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Study protocol for a pragmatic trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) model for engaging patients in opioid use disorder treatment
McNeely, Jennifer; Troxel, Andrea B; Kunins, Hillary V; Shelley, Donna; Lee, Joshua D; Walley, Alexander; Weinstein, Zoe M; Billings, John; Davis, Nichola J; Marcello, Roopa Kalyanaraman; Schackman, Bruce R; Barron, Charles; Bergmann, Luke
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.
PMID: 30777122
ISSN: 1940-0640
CID: 3687782
Financial Incentives Promote Smoking Cessation Directly, Not by Increasing Use of Cessation Aids [Letter]
Harhay, Michael O.; Troxel, Andrea B.; Brophy, Christine; Saulsgiver, Kathryn; Volpp, Kevin G.; Halpern, Scott D.
ISI:000457418900024
ISSN: 1546-3222
CID: 3646552
Effect of Financial Bonus Size, Loss Aversion, and Increased Social Pressure on Physician Pay-for-Performance: A Randomized Clinical Trial and Cohort Study
Navathe, Amol S; Volpp, Kevin G; Caldarella, Kristen L; Bond, Amelia; Troxel, Andrea B; Zhu, Jingsan; Matloubieh, Shireen; Lyon, Zoe; Mishra, Akriti; Sacks, Lee; Nelson, Carrie; Patel, Pankaj; Shea, Judy; Calcagno, Don; Vittore, Salvatore; Sokol, Kara; Weng, Kevin; McDowald, Nichia; Crawford, Paul; Small, Dylan; Emanuel, Ezekiel J
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.
PMCID:6484616
PMID: 30735234
ISSN: 2574-3805
CID: 3935622
Moderating Effects of Patient Characteristics on the Impact of Financial Incentives
Rosenthal, Meredith B; Troxel, Andrea B; Volpp, Kevin G; Stewart, Walter F; Sequist, Thomas D; Jones, James B; Hirsch, AnneMarie G; Hoffer, Karen; Zhu, Jingsan; Wang, Wenli; Hodlofski, Amanda; Finnerty, Darra; Huang, Jack J; Asch, David A
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.
PMCID:6222012
PMID: 29148344
ISSN: 1552-6801
CID: 3663512
Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer related Lymphedema of the Upper Extremity (CLUE)
Spinelli, Bryan; Kallan, Michael J; Zhang, Xiaochen; Cheville, Andrea; Troxel, Andrea; Cohn, Joy; Dean, Lorraine; Sturgeon, Kathleen; Evangelista, Margaret; Zhang, Zi; Ebaugh, David; Schmitz, Kathryn H
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.
PMID: 30291828
ISSN: 1532-821x
CID: 3329432
Financial Incentives Promote Smoking Cessation Directly, Not by Increasing Use of Cessation Aids [Letter]
Harhay, Michael O; Troxel, Andrea B; Brophy, Christine; Saulsgiver, Kathryn; Volpp, Kevin G; Halpern, Scott D
PMCID:6376943
PMID: 30290121
ISSN: 2325-6621
CID: 5085032
Comparison of Pharmacy Claims and Electronic Pill Bottles for Measurement of Medication Adherence Among Myocardial Infarction Patients
Mehta, Shivan J; Asch, David A; Troxel, Andrea B; Lim, Raymond; Lewey, Jennifer; Wang, Wenli; Zhu, Jingsan; Norton, Laurie; Marcus, Noora; Volpp, Kevin G
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.
PMID: 30045159
ISSN: 1537-1948
CID: 3216462
Response to Brown et al. 'Does the offer of e-cigarettes benefit smoking cessation among unselected smokers?' [Letter]
Harhay, Michael O; Troxel, Andrea B; Volpp, Kevin G; Halpern, Scott D
PMCID:6362982
PMID: 30411428
ISSN: 1360-0443
CID: 4113412
Phase II trial of nivolumab with chemotherapy as neoadjuvant treatment in inflammatory breast cancer. [Meeting Abstract]
Kwa, Maryann J.; Tray, Nancy; Esteva, Francisco J.; Novik, Yelena; Speyer, James L.; Oratz, Ruth; Meyers, Marleen Iva; Muggia, Franco; Ty, Victor; Troxel, Andrea; Schneider, Robert; Adams, Sylvia
ISI:000487345803405
ISSN: 0732-183x
CID: 5197792
Mobile Health Technologies for Older Adults with Cardiovascular Disease: Current Evidence and Future Directions
Searcy, Ryan P.; Summapund, Jenny; Estrin, Deborah; Pollak, John P.; Schoenthaler, Antoinette; Troxel, Andrea B.; Dodson, John A.
ISI:000460546000004
ISSN: 2196-7865
CID: 4450462