Comparison of 3 optimized delivery strategies for completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV in Uganda: A single-center randomized trial.

BACKGROUND: Expanding access to shorter regimens for tuberculosis (TB) prevention, such as once-weekly isoniazid and rifapentine taken for 3 months (3HP), is critical for reducing global TB burden among people living with HIV (PLHIV). Our coprimary hypotheses were that high levels of acceptance and completion of 3HP could be achieved with delivery strategies optimized to overcome well-contextualized barriers and that 3HP acceptance and completion would be highest when PLHIV were provided an informed choice between delivery strategies. METHODS AND FINDINGS: In a pragmatic, single-center, 3-arm, parallel-group randomized trial, PLHIV receiving care at a large urban HIV clinic in Kampala, Uganda, were randomly assigned (1:1:1) to receive 3HP by facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between facilitated DOT and facilitated SAT using a shared decision-making aid. We assessed the primary outcome of acceptance and completion (≥11 of 12 doses of 3HP) within 16 weeks of treatment initiation using proportions with exact binomial confidence intervals (CIs). We compared proportions between arms using Fisher's exact test (two-sided α = 0.025). Trial investigators were blinded to primary and secondary outcomes by study arm. Between July 13, 2020, and July 8, 2022, 1,656 PLHIV underwent randomization, with equal numbers allocated to each study arm. One participant was erroneously enrolled a second time and was excluded in the primary intention-to-treat analysis. Among the remaining 1,655 participants, the proportion who accepted and completed 3HP exceeded the prespecified 80% target in the DOT (0.94; 97.5% CI [0.91, 0.96] p < 0.001), SAT (0.92; 97.5% CI [0.89, 0.94] p < 0.001), and Choice (0.93; 97.5% CI [0.91, 0.96] p < 0.001) arms. There was no difference in acceptance and completion between any 2 arms overall or in prespecified subgroup analyses based on sex, age, time on antiretroviral therapy, and history of prior treatment for TB or TB infection. Only 14 (0.8%) participants experienced an adverse event prompting discontinuation of 3HP. The main limitation of the study is that it was conducted in a single center. Multicenter studies are now needed to confirm the feasibility and generalizability of the facilitated 3HP delivery strategies in other settings. CONCLUSIONS: Short-course TB preventive treatment was widely accepted by PLHIV in Uganda, and very high levels of treatment completion were achieved in a programmatic setting with delivery strategies tailored to address known barriers. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934931.

Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis.

BACKGROUND: Effective strategies are needed to facilitate the prompt diagnosis and treatment of tuberculosis in countries with a high burden of the disease. METHODS: We conducted a cluster-randomized trial in which Ugandan community health centers were assigned to a multicomponent diagnostic strategy (on-site molecular testing for tuberculosis, guided restructuring of clinic workflows, and monthly feedback of quality metrics) or routine care (on-site sputum-smear microscopy and referral-based molecular testing). The primary outcome was the number of adults treated for confirmed tuberculosis within 14 days after presenting to the health center for evaluation during the 16-month intervention period. Secondary outcomes included completion of tuberculosis testing, same-day diagnosis, and same-day treatment. Outcomes were also assessed on the basis of proportions. RESULTS: A total of 20 health centers underwent randomization, with 10 assigned to each group. Of 10,644 eligible adults (median age, 40 years) whose data were evaluated, 60.1% were women and 43.8% had human immunodeficiency virus infection. The intervention strategy led to a greater number of patients being treated for confirmed tuberculosis within 14 days after presentation (342 patients across 10 intervention health centers vs. 220 across 10 control health centers; adjusted rate ratio, 1.56; 95% confidence interval [CI], 1.21 to 2.01). More patients at intervention centers than at control centers completed tuberculosis testing (adjusted rate ratio, 1.85; 95% CI, 1.21 to 2.82), received a same-day diagnosis (adjusted rate ratio, 1.89; 95% CI, 1.39 to 2.56), and received same-day treatment for confirmed tuberculosis (adjusted rate ratio, 2.38; 95% CI, 1.57 to 3.61). Among 706 patients with confirmed tuberculosis, a higher proportion in the intervention group than in the control group were treated on the same day (adjusted rate ratio, 2.29; 95% CI, 1.23 to 4.25) or within 14 days after presentation (adjusted rate ratio, 1.22; 95% CI, 1.06 to 1.40). CONCLUSIONS: A multicomponent diagnostic strategy that included on-site molecular testing plus implementation supports to address barriers to delivery of high-quality tuberculosis evaluation services led to greater numbers of patients being tested, receiving a diagnosis, and being treated for confirmed tuberculosis. (Funded by the National Heart, Lung, and Blood Institute; XPEL-TB ClinicalTrials.gov number, NCT03044158.).

Language-Concordant Care: a Qualitative Study Examining Implementation of Physician Non-English Language Proficiency Assessment.

BACKGROUND: Language concordance can increase access to care for patients with language barriers and improve patient health outcomes. However, systematically assessing and tracking physician non-English language skills remains uncommon in most health systems. This is a missed opportunity for health systems to maximize language-concordant care. OBJECTIVE: To determine barriers and facilitators to participation in non-English language proficiency assessment among primary care physicians. DESIGN: Qualitative, semi-structured interviews. PARTICIPANTS: Eleven fully and partially bilingual primary care physicians from a large academic health system with a language certification program (using a clinician oral proficiency interview). APPROACH: Interviews aimed to identify barriers and facilitators to participation in non-English language assessment. Two researchers independently and iteratively coded transcripts using a thematic analysis approach with constant comparison to identify themes. KEY RESULTS: Most participants were women (N= 9; 82%). Participants reported proficiency in Cantonese, Mandarin, Russian, and Spanish. All fully bilingual participants (n=5) had passed the language assessment; of the partially bilingual participants (n=6), four did not test, one passed with marginal proficiency, and one did not pass. Three themes emerged as barriers to assessment participation: (1) beliefs about the negative consequences (emotional and material) of not passing the test, (2) time constraints and competing demands, and (3) challenging test format and structure. Four themes emerged as facilitators to increase assessment adoption: (1) messaging consistent with professional ethos, (2) organizational culture that incentivizes certification, (3) personal empowerment about language proficiency, and (4) individuals championing certification. CONCLUSIONS: To increase language assessment participation and thus ensure quality language-concordant care, health systems must address the identified barriers physicians experience and leverage potential facilitators. Findings can inform health system interventions to standardize the requirements and process, increase transparency, provide resources for preparation and remediation, utilize messaging focused on patient care quality and safety, and incentivize participation.

Applying the COM-B behaviour change model to a pilot study delivering volatile pyrethroid spatial repellents and insecticide-treated clothing to forest-exposed populations in Mondulkiri Province, Cambodia.

BACKGROUND: Southeast Asia is making tremendous progress towards their 2030 malaria elimination goal but needs new interventions to stop forest malaria. This study trials two new vector control tools, a volatile pyrethroid spatial repellent (VPSR) and insecticide-treated clothing (ITC), amongst forest-exposed populations in Mondulkiri Province Cambodia to inform their potential use for eliminating forest malaria. METHODS: 21 forest-exposed individuals were given a questionnaire on their perceptions of malaria and preventive practices used, after which they trialed two products sequentially. Clothes was treated with ITC by the study team. Mixed methods were used to understand their experience, attitudes, and preferences regarding the products trialed. Quantitative data was summarized and qualitative insights were analysed using thematic analysis, applying the Capability, Opportunity, and Motivation Behaviour Change (COM-B) model and Behaviour Change Wheel Framework to identify intervention functions to support tailored product rollout amongst these populations. RESULTS: Study participants reported a need for protection from mosquito bites in outdoor and forest-exposed settings and perceived both products trialed to be effective for this purpose. The VPSR product was preferred when travel was not required, whereas ITC was preferred for ease of use when going to the forest, especially in rainy conditions. COM-B analysis identified that key enablers for use of both products included their perceived efficacy and ease of use, which required no skill or preparation. For barriers to use, the odour of ITC was sometimes perceived as being toxic, as well as its inability to protect uncovered skin from mosquito bites, while the perceived usefulness of the VPSR product trialed was limited by its water sensitivity in rainy forest settings. Intervention components to encourage appropriate and sustained use of these products include education about how to use these products and what to expect, persuasion to use them from community leaders and targeted channels, and enablement to facilitate convenient and affordable access. CONCLUSION: The rollout of VPSRs and ITC amongst forest-exposed populations can be useful for eliminating malaria in Southeast Asia. Study findings can be applied to increase product uptake among forest exposed populations in Cambodia, while manufacturers can aim to develop products that are rainproof, easy to use in forest settings, and have favourable odour profiles to target users.

Multi-Level Influences of Smoke-Free Policies in Subsidized Housing: Applying the COM-B Model and Neighborhood Assessments to Inform Smoke-Free Policies.

Smoke-free policies in multi-unit housing are associated with reduced exposure to secondhand smoke (SHS); however, attitudes toward comprehensive smoke-free policies among residents in subsidized multi-unit housing are unknown. In this mixed-methods study, we explored the socio-ecological context for tobacco and cannabis use and attitudes toward policies restricting indoor use of these products through interviews with residents (N = 134) and staff (N = 22) in 15 federally subsidized multi-unit housing in San Francisco, California. We conducted a geo-spatial and ethnographic environmental assessment by mapping alcohol, cannabis, and tobacco retail density using ArcGIS, and conducted systematic social observations of the neighborhood around each site for environmental cues to tobacco use. We used the Capability, Opportunity, and Motivation behavior (COM-B) model to identify factors that might influence implementation of smoke-free policies in multi-unit housing. Knowledge and attitudes toward tobacco and cannabis use, social norms around smoking, neighborhood violence, and cannabis legalization were some of the social-ecological factors that influenced tobacco use. There was spatial variation in the availability of alcohol, cannabis, and tobacco stores around sites, which may have influenced residents' ability to maintain smoke-free homes. Lack of skill on how to moderate indoor smoking (psychological capability), lack of safe neighborhoods (physical opportunity), and the stigma of smoking outdoors in multi-unit housing (motivation) were some of the barriers to adopting a smoke-free home. Interventions to increase adoption of smoke-free policies in multi-unit housing need to address the co-use of tobacco and cannabis and commercial and environmental determinants of tobacco use to facilitate smoke-free living.

Informal Caregiving Among Faculty at a Large Academic Health Sciences University in the United States: an Opportunity for Policy Changes.

OBJECTIVE: This article aims to determine the prevalence of caregiving among faculty at a large academic health sciences institution, to examine the effect of gender and other demographic and professional covariates on caregiving status, and to explore caregiver-generated policy recommendations. METHOD: A cross-sectional, mixed-methods survey was collected from June through August 2018. Participants were faculty within one of the institution's health professional schools (dentistry, medicine, nursing, or pharmacy) receiving at least 50% salary from the institution. In addition to demographic information, we collected academic series and rank, and assessed association between covariates on caregiving status using logistic regression. We analyzed open-ended responses using thematic analysis to identify themes in caregiver barriers and policy suggestions. RESULTS: Among 657 eligible respondents, 11.4% were informal caregivers. Women were more likely to be caregivers than men (aOR 2.53, 95% CI: 1.40, 4.78), as were older faculty. Caregivers identified unsupportive climate or unrealistic work expectations, concern about career advancement, insufficient information about policies, and concern about colleague burden as barriers to support. Suggestions for workplace support included improved leave policies, increased flexibility, caregiver resource support, improved clarity and dissemination of policy information, and financial support. CONCLUSIONS: Women faculty are more likely to be informal caregivers, exacerbating disparities within academic medicine for promotion and retention among women faculty. Institutions might include caregiving status in annual burnout surveys to guide the development of structural support and policies for extension of family leave beyond childbearing (or catastrophic leave), flexibility in work hours, and subsidized eldercare services.

Risks and Opportunities to Ensure Equity in the Application of Big Data Research in Public Health.

The big data revolution presents an exciting frontier to expand public health research, broadening the scope of research and increasing the precision of answers. Despite these advances, scientists must be vigilant against also advancing potential harms toward marginalized communities. In this review, we provide examples in which big data applications have (unintentionally) perpetuated discriminatory practices, while also highlighting opportunities for big data applications to advance equity in public health. Here, big data is framed in the context of the five Vs (volume, velocity, veracity, variety, and value), and we propose a sixth V, virtuosity, which incorporates equity and justice frameworks. Analytic approaches to improving equity are presented using social computational big data, fairness in machine learning algorithms, medical claims data, and data augmentation as illustrations. Throughout, we emphasize the biasing influence of data absenteeism and positionality and conclude with recommendations for incorporating an equity lens into big data research.

Promoting healthy eating in Latin American restaurants: a qualitative survey of views held by owners and staff.

BACKGROUND: Restaurants, particularly independently-owned ones that serve immigrant communities, are important community institutions in the promotion of dietary health. Yet, these restaurants remain under-researched, preventing meaningful collaborations with the public health sector for healthier community food environments. This research aimed to examine levels of acceptability of healthy eating promotion strategies (HEPS) in independently-owned Latin American restaurants (LARs) and identify resource needs for implementing HEPS in LARs. METHODS: We completed semi-structured, online discussions with LAR owners and staff (n = 20), predominantly from New York City (NYC), to examine current engagement, acceptability, potential barriers, and resource needs for the implementation of HEPS. Verbatim transcripts were analyzed independently by two coders using Dedoose, applying sentiment weighting to denote levels of acceptability for identified HEPS (1 = low, 2 = medium/neutral, 3 = high). Content analysis was used to examine factors associated with HEPS levels of acceptability and resource needs, including the influence of the Coronavirus pandemic (COVID-19). RESULTS: The most acceptable HEPS was menu highlights of healthier items (mean rating = 2.8), followed by promotion of healthier items (mean rating = 2.7), increasing healthy offerings (mean rating = 2.6), nutrition information on the menu (mean rating = 2.3), and reduced portions (mean rating = 1.7). Acceptability was associated with factors related to perceived demand, revenue, and logistical constraints. COVID-19 had a mixed influence on HEPS engagement and acceptability. Identified resource needs to engage in HEPS included nutrition knowledge, additional expertise (e.g., design, social media, culinary skills), and assistance with food suppliers and other restaurant operational logistics. Respondents also identified potential policy incentives. CONCLUSIONS: LARs can positively influence eating behaviors but doing so requires balancing public health goals and business profitability. LARs also faced various constraints that require different levels of assistance and resources, underscoring the need for innovative engagement approaches, including incentives, to promote these changes.

Scoping review of managed alcohol programs.

BACKGROUND: Internationally, strategies focusing on reducing alcohol-related harms in homeless populations with severe alcohol use disorder (AUD) continue to gain acceptance, especially when conventional modalities focused on alcohol abstinence have been unsuccessful. One such strategy is the managed alcohol program (MAP), an alcohol harm reduction program managing consumption by providing eligible individuals with regular doses of alcohol as a part of a structured program, and often providing resources such as housing and other social services. Evidence to the role of MAPs for individuals with AUD, including how MAPs are developed and implemented, is growing. Yet there has been limited collective review of literature findings. METHODS: We conducted a scoping review to answer, "What is being evaluated in studies of MAPs? What factors are associated with a successful MAP, from the perspective of client outcomes? What are the factors perceived as making them a good fit for clients and for communities?" We first conducted a systematic search in PubMed, Embase, PsycINFO, CINAHL, Sociological Abstracts, Social Services Abstracts, and Google Scholar. Next, we searched the gray literature (through focused Google and Ecosia searches) and references of included articles to identify additional studies. We also contacted experts to ensure relevant studies were not missed. All articles were independently screened and extracted. RESULTS: We included 32 studies with four categories of findings related to: (1) client outcomes resulting from MAP participation, (2) client experience within a MAP; (3) feasibility and fit considerations in MAP development within a community; and (4) recommendations for implementation and evaluation. There were 38 established MAPs found, of which 9 were featured in the literature. The majority were located in Canada; additional research works out of Australia, Poland, the USA, and the UK evaluate potential feasibility and fit of a MAP. CONCLUSIONS: The growing literature showcases several outcomes of interest, with increasing efforts aimed at systematic measures by which to determine the effectiveness and potential risks of MAP. Based on a harm reduction approach, MAPs offer a promising, targeted intervention for individuals with severe AUD and experiencing homelessness. Research designs that allow for longitudinal follow-up and evaluation of health- and housing-sensitive outcomes are recommended.

Completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV: Interim analysis of a hybrid type 3 effectiveness-implementation randomized trial.

BACKGROUND: Scaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid-rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization's (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa. METHODS AND FINDINGS: The 3HP Options Trial is a pragmatic, parallel type 3 effectiveness-implementation randomized trial comparing 3 optimized strategies for delivering 3HP-facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid-to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (≥11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes. CONCLUSIONS: 3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934931.

What matters when exploring fidelity when using health IT to reduce disparities?

BACKGROUND: Implementation of evidence-based interventions often involves strategies to engage diverse populations while also attempting to maintain external validity. When using health IT tools to deliver patient-centered health messages, systems-level requirements are often at odds with 'on-the ground' tailoring approaches for patient-centered care or ensuring equity among linguistically diverse populations. METHODS: We conducted a fidelity and acceptability-focused evaluation of the STAR MAMA Program, a 5-month bilingual (English and Spanish) intervention for reducing diabetes risk factors among 181 post-partum women with recent gestational diabetes. The study's purpose was to explore fidelity to pre-determined 'core' (e.g. systems integration) and 'modifiable' equity components (e.g. health coaching responsiveness, and variation by language) using an adapted implementation fidelity framework. Participant-level surveys, systems-level databases of message delivery, call completion, and coaching notes were included. RESULTS: 96.6% of participants are Latina and 80.9% were born outside the US. Among those receiving the STAR MAMA intervention; 55 received the calls in Spanish (61%) and 35 English (39%). 90% (n = 81) completed ≥ one week. Initially, systems errors were common, and increased triggers for health coach call-backs. Although Spanish speakers had more triggers over the intervention period, the difference was not statistically significant. Of the calls triggering a health coach follow-up, attempts were made for 85.4% (n = 152) of the English call triggers and for 80.0% (n = 279) of the Spanish call triggers (NS). Of attempted calls, health coaching calls were complete for 55.6% (n = 85) of English-language call triggers and for 56.6% of Spanish-language call triggers (NS). Some differences in acceptability were noted by language, with Spanish-speakers reporting higher satisfaction with prevention content (p = < 0.01) and English-speakers reporting health coaches were less considerate of their time (p = 0.03). CONCLUSIONS: By exploring fidelity by language-specific factors, we identified important differences in some but not all equity indicators, with early systems errors quicky remedied and high overall engagement and acceptability. Practice implications include: (1) establishing criteria for languge-equity in interventions, (2) planning for systems level errors so as to reduce their impact between language groups and over time; and (3) examining the impact of engagement with language-concordant interventions on outcomes, including acceptability. Trial Registration National Clinical Trials registration number: CT02240420 Registered September 15, 2014. ClinicalTrials.gov.

The "Foresty Way": My Mother's Brave Choice of Medical Aid in Dying.

I miss my mom, who died last year, and I want to tell the happy story of her death, or perhaps the story of her happy death through her choosing and accomplishing medical aid in dying. My mom was 85 when she died, had atypical presentation of lymphoma which took time to diagnose, and went through 3 painful months of surgery, radiation, and a single horrific round of chemotherapy. She suffered a lot. When she was in the hospital recovering from chemo, I witnessed 3 amazing doctors being true to core values of their profession. But the most profound aspect and gift of the events surrounding her death was the way in which making an informed choice gave my mom back her presence-allowing her both peace and power in the end of her life.

Selecting and Improving Quasi-Experimental Designs in Effectiveness and Implementation Research.

Interventional researchers face many design challenges when assessing intervention implementation in real-world settings. Intervention implementation requires holding fast on internal validity needs while incorporating external validity considerations (such as uptake by diverse subpopulations, acceptability, cost, and sustainability). Quasi-experimental designs (QEDs) are increasingly employed to achieve a balance between internal and external validity. Although these designs are often referred to and summarized in terms of logistical benefits, there is still uncertainty about (a) selecting from among various QEDs and (b) developing strategies to strengthen the internal and external validity of QEDs. We focus here on commonly used QEDs (prepost designs with nonequivalent control groups, interrupted time series, and stepped-wedge designs) and discuss several variants that maximize internal and external validity at the design, execution and implementation, and analysis stages.

Impact of a Primary Care CKD Registry in a US Public Safety-Net Health Care Delivery System: A Pragmatic Randomized Trial.

BACKGROUND: Many individuals with chronic kidney disease (CKD) do not receive guideline-concordant care. We examined the impact of a team-based primary care CKD registry on clinical measures and processes of care among patients with CKD cared for in a public safety-net health care delivery system. STUDY DESIGN: Pragmatic trial of a CKD registry versus a usual-care registry for 1 year. SETTING & PARTICIPANTS: Primary care providers (PCPs) and their patients with CKD in a safety-net primary care setting in San Francisco. INTERVENTION: The CKD registry identified at point of care all patients with CKD, those with blood pressure (BP)>140/90mmHg, those without angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) prescription, and those without albuminuria quantification in the past year. It also provided quarterly feedback pertinent to these metrics to promote "outreach" to patients with CKD. The usual-care registry provided point-of-care cancer screening and immunization data. OUTCOMES: Changes in systolic BP at 12 months (primary outcome), proportion of patients with BP control, prescription of ACE inhibitors/ARBs, quantification of albuminuria, severity of albuminuria, and estimated glomerular filtration rate. RESULTS: The patient population (n=746) had a mean age of 56.7±12.1 (standard deviation) years, was 53% women, and was diverse (8% non-Hispanic white, 35.7% black, 24.5% Hispanic, and 24.4% Asian). Randomization to the CKD registry (30 PCPs, 285 patients) versus the usual-care registry (49 PCPs, 461 patients) was associated with 2-fold greater odds of ACE inhibitor/ARB prescription (adjusted OR, 2.25; 95% CI, 1.45-3.49) and albuminuria quantification (adjusted OR, 2.44; 95% CI, 1.38-4.29) during the 1-year study period. Randomization to the CKD registry was not associated with changes in systolic BP, proportion of patients with uncontrolled BP, or degree of albuminuria or estimated glomerular filtration rate. LIMITATIONS: Potential misclassification of CKD; missing baseline medication data; limited to study of a public safety-net health care system. CONCLUSIONS: A team-based safety-net primary care CKD registry did not improve BP parameters, but led to greater albuminuria quantification and more ACE inhibitor/ARB prescriptions after 1 year. Adoption of team-based CKD registries may represent an important step in translating evidence into practice for CKD management.

Designing a behavioral intervention using the COM-B model and the theoretical domains framework to promote gas stove use in rural Guatemala: a formative research study.

BACKGROUND: Three billion people use solid cooking fuels, and 4 million people die from household air pollution annually. Shifting households to clean fuels, like liquefied petroleum gas (LPG), may protect health only if stoves are consistently used. Few studies have used an implementation science framework to systematically assess "de-implementation" of traditional stoves, and none have done so with pregnant women who are more likely to adopt new behaviors. We evaluated an introduced LPG stove coupled with a phased behavioral intervention to encourage exclusive gas stove use among pregnant women in rural Guatemala. METHODS: We enrolled 50 women at < 20 weeks gestation in this prospective cohort study. All women received a free 3-burner LPG stove and ten tank refills. We conducted formative research using COM-B Model and Theoretical Domains Framework (TDF). This included thematic analysis of focus group findings and classes delivered to 25 pregnant women (Phase 1). In Phase 2, we complemented classes with a home-based tailored behavioral intervention with a different group of 25 pregnant women. We mapped 35 TDF constructs onto survey questions. To evaluate stove use, we placed temperature sensors on wood and gas stoves and estimated fraction of stove use three times during pregnancy and twice during the first month after infant birth. RESULTS: Class attendance rates were above 92%. We discussed feasible ways to reduce HAP exposure, proper stove use, maintenance and safety. We addressed food preferences, ease of cooking and time savings through cooking demonstrations. In Phase 2, the COM-B framework revealed that other household members needed to be involved if the gas stove was to be consistently used. Social identity and empowerment were key in decisions about stove repairs and LPG tank refills. The seven intervention functions included training, education, persuasion, incentivization, modelling, enablement and environmental restructuring. Wood stove use dropped upon introduction of the gas stove from 6.4 h to 1.9 h. CONCLUSIONS: This is the first study using the COM-B Model to develop a behavioral intervention that promotes household-level sustained use of LPG stoves. This study lays the groundwork for a future LPG stove intervention trial coupled with a behavioral change intervention. TRIAL REGISTRATION: NCT02812914, registered 3 June 2016, retrospectively registered.

Language-concordant automated telephone queries to assess medication adherence in a diverse population: a cross-sectional analysis of convergent validity with pharmacy claims.

BACKGROUND: Clinicians have difficulty accurately assessing medication non-adherence within chronic disease care settings. Health information technology (HIT) could offer novel tools to assess medication adherence in diverse populations outside of usual health care settings. In a multilingual urban safety net population, we examined the validity of assessing adherence using automated telephone self-management (ATSM) queries, when compared with non-adherence using continuous medication gap (CMG) on pharmacy claims. We hypothesized that patients reporting greater days of missed pills to ATSM queries would have higher rates of non-adherence as measured by CMG, and that ATSM adherence assessments would perform as well as structured interview assessments. METHODS: As part of an ATSM-facilitated diabetes self-management program, low-income health plan members typed numeric responses to rotating weekly ATSM queries: "In the last 7 days, how many days did you MISS taking your …" diabetes, blood pressure, or cholesterol pill. Research assistants asked similar questions in computer-assisted structured telephone interviews. We measured continuous medication gap (CMG) by claims over 12 preceding months. To evaluate convergent validity, we compared rates of optimal adherence (CMG ≤ 20%) across respondents reporting 0, 1, and ≥ 2 missed pill days on ATSM and on structured interview. RESULTS: Among 210 participants, 46% had limited health literacy, 57% spoke Cantonese, and 19% Spanish. ATSM respondents reported ≥1 missed day for diabetes (33%), blood pressure (19%), and cholesterol (36%) pills. Interview respondents reported ≥1 missed day for diabetes (28%), blood pressure (21%), and cholesterol (26%) pills. Optimal adherence rates by CMG were lower among ATSM respondents reporting more missed days for blood pressure (p = 0.02) and cholesterol (p < 0.01); by interview, differences were significant for cholesterol (p = 0.01). CONCLUSIONS: Language-concordant ATSM demonstrated modest potential for assessing adherence. Studies should evaluate HIT assessments of medication beliefs and concerns in diverse populations. TRIAL REGISTRATION: NCT00683020 , registered May 21, 2008.

Clinician Perspectives on the Management of Abnormal Subcritical Tests in an Urban Academic Safety-Net Health Care System.

BACKGROUND: Missed or delayed follow-up of abnormal subcritical tests (tests that do not require immediate medical attention) can lead to poor patient outcomes. Safety-net health systems with limited resources and socially complex patients are vulnerable to safety gaps resulting from delayed management. Clinician perspectives to identify system challenges, vulnerable situations, and potential solutions were sought in focus groups. METHODS: Five semistructured focus groups were conducted in 2015 with purposefully sampled clinicians from radiology, hospital medicine, emergency medicine, risk management, and ambulatory care from an urban, academic, integrated, safety-net health system. Thematic analysis identified challenges of current management of abnormal subcritical tests, vulnerable situations, and solution characteristics. A total of 43 clinicians participated. RESULTS: Clinicians cited challenges in assigning responsibility for follow-up and identified tests pending at discharge and tests requiring delayed follow-up as vulnerable situations. The lack of tracking systems and missing contact information for patients and providers exacerbated these challenges. Proposed solution characteristics involved protocols to aid in assigning responsibility, reliable paths of communication, and systems to track the status of tests. Clinicians noted a strong desire for integration of the work flow and technology solutions into existing structures. CONCLUSION: In an urban safety-net setting, clinicians recommended outlining clear chains of responsibility and communication in the management of subcritical test results, and employing simple, integrated technological solutions that allow for tracking and management of tests. Existing test management solutions should be adapted to work within safety-net systems, which often have fewer resources and more complex patients and may function in the absence of integrated technology systems.

Qualitative analysis of programmatic initiatives to text patients with mobile devices in resource-limited health systems.

BACKGROUND: Text messaging is an affordable, ubiquitous, and expanding mobile communication technology. However, safety net health systems in the United States that provide more care to uninsured and low-income patients may face additional financial and infrastructural challenges in utilizing this technology. Formative evaluations of texting implementation experiences are limited. We interviewed safety net health systems piloting texting initiatives to study facilitators and barriers to real-world implementation. METHODS: We conducted telephone interviews with various stakeholders who volunteered from each of the eight California-based safety net systems that received external funding to pilot a texting-based program of their choosing to serve a primary care need. We developed a semi-structured interview guide based partly on the Consolidated Framework for Implementation Research (CFIR), which encompasses several domains: the intervention, individuals involved, contextual factors, and implementation process. We inductively and deductively (using CFIR) coded transcripts, and categorized themes into facilitators and barriers. RESULTS: We performed eight interviews (one interview per pilot site). Five sites had no prior texting experience. Sites applied texting for programs related to medication adherence and monitoring, appointment reminders, care coordination, and health education and promotion. No site texted patient-identifying health information, and most sites manually obtained informed consent from each participating patient. Facilitators of implementation included perceived enthusiasm from patients, staff and management belief that texting is patient-centered, and the early identification of potential barriers through peer collaboration among grantees. Navigating government regulations that protect patient privacy and guide the handling of protected health information emerged as a crucial barrier. A related technical challenge in five sites was the labor-intensive tracking and documenting of texting communications due to an inability to integrate texting platforms with electronic health records. CONCLUSIONS: Despite enthusiasm for the texting programs from the involved individuals and organizations, inadequate data management capabilities and unclear privacy and security regulations for mobile health technology slowed the initial implementation and limited the clinical use of texting in the safety net and scope of pilots. Future implementation work and research should investigate how different texting platform and intervention designs affect efficacy, as well as explore issues that may affect sustainability and the scalability.

The Action Research Program: Experiential Learning in Systems-Based Practice for First-Year Medical Students.

PROBLEM: Systems-based practice focuses on the organization, financing, and delivery of medical services. The American Association of Medical Colleges has recommended that systems-based practice be incorporated into medical schools' curricula. However, experiential learning in systems-based practice, including practical strategies to improve the quality and efficiency of clinical care, is often absent from or inconsistently included in medical education. INTERVENTION: A multidisciplinary clinician and nonclinician faculty team partnered with a cardiology outpatient clinic to design a 9-month clerkship for 1st-year medical students focused on systems-based practice, delivery of clinical care, and strategies to improve the quality and efficiency of clinical operations. The clerkship was called the Action Research Program. In 2013-2014, 8 trainees participated in educational seminars, research activities, and 9-week clinic rotations. A qualitative process and outcome evaluation drew on interviews with students, clinic staff, and supervising physicians, as well as students' detailed field notes. CONTEXT: The Action Research Program was developed and implemented at the University of California, San Francisco, an academic medical center in the United States. All educational activities took place at the university's medical school and at the medical center's cardiology outpatient clinic. OUTCOME: Students reported and demonstrated increased understanding of how care delivery systems work, improved clinical skills, growing confidence in interactions with patients, and appreciation for patients' experiences. Clinicians reported increased efficiency at the clinic level and improved performance and job satisfaction among medical assistants as a result of their unprecedented mentoring role with students. Some clinicians felt burdened when students shadowed them and asked questions during interactions with patients. Most student-led improvement projects were not fully implemented. LESSONS LEARNED: The Action Research Program is a small pilot project that demonstrates an innovative pairing of experiential and didactic training in systems-based practice. Lessons learned include the need for dedicated time and faculty support for students' improvement projects, which were the least successful aspect of the program. We recommend that future projects aiming to combine clinical training and quality improvement projects designate distinct blocks of time for trainees to pursue each of these activities independently. In 2014-2015, the University of California, San Francisco School of Medicine incorporated key features of the Action Research Program into the standard curriculum, with plans to build upon this foundation in future curricular innovations.

Strategies for implementing implementation science: a methodological overview.

A key reason for the consistent gaps between evidence and practice across all areas of medicine is that there has been little attempt to identify or target factors critical for successful implementation of an evidence-based intervention. There is either no explicit implementation strategy or the strategy is based on a best guess rather than on a systematic assessment of crucial barriers and enablers. A different approach is needed to close the evidence-practice gap and thereby achieve the triple aim of improved health, improved patient experience and reduced healthcare costs. We present three fundamental principles of implementation science, which is a methodology that offers a systematic and comprehensive approach to improving healthcare practice and a series of 'how to' steps to conduct implementation science research. In an accompanying article, a scoping review of the types of implementation science research conducted in emergency medicine is reviewed, and several of the principles related to this review are discussed.