Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

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.

A virtual recruitment protocol promotes enrollment of underrepresented groups in a diabetes prevention trial.

Strategies are needed to ensure greater participation of underrepresented groups in diabetes research. We examined the impact of a remote study protocol on enrollment in diabetes research, specifically the Pre-NDPP clinical trial. Recruitment was conducted among 2807 diverse patients in a safety-net healthcare system. Results indicated three-fold greater odds of enrolling in remote versus in-person protocols (AOR 2.90; P < 0.001 [95% CI 2.29-3.67]). Priority populations with significantly higher enrollment included Latinx and Black individuals, Spanish speakers, and individuals who had Medicaid or were uninsured. A remote study design may promote overall recruitment into clinical trials, while effectively supporting enrollment of underrepresented groups.

Parkinson disease patients' and carepartners' perceptions of palliative care.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A Multi-Method Study of Patient Reach and Attendance in a Pragmatic Trial of Diabetes Shared Medical Appointments.

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.

Models for Delivering Weight Management in Primary Care: Qualitative Results from the MOST Obesity Study.

BACKGROUND: Obesity is a leading cause of morbidity and mortality in the United States (US). Primary care medical practices can educate patients about the health effects of obesity and help patients with obesity lose and manage their weight. However, implementation of weight management in primary care is challenging. We sought to examine how practices that implement weight management services do so feasibly. METHODS: Multiple methods including site visits, observations, interviews, and document reviews were utilized to identify and learn from primary care practices located across the US. A qualitative multidimensional classification of empirical cases was performed to identify unique delivery features that were feasible to implement in primary care. RESULTS: Across 21 practices, 4 delivery models were identified: group, integrated into standard primary care, hiring an "other" professional, and using a specific program. Model characteristics included who delivered the weight management services, whether delivered to an individual or group, the types of approaches used, and how the care was reimbursed or paid. Most practices integrated weight management services and primary care delivery, although some created specific carve-out programs. CONCLUSION: This study identified 4 models that may serve to overcome challenges in delivering weight management services in primary care. Based on practice characteristics, preferences, and resources, primary care practices can identify a model for successfully implementing weight management services that best fits their context and needs. It is time for primary care to truly address obesity care as the health issue it is and make it a standard of care for all patients with obesity.

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care.

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.

Integrated Primary Care and Health Behavior Support: A Survey of Behavioral Health Providers.

OBJECTIVES: Many behavioral health providers (BHPs) in primary care practices spend a majority of their time addressing mental health rather than behavior change. We wanted to better understand the practice of BHPs in integrated primary care. METHODS: Survey of BHPs from practices participating in the Colorado State Innovation Model (SIM) initiative. The survey measured what diagnoses BHPs receive referrals to treat, what they treat regardless of referral reason, which techniques they use, and think are most effective for mental health diagnoses and behavior change/weight management support, and their interest in providing support for weight management. Results were analyzed using descriptive statistics and Spearman correlations. RESULTS: We received 79 surveys representing 64 out of 248 SIM practices (practice response rate of 26%). BHPs reported addressing health-related behaviors with patients referred to them for mental health diagnoses. They expressed interest in health behavior and believed the techniques they use for traditional mental health diagnoses also support behavior change. Most reported using cognitive behavioral therapy (89%), mindfulness (94%), and relaxation/stress management (94%). Time in practice was associated with receiving more referrals for weight management (rho(76) = .271, P = .018) and with addressing diet (rho(75) = .339, P = .003) and weight management (rho(75) = .323, P = .005). BHPs in practices that had care managers were more likely to report receiving referrals for weight management than BHPs in practices that did not employ a case manager (rτ(76) = .222, P = .038); practices employing a health coach were more likely to receive referrals for physical activity than practices without a health coach (rτ(76) = .257, P = .015). CONCLUSIONS: BHPs are interested in and frequently address health related behavior. Formalizing health behavior services from BHPs in primary care may provide opportunities to better support patients with behavior change and subsequently improve health outcomes.

Primary care provider uptake of intensive behavioral therapy for obesity in Medicare patients, 2013-2019.

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.

Lung cancer screening in rural primary care practices in Colorado: time for a more team-based approach?

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.

Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation.

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.

An Assessment of Weight Loss Management in Health System Primary Care Practices.

BACKGROUND: Primary care practices can help patients address obesity through weight loss; however, there are many barriers to doing so. This study examined weight management services provided and factors associated with higher reported provision of services. METHODS: A survey was given to practice members in 18 primary care practices in a Colorado-based health system. The survey assessed weight management services to determine the amount and type of weight loss assistance provided and other factors that may be important. We used descriptive statistics to summarize responses and linear regression with generalized estimating equations to assess the association between the practice and practice member characteristics and the amount of weight management services provided. RESULTS: The overall response rate was 64% (254/399). On average, clinicians reported performing 73% of the services, and when grouped into minimal, basic, and extensive, the clinicians on average performed 87%, 68%, and 69% of them, respectively. In a multivariable model adjusted for demographics, factors associated with performing more services included perception of overall better practice culture and perception of weight management implementation climate. CONCLUSIONS: Practice-associated factors such as culture and implementation climate may be worth examining to understand how to implement weight management in primary care.

Between a Rock and a Hard Place: The Challenges of Caregiving During a Pandemic for Parkinson's Family Care Partners.

Aim: To understand Parkinson's Disease (PD) care partners' a) specific challenges that led to worsening strain and b) their suggestions for supports to help them during the ongoing pandemic. Method: Using a qualitative descriptive design, semi-structured interviews with family care partners (n = 19) were completed. Participants were recruited from 10 sites across the United States that varied in size, demographics of patient population served, and geographic location (urban, suburban, rural). Interviews were audio-recorded, de-identified, transcribed verbatim, and coded in a phased manner. The research team analyzed the data and identified themes. Results: During the pandemic, the already difficult task of caregiving was made worse by having to choose between poor options. Five themes exemplified PD care partner experiences: (1) Managing risks and benefits of medical care in settings outside the home vs meeting these needs at home; (2) Struggling to maintain employment benefits with the costs of care and risks of bringing in outside caregivers; (3) Struggling to balance caregiving and self-care; (4) Struggling to be supportive and taking on new caregiving roles in the face of less support services; and (5) Wanting social connections and feeling pressured to maintain isolation. Care partners wanted timely access to, and guidance from healthcare teams to help them. Conclusions: Care partner burden was worsened by lack of guidance when confronted by choices that could lead to negative outcomes. Movement disorder and palliative care providers may be able to alleviate some care partner burden through building systems for timely access and guidance.

Values and Meaning in Rural Primary Care Practices: Implications for Interventions Within Context.

OBJECTIVES: It is important to understand the unique perspectives and values that motivate patients and clinicians in rural primary care settings to participate in clinical care activities. Our objective was to explore perspectives, preferences, and values related to primary care that could influence implementation of evidence-based programs. METHODS: Qualitative study utilizing semi-structured interviews and using immersion/crystallization and thematic analysis. Participants were primary care practice members (clinicians, clinical staff, and administrators) and their patients in rural Colorado. RESULTS: Twenty-six practice members and 23 patients across 9 practices participated. There were 4 emergent themes that were consistent across practice members and some patients. Patient perspectives are located in parenthesis. They included: (1) Focus on quality patient care, patient satisfaction, and continuity of care (patients appreciated quality and compassionate care), (2) Importance of prevention and wellness (patients appreciated help with preventing health problems), (3) Clinician willingness and ability to meet patient preferences for care (patients described comfort with local care), and (4) Passion for serving underserved, uninsured, or vulnerable populations (patients described their vulnerabilities). There were differences in how the perspectives were operationalized by practice member role, illustrating the importance of different ways of addressing these values. CONCLUSIONS: Successful implementation requires consideration of context, and much of context is understanding what is important to those involved in the primary care experience. This study sheds light on salient values of rural primary care practice members and their patients, which may inform interventions designed with and for this setting.

Primary Care Research Is Hard to Do During COVID-19: Challenges and Solutions.

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.

Methods for capturing and analyzing adaptations: implications for implementation research.

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.

Points of Concordance, Points of Discordance: A Qualitative Examination of Telemedicine Implementation.

INTRODUCTION: Health systems undertook a rapid transition to increase the use of telemedicine in the wake of the COVID-19 pandemic. A continued need for telemedicine services in the coming years is likely. This article examines telemedicine from multiple stakeholders' perspectives considering reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) outcomes. METHODS: Semistructured interviews were conducted with primary care practice team members and patients. Rapid qualitative analysis was used to identify themes in experiences and perceptions related to telemedicine implementation. The RE-AIM implementation framework was applied to thematic findings to understand influences on implementation outcomes. RESULTS: Twenty-four practice members and 17 patients across 5 clinics participated. All stakeholder groups reported that technological capabilities influenced patients' access to telemedicine and that certain patients and reasons for visits were not appropriate for telemedicine. All groups felt that telemedicine was a good option for some patients some of the time but not all patients all of the time. DISCUSSION: Telemedicine works well if it is used for the appropriate visits and patient types and with needed technological elements. Older age may limit the feasibility of telehealth for some patients. Added administrative work and associated costs support systematic screening to determine visit appropriateness for telemedicine.

The Balance Between Serving the Community and the Reality of Treating Opioid Use Disorder in Rural Primary Care Practices.

Medication assisted treatment (MAT) is an evidence-based solution to combatting opioid use disorder (OUD); however, MAT is largely unavailable in rural areas. This study investigated clinician and staff perceptions related to OUD and MAT, in particular, buprenorphine treatment, in rural primary care practices. In this qualitative study, we interviewed staff members from 42 practices and analyzed the data using a grounded hermeneutic editing approach. Four key themes emerged: 1) policies and procedures to reduce opioid prescribing were already in place, 2) there was an emotional toll to treating "those types" of patients, 3) there is a lack of local resources for help with chronic pain and buprenorphine treatment, and 4) there is a strong desire to help local patients and community members but hesitancy to engage in buprenorphine treatment. Although there was almost no provision of MAT, many practices were interested in learning more to help their communities.

Increasing Capacity for Treatment of Opioid Use Disorder in Rural Primary Care Practices.

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.

PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial.

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.

Experiences of stigma in hospitals with addiction consultation services: A qualitative analysis of patients' and hospital-based providers' perspectives.

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.