Expanding Outcomes in Cancer Screening Safety Net Programs: Promoting Sustainability and Policy Reform.

Community-engaged patient navigation safety net programs are established as an evidence-based approach to address cancer prevention and early detection efforts, but barriers to expand and sustain such programs persist. In addition, few studies describe how these programs impact buy-in among communities and policy change within health care systems and government. We describe how we used the Capacity for Sustainability Framework to guide efforts for program sustainability and community, institutional, and policy level change in a breast cancer screening and patient navigation safety net program. The nine domains of the Capacity for Sustainability Framework were used to develop program logic models, to inform program implementation and quality improvement agendas, and to guide multi-level partner and stakeholder engagement, outreach, and dissemination of outcomes. The program is currently in its seventh year and continues to be annually funded by a city public health department. In 2021, additional 5-year renewable funding from a state public health department was secured. In addition, institutional program support was expanded for patients diagnosed with breast cancer. Program leaders worked with policymakers to draft legislation to support training certification and third-payor reimbursement for patient navigators and community health workers. The program is well-known and trusted among community members, community-based organizations, and providers. Community, organizational, and policy-level outcomes demonstrate that community-engaged patient navigation safety net programs can influence more than individual and interpersonal outcomes and can be sustained over time.

Fentanyl Exposure and Detection Strategies Utilized by Clinical Trial Participants Seeking Linkage to Opioid Use Disorder Treatment at a Syringe Service Program.

INTRODUCTION: The USA continues to face a fentanyl-driven overdose epidemic. Prior research has demonstrated users of illicit opioids are concerned about fentanyl exposure and overdose, but the strategies they report using to detect fentanyl's presence lack empirical support. This study compares self-report and biologically detected fentanyl use and investigates overdose risk and risk reduction behaviors among a sample of high-risk people who use opioids. METHODS: Structured enrollment interviews conducted as part of a larger clinical trial assessed self-reported fentanyl exposure as well as strategies used to determine believed fentanyl exposure and prevent overdose among 240 participants enrolled at a Chicago, IL syringe service program. Urinalysis measured actual fentanyl exposure. RESULTS: Most participants identified as African American (66.7%) and had considerable overdose experience (76.7% lifetime and 48% in the past year). Most also tested positive for fentanyl (93.75%) despite reporting no past year use of fentanyl or fentanyl-adulterated drugs (64.17%). The most utilized approaches reported for identifying fentanyl exposure were stronger effects of the drug (60.7%), sight or taste (46.9%), and being told by someone using the same drugs (34.2%). Few participants (14%) reported using fentanyl test strips. No significant associations were identified between self-report and urinalysis measures or urinalysis results and risk reduction strategies. CONCLUSION: This study adds to prior fentanyl exposure risk research. The disconnect between participants' fentanyl detection methods and reported overdose experiences supports the need for more research to identify and understand factors driving access and use of overdose prevention resources and strategies.

Cost-effectiveness of full and partial opioid agonists for opioid use disorder in outpatient settings: United States healthcare sector perspective.

INTRODUCTION: Studies show that medications for opioid use disorder (MOUD) reduce illicit opioid use, emergency healthcare services, opioid-related overdose, and death. However, few studies have investigated the long-term cost-effectiveness of MOUD in office-based opioid treatment (OBOT) and opioid treatment program (OTP) settings. We aimed to estimate the cost, utility, quality-adjusted life years gained (QALYs), and incremental cost-effectiveness ratios (ICERs) of three MOUD compared to each other and counseling without medication from a US healthcare sector perspective. METHODS: Our study developed a Markov model to conduct a cost-effectiveness analysis of counseling and three MOUD in the OBOT and OTP settings: sublingual buprenorphine/naloxone (BUPNX), buprenorphine extended-release (XR-BUP) injection, and oral methadone. The model included five health states representing combinations of receiving or off treatment while either using or not actively using illicit opioids, and death. The cycle length was one month; the time-horizon was ten years. The study obtained model inputs from systematic reviews of published literature and public data. A 3 % annual discount rate was applied to cost and utility calculation. The primary outcomes included total costs, life-years (LYs), QALYs, and ICERs. We also conducted a scenario analysis using a hypothetical OBOT outpatient setting with methadone. RESULTS: In the base-case OBOT setting, the total costs and QALYs, respectively, were counseling $22,848, 5.60; BUPNX $29,875, 5.82; and XR-BUP $63,936, 5.87. ICERs were $32,345/QALY (BUPNX vs. counseling) and $625,858/QALY (XR-BUP vs BUPNX). In the OTP setting, the total costs of counseling, methadone, BUPNX, and XR-BUP were $20,124, $27,000, $33,500, and $75,272, respectively. QALYs of methadone were 5.86. QALYs of counseling, BUPNX, and XR-BUP remained the same as in the OBOT setting. Incremental ICERs were $26,714/QALY (methadone vs counseling) and $3,337,623/QALY (XR-BUP vs methadone). BUPNX was dominated by methadone. In the scenario analysis, BUPNX was also dominated by methadone. CONCLUSIONS: Outpatient MOUD resulted in important gains in quality of life and life expectancy. In both OBOT and OTP settings, XR-BUP was not cost-effective. BUPNX was cost-effective in the OBOT setting, while it was dominated by methadone in the OTP setting. The cost-effectiveness of BUPNX and XR-BUP could be enhanced if the costs of these medications were reduced.

Mi-CARE: Comparing Three Evidence-Based Interventions to Promote Colorectal Cancer Screening among Ethnic Minorities within Three Different Clinical Contexts.

Multiple evidence-based interventions (EBIs) have been developed to improve the completion of colorectal cancer (CRC) screening within Federally Qualified Health Centers (FQHCs) and other safety net settings in marginalized communities. Little effort has been made, however, to evaluate their relative effectiveness across different clinical contexts and populations. To this end, we tested the relative effectiveness of three EBIs (mailed birthday cards, lay navigation, and provider-delivered education) among a convenience sample of 1252 patients (aged 50-75 years old, who were due for CRC screening and scheduled for a visit at one of three clinics within a network of Federally Qualified Health Centers (FQHCs) in the United States. To be eligible for the study, patients had to identify as African American (AA) or Latino American (LA). We compared the effects of the three EBIs on CRC screening completion using logistic regression. Overall, 20% of the study population, an increase from a baseline of 13%, completed CRC screening. Clinical demographics appeared to influence the effectiveness of the EBIs. Mailed birthday reminders appeared to be the most effective within the multi-ethnic clinic (p = 0.03), provider-delivered education within the predominantly LA clinic (p = 0.02), and lay navigation within the predominantly AA clinic (p = 0.03). These findings highlight the importance of understanding clinical context when selecting which evidence-based interventions to deploy.

Medication-assisted recovery for opioid use disorder: A guide.

Considering offering medical intervention for OUD to reduce mortality? It's essential to understand the clinical benefits, limitations, and regulation of available agents.

Surgical opioid-avoidance protocol: a postoperative pharmacological multimodal analgesic intervention in diverse patient populations.

INTRODUCTION: This study evaluated the effect of a surgical opioid-avoidance protocol (SOAP) on postoperative pain scores. The primary goal was to demonstrate that the SOAP was as effective as the pre-existing non-SOAP (without opioid restriction) protocol by measuring postoperative pain in a diverse, opioid-naive patient population undergoing inpatient surgery across multiple surgical services. METHODS: This prospective cohort study was divided into SOAP and non-SOAP groups based on surgery date. The non-SOAP group had no opioid restrictions (n=382), while the SOAP group (n=449) used a rigorous, opioid-avoidance order set with patient and staff education regarding multimodal analgesia. A non-inferiority analysis assessed the SOAP impact on postoperative pain scores. RESULTS: Postoperative pain scores in the SOAP group compared with the non-SOAP group were non-inferior (95% CI: -0.58, 0.10; non-inferiority margin=-1). The SOAP group consumed fewer postoperative opioids (median=0.67 (IQR=15) vs 8.17 morphine milliequivalents (MMEs) (IQR=40.33); p<0.01) and had fewer discharge prescription opioids (median=0 (IQR=60) vs 86.4 MMEs (IQR=140.4); p<0.01). DISCUSSION: The SOAP was as effective as the non-SOAP group in postoperative pain scores across a diverse patient population and associated with lower postoperative opioid consumption and discharge prescription opioids.

Building a statewide network of MOUD expertise using tiered ECHO® mentoring opportunities.

BACKGROUND: Expanding access to workforce training for opioid use disorder (OUD) treatment continues to be a priority. This study explored the use of tiered mentoring opportunities within an ECHO® model to expand treatment capacity and develop a statewide network of medications for OUD (MOUD) expertise. ECHO® engages participants in a virtual community to learn best practices through case-based learning and interactions with experts. METHODS: We studied two incentivized Illinois MOUD ECHO® training programs by examining aggregate demographic and prescribing data across eight training cohorts (n = 199 participants). Participants (n = 51) in the last two cohorts were evaluated with expanded pre- and post-training surveys. Qualitative interviews were completed with a subset (n = 13) to examine effects observed in the survey data. RESULTS: For the whole group, we found a geographic expansion of the participants' prescribing capacity that reached into rural and other underserved areas in Illinois. Participants in the last two cohorts reported both increased self-efficacy for OUD treatment and increased connectedness to the addiction treatment community in Illinois. Participants who progressed through the tiered mentorship roles were found to exhibit stepwise increases in reported self-efficacy and connectedness measures. CONCLUSION: An incentivized ECHO® program yielded substantive outcomes in terms of increased prescribing capacity across the state. The use of tiered mentoring opportunities enabled participants to develop MOUD expertise and support novice providers in a growing statewide network. There is potential to train professionals to a high level of expertise when the ECHO® model is combined with a mentorship pathway.

Assessing the interrelationship between stigma, social influence, and cervical cancer prevention in an urban underserved setting: An exploratory study.

In the US, incidence and mortality from cervical cancer disproportionately affects racial/ethnic minorities and low-income women. Despite affordable access to primary and secondary prevention measures at Federally Qualified Health Centers (FQHCs), Human Papillomavirus (HPV) vaccination and screening rates are low, suggesting the presence of non-financial barriers to uptake in this population. This explanatory sequential mixed-methods study sought to explore factors that influence the acceptability of cervical cancer prevention services among parents and legal guardians of vaccine-eligible girls attending an urban FQHC and to assess social influences related to cervical cancer prevention. Participants included eight mothers, one father, and two grandparents/legal guardians. Nine participants self-identified as Black/Afro-Caribbean, or African American, two as Latinx, and one as Native American. The quantitative data suggested discordance between participants' cervical cancer prevention knowledge and their practices. Most indicated that their daughters had received the HPV vaccine but were unsure about HPV transmission modes. Qualitative data revealed that participants were comfortable disclosing information on HPV infection and vaccination status, and most women were likely to share information related to cervical cancer testing and diagnosis. Few comments indicated personal stigma on the part of participants, but there was frequent expression of perceived public stigma (shaming and blaming women), gender differences (men are indifferent to risk), and distrust of the healthcare system. Findings highlight several concepts including the disharmony between knowledge and practice, prevalent perceived public stigma, cumbersome attitudes on the part of men regarding HPV and cervical cancer, and distrust of the healthcare system.

Identifying unique barriers to implementing rural emergency department-based peer services for opioid use disorder through qualitative comparison with urban sites.

BACKGROUND: In an effort to address the current opioid epidemic, a number of hospitals across the United States have implemented emergency department-based interventions for engaging patients presenting with opioid use disorder. The current study seeks to address gaps in knowledge regarding implementation of a sub-type of such interventions, emergency department-based peer support services, in rural areas by comparing implementation of rural and urban programs that participated in Indiana's Recovery Coach and Peer Support Initiative (RCPSI). METHODS: We conducted a secondary analysis of qualitative semi-structured implementation interviews collected as part of an evaluation of 10 programs (4 rural and 6 urban) participating in the RCPSI. We conducted interviews with representatives from each program at 3 time points over the course of the first year of implementation. Our deductive coding process was guided by the Consolidated Framework for Implementation Research (CFIR) and an external context taxonomy. RESULTS: We identified key differences for rural programs corresponding to each of the 5 primary constructs in the coding scheme. (1) Intervention characteristics: rural sites questioned intervention fit with their context, required more adaptations, and encountered unexpected costs. (2) External context: rural sites were not appropriately staffed to meet patient needs, encountered logistical and legal barriers regarding patient privacy, and had limited patient transportation options. (3) Inner setting: rural sites lacked strong mechanisms for internal communication and difficulties integrating with pre-existing culture and climate. (4) Characteristics of individuals: some rural providers resisted working with peers due to pre-existing attitudes and beliefs. (5) Implementation process: rural sites spent more time identifying external partners and abandoned more components of their initial implementation plans. CONCLUSIONS: Findings demonstrate how rural programs faced greater challenges implementing emergency department-based peer services over time. These challenges required flexible adaptations to originally intended plans. Rural programs likely require flexibility to adapt interventions that were developed in urban settings to ensure success considering local contextual constraints that were identified by our analysis.

Syringe service program-based telemedicine linkage to opioid use disorder treatment: protocol for the STAMINA randomized control trial.

BACKGROUND: A key strategy for mitigating the current opioid epidemic is expanded access to medications for treating opioid use disorder (MOUD). However, interventions developed to expand MOUD access have limited ability to engage opioid users at higher levels of overdose risk, such as those who inject opioids. This paper describes the study protocol for testing STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention through NAvigation), an intervention that engages high-risk opioid users at community-based syringe service programs (SSP) and quickly links them to MOUD using a telemedicine platform. METHODS: This randomized control trial will be conducted at three SSP sites in Chicago. All participants will complete an initial assessment with a provider from a Federally Qualified Health Center who can prescribe or refer MOUD services as appropriate. The control arm will receive standard referral to treatment and the intervention arm will receive immediate telemedicine linkage to the provider and (depending on the type of MOUD prescribed) provided transportation to pick up their induction prescription (for buprenorphine or naltrexone) or attend their intake appointment (for methadone). We aim to recruit a total of 273 participants over two years to provide enough power to detect a difference in our primary outcome of MOUD treatment linkage. Secondary outcomes include treatment engagement, treatment retention, and non-MOUD opioid use. Data will be collected using structured interviews and saliva drug tests delivered at baseline, three months, and six months. Fixed and mixed effects generalized linear regression analyses and survival analysis will be conducted to compare the probabilities of a successful treatment linkage between the two arms, days retained in treatment, and post-baseline opioid and other drug use. DISCUSSION: If successful, STAMINA's telemedicine approach will significantly reduce the amount of time between SSP clients' initial indication of interest in the medication and treatment initiation. Facilitating this process will likely lead to stronger additional treatment- and recovery-oriented outcomes. This study is also timely given the need for more rigorous testing of telemedicine interventions in light of temporary regulatory changes that have occurred during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov (Clinical Trials ID: NCT04575324 and Protocol Number: 1138-0420). Registered 29 September 2020. The study protocol is also registered on the Open Science Framework (DOI 10.17605/OSF.IO/4853 M).

Reducing Opioid Mortality in Illinois (ROMI): A case management/peer recovery coaching critical time intervention clinical trial protocol.

Individuals with a history of opioid use are disproportionately represented in Illinois jails and prisons and face high risks of overdose and relapse at community reentry. Case management and peer recovery coaching are established interventions that may be leveraged to improve linkage to substance use treatment and supportive services during these critical periods of transition. We present the protocol for the Reducing Opioid Mortality in Illinois (ROMI), a type I hybrid effectiveness-implementation randomized trial of a case management, peer recovery coaching and overdose education and naloxone distribution (CM/PRC + OEND) critical time intervention (CTI) compared to OEND alone. The CM/PRC + OEND is a novel, 12-month intervention that involves linkage to substance use treatment and support for continuity of care, skills building, and navigation and engagement of social services that will be implemented using a hub-and-spoke model of training and supervision across the study sites. At least 1000 individuals released from jails and prisons spanning urban and rural settings will be enrolled. The primary outcome is engagement in medication for opioid use disorder. Secondary outcomes include health insurance enrollment, mental health service engagement, and re-arrest/recidivism, parole violation, and/or reincarceration. Mixed methods will be used to evaluate process and implementation outcomes including fidelity to, barriers to, facilitators of, and cost of the intervention. Videoconferencing and other remote processes will be leveraged to modify the protocol for safety during the COVID-19 pandemic. Results of the study may improve outcomes for vulnerable persons at the margin of behavioral health and the criminal legal system.

Detection of Promoter DNA Methylation in Urine and Plasma Aids the Detection of Non-Small Cell Lung Cancer.

PURPOSE: Low-dose CT screening can reduce lung cancer-related mortality. However, CT screening has an FDR of nearly 96%. We sought to assess whether urine samples can be a source for DNA methylation-based detection of non-small cell lung cancer (NSCLC). EXPERIMENTAL DESIGN: This nested case-control study of subjects with suspicious nodules on CT imaging obtained plasma and urine samples preoperatively. Cases (n = 74) had pathologic confirmation of NSCLC. Controls (n = 27) had a noncancer diagnosis. We detected promoter methylation in plasma and urine samples using methylation on beads and quantitative methylation-specific real-time PCR for cancer-specific genes (CDO1, TAC1, HOXA7, HOXA9, SOX17, and ZFP42). RESULTS: DNA methylation at cancer-specific loci was detected in both plasma and urine, and was more frequent in patients with cancer compared with controls for all six genes in plasma and in CDO1, TAC1, HOXA9, and SOX17 in urine. Univariate and multivariate logistic regression analysis showed that methylation detection in each one of six genes in plasma and CDO1, TAC1, HOXA9, and SOX17 in urine were significantly associated with the diagnosis of NSCLC, independent of age, race, and smoking pack-years. When methylation was detected for three or more genes in both plasma and urine, the sensitivity and specificity for lung cancer diagnosis were 73% and 92%, respectively. CONCLUSIONS: DNA methylation-based biomarkers in plasma and urine could be useful as an adjunct to CT screening to guide decision-making regarding further invasive procedures in patients with pulmonary nodules.

The Growing Trend of Health Coaches in Team-Based Primary Care Training A Multicenter Pilot Study.

BACKGROUND AND OBJECTIVES: Team-based care with health coaches has improved the quality and cost effectiveness of chronic disease management and prevention. Clinical health coaches partner with patients to identify health goals, create action plans, overcome barriers to change, reinforce physician recommendations, and coordinate care. It is important to train resident physicians to practice in team-based settings. To date, there have been no studies of resident family physician exposure to health coaches. METHODS: We surveyed 465 residency directors through a larger omnibus survey sent out by CERA; the response rate was 53.7%. Directors were asked about resident exposure to health coaches, the types of patients seen by health coaches, and the training background of the health coaches. We used chi-square tests to examine the relationship among these variables and program characteristics including status as a patient-centered medical home. RESULTS: Almost two-thirds of the programs reported at least some residents had exposure to health coaches. Residents who trained in continuity sites with a PCMH certification of level 3 were more likely to have any exposure to health coaches (P<.05). There were multiple significant relationships between populations of patients seen and the training background of health coaches. CONCLUSIONS: To improve quality, reduce costs, and become more patient centered, primary care is rapidly transforming into a team sport with a broadening roster of new players, including health coaches. This study documents positive rates of resident exposure to health coaches but also great variability in types and amount of exposure that merit further investigation and exploration of ways to grow family medicine residency contact with a diversifying practice team.

Using Drug Prescribing Patterns to Identify Stewards of Cost-Conscious Care.

PURPOSE: To characterize family physicians (FPs) who are stewards of care by consistently prescribing omeprazole over esomeprazole. METHODS: Cross-sectional analysis of physicians prescribing omeprazole or esomeprazole under Medicare Part D in 2014. RESULTS: There was a regional trend with 49% of Western FPs but only 6% of Southern FPs rarely prescribing esomeprazole. Physicians had increased odds of being a steward if they worked with a care coordinator (P < .001), at a patient-centered medical home (P < .001), or in a large practice (P < .001). CONCLUSIONS: If these findings are replicated across multiple drugs, future outreach could be conducted based on provider prescribing patterns.

Denial: The Greatest Barrier to the Opioid Epidemic.

"Why can't you be like my old doctor?" This essay explores my experiences as a new family physician in a rural town endemic with liberal opioid prescribing practices and opioid addiction. I detail my inner turmoil while overcoming resistance to change, the influence of these experiences on my professional growth, and my decision to offer medication-assisted treatment.

Medicare Part D: Patients Bear The Cost Of 'Me Too' Brand-Name Drugs.

Prescription drugs are a major source of US health care expenditure. "Me too" brand-name medications contribute to the cost of drugs, which is substantial for consumers. In 2013 patient copayments averaged 10.5 times more for two commonly prescribed brand-name medications versus generic therapeutic alternatives.