Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke

Implementation Science

E. Paul Wileyto¹  Alison Buttenheim²  Sarah Evers-Casey³  Jody Nicoloso³  Brian P. Jenssen⁴  Sue Ware⁵  Anna-Marika Bauer⁵  Kelly Zentgraf⁵  Adina Lieberman⁵  Robert Schnoll⁶  Rachel Shelton⁷  David A. Asch⁸  Callie Scott⁹  Alicia B. W. Clifton⁹  Tasnim Salam⁹  Lawrence N. Shulman^1,10  Justin Bekelman^1,11  Katharine A. Rendle^1,12  Rinad Beidas^1,13  Peter Gabriel^1,14  Krisda Chaiyachati^1,15  Frank Leone^1,16  Julissa Melo^1,17  Jessica Chen^1,17 

[1] Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, USA;Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Comprehensive Smoking Treatment Program, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, USA;Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Penn Implementation Science Center (PISCE@LDI), Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, USA;Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia, USA;Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, USA;Penn Implementation Science Center (PISCE@LDI), Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia, USA;Penn Center for Cancer Care Innovation, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;Pulmonary, Allergy, & Critical Care Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA;University of Pennsylvania Health System, Philadelphia, USA;

关键词: Tobacco use;    Tobacco use treatment;    Behavioral economics;    Electronic health record;    Pragmatic trials;   

DOI  :  10.1186/s13012-021-01139-7

来源: Springer

【 摘 要 】

BackgroundRoutine evidence-based tobacco use treatment minimizes cancer-specific and all-cause mortality, reduces treatment-related toxicity, and improves quality of life among patients receiving cancer care. Few cancer centers employ mechanisms to systematically refer patients to evidence-based tobacco cessation services. Implementation strategies informed by behavioral economics can increase tobacco use treatment engagement within oncology care.MethodsA four-arm cluster-randomized pragmatic trial will be conducted across nine clinical sites within the Implementation Science Center in Cancer Control Implementation Lab to compare the effect of behavioral economic implementation strategies delivered through embedded messages (or “nudges”) promoting patient engagement with the Tobacco Use Treatment Service (TUTS). Nudges are electronic medical record (EMR)-based messages delivered to patients, clinicians, or both, designed to counteract known patient and clinician biases that reduce treatment engagement. We used rapid cycle approaches (RCA) informed by relevant stakeholder experiences to refine and optimize our implementation strategies and methods prior to trial initiation. Data will be obtained via the EMR, clinician survey, and semi-structured interviews with a subset of clinicians and patients. The primary measure of implementation is penetration, defined as the TUTS referral rate. Secondary outcome measures of implementation include patient treatment engagement (defined as the number of patients who receive FDA-approved medication or behavioral counseling), quit attempts, and abstinence rates. The semi-structured interviews, guided by the Consolidated Framework for Implementation Research, will assess contextual factors and patient and clinician experiences with the nudges.DiscussionThis study will be the first in the oncology setting to compare the effectiveness of nudges to clinicians and patients, both head-to-head and in combination, as implementation strategies to improve TUTS referral and engagement. We expect the study to (1) yield insights into the effectiveness of nudges as an implementation strategy to improve uptake of evidence-based tobacco use treatment within cancer care, and (2) advance our understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how patients with cancer who smoke are best engaged in tobacco use treatment and may lead to future research focused on scaling this approach across diverse centers.Trial registrationClinicaltrials.gov, NCT04737031. Registered 3 February 2021.

【 授权许可】

CC BY