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

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.

Study on the Conduction Analysis and Blocking Intervention Scheme of Emotional Disorders between Cancer Patients and Their Families

“…In the study, some scholars reported the care burden of caregivers of advanced cancer patients and summarized the caregiver problems into the following categories, namely, economic problems, psychological burden, and lack of access to information [ 8 ]. Some data indicate that cancer caregivers' primary concern in the care process is to alleviate the patient's suffering and deliberately ignore their own problems, preventing most of the negative emotional barriers from being addressed in a timely manner [ 9 ]. In a study of 200 family caregivers, scholars found that less than half of the caregivers were willing to seek professional help on their own problems.…”

Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke

“…We conducted a cluster-randomized pragmatic trial across five hospitals and six clinics within Penn Medicine's Abramson Cancer Center. 40 Clinician clusters were randomized into four arms: clinician nudge, patient nudge, both clinician and patient nudge, or usual care. Patients were nested within clinician clusters.…”

“…During preparation for this trial, we identified alternate workflows that clinicians used to provide tobacco use medications without referring patients to the TUT program. 40 We chose an inclusive, pragmatic outcome definition of penetration to capture all observable TUT behaviors. Thus, the primary implementation outcome was penetration of TUT, defined as the proportion of patients who received either a treatment referral (via the BPA or elsewhere in the EHR workflow) or a prescription for tobacco treatment medication (ie, nicotine replacement, varenicline, or bupropion).…”

Nudging oral habits; application of behavioral economics in oral health promotion: a critical review

“…For example, putting up posters or signs in public places such as bars or restaurants that highlight the risks of smoking or drinking excessively. Jenssen et al (41) conducted a trial in nine clinical sites within the Cancer Control Implementation Lab of the Implementation Science Centre to assess the effect of behavioral economic implementation strategies provided via embedded messages (or "nudges") encouraging patient involvement with the Tobacco Use Treatment Service. Nudges were electronic medical record (EMR)-based messages sent to patients, clinicians, or both, intending to counter specific patient and clinician biases that reduce treatment engagement (41).…”

“…Jenssen et al (41) conducted a trial in nine clinical sites within the Cancer Control Implementation Lab of the Implementation Science Centre to assess the effect of behavioral economic implementation strategies provided via embedded messages (or "nudges") encouraging patient involvement with the Tobacco Use Treatment Service. Nudges were electronic medical record (EMR)-based messages sent to patients, clinicians, or both, intending to counter specific patient and clinician biases that reduce treatment engagement (41). Drake et al (42) proposed a Clinical Decision Support (CDS) intervention to encourage clinicians to use the CDS instrument in order to increase tobacco cessation among tobacco users.…”