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
Authors: Jenssen Brian P. , Schnoll Robert , Beidas Rinad , Bekelman Justin , Bauer Anna-Marika , Scott Callie , Evers-Casey Sarah , Nicoloso Jody , Gabriel Peter , Asch David A. , Buttenheim Alison , Chen Jessica , Melo Julissa , Shulman Lawrence N. , Clifton Alicia B. W. , Lieberman Adina , Salam Tasnim , Zentgraf Kelly , Rendle Katharine A. , Chaiyachati Krisda , Shelton Rachel , Wileyto E. Paul , Ware Sue , Leone Frank 
Published: July 2021

Abstract
Background
Routine 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.

Methods
A 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.

Discussion
This 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 registration
Clinicaltrials.gov, NCT04737031. Registered 3 February 2021.