Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

Asthma morbidity measures across Black ethnic subgroups.

BACKGROUND: Black adults are disproportionately affected by asthma and are often considered a homogeneous group in research studies despite cultural and ancestral differences. OBJECTIVE: We sought to determine if asthma morbidity differs across adults in Black ethnic subgroups. METHODS: Adults with moderate-severe asthma were recruited across the continental United States and Puerto Rico for the PREPARE (PeRson EmPowered Asthma RElief) trial. Using self-identifications, we categorized multiethnic Black (ME/B) participants (n = 226) as Black Latinx participants (n = 146) or Caribbean, continental African, or other Black participants (n = 80). African American (AA/B) participants (n = 518) were categorized as Black participants who identified their ethnicity as being American. Baseline characteristics and retrospective asthma morbidity measures (self-reported exacerbations requiring systemic corticosteroids [SCs], emergency department/urgent care [ED/UC] visits, hospitalizations) were compared across subgroups using multivariable regression. RESULTS: Compared with AA/B participants, ME/B participants were more likely to be younger, residing in the US Northeast, and Spanish speaking and to have lower body mass index, health literacy, and <1 comorbidity, but higher blood eosinophil counts. In a multivariable analysis, ME/B participants were significantly more likely to have ED/UC visits (incidence rate ratio [IRR] = 1.34, 95% CI = 1.04-1.72) and SC use (IRR = 1.27, 95% CI = 1.00-1.62) for asthma than AA/B participants. Of the ME/B subgroups, Puerto Rican Black Latinx participants (n = 120) were significantly more likely to have ED/UC visits (IRR = 1.64, 95% CI = 1.22-2.21) and SC use for asthma (IRR = 1.43, 95% CI = 1.06-1.92) than AA/B participants. There were no significant differences in hospitalizations for asthma among subgroups. CONCLUSIONS: ME/B adults, specifically Puerto Rican Black Latinx adults, have higher risk of ED/UC visits and SC use for asthma than other Black subgroups.

Preference for and impact of telehealth vs in-person asthma visits among Black and Latinx adults.

BACKGROUND: Black and Latinx adults experience disproportionate asthma-related morbidity and limited specialty care access. The severe acute respiratory syndrome coronavirus 2 pandemic expanded telehealth use. OBJECTIVE: To evaluate visit type (telehealth [TH] vs in-person [IP]) preferences and the impact of visit type on asthma outcomes among Black and Latinx adults with moderate-to-severe asthma. METHODS: For this PREPARE trial ancillary study, visit type preference was surveyed by e-mail or telephone post-trial. Emergency medical record data on visit types and asthma outcomes were available for a subset (March 2020 to April 2021). Characteristics associated with visit type preferences, and relationships between visit type and asthma outcomes (control [Asthma Control Test] and asthma-related quality of life [Asthma Symptom Utility Index]), were tested using multivariable regression. RESULTS: A total of 866 participants consented to be surveyed, with 847 respondents. Among the participants with asthma care experience with both visit types, 42.0% preferred TH for regular checkups, which associated with employment (odds ratio [OR] = 1.61; 95% confidence interval [CI], 1.09-2.39; P = .02), lower asthma medication adherence (OR = 1.06; 95% CI, 1.01-1.11; P = .03), and having more historical emergency department and urgent care asthma visits (OR = 1.10 for each additional visit; 95% CI, 1.02-1.18; P = .02), after adjustment. Emergency medical record data were available for 98 participants (62 TH, 36 IP). Those with TH visits were more likely Latinx, from the Southwest, employed, using inhaled corticosteroid-only controller therapy, with lower body mass index, and lower self-reported asthma medication adherence vs those with IP visits only. Both groups had comparable Asthma Control Test (18.4 vs 18.9, P = .52) and Asthma Symptom Utility Index (0.79 vs 0.84, P = .16) scores after adjustment. CONCLUSION: TH may be similarly efficacious as and often preferred over IP among Black and Latinx adults with moderate-to-severe asthma, especially for regular checkups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02995733.

Implementation strategies preferred by primary care clinicians to facilitate cancer prevention and control activities.

Key clinical and community members need to be involved in the identification of feasible and impactful implementation strategies for translation of evidence-based interventions into practice. While a wide range of implementation strategies has been developed, there is little research on their applicability for cancer prevention and control (CPC) efforts in primary care. We conducted a survey of primary care physicians to identify implementation strategies they perceive as most feasible and impactful. The survey included both primary prevention behavior change counseling and cancer screening issues. Analyses contrasted ratings of feasibility and impact of nine implementation strategies, and among clinicians in different settings with a focus on comparisons between clinicians in rural vs. non-rural settings. We recruited a convenience sample of 326 respondents from a wide range of practice types from four practice-based research networks in 49 states and including 177 clinicians in rural settings. Ratings of impact were somewhat higher than those for feasibility. Few of the nine implementation strategies were high on both impact and feasibility. Only 'adapting to my practice' was rated higher than a 4 ("moderate") on both impact and feasibility. There were relatively few differences between rural and non-rural clinicians or associated with other clinician or setting characteristics. There is considerable variability in perceived impact and feasibility of implementation strategies for CPC activities among family medicine clinicians. It is important to assess both feasibility and impact of implementation strategies as well as their generalizability across settings. Our results suggest that optimal strategies to implement evidence-based CPC activities will likely need to be adapted for primary care settings. Future research is needed to replicate these findings and identify practical, implementation partner informed implementation strategies.

Research interests of family physicians applying for research training.

BACKGROUND: There is an ongoing need for research to support the practice of high quality family medicine. The Family Medicine Discovers Rapid Cycle Scientific Discovery and Innovation (FMD RapSDI) program is designed to build capacity for family medicine scientific discovery and innovation in the United States. Our objective was to describe the applicants and research questions submitted to the RapSDI program in 2019 and 2020. METHODS: Descriptive analysis for applicant characteristics and rapid qualitative analysis using principles of grounded theory and content analysis to examine the research questions and associated themes. We examined differences by year of application submission and the applicant's career stage. RESULTS: Sixty-five family physicians submitted 70 applications to the RapSDI program; 45 in 2019 and 25 in 2020. 41% of applicants were in practice for five years or less (n = 27), 18% (n = 12) were in in practice 6-10 years, and 40% (n = 26) were ≥ 11 years in practice. With significant diversity in questions, the most common themes were studies of new innovations (n = 20, 28%), interventions to reduce cost (n = 20, 28%), improving screening or diagnosis (n = 19, 27%), ways to address mental or behavioral health (n = 18, 26%), and improving care for vulnerable populations (n = 18, 26%). CONCLUSION: Applicants proposed a range of research questions and described why family medicine is optimally suited to address the questions. Applicants had a desire to develop knowledge to help other family physicians, their patients, and their communities. Findings from this study can help inform other family medicine research capacity building initiatives.

Caribbean Latinx with moderate-severe asthma bear greater asthma morbidity than other Latinx.

BACKGROUND: Hispanic/Latinx (HL) ethnicity encompasses racially and culturally diverse subgroups. Studies suggest that Puerto Ricans (PR) may bear greater asthma-related morbidity than Mexicans, but these were conducted in children or had limited clinical characterization. OBJECTIVES: This study sought to determine whether disparities in asthma morbidity exist among HL adult subgroups. METHODS: Adults with moderate-severe asthma were recruited from US clinics, including from Puerto Rico, for the Person Empowered Asthma Relief (PREPARE) trial. Considering the shared heritage between PR and other Caribbean HL (Cubans and Dominicans [C&D]), the investigators compared baseline self-reported clinical characteristics between Caribbean HL (CHL) (PR and C&D: n = 457) and other HLs (OHL) (Mexicans, Spaniards, Central/South Americans; n = 141), and between CHL subgroups (C&D [n = 56] and PR [n = 401]). This study compared asthma morbidity measures (self-reported exacerbations requiring systemic corticosteroids, emergency department/urgent care (ED/UC) visits, hospitalizations, health care utilization) through negative binomial regression. RESULTS: CHL compared to OHL were similar in age, body mass index, poverty status, blood eosinophils, and fractional exhaled nitric oxide but were prescribed more asthma controller therapies. Relative to OHL, CHL had significantly increased odds of asthma exacerbations (odds ratio [OR]: 1.84; 95% CI: 1.4-2.4), ED/UC visits (OR: 1.88; 95% CI: 1.4-2.5), hospitalization (OR: 1.98; 95% CI: 1.06-3.7), and health care utilization (OR: 1.91; 95% CI: 1.44-2.53). Of the CHL subgroups, PR had significantly increased odds of asthma exacerbations, ED/UC visits, hospitalizations, and health care utilization compared to OHL, whereas C&D only had increased odds of exacerbations compared to OHL. PR compared to C&D had greater odds of ED/UC and health care utilization. CONCLUSIONS: CHL adults, compared with OHL, adults reported nearly twice the asthma morbidity; these differences are primarily driven by PR. Novel interventions are needed to reduce morbidity in this highly impacted population.

Socioeconomic status associates with worse asthma morbidity among Black and Latinx adults.

BACKGROUND: Asthma disproportionately affects African American/Black (AA/B) and Hispanic/Latinx (H/L) patients and individuals with low socioeconomic status (SES), but the relationship between SES and asthma morbidity within these racial/ethnic groups is inadequately understood. OBJECTIVE: To determine the relationship between SES and asthma morbidity among AA/B and H/L adults with moderate to severe asthma using multidomain SES frameworks and mediation analyses. METHODS: We analyzed enrollment data from the PeRson EmPowered Asthma RElief randomized trial, evaluating inhaled corticosteroid supplementation to rescue therapy. We tested for direct and indirect relationships between SES and asthma morbidity using structural equation models. For SES, we used a latent variable defined by poverty, education, and unemployment. For asthma morbidity, we used self-reported asthma exacerbations in the year before enrollment (corticosteroid bursts, emergency room/urgent care visits, or hospitalizations), and Asthma Control Test scores. We tested for mediation via health literacy, perceived stress, and self-reported discrimination. All models adjusted for age, sex, body mass index, ethnicity, and comorbidities. RESULTS: Among 990 AA/B and H/L adults, low SES (latent variable) was directly associated with hospitalizations (ß = 0.24) and worse Asthma Control Test scores (ß = 0.20). Stress partially mediated the relationship between SES and increased emergency room/urgent care visits and worse asthma control (ß = 0.03 and = 0.05, respectively). Individual SES domains were directly associated with asthma morbidity. Stress mediated indirect associations between low educational attainment and unemployment with worse asthma control (ß = 0.05 and = 0.06, respectively). CONCLUSIONS: Lower SES is directly, and indirectly through stress, associated with asthma morbidity among AA/B and H/L adults. Identification of stressors and relevant management strategies may lessen asthma-related morbidity among these populations.

A Unique Model and Workforce to Address Health-Related Social Needs and Health Equity: Regional Health Connectors in Colorado.

Unmet health-related social needs contribute to high morbidity and poor population health. Improving social conditions are likely to reduce health disparities and improve the health of the overall U.S. population. The primary objective of this article is to describe an innovative workforce model, called Regional Health Connectors (RHCs), and how they address health-related social needs in Colorado. This is a program evaluation that analyzed field notes and interview data from 2021-2022. We applied our findings to the framework developed by the National Academies of Sciences, Engineering, and Medicine's (NASEM's) report on strengthening social care integration into health care (2019). We found that RHCs address the following health-related social needs most commonly: food insecurity (n = 18 of 21 regions or 85% of all regions), housing (n = 17 or 81% of all regions), transportation (n = 11 or 52% of all regions), employment opportunities (n = 10 or 48% of all regions), and income/financial assistance (n = 11 or 52% of all regions). RHCs interacted across many sectors to address health-related social needs and provided multiple types of support to primary care practices at the organizational level. Examples of emerging impact of RHCs are described and mapped onto the NASEM framework. Findings from this program evaluation add to the growing landscape of knowledge and importance of detecting and addressing health-related social needs. We conclude that RHCs are a unique and emerging workforce that addresses multiple domains needed to integrate social care into health care.

Blood Pressure Visit Intensification in Treatment (BP-Visit) Findings: a Pragmatic Stepped Wedge Cluster Randomized Trial.

BACKGROUND: Shortening time between office visits for patients with uncontrolled hypertension represents a potential strategy for improving blood pressure (BP). OBJECTIVE: We evaluated the impact of multimodal strategies on time between visits and on improvement in systolic BP (SBP) among patients with uncontrolled hypertension. DESIGN: We used a stepped-wedge cluster randomized controlled trial with three wedges involving 12 federally qualified health centers with three study periods: pre-intervention, intervention, and post-intervention. PARTICIPANTS: Adult patients with diagnosed hypertension and two BPs ≥ 140/90 pre-randomization and at least one visit during post-randomization control period (N = 4277). INTERVENTION: The core intervention included three, clinician hypertension group-based trainings, monthly clinician feedback reports, and monthly meetings with practice champions to facilitate implementation. MAIN MEASURES: The main measures were change in time between visits when BP was not controlled and change in SBP. A secondary planned outcome was changed in BP control among all hypertension patients in the practices. KEY RESULTS: Median follow-up times were 34, 32, and 32 days and the mean SBPs were 142.0, 139.5, and 139.8 mmHg, respectively. In adjusted analyses, the intervention did not improve time to the next visit compared with control periods, HR = 1.01 (95% CI: 0.98, 1.04). SBP was reduced by 1.13 mmHg (95% CI: -2.10, -0.16), but was not maintained during follow-up. Hypertension control (< 140/90) in the practices improved by 5% during intervention (95% CI: 2.6%, 7.3%) and was sustained post-intervention 5.4% (95% CI: 2.6%, 8.2%). CONCLUSIONS: The intervention failed to shorten follow-up time for patients with uncontrolled BP and showed very small, statistically significant improvements in SBP that were not sustained. However, the intervention showed statistically and clinically relevant improvement in hypertension control suggesting that the intervention affected clinician decision-making regarding BP control apart from visit frequency. Future practice initiatives should consider hypertension control as a primary outcome. CLINICAL TRIAL: www.ClinicalTrials.gov Identifier: NCT02164331.

Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care.

PURPOSE: Diabetes affects approximately 34 million Americans and many do not achieve glycemic targets. Continuous glucose monitoring (CGM) is associated with improved health outcomes for patients with diabetes. Most adults with diabetes receive care for their diabetes in primary care practices, where uptake of CGM is unclear. METHODS: We used a cross-sectional web-based survey to assess CGM prescribing behaviors and resource needs among primary care clinicians across the United States. We used descriptive statistics and multivariable regression to identify characteristics associated with prescribing behaviors, openness to prescribing CGM, and to understand resources needed to support use of CGM in primary care. RESULTS: Clinicians located more than 40 miles from the nearest endocrinologist's office were more likely to have prescribed CGM and reported greater likelihood to prescribe CGM in the future than those located within 10 miles of an endocrinologist. Clinicians who served more Medicare patients reported favorable attitudes toward future prescribing and higher confidence using CGM to manage diabetes than clinicians with lower Medicare patient volume. The most-needed resources to support CGM use in primary care were consultation on insurance issues and CGM training. CONCLUSIONS: Primary care clinicians are interested in using CGM for patients with diabetes, but many lack the resources to implement use of this diabetes technology. Use of CGM can be supported with education in the form of workshops and consultation on insurance issues targeted toward residents, recent graduates, and practices without a nearby endocrinologist. Continued expansion of Medicare and Medicaid coverage for CGM can also support CGM use in primary care.

Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study.

BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).

Using a group medical visit model to promote healthy behaviour change with an underserved population.

BACKGROUND: Models of care are needed to address physical activity, nutrition promotion and weight loss in primary care settings, especially with underserved populations who are disproportionately affected by chronic illness. Group medical visits (GMVs) are one approach that can help overcome some of the barriers to behaviour change in underserved populations, including the amount of time required to care for these patients due to socio-economic stressors and psychosocial complexities (1). GMVs have been shown to improve care in coronary artery disease and diabetes, but more evidence is needed in underserved settings. OBJECTIVE: This project sought to evaluate a GMV incorporating a physical activity component in an underserved patient population, measuring biometric and motivation outcome measures. METHODS: This project used a pre-post intervention study design through patient surveys at baseline and 12 weeks. We included validated motivational measures along with self-reported demographic information. A GMV intervention promoting physical activity and nutrition to promote weight loss was delivered by an interdisciplinary primary care team and community partners in a Federally Qualified Health Center in Rochester, NY. The intervention consisted of six, 2-hour sessions that occurred every other week at the clinic site. RESULTS: Participants lost a significant amount of weight and maintained the weight loss at 6 months. In addition, there was a significant improvement in motivation measures. CONCLUSION: This study provides preliminary evidence that our GMV model can improve weight loss and autonomous motivation in an underserved population. This project has potential for scalability and sustainability.

Addressing Medication Costs During Primary Care Visits: A Before-After Study of Team-Based Training.

Background: Medications contribute to patients' out-of-pocket costs, yet most clinicians do not routinely screen for patients' cost-of-medication (COM) concerns. Objective: To assess whether a single training session improves COM conversations. Design: Before-after cross-sectional surveys of patients and qualitative interviews with clinicians and staff. Setting: 7 primary care practices in 3 U.S. states. Participants: In total, 700 patients were surveyed from May 2017 to January 2018: 50 patients per practice before the intervention and another 50 patients per practice after the intervention. Eligibility criteria included age 18 years or older and taking 1 or more long-term medications. Qualitative interviews with 45 staff members were conducted. Intervention: A single 60-minute training session for clinicians and staff from each practice on COM importance, team-based screening, and cost-saving strategies. Measurements: Patient data (demographics, number of long-term medications, total monthly out-of-pocket medication costs, and history of cost-related medication nonadherence) were obtained immediately before and 3 months after the intervention. Practice staff were interviewed 3 months after the intervention. Results: A total of 700 patient surveys were completed. Frequency of COM discussion improved in 6 of the 7 practices and remained unchanged in 1 practice. Overall, COM conversations with patients increased from 17% at baseline to 32% postintervention (P = 0.00). There was substantial heterogeneity among sites in before-after differences in patient-reported out-of-pocket COM. Qualitative analyses from key informant interviews showed wide variation in implementation of screening approaches, workflow, adoption of a team-based approach, and strategies for addressing COM. Limitation: It is not known whether improvements in COM conversations were sustained beyond 3 months. Conclusion: A single team training to screen and address patients' medication cost concerns improved COM discussions over the short term. Further research is needed to assess sustained effects and impact on patient costs and medication adherence and to determine whether more intensive, scalable interventions are needed. Primary Funding Source: Robert Wood Johnson Foundation.

"Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV.

BACKGROUND: Little is known about strategies to improve patient activation, particularly among persons living with HIV (PLWH). OBJECTIVE: To assess the impact of a group intervention and individual coaching on patient activation for PLWH. DESIGN: Pragmatic randomized controlled trial. SITES: Eight practices in New York and two in New Jersey serving PLWH. PARTICIPANTS: Three hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy. INTERVENTION: Six 90-min group training sessions covering use of an ePersonal Health Record loaded onto a handheld mobile device and a single 20-30 min individual pre-visit coaching session. MAIN MEASURES: The primary outcome was change in Patient Activation Measure (PAM). Secondary outcomes were changes in eHealth literacy (eHEALS), Decision Self-efficacy (DSES), Perceived Involvement in Care Scale (PICS), health (SF-12), receipt of HIV-related care, and change in HIV viral load (VL). KEY RESULTS: The intervention group showed significantly greater improvement than the control group in the primary outcome, the PAM (difference 2.82: 95% confidence interval [CI] 0.32-5.32). Effects were largest among participants with lowest quartile PAM at baseline (p < 0.05). The intervention doubled the odds of improving one level on the PAM (odds ratio 1.96; 95% CI 1.16-3.31). The intervention group also had significantly greater improvement in eHEALS (difference 2.67: 95% CI 1.38-3.9) and PICS (1.27: 95% CI 0.41-2.13) than the control group. Intervention effects were similar by race/ethnicity and low education with the exception of eHealth literacy where effects were stronger for minority participants. No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load. CONCLUSIONS: The patient activation intervention modestly improved several domains related to patient empowerment; effects on patient activation were largest among those with the lowest levels of baseline patient activation. TRIAL REGISTRATION: This study is registered at Clinical Trials.Gov (NCT02165735).

Who Uses Mobile Phone Health Apps and Does Use Matter? A Secondary Data Analytics Approach.

BACKGROUND: Mobile phone use and the adoption of healthy lifestyle software apps ("health apps") are rapidly proliferating. There is limited information on the users of health apps in terms of their social demographic and health characteristics, intentions to change, and actual health behaviors. OBJECTIVE: The objectives of our study were to (1) to describe the sociodemographic characteristics associated with health app use in a recent US nationally representative sample; (2) to assess the attitudinal and behavioral predictors of the use of health apps for health promotion; and (3) to examine the association between the use of health-related apps and meeting the recommended guidelines for fruit and vegetable intake and physical activity. METHODS: Data on users of mobile devices and health apps were analyzed from the National Cancer Institute's 2015 Health Information National Trends Survey (HINTS), which was designed to provide nationally representative estimates for health information in the United States and is publicly available on the Internet. We used multivariable logistic regression models to assess sociodemographic predictors of mobile device and health app use and examine the associations between app use, intentions to change behavior, and actual behavioral change for fruit and vegetable consumption, physical activity, and weight loss. RESULTS: From the 3677 total HINTS respondents, older individuals (45-64 years, odds ratio, OR 0.56, 95% CI 0.47-68; 65+ years, OR 0.19, 95% CI 0.14-0.24), males (OR 0.80, 95% CI 0.66-0.94), and having degree (OR 2.83, 95% CI 2.18-3.70) or less than high school education (OR 0.43, 95% CI 0.24-0.72) were all significantly associated with a reduced likelihood of having adopted health apps. Similarly, both age and education were significant variables for predicting whether a person had adopted a mobile device, especially if that person was a college graduate (OR 3.30). Individuals with apps were significantly more likely to report intentions to improve fruit (63.8% with apps vs 58.5% without apps, P=.01) and vegetable (74.9% vs 64.3%, P<.01) consumption, physical activity (83.0% vs 65.4%, P<.01), and weight loss (83.4% vs 71.8%, P<.01). Individuals with apps were also more likely to meet recommendations for physical activity compared with those without a device or health apps (56.2% with apps vs 47.8% without apps, P<.01). CONCLUSIONS: The main users of health apps were individuals who were younger, had more education, reported excellent health, and had a higher income. Although differences persist for gender, age, and educational attainment, many individual sociodemographic factors are becoming less potent in influencing engagement with mobile devices and health app use. App use was associated with intentions to change diet and physical activity and meeting physical activity recommendations.

Effectiveness of a clinician intervention to improve physical activity discussions in underserved adults.

BACKGROUND: Physical activity (PA) counselling is challenging in primary care. It is unknown whether clinician training on the 5As (Ask, Advise, Agree, Assist, Arrange) improves PA counselling skills. OBJECTIVE: To evaluate the effect of a clinician training intervention on PA counselling for underserved adults using the 5As framework. METHODS: Pragmatic pilot clinical trial was used in the study. Clinicians (n = 13) were randomly assigned to two groups. Each group received the intervention consisting of four 1-hour training sessions to teach the 5As for PA counselling. Patient-clinician visits (n = 325) were audio recorded at baseline, immediately post-intervention, and at 6 months. Outcomes were the frequency and quality of PA discussions using the 5As, assessed by blinded coders. RESULTS: Patients' mean age was 44 years; 75% were African American. PA was discussed in 37% (n = 119) of visits overall and did not change from baseline to follow-up. When PA discussions occurred, the frequency of 5As increased from baseline to follow-up for Advise (51-54%), Agree (11-26%), and Assist (11-17%); however, none of the 5As had a statistically significant increase. For Agree, exploration of patient willingness to engage in PA increased from 23% at baseline to 50% at follow-up. CONCLUSION: A clinician-directed intervention to improve PA counselling increased the frequency of Advise, Agree and Assist, and the quality of Ask and Agree statements, though the absolute numbers were small and only Agree reached statistical significance. Future research is needed to understand the factors that affect the optimal uptake and approach to 5As counselling.

Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system.

BACKGROUND: Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. DISCUSSION: Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.

Bone health issues in breast cancer survivors: a Medicare Current Beneficiary Survey (MCBS) study.

PURPOSE: Breast cancer treatments (chemotherapy and hormone therapy) can cause a rapid loss in bone mineral density, leading to osteoporosis and fractures later in life. Fortunately, preventative measures (vitamin D, exercise, etc.) can delay bone loss if employed early enough. This study compares the prevalence of osteoporosis and osteoporosis-related discussions with physicians among female breast cancer survivors and females with no cancer history to determine if breast cancer patients are being correctly advised on their high risk of bone loss. METHODS: The 2003 Medicare Current Beneficiary Survey, a nationally representative sample of 550 women with a breast cancer history and 6,673 women with no cancer history aged ≥65, was used. The first set of dependent variables collected information on bone health (osteoporosis, falls, and fractures). The second set of dependent variables collected information on bone health discussions with their physician. Multivariate logistic regression models were used to evaluate whether breast cancer was independently associated with bone health issues. RESULTS: After adjustment for confounders, a breast cancer diagnosis was found to be associated with a higher prevalence of an osteoporosis diagnosis over their lifetime (adjusted odds ratio (OR(adj)) = 1.32, 95 % confidence interval (95 % CI) = 1.08-1.61) and falls in the previous year (OR(adj) = 1.23, 95 % CI = 1.01-1.51) compared to respondents without a cancer diagnosis. However, breast cancer respondents were not more likely than respondents without a cancer diagnosis to discuss osteoporosis with their physician (OR(adj) = 1.20, 95 % CI = 0.96-1.50) or be told they are at high risk for osteoporosis (OR(adj) = 1.41, 95 % CI = 0.95-2.10). CONCLUSIONS: A breast cancer diagnosis was associated with an increased prevalence of osteoporosis and falls. Nevertheless, breast cancer respondents were not more likely to discuss osteoporosis with their physician nor were they more likely to be considered high risk for osteoporosis. Increased dialogue between physician and breast cancer patient pertaining to bone loss is needed.