Faculty Bibliography

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.

A lack of cost information has been cited as a barrier to implementation and a limitation of implementation research. This paper explains how implementation researchers might optimize their measurement and inclusion of costs, building on traditional economic evaluations comparing costs and effectiveness of health interventions. The objective of all economic evaluation is to inform decision-making for resource allocation and to measure costs that reflect opportunity costs-the value of resource inputs in their next best alternative use, which generally vary by decision-maker perspective(s) and time horizon(s). Analyses that examine different perspectives or time horizons must consider cost estimation accuracy, because over longer time horizons, all costs are variable; however, with shorter time horizons and narrower perspectives, one must differentiate the fixed and variable costs, with fixed costs generally excluded from the evaluation. This paper defines relevant costs, identifies sources of cost data, and discusses cost relevance to potential decision-makers contemplating or implementing evidence-based interventions. Costs may come from the healthcare sector, informal healthcare sector, patient, participant or caregiver, and other sectors such as housing, criminal justice, social services, and education. Finally, we define and consider the relevance of costs by phase of implementation and time horizon, including pre-implementation and planning, implementation, intervention, downstream, and adaptation, and through replication, sustainment, de-implementation, or spread.

PURPOSE/OBJECTIVE:The omission of radiation therapy (RT) in elderly women with stage 1 estrogen-receptor positive (ER+) breast cancer receiving endocrine therapy (ET) is an acceptable strategy based on randomized trial data. Less is known about the omission of ET +/- RT. PATIENT AND METHODS/METHODS:We analyzed SEER-Medicare data for 13,321 women ≥ 66 years with stage I ER+ breast cancer from 2007-2012 who underwent breast conserving surgery. Patients were classified into 4 groups: 1) ET+RT (reference) 2) ET alone (ET), 3) RT alone (RT) and 4) neither RT nor ET (NT). Second breast cancer events (SBCE) were captured using Chubak's high-specificity algorithm. We used Chi-square tests for descriptive statistics, multivariable multinomial logistic regression to estimate relative risks (RR) of undergoing a treatment, and multivariable, propensity-weighted competing-risks survival regression to estimate standardized hazard ratio (SHR) of SBCE. We set significance at p≤0.01. RESULTS:Most women underwent both treatments, with 44% undergoing ET+RT, 41% RT, 6.6% ET, and 8.6% NT but practice patterns varied over time: from 2007-2012, RT decreased from 49% to 30%, whereas ET and ET+RT increased (ET: 5.4% to 9.6%; ET+RT: 38% to 51%). Compared to patients 66-69 years, patients 80-85 years were more likely to receive NT (OR=8.9), RT (OR=1.9), or ET (OR=8.8) vs. ET+RT (p<0.01).3% of subjects had an SBCE (2.2% ET+RT, 3.0% RT, 3.2% ET, 7.0% NT). Relative to ET+RT, NT and ET were associated with higher SBCE (NT: SHR 3.7, p<0.001; ET: SHR 2.2, p=0.008)), whereas RT was not associated with a higher SBCE (SHR 1.21, p=0.137). Clinical factors associated with higher SBCE were HER2 positivity and pT1c (SHR 1.7, p=0.006). CONCLUSIONS:Treatment with RT alone in older women with stage I ER+ disease is decreasing. RT alone is not associated with an increased risk for SBCE. By contrast, NT and ET are both associated with higher SBCE in multivariable analysis with propensity weighting. Further study of the omission of endocrine therapy in this patient population is warranted.

OBJECTIVES/UNASSIGNED:This study investigated differences in the provision of root canal therapy and outcomes in a publicly insured cohort of children and adolescents. METHODS/UNASSIGNED:New York State Medicaid administrative claims from 2006 to 2018 were analyzed. Enrollees aged 6-18 were included in the study if they had initial non-surgical root canal therapy (NSRCT), in the permanent dentition, that allowed for at least 1 year of post-treatment follow-up. Descriptive analyses, multivariable logistic regression, and multivariable Cox proportional hazard models were used to examine the association between demographic variables (gender, age, race/ethnicity, and area-based factors) and dental treatment provision and outcomes. RESULTS/UNASSIGNED:Male gender was associated with having more than one initial NSRCT (adjusted odds ratio (aOR) = 1.06; 95% confidence interval (CI) = 1.02-1.10), as was rurality (aOR = 1.15; 95% CI = 1.06-1.24). Black/African American (AA) and Hispanic children were less likely than non-Hispanic white children to have multiple NSRCTs (aOR = 0.88; 95% CI = 0.83-0.93 and aOR = 0.78; 95% CI = 0.74-0.83). Being older or female conferred a lower hazard of an untoward event (aHR = 0.93; 95% CI = 0.92-0.94 and aHR = 0.86; 95% CI = 0.81-0.91). Compared to non-Hispanic white children, Hispanic and Black/AA children had a higher risk of untoward event (aHR = 1.31; 95% CI = 1.21-1.41 and aHR = 1.55; 95% CI = 1.43-1.67) while children of Asian descent had a lower incidence after initial NSRCT (aHR = 0.79; 95% CI = 0.71-0.88). CONCLUSION/UNASSIGNED:Race/ethnicity was the strongest demographic predictor of provision of initial non-surgical root canal therapy, subsequent placement of a permanent restoration and the occurrence of an untoward event after NSRCT in this cohort.

Background Lupus nephritis can occur as an isolated component of disease activity or be accompanied by diverse extrarenal symptoms that can adversely affect a patient's quality of life (QOL). Whether renal disease absent other activity is sufficient to decrease QOL is unknown. A lack of reported QOL impairment may place patients at risk for delayed diagnosis of nephritis or medication noncompliance yet nephritis trials have largely neglected QOL. As such, this study leveraged the multi-center multi-racial Accelerating Medicines Partnership (AMP) lupus nephritis cohort to assess QOL measured by PROMIS-29. Methods Patients (n=182) fulfilling ACR or SLICC criteria for SLE with a uPCR >= .5 and biopsy Class III, IV, V, or mixed were consecutively enrolled in AMP at the time of renal biopsy and clinical history, PROMIS-29, and disease activity as assessed by the hybrid SELENA-SLEDAI were recorded. Patients were determined to have extrarenal clinical activity if, after excluding all laboratory parameters from the SLEDAI, the score remained >= 1. Raw PROMIS-29 scores were transformed to t-scores with the mean of 50 +/- 10 representing the US population and a difference of 5 points considered clinically meaningful. PROMIS-29 physical and mental health summary scores were calculated according to published formulas. Results Forty-three percent of patients (n=78) had extrarenal clinical manifestations including vasculitis (4%), arthritis (39%), rash (45%), alopecia (42%), mucosal ulcers (13%), pleurisy (12%), pericarditis (8%), and fever (4%). Patients with isolated renal disease (n=104, 57%) did not have PROMIS-29 scores that differed clinically from the US population whereas patients with extrarenal disease reported deficits in physical functioning, fatigue, social functioning, and pain (table 1). Patients with extrarenal disease had significantly lower physical health summary scores compared to patients with isolated disease (median [IQR]: 40.31 [35.79, 47.02] p<0.001 vs. 48.6 [40.14, 57.08]) and significantly lower mental health summary scores (44.12 [38.63, 51.39], p=0.024 vs. 48.67 [40.51, 55.07]). Female and African American patients and those with nephrotic range proteinuria or undergoing first biopsy had significantly lower physical health summary scores, but mental health summary scores did not differ by these variables. Patients on greater than 20 mg of prednisone had both significantly lower physical and mental health summary scores compared to those on lower doses. PROMIS-29 scores did not differ by low complements, anti-dsDNA, or anti-Ro antibodies. Stepwise multivariable linear regression analysis demonstrated that the association between extrarenal disease and lower PROMIS-29 summary scores was primarily driven by arthritis and independent of potential confounders (tables 2 and 3). Conclusion The majority of patients had isolated renal disease and report a QOL similar to that of the general population. In contrast, those with extrarenal manifestations report significantly worse QOL outcomes. These results reinforce the critical importance of routine laboratory surveillance and medication compliance for nephritis even in patients with seemingly quiescent clinical disease since lupus nephritis is often asymptomatic

BACKGROUND:A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. METHODS:The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. DISCUSSION/CONCLUSIONS:Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. TRIAL REGISTRATION/BACKGROUND:This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.

BACKGROUND:Almost half of Veterans with localized prostate cancer receive inappropriate, wasteful staging imaging. Our team has explored the barriers and facilitators of guideline-concordant prostate cancer imaging and found that (1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment and (2) physicians trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from imaging-avid colleagues. We used a theory-based approach to design a multi-level intervention strategy to promote guideline-concordant imaging to stage incident prostate cancer. METHODS:We designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Domains Framework (TDF) and Behavior Change Wheel, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: (1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers' and to published guidelines, (2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and (3) a CPRS Clinical Order Check for potentially guideline-discordant imaging orders. The intervention will be introduced to 10 participating geographically distributed study sites. DISCUSSION/CONCLUSIONS:This study is a significant contribution to implementation science, providing VHA an opportunity to ensure delivery of high-quality care at the lowest cost using a theory-based approach. The study is ongoing. Preliminary data collection and recruitment have started; analysis has yet to be performed. TRIAL REGISTRATION/BACKGROUND:CliniclTrials.gov NCT03445559. Prospectively registered on February 26, 2018.

We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.

OBJECTIVE:This study evaluated costs and healthcare utilization associated with a culturally-sensitive, medical and education program for pediatric Latino patients with type 1 diabetes. RESEARCH DESIGN AND METHODS/METHODS:Program participants included Latino children ages 1-20 years old diagnosed with type 1 diabetes (n = 57). Control subjects with type 1 diabetes were matched by age, sex, and zip code to intervention participants from the Colorado All Payer Claims Database. Data included emergency department (ED) visits, hospitalizations, demographic information, and health insurance claims data 180 days prior to program start/index date through 1 year after program start/index date. We tracked program staff time and estimated costs for healthcare utilization using data from the scientific literature. Generalized Estimating Equation (GEE) models with logit link were used to estimate group differences in probabilities of ED visits and hospitalizations over 6-month periods pre/post-study, accounting for correlation of within-subject data across time points. Sensitivity analyses modeled longer-term cost differences under different assumptions. RESULTS:The intervention group had fewer hospitalizations, 2% versus 12% of controls (p = 0.047,OR = 0.13;95%CI: 0.02-0.97) for 6 months following start date. The intervention group had fewer ED visits, 19% versus 32% in controls (n.s.; p = 0.079,OR = 0.52;95%CI:0.25-1.08) and significantly fewer hospitalizations, 4% versus 15% of controls (p = 0.039,OR = 0.21;95%CI: 0.05-0.93) 6-12 months post-start date. One-year per-patient program costs of $633 and healthcare cost savings of $2710 yielded total per-patient savings of $2077, or a 5-year cost savings of $14,106. CONCLUSION/CONCLUSIONS:This unique type 1 diabetes management program altered health service utilization of program participants, reducing major healthcare cost drivers, ED visits, and hospitalizations.

BACKGROUND:National Comprehensive Cancer Network (NCCN) guidelines for incident prostate cancer staging imaging have been widely circulated and accepted as best practice since 1996. Despite these clear guidelines, wasteful and potentially harmful inappropriate imaging of men with prostate cancer remains prevalent. AIM/OBJECTIVE:To understand changing population-level patterns of imaging among men with incident prostate cancer, we created a state-transition microsimulation model based on existing literature and incident prostate cancer cases. METHODS:To create a cohort of patients, we identified incident prostate cancer cases from 2004 to 2009 that were diagnosed in men ages 65 and older from SEER. A microsimulation model allowed us to explore how this cohort's survival, quality of life, and Medicare costs would be impacted by making imaging consistent with guidelines. We conducted a probabilistic analysis as well as one-way sensitivity analysis. RESULTS:When only imaging high-risk men compared to the status quo, we found that the population rate of imaging dropped from 53 to 38% and average per-person spending on imaging dropped from $236 to $157. The discounted and undiscounted incremental cost-effectiveness ratios indicated that ideal upfront imaging reduced costs and slightly improved health outcomes compared with current practice patterns, that is, guideline-concordant imaging was less costly and slightly more effective. CONCLUSION/CONCLUSIONS:This study demonstrates the potential reduction in cost through the correction of inappropriate imaging practices. These findings highlight an opportunity within the healthcare system to reduce unnecessary costs and overtreatment through guideline adherence.