An Obesity-Centric Approach with and Without Anti-Obesity Medications Compared to the Usual-Care Approach to Management of Patients with Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial (EMPOWER-T2D).

INTRODUCTION: This study aimed to compare weight loss and glycated hemoglobin (HbA1c)-reduction effects of two obesity-centric, weight-loss management approaches (with or without anti-obesity medication) versus usual glucose-centric care in patients with obesity and type 2 diabetes. METHODS: Single-center, randomized, open-label, 3-armed, parallel-group, pragmatic, noninferiority trial, July 2020 to August 2022. Adults enrolled in the Cleveland Clinic Employee Health Plan (body mass index [BMI] ≥ 30 kg/m2, type 2 diabetes diagnosis, HbA1c > 7.5%) were randomized to usual glucose-centric management ("Usual-Care" group) or one of two obesity-centric management strategies: participation in a weight management program plus anti-obesity medication ("WMP + AOM" group), or WMP participation without anti-obesity medication ("WMP-Only" group). Primary endpoints were changes in weight and HbA1c, baseline to month 12. RESULTS: Due to enrollment and retention challenges, largely related to COVID-19, only 74/300 planned participants were randomized and the study was terminated early. Participants were predominantly female (59%), median (interquartile range [IQR]) age 53.5 (47, 60) years, 68% white, with baseline median (IQR) BMI and HbA1c of 37.4 (34.2, 42.7) kg/m2 and 8.8% (7.9%, 10.4%), respectively. At month 12, mean (90% confidence interval [CI]) percentage weight change in the Usual-Care, WMP-Only, and WMP + AOM groups was - 4.5% (- 6.5%, - 2.5%), - 6.7% (- 8.7%, - 4.7%), and - 8.7% (- 10.7%, - 6.8%), respectively; mean (90% CI) HbA1c change was - 1.7% (- 2.1%, - 1.2%), - 2.2% (- 2.7%, - 1.8%), and - 2.2% (- 2.6%, - 1.7%), respectively. WMP + AOM was superior to Usual-Care for weight change (P = 0.02); both WMP + AOM and WMP-Only were noninferior (P ≤ 0.01) to Usual-Care for change in HbA1c. CONCLUSIONS: Including anti-obesity medication was associated with superior weight loss with noninferior HbA1c reductions, warranting further evaluation in larger study populations of obesity-focused approaches to type 2 diabetes management. Graphical abstract available for this article. TRIAL REGISTRATION: ClinicalTrials.gov NCT03799198.

Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial.

Importance: The clinical efficacy of antiobesity medications (AOMs) as adjuncts to lifestyle intervention is well characterized, but data regarding their use in conjunction with workplace wellness plans are lacking, and coverage of AOMs by US private employers is limited. Objective: To determine the effect of combining AOMs with a comprehensive, interdisciplinary, employer-based weight management program (WMP) compared with the WMP alone on weight loss, treatment adherence, and work productivity and limitations. Design, Setting, and Participants: This 1-year, single-center, open-label, parallel-group, real-world, randomized clinical trial was conducted at the Cleveland Clinic's Endocrinology and Metabolism Institute in Cleveland, Ohio, from January 7, 2019, to May 22, 2020. Participants were adults with obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥30) enrolled in the Cleveland Clinic Employee Health Plan. Interventions: In total, 200 participants were randomized 1:1, 100 participants to WMP combined with an AOM (WMP+Rx), and 100 participants to WMP alone. The WMP was the Cleveland Clinic Endocrinology and Metabolism Institute's employer-based integrated medical WMP implemented through monthly multidisciplinary shared medical appointments. Participants in the WMP+Rx group initiated treatment with 1 of 5 US Food and Drug Administration-approved medications for chronic weight management (orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide, 3.0 mg) according to standard clinical practice. Main Outcomes and Measures: The primary end point was the percentage change in body weight from baseline to month 12. Results: The 200 participants were predominately (177 of 200 [88.5%]) women, had a mean (SD) age of 50.0 (10.3) years, and a mean (SD) baseline weight of 105.0 (19.0) kg. For the primary intention-to-treat estimand, the estimated mean (SE) weight loss was -7.7% (0.7%) for the WMP+Rx group vs -4.2% (0.7%) for the WMP group, with an estimated treatment difference of -3.5% (95% CI, -5.5% to -1.5%) (P < .001). The estimated percentage of participants achieving at least 5% weight loss was 62.5% for WMP+Rx vs 44.8% for WMP (P = .02). The rate of attendance at shared medical appointments was higher for the WMP+Rx group than for the WMP group. No meaningful differences in patient-reported work productivity or limitation measures were observed. Conclusions and Relevance: Clinically meaningful superior mean weight loss was achieved when access to AOMs was provided in the real-world setting of an employer-based WMP, compared with the WMP alone. Such results may inform employer decisions regarding AOM coverage and guide best practices for comprehensive, interdisciplinary employer-based WMPs. Trial Registration: ClinicalTrials.gov Identifier: NCT03799198.

Feasibility of electronic sleep disorder screening in healthcare workers of a large healthcare system.

STUDY OBJECTIVES: Many healthcare workers live with sleep disorders and may be unaware of their condition. We aimed to ascertain sleep disorder symptoms including high-risk obstructive sleep apnea (hrOSA), significant insomnia, and excessive daytime sleepiness (EDS) by work shift in a sample of healthcare workers. We aim to inform the development of a mobile application for sleep disorder screening and electronically-delivered follow-up recommendations. METHODS: An initial survey, including the Epworth Sleepiness Scale (ESS) for EDS, Insomnia Severity Scale (ISI) for insomnia, and STOP questionnaire for hrOSA, was completed by healthcare workers at the Cleveland Clinic. A follow-up survey sent ∼3-6 months after screening assessed perceptions of the utility of screening and subsequent actions taken by those with abnormal scores. RESULTS: 871 of 2851 (30.7%) workers who participated had abnormal ESS scores, with a significantly greater portion of night shift workers with abnormal scores compared to day or evening shift workers (p < 0.001). 27.5% of all workers had moderate to severe insomnia symptoms, with higher percentages of moderate or severe scores in evening and night shift workers (p < 0.001). 36.9% of workers had hrOSA, and of those previously diagnosed with obstructive sleep apnea (OSA) and using positive airway pressure therapy, over 90% reported treatment adherence (≥4 h per night). At follow-up, 92% of 484 respondents believed that sleep screening was valuable, with most taking some action after receiving abnormal results and over a quarter seeking sleep center treatment. CONCLUSIONS: Many healthcare workers, especially shift workers, experience sleep disorder symptoms, and our findings suggest that electronic sleep disorder symptom screening is feasible.

Medical and Pharmacy Costs for New Hire Nurses Following a Physical Strength Evaluation Screening in a Large Health System.

Nurses often encounter situations that require lifting patients, often using awkward body positions. Hiring nurses with strength suitable for these jobs decreases nurses' risk for illness and injury and would be expected to result in more appropriate and lower health care, pharmacy, and disability costs. The physical strength of new hire nurse applicants was assessed using a defensible isokinetic evaluation in the years 2011 and 2012. Health care and pharmacy costs were monitored for the first 12 months following date of hire and compared with costs for nurses hired without screening during the prior 2 years (2009 and 2010). The strength assessment group had significantly (p < .05) lower health care and pharmacy costs per member per month (PMPM) compared with the comparison group. The study suggests that use of physical capability strength assessment is effective in hiring nurses with appropriate strength capability, resulting in significant health care and pharmacy cost avoidance.