Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol.

BACKGROUND: As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411-93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1-3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside 'one-stop-shop' approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic's current practice of usual care, which includes comprehensive patient navigation. METHODS: A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the "simplified care" pathway (intervention group) or the "usual care" pathway (control group). Block randomization will be performed with a 1:1 randomization. DISCUSSION: Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. TRIAL REGISTRATION: We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial.

BACKGROUND: The clinical burden of Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI) is increasing. There is a critical need to advance understanding of the effectiveness and sustainability of innovative approaches to clinical care of patients having these conditions. METHODS: We aim to assess the effectiveness of a Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) in a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial in which 20 consenting clinicians across primary care clinics in a Federally Qualified Health Center system in San Diego, CA, will be randomized at a ratio of 1:1 to either participate in (1) weekly multi-disciplinary team-based case consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO (Extension for Community Healthcare Outcomes)) with monthly interactive webinars and quarterly short courses or (2) monthly interactive webinars and quarterly short courses alone (a control group); 856 patients will be assigned to participating clinicians (42 patients per clinician). Patient outcomes will be evaluated according to the study arm of their respective clinicians. Quantitative and qualitative outcomes will be measured at 3- and 6-months post-baseline for clinicians and every 3-months post assignment to a participating clinician for patients. The primary patient outcome is change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Analyses of differences in outcomes at both the patient and clinician levels will include a linear mixed model to compare change in outcomes from baseline to each post-baseline assessment between the randomized study arms. A concurrent prospective cohort study will compare the LC&FIRP patient population to the population enrolled in a university health system. Longitudinal data analysis approaches will allow us to examine differences in outcomes between cohorts. DISCUSSION: We hypothesize that weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to the control group. This study will provide much needed evidence on the effectiveness of a technology-enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a federally qualified health center. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05167227 . Registered on December 22, 2021.

COVID-19 monoclonal antibody treatment impact on symptoms and post-COVID conditions among high-risk patients at a Federally Qualified Health Center.

BACKGROUND: Monoclonal antibody (mAb) treatment for COVID-19 is associated with improved clinical outcomes. However, there is limited information regarding the impact of treatment on symptoms and the prevalence of post-COVID Conditions (PCC). Understanding of the association between time to mAb infusion and the development of PCC is also limited. METHODS: This longitudinal study was conducted among patients with COVID-19 who received mAb infusions at a Federally Qualified Health Center in San Diego, CA. A series of telephone interviews were conducted at baseline and follow-up (14 days and 28+ days). A comprehensive symptom inventory was completed and physical and mental health status were measured using PROMIS-29 and PHQ-2. Pearson's Chi-squared tests and independent two-sample t-tests were performed to test for association between time to mAb infusion and outcomes at follow-up. A Poisson regression model was used to analyze whether time to mAb infusion predicts risk of developing PCC. RESULTS: Participants (N = 411) were 53% female, ranged in age from 16 to 92 years (mean 50), and a majority (56%) were Latino/Hispanic. Cross-sectional findings revealed a high symptom burden at baseline (70% of patients had cough, 50% had fever, and 44% had headache). The prevalence of many symptoms decreased substantially by the final follow-up survey (29% of patients had cough, 3% had fever, and 28% had headache). Longitudinal findings indicated that 10 symptoms decreased in prevalence from baseline to final follow-up, 2 remained the same, and 14 increased. The severity of symptoms and most patient-reported physical and mental health measure scores decreased over time. The prevalence of PCC was 69% when PCC was defined as ≥ 1 symptom at final follow-up. Time to mAb infusion was not significantly associated with any outcome at follow-up. Time to infusion was not associated with PCC status at final follow-up in the crude or adjusted Poisson regression models. CONCLUSIONS: The prevalence of PCC was high among this patient population following COVID-19 mAb treatment. Time to mAb infusion did not predict the development of PCC. Further research in these areas is essential to answer urgent clinical questions about effective treatments of COVID-19.

Understanding health disparities affecting utilization of tobacco treatment in low-income patients in an urban health center in Southern California.

Tobacco use disproportionately affects low-income communities. Prevalence among patients in Federally Qualified Health Centers (FQHCs) is higher (29.3%) than the general population (20%). Little is known about the rates of referrals to cessation services and cessation pharmacotherapy practices in FQHCs. This study will examine referral and prescribing patterns based on patient characteristics at a large FQHC in Southern California. We conducted a retrospective analysis of EHR data from 2019. Patients who were ≥ 18 years old and had "tobacco use" as an active problem were included in analyses. We characterized the proportion of 1) those who were referred to California Smokers' Helpline (CSH), 2) referred to smoking cessation counseling (SCC) at the FQHC clinic, or 3) received pharmacotherapy. Associations of demographic characteristics and comorbidities with referral types and uptake of services were evaluated using mixed-effects multinomial and logistic regressions. Of the 20,119 tobacco users identified, 87% had some cessation intervention: 66% were advised to quit and given information to contact CSH, while 21% were referred to SCC. Patients were least likely to get referred to cessation services if they had more medical, psychiatric, or substance use comorbidities, were in the lowest income group, were uninsured or were Hispanic. Although EHR systems have enhanced the ease of screening, most patients do not receive more than brief advice to quit during a PCP visit. Most (70%) low-income smokers see their PCPs at least once a year, making FQHCs excellent settings to promote smoking cessation initiatives in low-income populations.

Response to the Coronavirus Disease 2019 Pandemic Among People Experiencing Homelessness in Congregant Living Settings in San Diego, California.

During April 2020-August 2020, a preemptive testing strategy combined with accessible isolation and symptom screening among people experiencing homelessness in congregant living settings in San Diego, California, contributed to a low incidence proportion of coronavirus disease 2019 (0.9%). Proactively addressing challenges specific to a vulnerable population may prove impactful.

Integrative tobacco cessation: A survey assessing past quit strategies and future interest.

PURPOSE: Tobacco cessation remains a public health priority. Unassisted quits are most common despite evidence for a combination of guideline-recommended strategies. This paper reports findings from a pilot study designed to assess past quit strategies and tobacco users' receptiveness to using an integrative clinic that offers both conventional and alternative treatments for future cessation attempts. METHODS: Participants were recruited from a pool of individuals reporting for jury duty. Paper-pencil surveys assessed smoking, past cessation behaviors, and interest in use of the integrative clinic which offers both conventional and alternative treatments. Current and former smokers (n=304) returned surveys. RESULTS: Using multivariate logistic regression, past physiological quit strategies, past behavioral quit strategies, and use of multiple quit strategies increased agreement with interest in future use of an integrative clinic option. Additionally, there is support for the notion that if such a clinic were offered, smokers may be inclined to use this resource for a future quit attempt. CONCLUSIONS: An integrative clinic option for tobacco cessation may encourage smokers to try to quit, especially for those who have used varied cessation strategies in the past. Motivating smokers to use a combined approach for tobacco cessation is a potential future direction for tobacco cessation treatment. Developing and testing an integrative approach may support this effort.

Adolescent Smoking Cessation With Bupropion: The Role of Adherence.

INTRODUCTION: While many medications can be effective aids to quitting tobacco, real world adherence to smoking cessation medications may render a potentially effective medication ineffective. The present study investigated the role of adherence on treatment outcomes in a bupropion dose-response study among adolescent smokers trying to quit smoking. METHODS: Three hundred twelve adolescent boys (n = 143) and girls (n = 169) between the ages of 14-17 were enrolled in the study, and were randomly assigned to use either 300 mg, 150 mg or placebo bupropion to quit smoking. Among the eligibility criterion, participants had to smoke at least six cigarettes per day, be motivated to quit smoking (self report), have an exhaled carbon monoxide level greater than or equal to 10 ppm, and report at least two previous quit attempts. Adherence to medication was determined by both self-report and actual counts of unused medication and empty medication packaging. Smoking status was determined by a combination of self-report and biochemical verification (breath carbon monoxide and urine cotinine). RESULTS: Cotinine-confirmed quit rates were significantly higher as a function of high adherence (20.69%) relative to low adherence (0.00%) in the 300-mg Bupropion Sustained Release group. Overall adherence in all study conditions in this highly controlled study was high (74%), but was significantly lower in non-white participants. CONCLUSIONS: Effectiveness of bupropion for adolescent smoking cessation is contingent on achieving high rates of medication adherence, but considerable variations in adherence impacted outcomes. IMPLICATIONS: Few studies have assessed the safety and efficacy of medications to help adolescent smokers quit, and we conducted one such study assessing bupropion. In this analysis of that original study, we assess the role of adherence in use of medication and quit rates. We found that adherence was related to outcomes, particularly in the 300-mg dose of bupropion.

Considerations for practice-based research: a cross-sectional survey of chiropractic, acupuncture and massage practices.

BACKGROUND: Complementary and alternative medicine (CAM) use has steadily increased globally over the past two decades and is increasingly playing a role in the healthcare system in the United States. CAM practice-based effectiveness research requires an understanding of the settings in which CAM practitioners provide services. This paper describes and quantifies practice environment characteristics for a cross-sectional sample of doctors of chiropractic (DCs), licensed acupuncturists (LAcs), and licensed massage therapists (LMTs) in the United States. METHODS: Using a cross-sectional telephone survey of DCs (n = 32), LAcs (n = 70), and LMTs (n = 184) in the Tucson, AZ metropolitan area, we collected data about each location where practitioners work, as well as measures on practitioner and practice characteristics including: patient volume, number of locations where practitioners worked, CAM practitioner types working at each location, and business models of practice. RESULTS: The majority of practitioners reported having one practice location (93.8% of DCs, 80% of LAcs and 59.8% of LMTs) where they treat patients. Patient volume/week was related to practitioner type; DCs saw 83.13 (SD = 49.29) patients/week, LAcs saw 22.29 (SD = 16.88) patients/week, and LMTs saw 14.21 (SD =10.25) patients per week. Practitioners completed surveys for N = 388 practice locations. Many CAM practices were found to be multidisciplinary and/or have more than one practitioner: 9/35 (25.7%) chiropractic practices, 24/87 (27.6%) acupuncture practices, and 141/266 (53.0%) massage practices. Practice business models across CAM practitioner types were heterogeneous, e.g. sole proprietor, employee, partner, and independent contractor. CONCLUSIONS: CAM practices vary across and within disciplines in ways that can significantly impact design and implementation of practice-based research. CAM research and intervention programs need to be mindful of the heterogeneity of CAM practices in order to create appropriate interventions, study designs, and implementation plans.

Intervention development for integration of conventional tobacco cessation interventions into routine CAM practice.

BACKGROUND: Practitioners of complementary and alternative medicine (CAM) therapies are an important and growing presence in health care systems worldwide. A central question is whether evidence-based behavior change interventions routinely employed in conventional health care could also be integrated into CAM practice to address public health priorities. Essential for successful integration are intervention approaches deemed acceptable and consistent with practice patterns and treatment approaches of different types of CAM practitioners - that is, they have context validity. Intervention development to ensure context validity was integral to Project CAM Reach (CAMR), a project examining the public health potential of tobacco cessation training for chiropractors, acupuncturists and massage therapists (CAM practitioners). This paper describes formative research conducted to achieve this goal. METHODS: Intervention development, undertaken in three CAM disciplines (chiropractic, acupuncture, massage therapy), consisted of six iterative steps: 1) exploratory key informant interviews; 2) local CAM practitioner community survey; 3) existing tobacco cessation curriculum demonstration with CAM practitioners; 4) adapting/tailoring of existing curriculum; 5) external review of adaptations; 6) delivery of tailored curriculum to CAM practitioners with follow-up curriculum evaluation. RESULTS: CAM practitioners identified barriers and facilitators to addressing tobacco use with patients/clients and saw the relevance and acceptability of the intervention content. The intervention development process was attentive to their real world intervention concerns. Extensive intervention tailoring to the context of each CAM discipline was found unnecessary. Participants and advisors from all CAM disciplines embraced training content, deeming it to have broad relevance and application across the three CAM disciplines. All findings informed the final intervention. CONCLUSIONS: The participatory and iterative formative research process yielded an intervention with context validity in real-world CAM practices as it: 1) is patient/client-centered, emphasizing the practitioner's role in a healing relationship; 2) is responsive to the different contexts of CAM practitioners' work and patient/client relationships; 3) integrates relevant best practices from US Public Health Service Clinical Practice Guidelines on treating tobacco dependence; and 4) is suited to the range of healing philosophies, scopes of practice and practice patterns found in participating CAM practitioners. The full CAMR study to evaluate the impact of the CAMR intervention on CAM practitioners' clinical behavior is underway.

Tobacco brief intervention training for chiropractic, acupuncture, and massage practitioners: protocol for the CAM reach study.

BACKGROUND: Tobacco use remains the leading cause of morbidity and mortality in the US. Effective tobacco cessation aids are widely available, yet underutilized. Tobacco cessation brief interventions (BIs) increase quit rates. However, BI training has focused on conventional medical providers, overlooking other health practitioners with regular contact with tobacco users. The 2007 National Health Interview Survey found that approximately 20% of those who use provider-based complementary and alternative medicine (CAM) are tobacco users. Thus, CAM practitioners potentially represent a large, untapped community resource for promoting tobacco cessation and use of effective cessation aids. Existing BI training is not well suited for CAM practitioners' background and practice patterns, because it assumes a conventional biomedical foundation of knowledge and philosophical approaches to health, healing and the patient-practitioner relationship. There is a pressing need to develop and test the effectiveness of BI training that is both grounded in Public Health Service (PHS) Guidelines for tobacco dependence treatment and that is relevant and appropriate for CAM practitioners. METHODS/DESIGN: The CAM Reach (CAMR) intervention is a tobacco cessation BI training and office system intervention tailored specifically for chiropractors, acupuncturists and massage therapists. The CAMR study utilizes a single group one-way crossover design to examine the CAMR intervention's impact on CAM practitioners' tobacco-related practice behaviors. Primary outcomes included CAM practitioners' self-reported conduct of tobacco use screening and BIs. Secondary outcomes include tobacco using patients' readiness to quit, quit attempts, use of guideline-based treatments, and quit rates and also non-tobacco-using patients' actions to help someone else quit. DISCUSSION: CAM practitioners provide care to significant numbers of tobacco users. Their practice patterns and philosophical approaches to health and healing are well suited for providing BIs. The CAMR study is examining the impact of the CAMR intervention on practitioners' tobacco-related practice behaviors, CAM patient behaviors, and documenting factors important to the conduct of practice-based research in real-world CAM practices.

Activating lay health influencers to promote tobacco cessation.

OBJECTIVE: To evaluate the effect of tobacco cessation brief-intervention (BI) training for lay "health influencers," on knowledge, self-efficacy and the proportion of participants reporting BI delivery post-training. METHODS: Randomized, community-based study comparing In-person or Web-based training, with mailed materials. RESULTS: In-person and Web-training groups had significant post-training cessation knowledge and self-efficacy gains. All groups increased the proportion of individuals reporting BIs at follow-up, with no significant between-group differences. Irrespective of participants' prior intervention experience, 80%-86% reported BIs within the past 90 days; 71%-79% reported >1 in the past 30. CONCLUSIONS: Web and In-person training significantly increase health influencer cessation knowledge and self-efficacy. With minimal prompting and materials, even persons without BI experience can be activated to encourage tobacco cessation.

Helpers program: A pilot test of brief tobacco intervention training in three corporations.

BACKGROUND: Quitlines and worksite-sponsored cessation programs are effective and highly accessible, but limited by low utilization. Efforts to encourage use of cessation aids have focused almost exclusively on the smoker, overlooking the potential for friends, family, co-workers, and others in a tobacco user's social network to influence quitting and use of effective treatment. METHODS: Longitudinal, observational pilot feasibility study with 6-week follow-up survey. SETTING/PARTICIPANTS: Employees of three national corporations, with a combined target audience of 102,100 employees. INTERVENTION: The Helpers Program offers web-based, brief intervention training to activate social networks of tobacco users to encourage quitting and use of effective treatment. Helpers was offered from January 10 to March 31, 2008, as a treatment engagement strategy, together with Free & Clear's telephone/web-based cessation services. MAIN OUTCOME MEASURES: Website utilization, training completion, post-training changes in knowledge and self-efficacy with delivery of brief interventions, referrals to Free & Clear, and use of brief intervention training. RESULTS: There were 19,109 unique visitors to the Helpers website. Of these, 4727 created user accounts; 1427 registered for Helpers Training; 766 completed training. There were 445 visits to the referral page and 201 e-mail or letter referrals generated. There were 67 requests for technical support. Of follow-up survey respondents (n=289), 78.9% reported offering a brief intervention. CONCLUSIONS: Offering the Helpers Program website to a large, diverse audience as part of an employer-sponsored worksite health promotion program is both feasible and well accepted by employees. Website users will participate in training, encourage quitting, and refer smokers to quitline services.

Systems thinking to improve the public's health.

Improving population health requires understanding and changing societal structures and functions, but countervailing forces sometimes undermine those changes, thus reflecting the adaptive complexity inherent in public health systems. The purpose of this paper is to propose systems thinking as a conceptual rubric for the practice of team science in public health, and transdisciplinary, translational research as a catalyst for promoting the functional efficiency of science. The paper lays a foundation for the conceptual understanding of systems thinking and transdisciplinary research, and will provide illustrative examples within and beyond public health. A set of recommendations for a systems-centric approach to translational science will be presented.

Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation.

OBJECTIVE: To assess the safety and efficacy of sustained-release bupropion hydrochloride for adolescent smoking cessation. DESIGN: Prospective, randomized, double-blind, placebo-controlled, dose-ranging trial. SETTING: Metropolitan areas of Tucson and Phoenix, Arizona. PARTICIPANTS: Adolescents (N = 312) recruited through media and various community venues from March 1, 1999, through December 31, 2002, who were aged 14 to 17 years, smoked 6 or more cigarettes per day, had an exhaled carbon monoxide level of 10 ppm or greater, had at least 2 previous quit attempts, and had no other current major psychiatric diagnosis. INTERVENTION: Sustained-release bupropion hydrochloride, 150 mg/d (n = 105) or 300 mg/d (n = 104), or placebo (n = 103) for 6 weeks, plus weekly brief individual counseling. Subjects were followed up at 12 weeks (by telephone call) and 26 weeks. MAIN OUTCOME MEASURE: Confirmed 7-day point prevalence abstinence at 6 weeks and 30-day prolonged abstinence (carbon monoxide level < 10 ppm at each visit; urinary cotinine level < or = 50 microg/L at weeks 2 and 6). RESULTS: Cotinine-confirmed 7-day point prevalence abstinence rates at 6 weeks were as follows: placebo, 5.6%; 150 mg, 10.7%; and 300 mg, 14.5% (P = .03, 300 mg vs placebo). At 26 weeks, confirmed point prevalence abstinence rates were as follows: placebo, 10.3%; 150 mg, 3.1%; and 300 mg, 13.9% (P = .049). During treatment, confirmed point prevalence rates were significantly higher for 300 mg than placebo at every week except week 4. CONCLUSIONS: Sustained-release bupropion hydrochloride, 300 mg/d, plus brief counseling demonstrated short-term efficacy for adolescent smoking cessation. Abstinence rates were lower than those reported for adults, with rapid relapse after medication discontinuation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00344695.

Effectiveness of the nicotine inhaler for smoking cessation in an OTC setting.

OBJECTIVE: To evaluate the effectiveness of the Nicotrol nicotine inhaler as an aid to smoking cessation in over-the-counter (OTC) versus health-care-provider (HCP) conditions. METHODS: Five hundred twenty healthy smokers were randomized to the treatment conditions and followed for a year. RESULTS: At most follow-up visits, abstinence rates for the HCP group were 2 to 3 times those observed in the OTC group. Abstinence at 1 year was.77% in the OTC condition versus 3.08% in the HCP condition [P<.01]. Inhaler use was low. CONCLUSIONS: OTC nicotine inhaler appears to be ineffective, though quit rates are improved with HCP assistance.