Faculty Bibliography

In the Diabetes Prevention Program (DPP) randomized, controlled clinical trial, participants who were  ≥ 60 years of age in the intensive lifestyle (diet and physical activity) intervention had a 71% reduction in incident diabetes over the 3-year trial. However, few of the 26.4 million American adults age ≥65 years with prediabetes are participating in the National DPP. The BRInging the Diabetes prevention program to GEriatric Populations (BRIDGE) randomized trial compares an in-person DPP program Tailored for Older AdulTs (DPP-TOAT) to a DPP-TOAT delivered via group virtual sessions (V-DPP-TOAT) in a randomized, controlled trial design (N = 230). Eligible patients are recruited through electronic health records (EHRs) and randomized to the DPP-TOAT or V-DPP-TOAT arm. The primary effectiveness outcome is 6-month weight loss and the primary implementation outcome is intervention session attendance with a non-inferiority design. Findings will inform best practices in the delivery of an evidence-based intervention.

INTRODUCTION/UNASSIGNED:) model offers a long-term approach to treating tobacco use by encouraging people to quit, requit, or recommit to quit smoking every Monday. AIM/UNASSIGNED:model into multicomponent smoking cessation services among people with an MHC. METHODS/UNASSIGNED:= 36) received information about contacting their state Quitline for usual services. Primary outcomes were self-reported quit attempts, 7-day abstinence, and intervention satisfaction at 3 months. RESULTS/UNASSIGNED:email, and text messaging, respectively, were very or somewhat helpful. CONCLUSIONS/UNASSIGNED:delivery approaches to improve patient engagement and potential efficacy of the model. This trial is registered with clinicaltrials.gov (NCT04512248).

BACKGROUND:Surgical aortic valve replacement can be performed either through a minimally invasive (MI) or full sternotomy (FS) approach. The present study compared outcomes of MI versus FS for isolated surgery among patients enrolled in the PARTNER 3 low-risk trial. METHODS:Patients with severe, symptomatic aortic stenosis at low surgical risk with anatomy suitable for transfemoral access were eligible for PARTNER 3 enrollment. The primary outcome was the composite endpoint of death, stroke, or rehospitalization (valve-, procedure-, or heart-failure-related) at 1 year. Secondary outcomes included the individual components of the primary endpoint as well as patient-reported health status at 30 days and 1 year. RESULTS:In the PARTNER 3 study, 358 patients underwent isolated surgery at 68 centers through an MI (n=107) or FS (n=251) approach (8 patients were converted from MI to FS). Mean age and Society of Thoracic Surgeons score were similar between groups. The Kaplan-Meier estimate of the primary outcome was similar in the MI versus FS groups (16.9% versus 14.9%; hazard ratio [95% CI]: 1.15 [0.66 - 2.03]; P=0.618). There were no significant differences in the 1-year rates of all-cause death (2.8% versus 2.8%), all stroke (1.9% versus 3.6%), or rehospitalization (13.3% versus 10.6%, P > 0.05 for all). Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire score at 30 days or 1 year was comparable in both groups. CONCLUSIONS:For patients at low risk for isolated surgery, MI and FS approaches were associated with similar in-hospital and 1-year outcomes.

BACKGROUND:Social determinants of health (SDOH) refer to the social, economic, and psychosocial conditions that influence health. Lower levels of SDOH factors including income, education, and employment are associated with a higher prevalence of diabetes, poorer glycemic control, and increased diabetes-related mortality. Few studies have conducted a comprehensive evaluation of multiple SDOH factors in a population with type 2 diabetes mellitus (T2DM). OBJECTIVE:This study aimed to identify the range of SDOH challenges-including diabetes-related distress-that impact patients with insulin-dependent diabetes at an urban safety-net clinic using the 5-domain SDOH framework developed by the Healthy People 2020 initiative. METHODS:The pilot study used a cross-sectional, mixed methods approach. Participants were recruited from 3 programs within a general internal medicine clinic that provides ambulatory care for patients with uncontrolled T2DM. We administered an investigator-developed SDOH survey based on the Healthy People 2020 framework and the validated Diabetes Distress Scale (DDS), which assesses 4 domains of diabetes-related distress. One-on-one interviews were conducted to gain in-depth information about challenges. RESULTS:level of 11.0% (SD 2.6%). Overall, 92% (52/57) of participants had a barrier in at least one SDOH domain. SDOH challenges were most commonly reported in the domain of Health and Health Care (84%, 48/57), followed by Economic Stability (54%, n=31), Neighborhood and Built Environment (53%, n=30), Education and Health Literacy (47%, n=27), and Social and Community context (37%, n=21). The mean overall DDS score was 2.09 (SD 0.84), where scores of ≥2 indicate distress. Further, 79% (45/57) of participants had at least moderate diabetes-related distress in one of the 4 DDS domains. General themes that emerged from participant interviews included job interference with healthy behaviors, concerns about burdening others, challenges communicating with providers, and difficulty getting appointments in a timely manner. CONCLUSIONS:We found high levels of SDOH barriers across all 5 domains of the Center for Disease Control and Prevention's Healthy People 2020 framework, including significant levels of diabetes-related distress. Future programs to address SDOH barriers in patients with uncontrolled insulin-dependent diabetes should consider screening for and focusing on a wide range of challenges.

BACKGROUND:Financial distress is a barrier to cessation among low-income smokers. OBJECTIVE:To evaluate an intervention that integrated financial coaching and benefits referrals into a smoking cessation program for low-income smokers. DESIGN/METHODS:Randomized waitlist control trial conducted from 2017 to 2019. PARTICIPANTS/METHODS:Adult New York City residents were eligible if they reported past 30-day cigarette smoking, had income below 200% of the federal poverty level, spoke English or Spanish, and managed their own funds. Pregnant or breastfeeding people were excluded. Participants were recruited from two medical centers and from the community. INTERVENTION/METHODS:The intervention (n = 208) offered smoking cessation coaching, nicotine replacement therapy, money management coaching, and referral to financial benefits and empowerment services. The waitlist control (n=202) was usual care during a 6-month waiting period. MAIN MEASURES/METHODS:Treatment engagement, self-reported 7-day abstinence, and financial stress at 6 months. KEY RESULTS/RESULTS:At 6 months, intervention participants reported higher abstinence (17% vs. 9%, P=0.03), lower stress about finances (β, -0.8 [SE, 0.4], P=0.02), and reduced frequency of being unable to afford activities (β, -0.8 [SE, 0.4], P=0.04). Outcomes were stronger among participants recruited from the medical centers (versus from the community). Among medical center participants, the intervention was associated with higher abstinence (20% vs. 8%, P=0.01), higher satisfaction with present financial situation (β, 1.0 [SE, 0.4], P=0.01), reduced frequency of being unable to afford activities (β, -1.0 [SE, 0.5], P=0.04), reduced frequency in getting by paycheck-to-paycheck (β, -1.0 [SE, 0.4], P=0.03), and lower stress about finances in general (β, -1.0 [SE, 0.4], P = 0.02). There were no group differences in outcomes among people recruited from the community (P>0.05). CONCLUSIONS:Among low-income smokers recruited from medical centers, the intervention produced higher abstinence rates and reductions in some markers of financial distress than usual care. The intervention was not efficacious with people recruited from the community. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier: NCT03187730.

INTRODUCTION/BACKGROUND:Although prevalence of smoking in the USA has been decreasing for decades, smoking rates among low-income individuals remain elevated. Theories from behavioral economics and prior research suggest that financial stress may contribute to the difficulty that low-income smokers face in quitting. The present work is a secondary analysis of a randomized controlled trial that incorporated financial coaching and social services referrals into smoking cessation treatment. Primary analyses showed that participants randomized to the intervention (N = 208) were significantly more likely not to smoke, to have lower financial stress, and to be able to afford leisure activities (p < .05) than were control participants (N = 202). METHODS:This paper investigates subgroup discrepancies in attendance of intervention sessions and in uptake of various components of this intervention through exploratory analysis. RESULTS:Analysis using logistic regression indicated that decreased age, not having received higher education, and having income less than $1000 per month were predictive of decreased counseling attendance (p < .05). Few demographic factors were predictive of uptake of counseling components among those who attended counseling. CONCLUSIONS:These results can guide future efforts to increase participant engagement in the intervention. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier: NCT03187730.

BACKGROUND:Smoking remains a major public health issue among Chinese immigrants. Smoking cessation programs that focus on this population are scarce and have a limited population-level impact due to their low reach. Mobile messaging interventions have the potential to reach large audiences and expand smokers' access to smoking cessation treatment. OBJECTIVE:This study describes the development of a culturally and linguistically appropriate mobile messaging smoking cessation intervention for Chinese immigrant smokers delivered via WeChat, the most frequently used social media platform among Chinese people globally. METHODS:This study had 2 phases. In phase 1, we developed a mobile message library based on social cognitive theory and the US Clinical Practice Guidelines for Treating Tobacco Use and Dependence. We culturally adapted messages from 2 social cognitive theory-based text messaging smoking cessation programs (SmokefreeTXT and Decídetexto). We also developed new messages targeting smokers who were not ready to quit smoking and novel content addressing Chinese immigrant smokers' barriers to quitting and common misconceptions related to willpower and nicotine replacement therapy. In phase 2, we conducted in-depth interviews with 20 Chinese immigrant smokers (including 7 women) in New York City between July and August 2021. The interviews explored the participants' smoking and quitting experiences followed by assessment of the text messages. Participants reviewed 17 text messages (6 educational messages, 3 self-efficacy messages, and 8 skill messages) via WeChat and rated to what extent the messages enhanced their motivation to quit, promoted confidence in quitting, and increased awareness about quitting strategies. The interviews sought feedback on poorly rated messages, explored participant preferences for content, length, and format, discussed their concerns with WeChat cessation intervention, and solicited recommendations for frequency and timing of messages. RESULTS:Overall, participants reported that the messages enhanced their motivation to quit, offered encouragement, and made them more informed about how to quit. Participants particularly liked the messages about the harms of smoking and strategies for quitting. They reported barriers to applying some of the quitting strategies, including coping with stress and staying abstinent at work. Participants expressed strong interest in the WeChat mobile messaging cessation intervention and commented on its potential to expand their access to smoking cessation treatment. CONCLUSIONS:Mobile messages are well accepted by Chinese immigrant smokers. Research is needed to assess the feasibility, acceptability, and efficacy of WeChat mobile messaging smoking cessation interventions for promoting abstinence among Chinese immigrant smokers.

To determine whether an opt-out approach is effective for referral to treatment for tobacco use, we designed a clinical reminder for nurses in a primary care setting that provides a referral for patients who smoke cigarettes. We will use a two-arm, cluster-randomized design to assign nurses at the VA New York Harbor Healthcare System to test which mode of referral (opt-in vs opt-out) is more effective. All patients will be referred to evidence-based treatment for tobacco cessation including counseling from the New York State Quitline, and VetsQuit, a text messaging-based system for tobacco cessation counseling. We will measure patient engagement with the referral both in the short and long term to determine if referral modality had an impact on tobacco cessation treatment. We will also measure nurse engagement with the referral before, during, and after the implementation of the reminder to determine whether an opt-out approach is cost effective at the health system level. At the conclusion of this project, we expect to have developed and tested an opt-out system for increasing tobacco cessation treatment for Veterans in VA primary care and to have a thorough understanding of factors associated with implementation. Trial Registration:Clinicaltrials.govIdentifierNCT03477435.

AIMS/OBJECTIVE:We describe a clinical trial which is seeking to determine the effectiveness and understand implementation outcomes for tele-collaborative specialty care for Veterans with Gulf War Illness (GWI). MAIN METHODS/METHODS:This study will be a hybrid type 1 randomized effectiveness-implementation trial comparing tele-collaborative specialty care to electronic consultation for Gulf War Veterans with GWI (N = 220). In tele-collaborative specialty care, the specialty provider team will deliver health coaching and problem-solving treatment to Veterans and recommend a plan for analgesic optimization. In electronic consultation, the specialty provider team will make a one-time recommendation to the primary care team for locally delivered health coaching, problem-solving treatment and analgesic optimization. The primary aim will be to determine the effectiveness of tele-collaborative specialty care as compared to electronic consultation to reduce disability related to GWI. Our secondary aim will be to understand implementation outcomes. SIGNIFICANCE/CONCLUSIONS:There is a need to improve care for Veterans with GWI. A potentially useful model to improve care is tele-collaborative specialty care, where the specialists work with the primary care provider to synergistically treat the patients. DISCUSSION/CONCLUSIONS:This is the first clinical trial to prospectively compare different models of care for Veterans with GWI. This responds to multiple calls for research to improve treatment for Veterans with GWI, including from the National Academy of Medicine.

Low-income adults are significantly more likely to smoke, and face more difficulty in quitting, than people with high income. High rates of delay discounting (DD) may be an important factor contributing to the high rates of tobacco use among low-income adults. Future-oriented financial coaching may offer a novel approach in the treatment of smoking cessation among low-income adults. This secondary analysis (N = 251) of data from a randomized controlled trial examined the integration of future-oriented financial coaching into smoking cessation treatment for low-income smokers. Linear regression and finite mixture models (FMM) estimated the overall and the latent heterogeneity of the impact of the intervention versus usual care control on DD rates 6 months after randomization. Though standard linear regression found no overall difference in DD between intervention and control (β = -0.23, p = 0.338), the FMM identified two latent subgroups with different responses to the intervention. Subgroup 1 (79% of the sample) showed no difference in DD between intervention and control (β = 0.25, p = 0.08). Subgroup 2 (21% of the sample) showed significantly lower DD (β = -2.06, p = 0.003) among intervention group participants versus control at 6 months. Participants were more likely to be a member of subgroup 2 if they had lower baseline DD rates, were living at or below 100% of federal poverty, or were married/living with a partner. This study identified a group of low-income adults seeking to quit smoking who responded to financial coaching with decreased DD rates. These results can be used to inform future targeting of the intervention to individuals who may benefit most, as well as inform future treatment adaptations to support the subgroup of low-income smokers, who did not benefit.