Validation of dementia care-related scales among informal caregivers of Latinos with dementia or mild cognitive impairment.

Objectives: To test the psychometric properties of several dementia care-related scales among Latinos in the US. Design: We leveraged secondary baseline data from a one-arm mHealth trial on dementia caregiver support. We included 100 responses for caregiver-focused scales and 88 responses for care recipient-focused scales. Scales included the Neuropsychiatric Inventory Questionnaire Severity and Distress scales, six-item Zarit Burden Inventory, Ten-item Center for Epidemiologic Studies Depression Scale, Geriatric Depression Inventory, Quality of Life in Alzheimer's Disease, and Single-item Satisfaction With Life Scale. We calculated concurrent validity using Pearson and Spearman correlations and expected correlations amongst all variables in line with the Stress Process Framework. We calculated internal consistency reliability using Cronbach's alpha. Results: All concurrent validity correlations followed the expected directionality, with 19/21 inter-scale correlations in the total sample reaching statistical significance (p<0.05), and 17/21 reaching at least a low correlation (0.3). Cronbach's alpha ranged from 0.832 to 0.879 in all scales in the total sample. Conclusion: The English and Spanish caregiver-administered scales tested in this manuscript have good psychometric properties. Clinical Implications: The dementia care-related scales are now appropriately available for use among US Latinos in research and clinical contexts.

Local Health Equity Action Teams (LHEATS) as a Novel and Emerging Practice of the Communities Organizing to Promote Equity (COPE) Project in Kansas.

The Communities Organizing to Promote Equity (COPE) Project was implemented in 20 counties across Kansas to build capacity to address health equity by forming local health equity action teams (LHEATS), hiring and training community health workers, facilitating state-wide learning collaboratives, and tailoring communication strategies. We conducted interviews and focus groups with project stakeholders who identified pragmatic recommendations related to LHEAT formation and leadership, establishing trust, nurturing autonomy, and optimizing impact. Insights can improve future community-based health equity efforts. (Am J Public Health. 2024;114(S7):S570-S574. https://doi.org/10.2105/AJPH.2024.307802).

Community Organizations, Local Health Equity Action Teams, and a Learning Collaborative to Address COVID-19 Disparities in Urban and Rural Communities.

Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) Kansas worked with 10 Kansas counties from November 2020 through June 2022 to form local health equity action teams (LHEATs), develop COVID-19 testing strategies, foster communication about COVID-19, and share best practices through a learning collaborative. Participating counties documented 693 distinct COVID-19 testing and 178 communication activities. Although the intervention was not associated with changes in the proportion of positive COVID-19 tests, LHEATs in the learning collaborative implemented new testing strategies and responded to emerging COVID-19 challenges. (Am J Public Health. 2024;114(11):1202-1206. https://doi.org/10.2105/AJPH.2024.307771).

Communities organizing to promote equity: engaging local communities in public health responses to health inequities exacerbated by COVID-19-protocol paper.

Background: The COVID-19 pandemic has disproportionately impacted rural and under-resourced urban communities in Kansas. The state's response to COVID-19 has relied on a highly decentralized and underfunded public health system, with 100 local health departments in the state, few of which had prior experience engaging local community coalitions in a coordinated response to a public health crisis. Methods: To improve the capacity for local community-driven responses to COVID-19 and other public health needs, the University of Kansas Medical Center, in partnership with the Kansas Department of Health and Environment, will launch Communities Organizing to Promote Equity (COPE) in 20 counties across Kansas. COPE will establish Local Health Equity Action Teams (LHEATs), coalitions comprised of community members and service providers, who work with COPE-hired community health workers (CHWs) recruited to represent the diversity of the communities they serve. CHWs in each county are tasked with addressing unmet social needs of residents and supporting their county's LHEAT. LHEATs are charged with implementing strategies to improve social determinants of health in their county. Monthly, LHEATs and CHWs from all 20 counties will come together as part of a learning collaborative to share strategies, foster innovation, and engage in peer problem-solving. These efforts will be supported by a multilevel communications strategy that will increase awareness of COPE activities and resources at the local level and successes across the state. Our mixed methods evaluation design will assess the processes and impact of COPE activities as well as barriers and facilitators to implementation using aspects of both the Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) models. Discussion: This protocol is designed to expand community capacity to strategically partner with local public health and social service partners to prioritize and implement health equity efforts. COPE intentionally engages historically resilient communities and those living in underserved rural areas to inform pragmatic strategies to improve health equity.

A Novel Electronic Record System for Documentation and Efficient Workflow for Community Health Workers: Development and Usability Study.

BACKGROUND: The COVID-19 pandemic added to the decades of evidence that public health institutions are routinely stretched beyond their capacity. Community health workers (CHWs) can be a crucial extension of public health resources to address health inequities, but systems to document CHW efforts are often fragmented and prone to unneeded redundancy, errors, and inefficiency. OBJECTIVE: We sought to develop a more efficient data collection system for recording the wide range of community-based efforts performed by CHWs. METHODS: The Communities Organizing to Promote Equity (COPE) project is an initiative to address health disparities across Kansas, in part, through the deployment of CHWs. Our team iteratively designed and refined the features of a novel data collection system for CHWs. Pilot tests with CHWs occurred over several months to ensure that the functionality supported their daily use. Following implementation of the database, procedures were set to sustain the collection of feedback from CHWs, community partners, and organizations with similar systems to continually modify the database to meet the needs of users. A continuous quality improvement process was conducted monthly to evaluate CHW performance; feedback was exchanged at team and individual levels regarding the continuous quality improvement results and opportunities for improvement. Further, a 15-item feedback survey was distributed to all 33 COPE CHWs and supervisors for assessing the feasibility of database features, accessibility, and overall satisfaction. RESULTS: At launch, the database had 60 active users in 20 counties. Documented client interactions begin with needs assessments (modified versions of the Arizona Self-sufficiency Matrix and PRAPARE [Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences]) and continue with the longitudinal tracking of progress toward goals. A user-specific automated alerts-based dashboard displays clients needing follow-up and upcoming events. The database contains over 55,000 documented encounters across more than 5079 clients. Available resources from over 2500 community organizations have been documented. Survey data indicated that 84% (27/32) of the respondents considered the overall navigation of the database as very easy. The majority of the respondents indicated they were overall very satisfied (14/32, 44%) or satisfied (15/32, 48%) with the database. Open-ended responses indicated the database features, documentation of community organizations and visual confirmation of consent form and data storage on a Health Insurance Portability and Accountability Act-compliant record system, improved client engagement, enrollment processes, and identification of resources. CONCLUSIONS: Our database extends beyond conventional electronic medical records and provides flexibility for ever-changing needs. The COPE database provides real-world data on CHW accomplishments, thereby improving the uniformity of data collection to enhance monitoring and evaluation. This database can serve as a model for community-based documentation systems and be adapted for use in other community settings.

Impact of the COVID-19 Pandemic on Latino Families With Alzheimer Disease and Related Dementias: Qualitative Interviews With Family Caregivers and Primary Care Providers.

Background: Latino individuals experience disparities in the care of Alzheimer disease and related dementias (ADRD) and have disproportionately high COVID-19 infection and death outcomes. Objective: We aimed to gain an in-depth understanding of the impact of the COVID-19 pandemic among Latino families with ADRD in the United States. Methods: This was a qualitative study of 21 informal caregivers of Latino individuals with ADRD and 23 primary care providers who serve Latino patients. We recruited participants nationwide using convenience and snowball sampling methods and conducted remote interviews in English and Spanish. We organized the transcripts for qualitative review to identify codes and themes, using a pragmatic approach, a qualitative description methodology, and thematic analysis methods. Results: Qualitative analysis of transcripts revealed eight themes, including (1) the pandemic influenced mental and emotional health; (2) the pandemic impacted physical domains of health; (3) caregivers and care recipients lost access to engaging activities during the confinement; (4) the pandemic impacted Latino caregivers' working situation; (5) the pandemic impacted health care and community care systems; (6) health care and community care systems took measures to reduce the impact of the pandemic; (7) Latino families experienced barriers to remote communication during the pandemic; and (8) caregiver social support was critical for reducing social isolation and its sequalae. Conclusions: Latino families with ADRD experienced similar but also unique impacts compared to those reported in the general population. Unique impacts may result from Latino individuals' underserved status in the United States, commonly held cultural values, and their intersectionality with ADRD-related disability. Family caregiver social support was crucial during this time of adversity. These findings suggest the need for more equitable access, culturally appropriate and trustworthy content and delivery of health care and community services, as well as stronger financial and social supports for family caregivers.

Assessing Social Needs and Engaging Community Health Workers in Underserved Kansas Counties: Insights From Primary Care Providers and Clinic Managers.

INTRODUCTION: Rural and under-resourced urban communities face unique challenges in addressing patients' social determinants of health needs (SDoH). Community health workers (CHWs) can support patients experiencing social needs, yet little is known about how rural and under-resourced primary care clinics are screening for SDoH or utilizing CHWs. METHODS: Interviews were conducted with primary care clinic providers and managers across a geographically large and predominately rural state to assess screening practices for SDoH and related community resources, and perspectives on using CHWs to address SDoH. Interviews were conducted by phone, recorded, and transcribed. Data were analyzed using thematic analysis. We completed interviews with 27 respondents (12 providers and 15 clinic managers) at 26 clinics. RESULTS: Twelve (46.1%) clinics had a standardized process for capturing SDoH, but this was primarily limited to Medicare wellness visits. Staffing and time were identified as barriers to proper SDoH screening. Lack of transportation and affordable medication were the most cited SDoH. While respondents were all aware of CHWs, only 8 (30.8%) included a CHW on their care team. Perceived barriers to engaging CHWs included cost, space, and availability of qualified CHWs. Perceived benefits of engaging CHWs in their practice were: assisting patients with navigating resources and programs, relieving clinical staff of non-medical tasks, and bridging language barriers. CONCLUSIONS: Rural and under-resourced primary care clinics need help in identifying and addressing SDoH. CHWs could play an important part in addressing social needs and promoting preventive care if financial constraints could be addressed and local CHWs could be trained.

Perceived Value of Public Health and Health Policy Information Among Medical Students: A Cross-sectional Study.

Introduction: Health educators have had difficulty introducing health policy and public health training into an already intensive medical school curriculum. Although the COVID-19 pandemic may have changed perspectives on the importance of public health, it may not change educational approaches. Assessment of medical student opinions and perceptions of health policy and public health might influence the weight given to these topics in medical education. Methods: We used a 39-item instrument to cross-sectionally survey medical students, to assess their perceptions of the value of public health and health policy within their professional education. Results: One hundred two students completed the survey (13% response rate). Most students reported an interest in public health (94.1%) and health policy (92.2%). Although interested, most students lacked confidence in their knowledge of public health and health policy on both state (health policy 34.3% confident; public health 43.1%) and national (health policy 41.0%; public health 44.1%) levels. Most students perceived that their institution has not sufficiently prepared them to understand health policy (34% felt prepared) and most reported insufficient information to participate in policy discussions (30.3% sufficiently informed). Conclusions: Medical students reported an interest in public health and health policy while also reporting a lack of confidence in their level of preparedness to understand and participate in these fields, thus demonstrating a need for increased public health and health policy education within medical school curricula.

Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke: A Randomized Clinical Trial.

Importance: Adapting to different smoking cessation medications when an individual has not stopped smoking has shown promise, but efficacy has not been tested in racial and ethnic minority individuals who smoke and tend to have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Objective: To evaluate efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily. Design, Setting, and Participants: This randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC) included non-Hispanic Black adults who smoke and was conducted from May 2019 to January 2022 at a federally qualified health center in Kansas City, Missouri. Data analysis took place from March 2022 to January 2023. Interventions: Both groups received 18 weeks of pharmacotherapy with long-term follow-up through week 26. The ADT group consisted of 196 individuals who received a nicotine patch (NP) and up to 2 pharmacotherapy adaptations, with a first switch to varenicline at week 2 and, if needed, a second switch to bupropion plus NP (bupropion + NP) based on carbon monoxide (CO)-verified smoking status (CO ≥6 ppm) at week 6. The UC group consisted of 196 individuals who received NP throughout the duration of treatment. Main Outcomes and Measures: Anabasine-verified and anatabine-verified point-prevalence abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points). The χ2 test was used to compare verified abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points) between ADT and UC. A post hoc sensitivity analysis of smoking abstinence at week 12 was performed with multiple imputation using a monotone logistic regression with treatment and gender as covariates to impute the missing data. Results: Among 392 participants who were enrolled (mean [SD] age, 53 [11.6] years; 224 [57%] female; 186 [47%] ≤ 100% federal poverty level; mean [SD] 13 [12.4] cigarettes per day), 324 (83%) completed the trial. Overall, 196 individuals were randomized to each study group. Using intent-to-treat and imputing missing data as participants who smoke, verified 7-day abstinence was not significantly different by treatment group at 12 weeks (ADT: 34 of 196 [17.4%]; UC: 23 of 196 [11.7%]; odds ratio [OR], 1.58; 95% CI, 0.89-2.80; P = .12), 18 weeks (ADT: 32 of 196 [16.3%]; UC: 31 of 196 [15.8%]; OR, 1.04; 95% CI, 0.61-1.78; P = .89), and 26 weeks (ADT: 24 of 196 [12.2%]; UC: 26 of 196 [13.3%]; OR, 0.91; 95% CI, 0.50-1.65; P = .76). Of the ADT participants who received pharmacotherapy adaptations (135/188 [71.8%]), 11 of 135 (8.1%) were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had CO-verified abstinence at week 2 had 4.6 times greater odds of being abstinent at week 12 (37 of 129 [28.7%] abstinence) than those who did not respond to treatment (19 of 245 [7.8%] abstinence; OR; 4.6; 95% CI, 2.5-8.6; P < .001). Conclusions and Relevance: In this randomized clinical trial of adapted vs standard of care pharmacotherapy, adaptation to varenicline and/or bupropion + NP after failure of NP monotherapy did not significantly improve abstinence rates for Black adults who smoke relative to those who continued treatment with NP. Those who achieved abstinence in the first 2 weeks of the study were significantly more likely to achieve later abstinence, highlighting early treatment response as an important area for preemptive intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03897439.

Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke.

Background: The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Methods: The current study is comparing the efficacy of optimized (OPT) versus enhanced usual care (UC) for smoking cessation in African Americans (AA) who smoke cigarettes. AAs who smoke (n = 392) are randomized 1:1 to OPT or UC. Participants in both groups receive 7 sessions of smoking cessation counseling and18-weeks of pharmacotherapy with long-term follow-up through Week 26. OPT participants receive nicotine patch and up to two pharmacotherapy adaptations to varenicline and bupropion plus patch based on carbon monoxide verified smoking status (≥6 ppm) at Weeks 2 and 6. UC participants receive patch throughout the duration of treatment. We hypothesize that OPT will be more effective than UC on the primary outcome of biochemically verified abstinence at Week 12. Discussion: If effective, findings could broaden the scope of tobacco dependence treatment and move the field toward optimization strategies that impro ve abstinence for AA who smoke. Trial registration: NCT03897439.

Acceptability and Preliminary Effectiveness of a Remote Dementia Educational Training Among Primary Care Providers and Health Navigators.

BACKGROUND: Optimal care can improve lives of families with dementia but remains under-implemented. Most healthcare professional training is in person, time-intensive, and does not focus on key aspects such as early detection, and cultural competency. OBJECTIVE: We explored the acceptability and preliminary effectiveness of a training, The Dementia Update Course, which addressed these issues. We hypothesized that the training would lead to increased levels of perceived dementia care competency among key healthcare workers, namely primary care providers (PCPs) and health navigators (HNs). METHODS: We conducted pre-post training assessments among 22 PCPs and 32 HNs. The 6.5-h training was remote, and included didactic lectures, case discussion techniques, and materials on dementia detection and care. Outcomes included two 5-point Likert scales on acceptability, eleven on perceived dementia care competency, and the three subscales of the General Practitioners Confidence and Attitude Scale for Dementia. We used paired samples t-tests to assess the mean differences in all preliminary effectiveness outcomes. RESULTS: The training included 28.6% of PCPs and 15.6% of HNs that self-identified as non-White or Latino and 45.5% of PCPs and 21.9% of HNs who served in rural areas. PCPs (84.2%) and HNs (91.7%) reported a high likelihood to recommend the training and high satisfaction. Most preliminary effectiveness outcomes analyzed among PCPs (11/14) and all among HNs (8/8) experienced an improvement from pre- to post-training (p < 0.05). CONCLUSION: A relatively brief, remote, and inclusive dementia training was associated with high levels of acceptability and improvements in perceived dementia care competency among PCPs and HNs.

Impact of the COVID-19 pandemic on Latino families with Alzheimer's disease and related dementias: Perceptions of family caregivers and primary care providers.

Latinos experience disproportionately poor outcomes in dementia and COVID-19, which may synergistically impact their health. We explored the impact of the COVID-19 pandemic among Latino families with dementia via a qualitative descriptive study of 21 informal caregivers of Latinos with dementia and 24 primary care providers. Two themes arose: The impact of a global pandemic (e.g., accelerated cognitive and physical decline, or caregivers choosing between risking finances and the family's infection given the work situation) and Developing resilience to the effects of the pandemic (e.g., caregivers seeking vaccination sites, moving in with the care recipient and adopting telehealth).

Pandemic Food Response in Primary Care to Minimize Exposure for Elderly Food Insecure Population.

Introduction: Stay-at-home orders during the first wave of the COVID-19 pandemic encouraged individuals, especially the elderly, to stock up on food and supplies and remain home to limit exposure to the SARS-CoV-2 virus. However, individuals with food insecurity may be able only to afford a few days of food at a time, causing frequent outings to obtain food. An emergency food delivery system decreases the need for frequent outings. This study investigated: (1) whether elderly family medicine patients with previously reported food insecurity were making frequent trips to obtain food during the lockdown, and (2) if social determinants of health screening data could be used successfully to identify patients in need of emergency food delivery during the pandemic. Methods: Primary care patients 65 years and older with previously reported food insecurity were screened for referral to a community food delivery program. A cross-sectional secondary analysis of screening and referral data were conducted. Results: Clinic staff called 52 patients and completed screening of 30. For 23/30 respondents (76.7%), reported monthly outings to obtain food exceeded the recommended stay-at-home guidelines. In our sample, 22/30 (73.3%) reported current food need, 14/30 (46.7%) reported two or fewer days of food, 28/30 (93.3%) reported receiving home food delivery would keep them from going out, 24/30 (80.0%) agreed to food delivery, and 17 patients received a food delivery. Conclusions: Targeted screening and referral for food delivery may reduce the need for patients experiencing food insecurity to leave home during a pandemic or other disaster, potentially decreasing community exposure for a high-risk population. Primary care practices can utilize previously collected food insecurity and other social determinants of health data to identify and assist high-risk patients in a pandemic.

Implementation of cancer screening in rural primary care practices after joining an accountable care organisation: a multiple case study.

OBJECTIVE: To describe common strategies and practice-specific barriers, adaptations and determinants of cancer screening implementation in eight rural primary care practices in the Midwestern United States after joining an accountable care organisation (ACO). DESIGN: This study used a multiple case study design. Purposive sampling was used to identify a diverse group of practices within the ACO. Data were collected from focus group interviews and workflow mapping. The Consolidated Framework for Implementation Research (CFIR) was used to guide data collection and analysis. Data were cross-analysed by clinic and CFIR domains to identify common themes and practice-specific determinants of cancer screening implementation. SETTING: The study included eight rural primary care practices, defined as Rural-Urban Continuum Codes 5-9, in one ACO in the Midwestern United States. PARTICIPANTS: Providers, staff and administrators who worked in the primary care practices participated in focus groups. 28 individuals participated including 10 physicians; one doctor of osteopathic medicine; three advanced practice registered nurses; eight registered nurses, quality assurance and licensed practical nurses; one medical assistant; one care coordination manager; and four administrators. RESULTS: With integration into the ACO, practices adopted four new strategies to support cancer screening: care gap lists, huddle sheets, screening via annual wellness visits and information spread. Cross-case analysis revealed that all practices used both visit-based and population-based cancer screening strategies, although workflows varied widely across practices. Each of the four strategies was adapted for fit to the local context of the practice. Participants shared that joining the ACO provided a strong external incentive for increasing cancer screening rates. Two predominant determinants of cancer screening success at the clinic level were use of the electronic health record (EHR) and fully engaging nurses in the screening process. CONCLUSIONS: Joining an ACO can be a positive driver for increasing cancer screening practices in rural primary care practices. Characteristics of the practice can impact the success of ACO-related cancer screening efforts; engaging nurses to the fullest extent of their education and training and integrating cancer screening into the EHR can optimise the cancer screening workflow.

Pilot Testing All Nations Snuff Out Smokeless (ANSOS): A Culturally Tailored Smokeless Tobacco Cessation Program for American Indians.

American Indians have the highest rates of smokeless tobacco (SLT) use of any racial/ethnic group in the United States, yet no proven effective cessation programs exist for them. Because tobacco is a sacred plant to many American Indians, cessation programs must not portray it in a completely negative manner. Based on our successful All Nations Breath of Life smoking cessation program, we developed and pilot-tested the All Nations Snuff Out Smokeless (ANSOS) program. Of 48 participants who began the program, 33 completed to six months (68.8% retention rate). Among participants who completed the program, 11 (34%) self-reported abstinence. When those lost to follow-up are considered current users, the cessation rate is 22.9%. An additional 14 individuals reported decreasing use (29.2% of all participants), with an average of 3.4 days per week decrease. All Nations Snuff Out Smokeless shows promise as a culturally appropriate SLT cessation program and is ready for efficacy testing.

Challenges Faced by Rural Primary Care Providers When Caring for COPD Patients in the Western United States.

RATIONALE: Rural chronic obstructive pulmonary disease (COPD) patients have worse outcomes and higher mortality compared with urban patients. Reasons for these disparities likely include challenges to delivery of care that have not been explored. OBJECTIVE: To determine challenges faced by rural primary care providers when caring for COPD patients. METHODS: Rural primary care providers in 7 primarily western states were asked about barriers they experienced when caring for COPD patients. RESULTS: A total of 71 rural primary care medical providers completed the survey, of which 51% were physicians and 49% were advanced practice providers (APPs). A total of 61% used Global Initiative for Chronic Obstructive Lung Disease or American Thoracic Society/European Respiratory Society guidelines as an assessment and treatment resource. The presence of multiple chronic conditions and patient failure to recognize and report symptoms were the greatest barriers to diagnose COPD. A total of 89% of providers used spirometry to diagnose COPD, but only 62% were satisfied with access to spirometry. Despite recommendations, 41% of providers never test for alpha-1 antitrypsin deficiency. A total of 87% were comfortable with their ability to assess symptoms, but only 11% used a guideline-recommended assessment tool. Although most providers were satisfied with their ability to treat symptoms and exacerbations, only 66% were content with their ability to prevent exacerbations. Fewer providers were happy with their access to pulmonologists (55%) or pulmonary rehabilitation (37%). Subgroup analyses revealed differences based on provider type (APP versus physician) and location (Colorado and Kansas versus other states), but not on population or practice size. CONCLUSIONS: Rural providers face significant challenges when caring for COPD patients that should be targeted in future interventions to improve COPD outcomes.

Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial.

Importance: Rural populations have a higher prevalence of obesity and poor access to weight loss programs. Effective models for treating obesity in rural clinical practice are needed. Objective: To compare the Medicare Intensive Behavioral Therapy for Obesity fee-for-service model with 2 alternatives: in-clinic group visits based on a patient-centered medical home model and telephone-based group visits based on a disease management model. Design, Setting, and Participants: Cluster randomized trial conducted in 36 primary care practices in the rural Midwestern US. Inclusion criteria included age 20 to 75 years and body mass index of 30 to 45. Participants were enrolled from February 2016 to October 2017. Final follow-up occurred in December 2019. Interventions: All participants received a lifestyle intervention focused on diet, physical activity, and behavior change strategies. In the fee-for-service intervention (n = 473), practice-employed clinicians provided 15-minute in-clinic individual visits at a frequency similar to that reimbursed by Medicare (weekly for 1 month, biweekly for 5 months, and monthly thereafter). In the in-clinic group intervention (n = 468), practice-employed clinicians delivered group visits that were weekly for 3 months, biweekly for 3 months, and monthly thereafter. In the telephone group intervention (n = 466), patients received the same intervention as the in-clinic group intervention, but sessions were delivered remotely via conference calls by centralized staff. Main Outcomes and Measures: The primary outcome was weight change at 24 months. A minimum clinically important difference was defined as 2.75 kg. Results: Among 1407 participants (mean age, 54.7 [SD, 11.8] years; baseline body mass index, 36.7 [SD, 4.0]; 1081 [77%] women), 1220 (87%) completed the trial. Mean weight loss at 24 months was -4.4 kg (95% CI, -5.5 to -3.4 kg) in the in-clinic group intervention, -3.9 kg (95% CI, -5.0 to -2.9 kg) in the telephone group intervention, and -2.6 kg (95% CI, -3.6 to -1.5 kg) in the in-clinic individual intervention. Compared with the in-clinic individual intervention, the mean difference in weight change was -1.9 kg (97.5% CI, -3.5 to -0.2 kg; P = .01) for the in-clinic group intervention and -1.4 kg (97.5% CI, -3.0 to 0.3 kg; P = .06) for the telephone group intervention. Conclusions and Relevance: Among patients with obesity in rural primary care clinics, in-clinic group visits but not telephone-based group visits, compared with in-clinic individual visits, resulted in statistically significantly greater weight loss at 24 months. However, the differences were small in magnitude and of uncertain clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT02456636.

A non-randomized pilot study to test the feasibility of treating chronic pain and opioid prescription use in rural areas with acceptance and commitment therapy (T-PACT).

Chronic non-cancer pain (CNCP) involves one-third of the US population, and prescription opioids contribute to the opioid epidemic. The Centers for Disease Control and Prevention emphasizes maximizing non-opioid treatment, but many rural populations cannot access alternative therapies. Clinical and Translational Science Award hubs across four rural states performed a multi-site, single-arm intervention feasibility study testing methods and procedures of implementing a behavioral intervention, acceptance and commitment therapy, in primary care CNCP patients on chronic opioids. Using the CONSORT extension for feasibility studies, we describe lessons learned in recruiting/retaining participants, intervention implementation, data measurement, and multi-site procedures. Results inform a future definitive trial and potentially others conducting rural trials.