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

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

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.

Keywords: Behavioral economics; Electronic health record; Pragmatic trials; Tobacco use; Tobacco use treatment.

Conflict of interest statement

Dr. Schnoll has provided consultation to Pfizer, GlaxoSmithKline, and Curaleaf and has received free medication and placebo from Pfizer for past studies. Dr. Asch is a partner at VAL Health. Dr. Beidas receives royalties from Oxford University Press. She has provided consultation to the Camden Coalition of Healthcare Providers. She currently consults to United Behavioral Health and serves on the Clinical and Scientific Advisory Board for Optum Behavioral Health. Dr. Bekelman reports grants from Pfizer, grants from UnitedHealth Group, grants from Embedded Healthcare, grants from Blue Cross Blue Shield of North Carolina, personal fees from UnitedHealthcare, personal fees from CMS, personal fees from NCCN, personal fees from Optum, personal fees from CVS Health, personal fees from Astrazeneca (indirect via NCCN), outside the submitted work.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study schema outlining the study aims
Fig. 2
Fig. 2
Consort diagram
Fig. 3
Fig. 3
Best practice alert received by MAs during the index visit
Fig. 4
Fig. 4
Best practice alert received by clinicians during the subsequent visit
Fig. 5
Fig. 5
Patient nudge received via myPennMedicine prior to their subsequent visit

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