MarySue Beran, Heidi L. Ekstrom, A. Lauren Crain, Stephanie A. Hooker, Lilian Chumba, Deepika Appana, Kay Kromrey, Gopikrishna Kunisetty, Zeke M. McKinney, Nicolaas P. Pronk, Rashmi Sharma, Jennifer Vesely, Patrick J. O'Connor
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引用次数: 0
Abstract
Background
To promote use of lifestyle, pharmacologic, and surgical weight management options for adults with body mass index (BMI) ≥35 kg/m2 and type 2 diabetes (T2D), this project implements and evaluates a weight loss clinical decision support (WL-CDS) intervention that provides patient-specific estimates of the risks and benefits of evidence-based obesity management options to primary care clinicians (PCCs) and patients at primary care clinical encounters.
Methods
We randomize 38 primary care clinics to either (a) usual care (UC), or (b) the WL- CDS intervention that provides patients and PCCs recommendations for lifestyle changes and patient-specific obesity management options and estimates of benefits and risks of weight loss medications, or metabolic bariatric surgery (MBS) when indicated.
Primary endpoints
Outcomes assessed at 18-months after a patient-specific index date are (a) referral of eligible patients for MBS evaluation; (b) initiation or active management of FDA-approved medications for weight loss; and (c) weight trajectory. Outcomes measured within 1 month of index date are patient-reported (d) shared decision making about weight loss options, and (e) intention to engage in weight loss.
Conclusion
This study will deepen our understanding of how patients and PCCs use WL-CDS generated information to inform selection of obesity care options for adults with T2D and BMI ≥35 kg/m2.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.