A text message intervention to support latino dementia family caregivers (CuidaTEXT): feasibility study.

OBJECTIVES: To test the feasibility, acceptability, and preliminary efficacy of CuidaTEXT: a bidirectional text message intervention to support Latino dementia family caregivers. METHODS: CuidaTEXT is a six-month, bilingual intervention tailored to caregiver needs (e.g., education, problem-solving, resources). We used convenience sampling and reached 31 potential participants via clinics, registries, community promotion, and online advertising. We enrolled 24 Latino caregivers in a one-arm trial and assessed feasibility, acceptability, and preliminary efficacy within six months. RESULTS: None of the participants unsubscribed from CuidaTEXT and 83.3% completed the follow up survey. Most participants (85.7%) reported reading most text messages thoroughly. All participants reported being very or extremely satisfied with the intervention. Participants reported that CuidaTEXT helped a lot (vs not at all, a little, or somehow) in caring for their care recipient (71.4%; n = 15), for themselves (66.7%; n = 14), and understanding more about dementia (85.7%; n = 18). Compared to baseline, at six months caregiver behavioral symptom distress (0-60) decreased from 19.8 to 12.0 and depression (0-30) from 8.8 to 5.4 (p < .05). CONCLUSIONS: CuidaTEXT demonstrated high levels of feasibility, acceptability, and preliminary efficacy among Latino caregivers. CLINICAL IMPLICATIONS: CuidaTEXT's feasibility and potential for widespread implementation holds promise in supporting Latino caregivers of people with dementia.

Smoking Status, Nicotine Medication, Vaccination, and COVID-19 Hospital Outcomes: Findings from the COVID EHR Cohort at the University of Wisconsin (CEC-UW) Study.

INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Effectiveness of Recruitment Strategies of Latino Smokers: Secondary Analysis of a Mobile Health Smoking Cessation Randomized Clinical Trial.

BACKGROUND: Latinos remain disproportionately underrepresented in clinical trials, comprising only 2%-3% of research participants. In order to address health disparities, it is critically important to increase enrollment of Latino smokers in smoking cessation trials. There is limited research examining effective recruitment strategies for this population. OBJECTIVE: The purpose of this study was to compare the effectiveness of direct versus mass and high- versus low-effort recruitment strategies on recruitment and retention of Latino smokers to a randomized smoking cessation trial. We also examine how the type of recruitment might have influenced the characteristics of enrolled participants. METHODS: Latino smokers were enrolled into Decídetexto from 4 states-New Jersey, Kansas, Missouri, and New York. Participants were recruited from August 2018 until March 2021. Mass recruitment strategies included English and Spanish advertisements to the Latino community via flyers, Facebook ads, newspapers, television, radio, church bulletins, and our Decídetexto website. Direct, high-effort strategies included referrals from clinics or community-based organizations with whom we partnered, in-person community outreach, and patient registry calls. Direct, low-effort strategies included texting or emailing pre-existing lists of patients who smoked. A team of trained bilingual (English and Spanish) recruiters from 9 different Spanish-speaking countries of origin conducted recruitment, assessed eligibility, and enrolled participants into the trial. RESULTS: Of 1112 individuals who were screened, 895 (80.5%) met eligibility criteria, and 457 (457/895, 51.1%) enrolled in the trial. Within the pool of screened individuals, those recruited by low-effort recruitment strategies (both mass and direct) were significantly more likely to be eligible (odds ratio [OR] 1.67, 95% CI 1.01-2.76 and OR 1.70, 95% CI 0.98-2.96, respectively) and enrolled in the trial (OR 2.60, 95% CI 1.81-3.73 and OR 3.02, 95% CI 2.03-4.51, respectively) compared with those enrolled by direct, high-effort strategies. Among participants enrolled, the retention rates at 3 months and 6 months among participants recruited via low-effort strategies (both mass and direct) were similar to participants recruited via direct, high-effort methods. Compared with enrolled participants recruited via direct (high- and low-effort) strategies, participants recruited via mass strategies were less likely to have health insurance (44.0% vs 71.2% and 71.7%, respectively; P<.001), lived fewer years in the United States (22.4 years vs 32.4 years and 30.3 years, respectively; P<.001), more likely to be 1st generation (92.7% vs 76.5% and 77.5%, respectively; P=.007), more likely to primarily speak Spanish (89.3% vs 65.8% and 66.3%, respectively), and more likely to be at high risk for alcohol abuse (5.8 mean score vs 3.8 mean score and 3.9 mean score, respectively; P<.001). CONCLUSIONS: Although most participants were recruited via direct, high-effort strategies, direct low-effort recruitment strategies yielded a screening pool more likely to be eligible for the trial. Mass recruitment strategies were associated with fewer acculturated enrollees with lower access to health services-groups who might benefit a great deal from the intervention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03586596; https://clinicaltrials.gov/ct2/show/NCT03586596. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-DOI: 10.1016/j.cct.2020.106188.

Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.

Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen's d measure of effect size to evaluate differences. Results: Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen's d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen's d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance. Conclusions: The modified Zelen's design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.

Importance: African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels. Objectives: To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers. Design, Setting, and Participants: The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018. Interventions: Participants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]). Main Outcomes and Measures: The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d). Results: Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]). Conclusions and Relevance: Among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers. Trial Registration: ClinicalTrials.gov Identifier: NCT02360631.

Affective disorders, weight change, and patient engagement in a rural behavioral weight loss trial.

BACKGROUND: Adults in rural areas have a higher prevalence of obesity and some mental health conditions. The degree to which mental health influences weight loss among rural residents remains unclear. This study evaluated changes in body weight, physical activity, diet, and program engagement outcomes in a cohort of participants with vs. without an affective disorder in a behavioral weight loss trial. METHODS: A sample of 1407 adults with obesity were recruited from rural U.S. primary care practices to participate in a weight loss trial. In this secondary analysis, participants were stratified by those with vs. without an affective disorder at baseline. Mixed models were used to estimate changes in outcomes over 24 months. RESULTS: One-third of participants (n = 468) had an affective disorder. After covariate adjustment, both groups experienced significant weight loss over 24 months, but weight loss was significantly less among those with an affective disorder at all follow-up times (all p's < 0.001; 24-month weight loss -2.7 ±â€¯0.4 vs. -4.8 ±â€¯0.3 kg). Compared to those without an affective disorder, participants with an affective disorder also had significantly less improvement in physical activity and fruit/vegetable consumption, lower attendance at weight loss sessions, and less engagement in setting weight loss goals and strategies. CONCLUSION: Participants with an affective disorder lost less body weight and less improvement in lifestyle measures over 24 months. These trends paralleled reduced engagement in critical intervention activities such as weight loss session attendance. Future interventions should consider additional methods to minimize disengagement in adults with underlying affective disorders.

Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial.

Importance: Rural populations have a higher prevalence of obesity and poor access to weight loss programs. Effective models for treating obesity in rural clinical practice are needed. Objective: To compare the Medicare Intensive Behavioral Therapy for Obesity fee-for-service model with 2 alternatives: in-clinic group visits based on a patient-centered medical home model and telephone-based group visits based on a disease management model. Design, Setting, and Participants: Cluster randomized trial conducted in 36 primary care practices in the rural Midwestern US. Inclusion criteria included age 20 to 75 years and body mass index of 30 to 45. Participants were enrolled from February 2016 to October 2017. Final follow-up occurred in December 2019. Interventions: All participants received a lifestyle intervention focused on diet, physical activity, and behavior change strategies. In the fee-for-service intervention (n = 473), practice-employed clinicians provided 15-minute in-clinic individual visits at a frequency similar to that reimbursed by Medicare (weekly for 1 month, biweekly for 5 months, and monthly thereafter). In the in-clinic group intervention (n = 468), practice-employed clinicians delivered group visits that were weekly for 3 months, biweekly for 3 months, and monthly thereafter. In the telephone group intervention (n = 466), patients received the same intervention as the in-clinic group intervention, but sessions were delivered remotely via conference calls by centralized staff. Main Outcomes and Measures: The primary outcome was weight change at 24 months. A minimum clinically important difference was defined as 2.75 kg. Results: Among 1407 participants (mean age, 54.7 [SD, 11.8] years; baseline body mass index, 36.7 [SD, 4.0]; 1081 [77%] women), 1220 (87%) completed the trial. Mean weight loss at 24 months was -4.4 kg (95% CI, -5.5 to -3.4 kg) in the in-clinic group intervention, -3.9 kg (95% CI, -5.0 to -2.9 kg) in the telephone group intervention, and -2.6 kg (95% CI, -3.6 to -1.5 kg) in the in-clinic individual intervention. Compared with the in-clinic individual intervention, the mean difference in weight change was -1.9 kg (97.5% CI, -3.5 to -0.2 kg; P = .01) for the in-clinic group intervention and -1.4 kg (97.5% CI, -3.0 to 0.3 kg; P = .06) for the telephone group intervention. Conclusions and Relevance: Among patients with obesity in rural primary care clinics, in-clinic group visits but not telephone-based group visits, compared with in-clinic individual visits, resulted in statistically significantly greater weight loss at 24 months. However, the differences were small in magnitude and of uncertain clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT02456636.

Cancer survivorship and its association with perioperative opioid use for minor non-cancer surgery.

PURPOSE: Reducing high-risk prescription opioid use after surgery has become a key strategy in mitigating the opioid crisis. Yet, despite their vulnerabilities, we know little about how cancer survivors use opioids for non-cancer perioperative pain compared to those with no history of cancer. The purpose was to examine the association of cancer survivorship with the likelihood of receiving perioperative opioid therapy for non-cancer minor surgery. METHODS: Using 2007-2014 SEER-Medicare data for breast, colorectal, prostate, and non-cancer populations, we conducted retrospective cohort study of opioid-naïve Medicare beneficiaries who underwent one of six common minor non-cancer surgeries. Modified Poisson regression estimated the relative risk of receiving a perioperative opioid prescription associated with cancer survivorship compared to no history of cancer. Stabilized inverse probability of treatment weights were used to balance measurable covariates between cohorts. RESULTS: We included 1486 opioid-naïve older adult cancer survivors and 3682 opioid-naïve non-cancer controls. Cancer survivorship was associated with a 5% lower risk of receiving a perioperative opioid prescription (95% confidence interval: 0.89, 1.00; p = 0.06) compared to no history of cancer. Cancer survivorship was not associated with the extent of perioperative opioid exposure. CONCLUSION: Cancer survivors were slightly less likely to receive opioid therapy for non-cancer perioperative pain than those without a history of cancer. It is unclear if this reflects a reduced risk of opioid-related harms for cancer survivors or avoidance of appropriate perioperative pain therapy. Further examination of cancer survivors' experiences with and attitudes about opioids may inform improvements to non-cancer pain management for cancer survivors.

Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: implications for real-world primary care practice.

BACKGROUND: Obesity is a major risk factor behind some of the most common problems encountered in primary care. Although effective models for obesity treatment have been developed, the 'reach' of these interventions is poor and only a small fraction of primary care patients receive evidence-based treatment. The purpose of this study is to identify factors that impact the uptake (reach) of an evidence-based obesity treatment program within the context of a pragmatic cluster randomized controlled trial comparing three models of care delivery. METHODS: Recruitment and reach were evaluated by the following measures: 1) mailing response rates, 2) referral sources among participants contacting the study team, 3) eligibility rates, 4) participation rates, and 5) representativeness based on demographics, co-morbid conditions, and healthcare utilization of 1432 enrolled participants compared to > 17,000 non-participants from the clinic-based patient populations. Referral sources and participation rates were compared across study arms and level of clinic engagement. RESULTS: The response rate to clinic-based mailings was 13.2% and accounted for 66% of overall program recruitment. An additional 22% of recruitment came from direct clinic referrals and 11% from media, family, or friends. Of those screened, 87% were eligible; among those eligible, 86% enrolled in the trial. Participation rates did not vary across the three care delivery arms, but were higher at clinics with high compared to low provider involvement. In addition, clinics with high provider involvement had a higher rate of in clinic referrals (33% versus 16%) and a more representative sample with regards to BMI, rurality, and months since last clinic visit. However, across clinics, enrolled participants compared to non-participants were older, more likely to be female, more likely to have had a joint replacement but less likely to have CVD or smoke, and had fewer hospitalizations. CONCLUSIONS: A combination of direct patient mailings and in-clinic referrals may enhance the reach of primary care behavioral weight loss interventions, although more proactive outreach is likely necessary for men, younger patients, and those at greater medial risk. Strategies are needed to enhance provider engagement in referring patients to behavioral weight loss programs. TRIAL REGISTRATION: clnicialtrials.gov NCT02456636. Registered May 28, 2015, https://www.clinicaltrials.gov/ct2/results?cond=&term=RE-POWER&cntry=&state=&city=&dist=.

Insurance coverage and utilization of nicotine patches after receipt of a prescription.

Introduction: Changes in reimbursement policy have made nicotine replacement therapy (NRT) much more available, but little is known about what happens to patients after they receive their prescription. This study describes rates of successfully filling prescriptions for NRT and its association with type of insurance. Methods: We identified 224 patients who received a prescription for NRT during an outpatient visit to an academic medical center between January 1st 2016 and February 10th 2017. We conducted telephone surveys to assess whether they tried to fill their prescriptions and if so, determine the effects of insurance type on the ability to successfully fill the prescription. Results: Of 117 patients completing the survey, 23 (19.6%) did not attempt to fill and 6 (5.1%) had no insurance. Of the 90 patients with insurance who attempted to fill their prescription, 67 (74.4%) were successful and 23 (25.6%) were unsuccessful in obtaining medications. Success varied by insurance with successful fills ranging from 34 (87.2%) of those with commercial insurance, 24 (70.6%) with Medicaid, to 9 (52.9%) with Medicare. Of 37 participants living with another smoker, 31 (83.7%) wanted an NRT prescription specifically for their partner; several volunteered that they had shared patches with their partner. Conclusions: Despite widespread coverage for NRT, many patients may still encounter difficulties in getting their prescriptions filled. Some tobacco users might also benefit from getting NRT prescriptions for their partners that smoke.

Impact of Adding Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge: a Randomized Controlled Trial.

BACKGROUND: Cessation counseling and pharmacotherapy are recommended for hospitalized smokers, but better coordination between cessation counselors and providers might improve utilization of pharmacotherapy and enhance smoking cessation. OBJECTIVE: To compare smoking cessation counseling combined with care coordination post-hospitalization to counseling alone on uptake of pharmacotherapy and smoking cessation. DESIGN: Unblinded, randomized clinical trial PARTICIPANTS: Hospitalized smokers referred from primarily rural hospitals INTERVENTIONS: Counseling only (C) consisted of telephone counseling provided during the hospitalization and post-discharge. Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker's health care team and help for the smoker in obtaining pharmacotherapy. At 6 months post-hospitalization, persistent smokers were re-engaged with either CCC or C. MAIN MEASURES: Utilization of pharmacotherapy and smoking cessation at 3, 6, and 12 months post-discharge. KEY RESULTS: Among 606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis. Use of any cessation pharmacotherapy between 0 and 6 months (55.2%) and between 6 and 12 months (47.1%) post-discharge was similar across treatment arms though use of prescription-only pharmacotherapy between months 6-12 was significantly higher in the CCC group (30.1%) compared with the C group (18.6%) (RR, 1.61 (95% CI, 1.08, 2.41)). Self-reported abstinence rates of 26.2%, 20.3%, and 23.4% at months 3, 6, and 12, respectively, were comparable across the two treatment arms. Of those smoking at month 6, 12.5% reported abstinence at month 12. Validated smoking cessation at 12 months was 19.3% versus 16.9% in the CCC and C groups, respectively (RR, 1.13 (95% CI, 0.80, 1.61)). CONCLUSION: Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone. Re-engagement of smokers 6 months post-discharge can lead to new quitters, at which time care coordination might facilitate use of prescription medications. TRIAL REGISTRATION: NCT01063972.

Nutrition literacy predicts adherence to healthy/unhealthy diet patterns in adults with a nutrition-related chronic condition.

OBJECTIVE: To describe the relationship between adherence to distinct dietary patterns and nutrition literacy. DESIGN: We identified distinct dietary patterns using principal covariates regression (PCovR) and principal components analysis (PCA) from the Diet History Questionnaire II. Nutrition literacy was assessed using the Nutrition Literacy Assessment Instrument (NLit). Cross-sectional relationships between dietary pattern adherence and global and domain-specific NLit scores were tested by multiple linear regression. Mean differences in diet pattern adherence among three predefined nutrition literacy performance categories were tested by ANOVA. SETTING: Metropolitan Kansas City, USA. PARTICIPANTS: Adults (n 386) with at least one of four diet-related diseases. RESULTS: Three diet patterns of interest were derived: a PCovR prudent pattern and PCA-derived Western and Mediterranean patterns. After controlling for age, sex, BMI, race, household income, education level and diabetes status, PCovR prudent pattern adherence positively related to global NLit score (P < 0·001, ß = 0·36), indicating more intake of prudent diet foods with improved nutrition literacy. Validating the PCovR findings, PCA Western pattern adherence inversely related to global NLit (P = 0·003, ß = -0·13) while PCA Mediterranean pattern positively related to global NLit (P = 0·02, ß = 0·12). Using predefined cut points, those with poor nutrition literacy consumed more foods associated with the Western diet (fried foods, sugar-sweetened beverages, red meat, processed foods) while those with good nutrition literacy consumed more foods associated with prudent and Mediterranean diets (vegetables, olive oil, nuts). CONCLUSIONS: Nutrition literacy predicted adherence to healthy/unhealthy diet patterns. These findings warrant future research to determine if improving nutrition literacy effectively improves eating patterns.

"Vive Sin Tabaco ¡Decídete!" Feasibility and Acceptability of an e-Health Smoking Cessation Informed Decision-Making Tool Integrated in Primary Healthcare in Mexico.

Introduction:While smoking remains one of the leading causes of death in Mexico, uptake of evidence-based cessation therapy remains low. Widespread use of mobile devices and internet in Mexico has created new avenues for providing access to cessation treatment.Methods:We assessed the feasibility and acceptability of "Vive Sin Tabaco… ¡Decídete!" (English: Live without Tobacco…. Decide!), a web-based, informed decision-making tool designed to help Mexican smokers develop a quit plan and take advantage of cessation resources. We invited 164 smokers in two primary care clinics. Measures included physical, situational, and psychological nicotine dependence, interest in using pharmacotherapy and counseling, smoking status at 3 months, and satisfaction with the program.Results:Most participants were light smokers and reported low-to-moderate nicotine dependence. Immediately after using ¡Vive Sin Tabaco… ¡Decídete!, the majority were interested in quitting, set a quit date, and reported interest in using pharmacotherapy and cessation counseling. Follow-up rate at 3 months was 81.5%; seven-day point prevalence abstinence was 19.1% using intention-to-treat analysis.Conclusion:Integration of e-Health tools in primary healthcare settings has the potential to improve knowledge about cessation treatments among smokers and integrate smoking cessation into routine of care.

Direct observation of Medicaid beneficiary attempts to fill prescriptions for nicotine replacement medications.

OBJECTIVES: Although many states have expanded Medicaid coverage of cessation medications, utilization remains low. Anecdotal reports suggest that beneficiaries are at times denied coverage of cessation medications at the pharmacy counter. We conducted an observational community-wide case study of Medicaid beneficiary attempts to fill over-the-counter nicotine replacement therapy at pharmacies. METHODS: We recruited tobacco-using beneficiaries from a Federally Qualified Health Center, whose providers wrote paper prescriptions for nicotine patches. Study staff escorted beneficiaries to all eligible pharmacies (n = 18) in a Midwestern community to observe fill attempts. Study staff recorded encounters via smartphone into a secure database on a university server. RESULTS: Seven of 18 pharmacies (39%) did not fill the prescription on the day of the attempt. Of these, 6 offered to order the patch for pick-up at a later date. All (4/4) chain pharmacies filled the prescription; 2/3 mass merchant pharmacies failed to fill. Combining successful same-day fills with offers to order for pick-up, 17/18 (94%) would ultimately have been able to obtain patches. CONCLUSION: This pilot study found that many beneficiaries left pharmacies without a prescription in hand. Successful same-day fills varied markedly by store type. For people with low incomes, transportation presents a major barrier for delayed pick-up. In addition, delays can fuel ambivalence toward quitting. Future research based on this pilot study might address whether patients who fail to secure a same-day prescription ever fill the prescription and, if not, the degree to which this barrier contributes to success or failure in quitting.

Impact of Telephone-Based Care Coordination on Use of Cessation Medications Posthospital Discharge: A Randomized Controlled Trial.

INTRODUCTION: Smokers benefit from ongoing cessation support upon leaving the hospital and returning to their home environment. This study examined the impact of telephone-delivered care coordination on utilization of and adherence to cessation pharmacotherapy after hospital discharge. METHODS: Inpatient smokers (n = 606) were randomized to receive counseling with care coordination (CCC) or counseling alone (C) for smoking cessation. Both groups received written materials and telephone-based cessation counseling during hospitalization and postdischarge. CCC recipients received help in selecting, obtaining, and refilling affordable pharmacotherapy prescriptions during and after hospitalization. Study outcomes included self-reported utilization, duration of use, and type of medication during the 3 months postdischarge. RESULTS: Of the 487 (80%) of participants completing 3-month follow-up, 211 (43.3%) reported using cessation pharmacotherapy postdischarge; this did not differ by study arm (CCC: 44.7%, C: 42.0%, p = .55). Use of pharmacotherapy postdischarge was associated with smoking at least 20 cigarettes/day at baseline (odds ratio [OR]: 1.48; 95% confidence interval [CI]: 1.00-2.19) and receipt of pharmacotherapy during hospitalization (OR: 4.00; 95% CI: 2.39-6.89). Smokers with Medicaid (OR: 2.29; 95% CI: 1.32-4.02) or other insurance (OR: 1.69; 95% CI: 1.01-2.86) were more likely to use pharmacotherapy postdischarge than those with no health care coverage. Less than one in four (23.8% of CCC; 22.2% of C) continued pharmacotherapy beyond 4 weeks. CONCLUSIONS: Supplemental care coordination did not improve use of postdischarge pharmacotherapy beyond that of inpatient treatment and behavioral counseling. Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge. IMPLICATIONS: Many hospitalized smokers do not receive the benefits of cessation pharmacotherapy postdischarge and telephone quitline programs often fail to help smokers procure pharmacotherapy. Thus, effective strategies are needed to improve utilization and adherence to evidence-based cessation therapies when smokers leave the hospital. We found that use of postdischarge pharmacotherapy was strongly associated with receipt of pharmacotherapy during the hospitalization and with the availability of insurance to cover the costs of treatment. Additional efforts to coordinate pharmacotherapy services did not improve either utilization or adherence to therapy.

Pharmaceutical assistance programs to support smoking cessation medication access.

OBJECTIVES: Rural smokers are more likely to be uninsured and live in poverty, which may pose significant cost barriers to accessing smoking cessation medications. As part of a randomized clinical trial, we provided support to connect low-income smokers with the use of pharmaceutical assistance programs (PAPs) to improve medication access. METHODS: Study participants were rural smokers enrolled in a randomized clinical trial testing in-office telemedicine versus telephone-based approaches to deliver counseling sessions. For potentially qualified participants, we developed a system to connect them with PAPs that provided smoking cessation medications at low or no cost. Participants reported medication utilization 3 and 6 months after randomization. RESULTS: Of the 560 study participants, 312 (55.7%) met initial screening criteria for PAP eligibility. Of those eligible, 104 (33.3%) initiated a PAP application, with 49 (15.7%) completing the application and ultimately receiving medications through the programs. Despite the availability of assistance with the PAP application process, overall medication use among those that were eligible for PAP was significantly lower than among participants with higher incomes or access to prescription insurance (60.4% vs. 51.3%; P = 0.04). Abstinence among PAP-eligible smokers was also lower at the 3-month follow-up (P = 0.01), but this difference was not present at the 6- and 12-month follow-up surveys. CONCLUSION: With substantial assistance, some low-income smokers without prescription insurance can get effective smoking cessation medications through PAPs, but overall access remains worse than among those with higher incomes or prescription insurance.

Effectiveness comparison of cardio-selective to non-selective ß-blockers and their association with mortality and morbidity in end-stage renal disease: a retrospective cohort study.

BACKGROUND: Within-class comparative effectiveness studies of ß-blockers have not been performed in the chronic dialysis setting. With widespread cardiac disease in these patients and potential mechanistic differences within the class, we examined whether mortality and morbidity outcomes varied between cardio-selective and non-selective ß-blockers. METHODS: Retrospective observational study of within class ß-blocker exposure among a national cohort of new chronic dialysis patients (N = 52,922) with hypertension and dual eligibility (Medicare-Medicaid). New ß-blocker users were classified according to their exclusive use of one of the subclasses. Outcomes were all-cause mortality (ACM) and cardiovascular morbidity and mortality (CVMM). The associations of cardio-selective and non-selective agents on outcomes were adjusted for baseline characteristics using Cox proportional hazards. RESULTS: There were 4938 new ß-blocker users included in the ACM model and 4537 in the CVMM model: 77 % on cardio-selective ß-blockers. Exposure to cardio-selective and non-selective agents during the follow-up period was comparable, as measured by proportion of days covered (0.56 vs. 0.53 in the ACM model; 0.56 vs 0.54 in the CVMM model). Use of cardio-selective ß-blockers was associated with lower risk for mortality (AHR = 0.84; 99 % CI = 0.72-0.97, p = 0.0026) and lower risk for CVMM events (AHR = 0.86; 99 % CI = 0.75-0.99, p = 0.0042). CONCLUSION: Among new ß-blockers users on chronic dialysis, cardio-selective agents were associated with a statistically significant 16 % reduction in mortality and 14 % in cardiovascular morbidity and mortality relative to non-selective ß-blocker users. A randomized clinical trial would be appropriate to more definitively answer whether cardio-selective ß-blockers are superior to non-selective ß-blockers in the setting of chronic dialysis.

Comparative Effectiveness of Renin-Angiotensin System Antagonists in Maintenance Dialysis Patients.

BACKGROUND/AIMS: Whether angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) are differentially associated with reductions in cardiovascular events and mortality in patients receiving maintenance dialysis is uncertain. We compared outcomes between ACE and ARB users among hypertensive, maintenance dialysis patients. METHODS: National retrospective cohort study of hypertensive, Medicare-Medicaid eligible patients initiating chronic dialysis between 1/1/2000 to 12/31/2005. The exposure of interest was new use of either an ACEI or ARB. Outcomes were all-cause mortality (ACM) and combined cardiovascular hospitalization or death (CV-endpoint). Cox proportion hazards models were used to compare the effect of ACEI vs ARB use on ACM and, separately, CV-endpoint. RESULTS: ACM models were based on 3,555 ACEI and 1,442 ARB new users, while CV-endpoint models included 3,289 ACEI and 1,346 ARB new users. After statistical adjustments, ACEI users had higher hazard ratios for ACM (AHR = 1.22, 99% CI 1.05-1.42) and CV-endpoint (AHR = 1.12, 99% CI 0.99-1.27). CONCLUSIONS: Patients initiating maintenance dialysis who received an ACEI faced an increased risk for mortality and a trend towards an increased risk for CV-endpoints when compared to patients who received an ARB. Validation of these results in a rigorous clinical trial is warranted.

Novel Method for Recruiting Representative At-Risk Individuals into Cancer Prevention Trials: Online Health Risk Assessment in Employee Wellness Programs.

Participation in cancer prevention trials (CPT) is lower than 3 % among high-risk healthy individuals, and racial/ethnic minorities are the most under-represented. Novel recruitment strategies are therefore needed. Online health risk assessment (HRA) serves as a gateway component of nearly all employee wellness programs (EWPs) and may be a missed opportunity. This study aimed to explore employees' interest, willingness, motivators, and barriers of releasing their HRA responses to an external secure research database for recruitment purpose. We used qualitative research methods (focus group and individual interviews) to examine employees' interest and willingness in releasing their online HRA responses to an external, secure database to register as potential CPT participants. Fifteen structured interviews (40 % of study participants were of racial/ethnic minority) were conducted, and responses reached saturation after four interviews. All employees showed interest and willingness to release their online HRA responses to register as a potential CPT participant. Content analyses revealed that 91 % of participants were motivated to do so, and the major motivators were to (1) obtain help in finding personally relevant prevention trials, (2) help people they know who are affected by cancer, and/or (3) increase knowledge about CPT. A subset of participants (45 %) expressed barriers of releasing their HRA responses due to concerns about credibility and security of the external database. Online HRA may be a feasible but underutilized recruitment method for cancer prevention trials. EWP-sponsored HRA shows promise for the development of a large, centralized registry of racially/ethnically representative CPT potential participants.