Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.

BACKGROUND: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. METHODS: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

Hospitalization as an opportunity to engage underserved individuals in shared decision-making for lung cancer screening: results from two randomized pilot trials.

PURPOSE: Medicare requires tobacco dependence counseling and shared decision-making (SDM) for lung cancer screening (LCS) reimbursement. We hypothesized that initiating SDM during inpatient tobacco treatment visits would increase LCS among patients with barriers to proactively seeking outpatient preventive care. METHODS: We collected baseline assessments and performed two pilot randomized trials at our safety-net hospital. Pilot 1 tested feasibility, acceptability, and preliminary efficacy of a nurse practitioner initiating SDM for LCS during hospitalization (Inpatient SDM). We collected qualitative data on barriers encountered during Pilot 1. Pilot 2 added a community health worker (CHW) to address barriers to LCS completion (Inpatient SDM + CHW-navigation). For both studies, preliminary efficacy was an intention-to-treat analysis of LCS completion at 3 months between intervention and comparator (furnishing of LCS decision aid only) groups. RESULTS: Baseline assessments showed that patients preferred in-person LCS discussions versus self-reviewing materials; overall 20% had difficulty understanding written information. In Pilot 1, 4% (2/52) in Inpatient SDM versus 2% (1/48, comparator) completed LCS (p = 0.6), despite 89% (89/100) desiring LCS. Primary care providers noted that competing priorities and patient factors (e.g., social barriers to keeping appointments) prevented the intervention from working as intended. In Pilot 2, 50% (5/10) in Inpatient SDM + CHW-navigation versus 9% (1/11, comparator) completed LCS (p < 0.05). Many patients were ineligible due to recent diagnostic chest CT (Pilot 1: 255/659; Pilot 2: 239/527). CONCLUSIONS: Inpatient SDM + CHW-navigation shows promise to improve LCS rates among underserved patients who smoke, but feasibility is limited by recent diagnostic chest CT among inpatients. Implementing CHW-navigation in other clinical settings may facilitate LCS for underserved patients. TRAIL REGISTRATION: ClinicalTrials.gov Identifier: NCT03276806 (8 September 2017); NCT03793894 (4 January 2019).

Disparities in Utilization of Ambulatory Cholecystectomy: Results From Three States.

BACKGROUND: Inpatient cholecystectomy is associated with higher cost and morbidity relative to ambulatory cholecystectomy, yet the latter may be underutilized by minority and underinsured patients. The purpose of this study was to examine the effects of race, income, and insurance status on receipt of and outcomes following ambulatory cholecystectomy. MATERIALS AND METHODS: Retrospective observational cohort study of patients 18-89 undergoing cholecystectomy for benign indications in Florida, Iowa, and New York, 2011-2014 using administrative databases. The primary outcome of interest was odds of having ambulatory cholecystectomy; secondary outcomes included intraoperative and postoperative complications, and 30-day unplanned admissions following ambulatory cholecystectomy. RESULTS: Among 321,335 cholecystectomies, 190,734 (59.4%) were ambulatory and 130,601 (40.6%) were inpatient. Adjusting for age, sex, insurance, income, residential location, and comorbidities, the odds of undergoing ambulatory versus inpatient cholecystectomy were significantly lower in black (aOR = 0.71, 95% CI [0.69, 0.73], P< 0.001) and Hispanic (aOR = 0.71, 95% CI [0.69, 0.72], P< 0.001) patients compared to white patients, and significantly lower in Medicare (aOR = 0.77, 95% CI [0.75, 0.80] P < 0.001), Medicaid (aOR = 0.56, 95% CI [0.54, 0.57], P< 0.001) and uninsured/self-pay (aOR = 0.28, 95% CI [0.27, 0.28], P< 0.001) patients relative to privately insured patients. Patients with Medicaid and those classified as self-pay/uninsured had higher odds of postoperative complications and unplanned admission as did patients with Medicare compared to privately insured individuals. CONCLUSIONS: Racial and ethnic minorities and the underinsured have a higher likelihood of receiving inpatient as compared to ambulatory cholecystectomy. The higher incidence of postoperative complications in these patients may be associated with unequal access to ambulatory surgery.

Examination of Elective Bariatric Surgery Rates Before and After US Affordable Care Act Medicaid Expansion.

Importance: There is limited evidence on whether the Affordable Care Act Medicaid expansion beginning in 2014 improved access to elective procedures. Uninsured individuals are at higher risk of obesity and may have experienced improved uptake of bariatric surgery following Medicaid expansion. Objective: To examine the association between Medicaid expansion and the receipt of inpatient elective bariatric surgery among Medicaid-covered and uninsured individuals aged 26 to 64 years. Design Setting and Participants: This cohort study used difference-in-differences analysis of all-payer data (2010-2017) of 637 557 elective bariatric surgeries for patients aged 26 to 74 years from 11 Medicaid expansion states and 6 nonexpansion states. Nonexpansion states and individuals aged 65 to 74 years were control cohorts. Data analysis was performed from July 6, 2020, to July 23, 2021. Exposure: Living in a Medicaid expansion state. Main Outcomes and Measures: The main outcomes were the (1) number of elective bariatric surgeries, (2) population count, and (3) rate of bariatric surgery (number of surgeries per 10 000 population) among Medicaid-covered and uninsured individuals. Results: Of the 600 798 elective bariatric surgeries in adults aged 26 to 64 years between 2010 and 2017 from the 17 study states, Medicaid-covered and uninsured individuals accounted for 18.3% of the total surgery volume in expansion states and 14.5% in nonexpansion states. A total of 296 798 patients (78.9%) in expansion states were women vs 177 386 (78.9%) in nonexpansion states. Among individuals aged 26 to 64 years, the median age was 44 (IQR, 37-52) years. Racial and ethnic distribution was non-Hispanic White, 60.2%; non-Hispanic Black, 17.7%; Hispanic, 16.6%; and other, 5.5%. Between 2013 and 2017, the volume of bariatric surgeries for Medicaid-covered and uninsured patients increased annually by 30.3% in expansion states and 16.5% in nonexpansion states. Medicaid expansion was associated with a 36.6% annual increase (95% CI, 8.2% to 72.5%) in surgery volume, a 9.0% annual increase (95% CI, 3.8% to 14.5%) in the population, and a 25.5% change (95% CI, -1.3% to 59.4%) in the rate of bariatric surgery. By race and ethnicity, Medicaid expansion was associated with an increase in the rate of bariatric surgery among non-Hispanic White individuals (31.6%; 95% CI, 6.1% to 63.0%) but no significant change among non-Hispanic Black (5.9%; 95% CI, -19.8% to 39.9%) and Hispanic (28.9%; 95% CI, -24.4% to 119.8%) individuals. Conclusions and Relevance: This cohort study found that Medicaid expansion was associated with increased rates of bariatric surgery among lower-income non-Hispanic White individuals, but not among Hispanic and non-Hispanic Black individuals.

Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.

INTRODUCTION: Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital. METHODS: In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data. RESULTS: Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants. CONCLUSIONS: Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.

Association of Obesity With Prescription Opioids for Painful Conditions in Patients Seeking Primary Care in the US.

Importance: Prior studies have identified an association between obesity and prescription opioid use in the US. However, the pain conditions that are factors in this association remain unestablished. Objective: To investigate the association between obesity and pain diagnoses recorded by primary care clinicians as reasons for prescription of opioids. Design, Setting, and Participants: A cross-sectional study including 565 930 patients aged 35 to 64 years with a body mass index (BMI) measurement recorded in 2016 was conducted. Electronic health records of patients seen by primary care clinicians in the US in the multipayer athenahealth network from January 1, 2015, to December 31, 2017, were reviewed, and data were analyzed from March 1 to September 15, 2019. Main Outcomes and Measures: Any prescription of opioids in the 365 days before or after the first BMI measurement in 2016 were identified. All International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, claims within 7 days before each opioid prescription were captured and classified using a pain diagnosis typologic system. Weight was categorized as underweight (BMI, 18.5-19.9), normal weight (BMI, 20.0-24.9), overweight (BMI, 25.0-29.9), obese I (BMI, 30-34.9), obese II (BMI, 35.0-39.9), obese III (BMI, 40.0-49.9), and obese IV (BMI, 50.0-80.0). Results: Among 565 930 patients, 329 083 (58.1%) were women. A total of 125 093 patients (22.1%) were aged 35 to 44 years, 199 384 patients (35.2%) were 45 to 54 years, and 241 453 patients (42.7%) were 55 to 64 years. A total of 177 631 patients (31.4%) were overweight and 273 135 patients (48.2%) were obese at baseline. Over 2 years, 93 954 patients (16.6%) were prescribed opioids. The risk of receiving prescription opioids increased progressively with BMI (adjusted relative risk for overweight: 1.08; 95% CI, 1.06-1.10; obese I: 1.24; 95% CI, 1.22-1.26; obese II: 1.33; 95% CI, 1.30-1.36; obese III: 1.48; 95% CI, 1.45-1.51; and obese IV, 1.71; 95% CI, 1.65-1.77). The percentage of patients with opioid prescriptions attributable to an overweight or obese BMI was 16.2% (95% CI, 15.0%-17.4%). Prescription opioids for management of osteoarthritis (relative risk for obese vs normal weight, 1.90; 95% CI, 1.77-2.05) and other joint disorders (relative risk, 1.63; 95% CI, 1.55-1.72) both had stronger associations with obesity than the mean for any pain diagnosis (relative risk, 1.33; 95% CI, 1.31-1.36). Osteoarthritis, other joint disorders, and other back disorders comprised a combined 53.4% of the absolute difference in prescription of opioids by obesity. Conclusions and Relevance: Joint and back disorders appear to be the most important diagnoses in explaining the increased receipt of opioid prescriptions among patients with obesity. Addressing the opioid crisis will require attention to underlying sources of demand for prescription opioids, including obesity, through its associations with pain.

Patient-Physician Discussions on Lung Cancer Screening: A Missed Teachable Moment to Promote Smoking Cessation.

INTRODUCTION: Little is known about whether patients and physicians perceive lung cancer screening (LCS) as a teachable moment to promote smoking cessation or the degree to which physicians in "real world" settings link LCS discussions with smoking cessation counseling. We sought to characterize patient and physician perspectives of discussions about smoking cessation during LCS. METHODS: We conducted a qualitative study (interviews and focus groups) with 21 physicians and 28 smokers screened in four diverse hospitals. Transcripts were analyzed for characteristics of communication about smoking cessation and LCS, the perceived effect on motivation to quit smoking, the degree to which physicians leverage LCS as a teachable moment to promote smoking cessation, and suggestions to improve patient-physician communication about smoking cessation in the context of LCS. RESULTS: Patients reported that LCS made them more cognizant of the health consequences of smoking, priming them for a teachable moment. While physicians and patients both acknowledged that smoking cessation counseling was frequent, they described little connection between their discussions regarding LCS and smoking cessation counseling. Physicians identified several barriers to integrating discussions on smoking cessation and LCS. They volunteered communication strategies by which LCS could be leveraged to promote smoking cessation. CONCLUSIONS: LCS highlights the harms of smoking to patients who are chronic, heavy smokers and thus may serve as a teachable moment for promoting smoking cessation. However, this opportunity is typically missed in clinical practice. IMPLICATIONS: LCS highlights the harms of smoking to heavily addicted smokers. Yet both physicians and patients reported little connection between LCS and tobacco treatment discussions due to multiple barriers. On-site tobacco treatment programs and post-screening messaging tailored to the LCS results are needed to maximize the health outcomes of LCS, including smoking quit rates and longer-term smoking-related morbidity and mortality.

Process evaluation of counseling delivered by a patient navigator in an efficacious smoking cessation intervention among low-income primary care patients.

INTRODUCTION: This exploratory study examined the relationship between receipt of counseling by a patient navigator and socio-demographic characteristics of primary care patients enrolled in a smoking cessation trial. METHODS: We grouped intervention participants (n = 177) into two categories: 1) no or some contact with the navigator or 2) minimum counseling intervention dose or higher delivered. RESULTS: In logistic regression analyses, controlling for patient race/ethnicity, education, age, gender, household annual income, stress/chaos/hassles composite score, heavy smoking, and substance use, non-Hispanic white participants had lower odds (aOR 0.30; 95% CI 0.13-0.70, p < 0.01) of receiving the minimum intervention dose or higher compared to all other race/ethnicity categories. There was also effect modification such that patients aged 50 or younger who were non-Hispanic white were less likely (aOR 0.09, 95% CI: 0.02-0.54, p < 0.01) to receive the minimum intervention dose compared to older patients from all other race/ethnicity groups. CONCLUSIONS: Future research should explore issues such as acceptability of the intervention to white and younger age participants, and the potential impact of co-occurring substance use disorders on intervention uptake.

The Effectiveness and Value of Patisiran and Inotersen for Hereditary Transthyretin Amyloidosis.

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation, Blue Shield of California, and California Health Care Foundation to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, AHIP, Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, Cambia Health Solutions, United Healthcare, Kaiser Permanente, Premera Blue Cross, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, National Pharmaceutical Council, Prime Therapeutics, Sanofi, Spark Therapeutics, Health Care Service Corporation, Editas, Alnylam, Regeneron, Mallinkrodt, Biogen, HealthPartners, and Novartis. Mickle, Dreitlein, and Pearson are ICER employees. Lasser, Cipriano, and Hoch have nothing to disclose.

Patient and Clinician Perspectives on Shared Decision-making in Early Adopting Lung Cancer Screening Programs: a Qualitative Study.

BACKGROUND: Guidelines recommend, and Medicare requires, shared decision-making between patients and clinicians before referring individuals at high risk of lung cancer for chest CT screening. However, little is known about the extent to which shared decision-making about lung cancer screening is achieved in real-world settings. OBJECTIVE: To characterize patient and clinician impressions of early experiences with communication and decision-making about lung cancer screening and perceived barriers to achieving shared decision-making. DESIGN: Qualitative study entailing semi-structured interviews and focus groups. PARTICIPANTS: We enrolled 36 clinicians who refer patients for lung cancer screening and 49 patients who had undergone lung cancer screening in the prior year. Participants were recruited from lung cancer screening programs at four hospitals (three Veterans Health Administration, one urban safety net). APPROACH: Using content analysis, we analyzed transcripts to characterize communication and decision-making about lung cancer screening. Our analysis focused on the recommended components of shared decision-making (information sharing, deliberation, and decision aid use) and barriers to achieving shared decision-making. KEY RESULTS: Clinicians varied in the information shared with patients, and did not consistently incorporate decision aids. Clinicians believed they explained the rationale and gave some (often purposely limited) information about the trade-offs of lung cancer screening. By contrast, some patients reported receiving little information about screening or its trade-offs and did not realize the CT was intended as a screening test for lung cancer. Clinicians and patients alike did not perceive that significant deliberation typically occurred. Clinicians perceived insufficient time, competing priorities, difficulty accessing decision aids, limited patient comprehension, and anticipated patient emotions as barriers to realizing shared decision-making. CONCLUSIONS: Due to multiple perceived barriers, patient-clinician conversations about lung cancer screening may fall short of guideline-recommended shared decision-making supported by a decision aid. Consequently, patients may be left uncertain about lung cancer screening's rationale, trade-offs, and process.

Depression and smoking characteristics among HIV-positive smokers in Russia: A cross-sectional study.

INTRODUCTION: Globally, persons with HIV infection, depression and substance use disorders have a higher smoking prevalence and smoke more heavily than other populations. These associations have not been explored among Russian smokers with HIV infection and substance use disorders. The purpose of this study was to examine the relationship between the presence of depressive symptoms and smoking outcomes in an HIV-positive cohort of Russian smokers with a history of substance use disorders (alcohol and/or drug use disorders). METHODS: We performed a cross-sectional secondary data analysis of a cohort of HIV-positive regular smokers with a history of substance use disorders recruited in St. Petersburg, Russia in 2012-2015. The primary outcome was heavy smoking, defined as smoking > 20 cigarettes per day. Nicotine dependence (moderate-very high) was a secondary outcome. The main independent variable was a high level of depressive symptoms in the past 7 days (defined as CES-D > = 24). We used multivariable logistic regression to examine associations between depressive symptoms and the outcomes, controlling for age, sex, education, income, running out of money for housing/food, injection drug use, and alcohol use measured by the AUDIT. RESULTS: Among 309 regular smokers, 79 participants (25.6%) had high levels of depressive symptoms, and 65 participants (21.0%) were heavy smokers. High levels of depressive symptoms were not significantly associated with heavy smoking (adjusted odds ratio [aOR] 1.50, 95% CI 0.78-2.89) or with moderate-very high levels of nicotine dependence (aOR 1.35, 95% CI 0.75-2.41). CONCLUSIONS: This study did not detect an association between depressive symptoms and smoking outcomes among HIV-positive regular smokers in Russia.

Effect of Patient Navigation and Financial Incentives on Smoking Cessation Among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Clinical Trial.

Importance: While the proportion of adults who smoke cigarettes has declined substantially in the past decade, socioeconomic disparities in cigarette smoking remain. Few interventions have targeted low socioeconomic status (SES) and minority smokers in primary care settings. Objective: To evaluate a multicomponent intervention to promote smoking cessation among low-SES and minority smokers. Design, Setting, and Participants: For this prospective, unblinded, randomized clinical trial conducted between May 1, 2015, and September 4, 2017, adults 18 years and older who spoke English, smoked 10 or more cigarettes per day in the past week, were contemplating or preparing to quit smoking, and had a primary care clinician were recruited from general internal medicine and family medicine practices at 1 large safety-net hospital in Boston, Massachusetts. Interventions: Patients were randomized to a control group that received an enhancement of usual care (n = 175 participants) or to an intervention group that received up to 4 hours of patient navigation delivered over 6 months in addition to usual care, as well as financial incentives for biochemically confirmed smoking cessation at 6 and 12 months following enrollment (n = 177 participants). Main Outcomes and Measures: The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months. Results: Among 352 patients who were randomized (mean [SD] age, 50.0 [11.0] years; 191 women [54.3%]; 197 participants who identified as non-Hispanic black [56.0%]; 40 participants who identified as Hispanic of any race [11.4%]), all were included in the intention-to-treat analysis. At 12 months following enrollment, 21 participants [11.9%] in the navigation and incentives group, compared with 4 participants [2.3%] in the control group, had quit smoking (odds ratio, 5.8; 95% CI, 1.9-17.1; number needed to treat, 10.4; P < .001). In prespecified subgroup analyses, the intervention was particularly beneficial for older participants (19 [19.8%] vs 1 [1.0%]; P < .001), women (17 [16.8%] vs 2 [2.2%]; P < .001), participants with household yearly income of $20 000 or less (15 [15.5%] vs 3 [3.1%]; P = .003), and nonwhite participants (21 [15.2%] vs 4 [3.0%]; P < .001). Conclusions and Relevance: In this study of adult daily smokers at 1 large urban safety-net hospital, patient navigation and financial incentives for smoking cessation significantly increased the rates of smoking cessation. Trial Registration: clinicaltrials.gov Identifier: NCT02351609.

Colon adenoma features and their impact on risk of future advanced adenomas and colorectal cancer.

AIM: To review the evidence on the association between specific colon adenoma features and the risk of future colonic neoplasia [adenomas and colorectal cancer (CRC)]. METHODS: We performed a literature search using the National Library of Medicine through PubMed from 1/1/2003 to 5/30/2015. Specific Medical Subject Headings terms (colon, colon polyps, adenomatous polyps, epidemiology, natural history, growth, cancer screening, colonoscopy, CRC) were used in conjunction with subject headings/key words (surveillance, adenoma surveillance, polypectomy surveillance, and serrated adenoma). We defined non-advanced adenomas as 1-2 adenomas each < 10 mm in size and advanced adenomas as any adenoma ≥ 10 mm size or with > 25% villous histology or high-grade dysplasia. A combined endpoint of advanced neoplasia included advanced adenomas and invasive CRC. RESULTS: Our search strategy identified 592 candidate articles of which 8 met inclusion criteria and were relevant for assessment of histology (low grade vs high grade dysplasia, villous features) and adenoma size. Six of these studies met the accepted quality indicator threshold for overall adenoma detection rate > 25% among study patients. We found 254 articles of which 7 met inclusion criteria for the evaluation of multiple adenomas. Lastly, our search revealed 222 candidate articles of which 6 met inclusion criteria for evaluation of serrated polyps. Our review found that villous features, high grade dysplasia, larger adenoma size, and having ≥ 3 adenomas at baseline are associated with an increased risk of future colonic neoplasia in some but not all studies. Serrated polyps in the proximal colon are associated with an increased risk of future colonic neoplasia, comparable to having a baseline advanced adenoma. CONCLUSION: Data on adenoma features and risk of future adenomas and CRC are compelling yet modest in absolute effect size. Future research should refine this risk stratification.

Patient navigation and financial incentives to promote smoking cessation in an underserved primary care population: A randomized controlled trial protocol.

Despite the high risk of tobacco-related morbidity and mortality among low-income persons, few studies have connected low-income smokers to evidence-based treatments. We will examine a smoking cessation intervention integrated into primary care. To begin, we completed qualitative formative research to refine an intervention utilizing the services of a patient navigator trained to promote smoking cessation. Next, we will conduct a randomized controlled trial combining two interventions: patient navigation and financial incentives. The goal of the intervention is to promote smoking cessation among patients who receive primary care in a large urban safety-net hospital. Our intervention will encourage patients to utilize existing smoking cessation resources (e.g., quit lines, smoking cessation groups, discussing smoking cessation with their primary care providers). To test our intervention, we will conduct a randomized controlled trial, randomizing 352 patients to the intervention condition (patient navigation and financial incentives) or an enhanced traditional care control condition. We will perform follow-up at 6, 12, and 18 months following the start of the intervention. Evaluation of the intervention will target several implementation variables: reach (participation rate and representativeness), effectiveness (smoking cessation at 12 months [primary outcome]), unintended consequences (e.g., purchase of illicit substances with incentive money), adoption (use of intervention across primary care suites), implementation (delivery of intervention), and maintenance (smoking cessation after conclusion of intervention). Improving the implementation of smoking cessation interventions in primary care settings serving large underserved populations could have substantial public health impact, reducing cancer-related morbidity/mortality and associated health disparities.

Patient navigation to promote smoking cessation among low-income primary care patients: a pilot randomized controlled trial.

We conducted a pilot randomized controlled trial to determine the feasibility and acceptability of a patient navigation intervention. Forty-seven smokers from one safety-net hospital were randomized to either a control group, in which they received a smoking cessation brochure and a list of smoking cessation resources, or a navigation group, in which they received the smoking cessation brochure, a list of smoking cessation resources, and patient navigation. Follow-up data were obtained for 33 participants. Nine (47.4%) of 19 of navigation group participants had engaged in smoking cessation treatment by 3 months versus 6 (42.9%) of 14 control group participants (chi-square p = ns). Patient navigation to promote engagement in smoking cessation treatment was feasible and acceptable to participants.

Is unhealthy substance use associated with failure to receive cancer screening and flu vaccination? A retrospective cross-sectional study.

Objective To compare cancer screening and flu vaccination among persons with and without unhealthy substance use. Design The authors analysed data from 4804 women eligible for mammograms, 4414 eligible for Papanicolou (Pap) smears, 7008 persons eligible for colorectal cancer (CRC) screening and 7017 persons eligible for flu vaccination. All patients were screened for unhealthy substance use. The main outcome was completion of cancer screening and flu vaccination. Results Among the 9995 patients eligible for one or more of the preventive services of interest, 10% screened positive for unhealthy substance use. Compared with women without unhealthy substance use, women with unhealthy substance use received mammograms less frequently (75.4% vs 83.8%; p<0.0001), but Pap smears no less frequently (77.9% vs 78.1%). Persons with unhealthy substance use received CRC screening no less frequently (61.7% vs 63.4%), yet received flu vaccination less frequently (44.7% vs 50.4%; p=0.01). In multivariable analyses, women with unhealthy substance use were less likely to receive mammograms (adjusted odds ratio 0.68; 95% CI 0.52 to 0.89), and persons with unhealthy substance use were less likely to receive flu vaccination (adjusted odds ratio 0.81; 95% CI 0.67 to 0.97). Conclusions Unhealthy substance use is a risk factor for not receiving all appropriate preventive health services.

Colorectal cancer screening among ethnically diverse, low-income patients: a randomized controlled trial.

BACKGROUND: Patient navigators may increase colorectal cancer (CRC) screening rates among adults in underserved communities, but prior randomized trials have been small or conducted at single sites and have not included substantial numbers of Haitian Creole-speaking or Portuguese-speaking patients. METHODS: We identified 465 primary care patients from 4 community health centers and 2 public hospital-based clinics who were not up-to-date with CRC screening and spoke English, Haitian Creole, Portuguese, or Spanish as their primary language. We enrolled participants from September 1, 2008, through March 31, 2009, and followed them up for 1 year after enrollment. We randomly allocated patients to receive a patient navigation-based intervention or usual care. Intervention patients received an introductory letter from their primary care provider with educational material, followed by telephone calls from a language-concordant navigator. The navigators offered patients the option of being screened by fecal occult blood testing or colonoscopy. The primary outcome was completion of any CRC screening within 1 year. Secondary outcomes included the proportions of patients screened by colonoscopy who had adenomas or cancer detected. RESULTS: During a 1-year period, intervention patients were more likely to undergo CRC screening than control patients (33.6% vs 20.0%; P < .001), to be screened by colonoscopy (26.4% vs 13.0%; P < .001), and to have adenomas detected (8.1% vs 3.9%; P = .06). In prespecified subgroup analyses, the navigator intervention was particularly beneficial for patients whose primary language was other than English (39.8% vs 18.6%; P < .001) and black patients (39.7% vs 16.7%; P = .004). CONCLUSIONS: Patient navigation increased completion of CRC screening among ethnically diverse patients. Targeting patient navigation to black and non-English-speaking patients may be a useful approach to reducing disparities in CRC screening. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01141114.

Health insurance and mortality in US adults.

OBJECTIVES: A 1993 study found a 25% higher risk of death among uninsured compared with privately insured adults. We analyzed the relationship between uninsurance and death with more recent data. METHODS: We conducted a survival analysis with data from the Third National Health and Nutrition Examination Survey. We analyzed participants aged 17 to 64 years to determine whether uninsurance at the time of interview predicted death. RESULTS: Among all participants, 3.1% (95% confidence interval [CI]=2.5%, 3.7%) died. The hazard ratio for mortality among the uninsured compared with the insured, with adjustment for age and gender only, was 1.80 (95% CI=1.44, 2.26). After additional adjustment for race/ethnicity, income, education, self- and physician-rated health status, body mass index, leisure exercise, smoking, and regular alcohol use, the uninsured were more likely to die (hazard ratio=1.40; 95% CI=1.06, 1.84) than those with insurance. CONCLUSIONS: Uninsurance is associated with mortality. The strength of that association appears similar to that from a study that evaluated data from the mid-1980s, despite changes in medical therapeutics and the demography of the uninsured since that time.

A multilevel intervention to promote colorectal cancer screening among community health center patients: results of a pilot study.

BACKGROUND: Colorectal cancer screening rates are low among poor and disadvantaged patients. Patient navigation has been shown to increase breast and cervical cancer screening rates, but few studies have looked at the potential of patient navigation to increase colorectal cancer screening rates. METHODS: The objective was to determine the feasibility and effectiveness of a patient navigator-based intervention to increase colorectal cancer screening rates in community health centers. Patients at the intervention health center who had not been screened for colorectal cancer and were designated as "appropriate for outreach" by their primary care providers received a letter from their provider about the need to be screened and a brochure about colorectal cancer screening. Patient navigators then called patients to discuss screening and to assist patients in obtaining screening. Patients at a demographically similar control health center received usual care. RESULTS: Thirty-one percent of intervention patients were screened at six months, versus nine percent of control patients (p < .001). CONCLUSION: A patient navigator-based intervention, in combination with a letter from the patient's primary care provider, was associated with an increased rate of colorectal cancer screening at one health center as compared to a demographically similar control health center. Our study adds to an emerging literature supporting the use of patient navigators to increase colorectal cancer screening in diverse populations served by urban health centers.