Faculty Bibliography

Background: Peer comparisons, providing feedback on clinician performance relative to peers, have been tested successfully in narrow settings such as increasing guideline-based antibiotic and opioid prescribing. However, there are no studies evaluating the effectiveness of peer comparisons on broader quality measures in the setting of alternative payment models.
Method(s): We conducted a cluster randomized trial with the Blue Cross Blue Shield of Hawaii to examine the impact of providing peer comparison feedback to its primary care practitioners (PCPs) on the quality of care. This study included patients of 86 PCPs randomized to receiving peer comparisons plus individual feedback (intervention group) versus individual feedback alone (control group). Feedback was provided on quality, cost, and utilization performance. All PCPs were also simultaneously moved to a new population-based primary care payment system. The primary outcome was the probability of achieving national benchmark thresholds on thirteen primary care focused quality metrics that included preventative and chronic disease measures. We analyzed the primary outcome using a generalized linear model, adjusting for patient characteristics, PCP characteristics, baseline proportion of measures achieved by the patient, and a quality measure fixed-effect, clustering standard errors at the PCP.
Result(s): The RCT included 27,930 patients and 31 PCPs in the control group and 46,694 patients and 55 PCPs in the intervention group. Patients nor PCPs exhibited large differences across groups, with small differences in demographics and panel size, respectively. In primary analysis, the patients in the peer comparisons intervention group experienced a 2.4 percentage point (pp) increase in the probability of achieving an eligible quality measure (95% CI 0.3 pp to 4.6 pp, p=0.03). Secondary analysis of individual measures indicated that Breast Cancer Screening (3.9 pp, 95% CI 0.2 to 6.0 pp, p< 0.001), Cervical Cancer Screening (2.4 pp, 95% CI 0.01to 4.8 pp, p=0.05), Colorectal Cancer Screening (2.8 pp, 95% CI 0.3 to 5.2 pp, p=0.03), Diabetes Care-Eye Exam (5.6 pp, 95% CI 1.6 to 9.5 pp, p = 0.006), Diabetes Care-Medical Attention for Nephrop-athy (2.5 pp, 95% CI 0.4 to 4.6 pp, p=0.02) and Review of Chronic Conditions (4.9 pp, 95% CI 0.0 to 9.8 pp, p=0.05) likely accounted for the increased overall quality score. Other measures demonstrated trends toward differential improvement, but associations were not significant. Cost and utilization did not demonstrate differences between arms.
Conclusion(s): A peer comparisons intervention that displayed quality information in a real-time dashboard in the setting of a broad primary care payment system change improved quality scores by over 2 percentage points. This highlights the ability of peer comparisons to influence clinician practice in broad endpoints and is reassuring in light of new payment programs that have begun sharing comparative feedback

PURPOSE/OBJECTIVE:The CDK 4/6 inhibitor palbociclib rapidly and reversibly inhibits the cell cycle. The goal of this study was to exploit the cell cycle through intermittent, alternating dosing with palbociclib/paclitaxel to enhance efficacy. We determined the combination dose-limiting toxicity (DLT) in patients with Rb protein-expressing, advanced breast cancer. PATIENTS AND METHODS/METHODS:This open-label, phase I trial (NCT01320592) enrolled patients to sequential cohorts of palbociclib orally dosed intermittently between days 1 and 19 of a 28-day cycle alternating with weekly paclitaxel. Dose escalation proceeded in a standard 3 + 3 design. Ten additional patients received the combination at the recommended phase II dose (RP2D). Those who reached response plateau ≥6 cycles could continue on palbociclib alone on a 3 week on/1 week off schedule at one dose level above their combination dose. RESULTS:paclitaxel. During C1, the most common adverse event was NTP, occurring in 15 patients (55.6%); grade 1 or 2 nausea and peripheral neuropathy were also observed in 8 patients each (29.6%). The clinical benefit rate was 55% at the RP2D; benefit was observed across all receptor subtypes. CONCLUSIONS:breast cancer regardless of subtype; efficacy trials are warranted.

Introduction: Using the National Health and Aging Trends Study (NHATS), we examined use of sleeping medication, difficulty falling asleep, and trouble falling back asleep among individuals with and without cognitive impairment.
Method(s): Binomial logistic regression examined sleep medication use and insomnia symptoms (difficulty falling asleep or falling back asleep after awakening) by cognitive impairment (no dementia and possible or probable dementia). Sleep-related variables were collected on frequency scales ranging from 1 (every day) to 5 (never). Of the sample, 71.1% were White (n=3,369), 20.7% were Black (n=982), 5.0% were Hispanic (n=235), and 2.4% other (n=113); 60.4% were female (n=2,662) and 39.6% were male (n=1,875).
Result(s): Respondents were classified as having no dementia (63.7%), possible dementia (8.5%), or probable dementia (12.9%). Of the sample, 10.7% reported medication use every night, 2.5% 5-6 nights/week, 5.7% 2-4 nights/week, 6.6% once/week and 59.4% reported no use. Of the respondents, 8.3% reported difficulty sleeping every night, 8.0% reported 5-6 nights/week, 21.4% reported 2-4 nights/week, 22.9% reported rarely, and 23.5% reported never experiencing difficulty sleeping. Regarding difficulty falling back asleep, 4.9% reported difficulty every night, 7.4% reported 5-6 nights/week, 26.0% reported 2-4 nights/week, 20.4% reported rarely, and 24.3% reported never. Compared to individuals who reported never using sleep medications, those reporting nightly use were significantly more likely to be cognitively impaired (OR=1.44,95%CI: 1.14-1.82). Compared to individuals reporting never having difficulty falling asleep, those reporting difficulty falling asleep nightly were not more likely to have cognitive impairment (OR=0.74 95%CI: 0.67 to 1.19). Compared to individuals reporting never having difficulty falling back asleep after awakening, those frequently reporting difficulty falling back asleep were less likely to be cognitively impaired (OR=0.44,95%CI:0.22 to 0.64).
Conclusion(s): Cognitive impairment was positively associated with sleep medication use in adjusted models, but not with trouble falling asleep or difficulty falling back asleep after awakening. Our findings are consistent with the literature on deleterious consequences of sleep medications

BACKGROUND:Congestive heart failure is a major cause of morbidity, mortality, and cost. Disease management programs have shown promise but lack firm evidence of effectiveness and scalability. We describe the motivation, design, and planned analyses of EMPOWER (Electronic Monitoring of Patients Offers Ways to Enhance Recovery), a randomized clinical trial of an innovative intervention incorporating behavioral economic principles with remote monitoring technology embedded within a healthcare system. METHODS AND RESULTS/RESULTS:EMPOWER is an ongoing, pragmatic, randomized clinical trial comparing usual care to an automated hovering intervention that includes patient-level incentives for daily weight monitoring and diuretic adherence combined with automated feedback into the clinical care pathway, enabling real-time response to concerning clinical symptoms. Identification of eligible patients began in May 2016, and implementation of the intervention is feasible. Trial processes are embedded into existing clinical pathways. The primary outcome is time to readmission for any cause. Cost-effectiveness analyses are planned to evaluate the healthcare costs and health outcomes of the approach. CONCLUSIONS:The EMPOWER trial incorporates leading-edge approaches in human motivation, derived from behavioral economics, with contemporary technology to provide scale and exception handling at low cost. The trial is also implemented within the naturalized environment of a health system, as much as possible taking advantage of the existing journeys of patients and workflows of clinicians. A goal of this pragmatic design is to limit resource utilization and also to test an intervention that would need minimal modification to be translated from research into a new way of practice. CLINICAL TRIAL REGISTRATION/BACKGROUND:URL: https://www.clinicaltrials.gov . Unique identifier: NCT02708654.

BACKGROUND:Treatment for opioid use disorder (OUD) is highly effective, yet it remains dramatically underutilized. Individuals with OUD have disproportionately high rates of hospitalization and low rates of addiction treatment. Hospital-based addiction consult services offer a potential solution by using multidisciplinary teams to evaluate patients, initiate medication for addiction treatment (MAT) in the hospital, and connect patients to post-discharge care. We are studying the effectiveness of an addiction consult model [Consult for Addiction Treatment and Care in Hospitals (CATCH)] as a strategy for engaging patients with OUD in treatment as the program rolls out in the largest municipal hospital system in the US. The primary aim is to evaluate the effectiveness of CATCH in increasing post-discharge initiation and engagement in MAT. Secondary aims are to assess treatment retention, frequency of acute care utilization and overdose deaths and their associated costs, and implementation outcomes. METHODS:A pragmatic trial at six hospitals, conducted in collaboration with the municipal hospital system and department of health, will be implemented to study the CATCH intervention. Guided by the RE-AIM evaluation framework, this hybrid effectiveness-implementation study (Type 1) focuses primarily on effectiveness and also measures implementation outcomes to inform the intervention's adoption and sustainability. A stepped-wedge cluster randomized trial design will determine the impact of CATCH on treatment outcomes in comparison to usual care for a control period, followed by a 12-month intervention period and a 6- to 18-month maintenance period at each hospital. A mixed methods approach will primarily utilize administrative data to measure outcomes, while interviews and focus groups with staff and patients will provide additional information on implementation fidelity and barriers to delivering MAT to patients with OUD. DISCUSSION/CONCLUSIONS:Because of their great potential to reduce the negative health and economic consequences of untreated OUD, addiction consult models are proliferating in response to the opioid epidemic, despite the absence of a strong evidence base. This study will provide the first known rigorous evaluation of an addiction consult model in a large multi-site trial and promises to generate knowledge that can rapidly transform practice and inform the potential for widespread dissemination of these services. TRIAL REGISTRATION/BACKGROUND:NCT03611335.

Importance/UNASSIGNED:Despite limited effectiveness of pay-for-performance (P4P), payers continue to expand P4P nationally. Objective/UNASSIGNED:To test whether increasing bonus size or adding the behavioral economic principles of increased social pressure (ISP) or loss aversion (LA) improves the effectiveness of P4P. Design, Setting, and Participants/UNASSIGNED:Parallel studies conducted from January 1 to December 31, 2016, consisted of a randomized clinical trial with patients cluster-randomized by practice site to an active control group (larger bonus size [LBS] only) or to groups with 1 of 2 behavioral economic interventions added and a cohort study comparing changes in outcomes among patients of physicians receiving an LBS with outcomes in propensity-matched physicians not receiving an LBS. A total of 8118 patients attributed to 66 physicians with 1 of 5 chronic conditions were treated at Advocate HealthCare, an integrated health system in Illinois. Data were analyzed using intention to treat and multiple imputation from February 1, 2017, through May 31, 2018. Interventions/UNASSIGNED:Physician participants received an LBS increased by a mean of $3355 per physician (LBS-only group); prefunded incentives to elicit LA and an LBS; or increasing proportion of a P4P bonus determined by group performance from 30% to 50% (ISP) and an LBS. Main Outcomes and Measures/UNASSIGNED:The proportion of 20 evidence-based quality measures achieved at the patient level. Results/UNASSIGNED:A total of 86 physicians were eligible for the randomized trial. Of these, 32 were excluded because they did not have unique attributed patients. Fifty-four physicians were randomly assigned to 1 of 3 groups, and 33 physicians (54.5% male; mean [SD] age, 57 [10] years) and 3747 patients (63.6% female; mean [SD] age, 64 [18] years) were included in the final analysis. Nine physicians and 864 patients were randomized to the LBS-only group, 13 physicians and 1496 patients to the LBS plus ISP group, and 11 physicians and 1387 patients to the LBS plus LA group. Physician characteristics did not differ significantly by arm, such as mean (SD) physician age ranging from 56 (9) to 59 (9) years, and sex (6 [46.2%] to 6 [66.7%] male). No differences were found between the LBS-only and the intervention groups (adjusted odds ratio [aOR] for LBS plus LA vs LBS-only, 0.86 [95% CI, 0.65-1.15; P = .31]; aOR for LBS plus ISP vs LBS-only, 0.95 [95% CI, 0.64-1.42; P = .81]; and aOR for LBS plus ISP vs LBS plus LA, 1.10 [95% CI, 0.75-1.61; P = .62]). Increased bonus size was associated with a greater increase in evidence-based care relative to the comparison group (risk-standardized absolute difference-in-differences, 3.2 percentage points; 95% CI, 1.9-4.5 percentage points; P < .001). Conclusions and Relevance/UNASSIGNED:Increased bonus size was associated with significantly improved quality of care relative to a comparison group. Adding ISP and opportunities for LA did not improve quality. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT02634879.

BACKGROUND:Medication adherence after myocardial infarction remains low. Pharmacy claims have typically been used to measure medication adherence, but electronic pill bottles may offer additional information. OBJECTIVE:The main objectives of this study were to compare the association of adherence measured by prescription claims and remote monitoring technologies with cardiovascular events. RESEARCH DESIGN/METHODS:This study was a secondary analysis of a remote monitoring intervention to increase medication adherence in myocardial infarction patients. SUBJECTS/METHODS:In total, 682 myocardial infarction patients were randomized to the intervention group with both medical and pharmacy benefits. MEASURES/METHODS:Pharmacy claims adherence was measured using proportion of days covered (PDC) and GlowCap adherence (GC) was measured as the proportion of days the pill bottle was opened. We compared the association of PDC and GC adherence for statins with time to first vascular readmission or death and assessed model fit using Akaike information criterion and Bayesian information criterion and the likelihood ratio test. RESULTS:Higher PDC was significantly associated with a lower hazard rate for vascular readmissions or death (hazard ratio=0.435; P=0.009). There was also an association between GC adherence and vascular readmissions or death (hazard ratio=0.313; P≤0.001). Adding the GC adherence variable to the model using only PDC improved the model fit (likelihood ratio test, P=0.001), as well as vice versa (P=0.050). CONCLUSIONS:Pharmacy claims data provide useful but not complete data for medication adherence monitoring. New wireless technologies have the potential to provide additional data about clinical outcomes.

While financial incentives to providers or patients are increasingly common as a quality improvement strategy, their impact on patient subgroups and health care disparities is unclear. To examine these patterns, we analyzed data from a randomized clinical trial of financial incentives to lower low-density lipoprotein (LDL) cholesterol levels in patients at risk for cardiovascular disease. Patients with higher baseline LDL experienced greater cholesterol reductions in the shared incentive arm (0.23 mg/dL per unit change in baseline LDL, 95% CI [-0.46, -0.00]) but were also less likely to have medication potency increases in the physician incentive arm ( OR = 0.98, 95% CI [0.97, 0.996]). Uninsured patients and those of race other than Black or White were less likely to have potency increases in the shared incentive arm ( OR = 0.15, 95% CI [0.03, 0.70] and OR = 0.09, 95% CI [0.01, 0.93], respectively). These findings suggest some differential response to incentives, particularly in the form of targeted medication changes.

OBJECTIVE:The goal of this study was to develop and assess intra and inter-rater reliability and validity of a clinical evaluation tool for breast cancer related lymphedema, for use in the context of outcome evaluation in clinical trials DESIGN: Blinded repeated measures observational study. SETTING/METHODS:Outpatient research laboratory. PARTICIPANTS/METHODS:Breast cancer survivors with and without lymphedema (N=71). INTERVENTIONS/METHODS:Not applicable. MAIN OUTCOME MEASURE/METHODS:The assessment of Intraclass Correlations (ICCs) for the Breast Cancer related Lymphedema in the Upper Extremity (CLUE) standardized clinical evaluation tool. RESULTS:Intra-rater reliability for the CLUE tool was ICC: 0.88 (95% CI: 0.71, 0.96). Inter-rater reliability for the CLUE tool was ICC: 0.90 (95% CI: 0.79, 0.95). Concurrent validity of the CLUE score (Pearson's r) was 0.79 with perometric inter-limb difference, and 0.53 with the Norman Lymphedema overall score. CONCLUSIONS:The CLUE tool shows excellent inter- and intra-rater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy.