adoption, implementation, and maintenance) is useful in designing research interventions that facilitate practice improvement. CONCLUSIONS Projects that meld research studies and practice improvement goals must pay attention to the potential confl icts between research and practice change, and must attempt to design research studies so that they facilitate rather than inhibit practice improvement. [ABSTRACT FROM AUTHOR]