Substance Related Disorders

Behaviors and Mental Disorders

All Conditions

Tobacco Use Disorder

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

All Drugs and Chemicals

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

The VM intervention builds upon the established TUT Service process. In addition to connecting the patient to TUT Service via electronic referral, it activates a medication management protocol that: 1) actively confirms no evidence of renal failure or pregnancy with oncology provider, 2) automates a referral to prescribing providers within the TUT Service team, prompting a call-back to patient within 24 hours, 3) provides written AVS instructions to contact TUT Service for initiation instructions and clinic appointment, and 4) pends a varenicline prescription to the medication list, ready for reconciliation by TUT Service prescribing clinicians. The protocol formalizes standard management principles for varenicline, including follow-up evaluation, pre-quit period duration, and side effect amelioration.

Tobacco Use Treatment Service and Varenicline Management

Robert Schnoll, PhD

Frank Leone, MD, MS

The research objective is to identify a simple, pragmatic, innovative way of enhancing Tobacco Use Treatment (TUT) rates within oncology. To investigate this possibility, the investigators propose methods that will allow them to: 1) evaluate the impact of standing orders to initiate a varenicline management protocol within outpatient cancer treatment workflow, 2) assess the potential for an EHR-based intervention to affect patient TUT behaviors, and 3) identify important facilitators and barriers that impact effectiveness of the intervention.

The investigators will assess whether including a standing order for prescription and management of varenicline (TUT Service+VM) within the workflow for cancer patients identified as current smokers will significantly increase TUT engagement rates compared to current standard of care (TUT Service alone). The investigators hypothesize that observed treatment engagement rates will be higher among clinicians exposed to TUT Service+VM than observed in clinicians exposed to TUT Service alone.

To reduce all-cause and cancer-specific mortality, the 2014 Surgeon General's Report emphasized the importance of effective tobacco use treatment (TUT) in cancer care. Unfortunately, up to 50% of cancer patients who smoke prior to their diagnosis continue to do so after diagnosis and treatment. This observation has lead the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the American Association for Cancer Research to call for implementation strategies integrating TUT directly within oncology care. At this time, many cancer centers and oncology practices fall short of providing consistent, high-quality TUT; only half of cancer centers report that they identify tobacco use among patients, and very few use systematic mechanisms to encourage TUT services.

In response, the National Cancer Institute (NCI) funded the Cancer Center Cessation Initiative (C3I) in 2017 with support from the NCI Cancer Moonshot Program. C3I's aim is to help build and sustain TUT infrastructure across the nation's cancer centers, ensuring that cancer patients are systematically screened for tobacco use and provided with evidence-based smoking cessation treatment. Abramson Cancer Center's work implementing the C3I tobacco use treatment service (TUT Service) has significantly improved rates of TUT within oncology practice, however the investigators have identified a number of important social-motivational obstacles to reaching the target of universal TUT. For instance, it is known that simple changes to treatment choice architecture in the electronic health record (EHR), i.e. utilizing an "opt-out" rather than "opt-in" structure, increases TUT Service engagement in a manner similar to other contexts of cancer care. Unfortunately, there remains unacceptable variation in clinician engagement rates. One significant reason for this variation is the individual clinician's perceptions of treatment effectiveness.( A strategy used elsewhere involved utilizing opt-out orders aimed at maximizing the use of varenicline, i.e. "Varenicline Management" (VM). VM resulted in increased clinician utilization and patient cessation within a relatively controlled environment of hospital-based cardiac and pulmonary care. However, it is unknown whether this type of intervention is generalizable to the complex, challenging environment of outpatient oncology.

The goal of this study is to determine if the default for a varenicline order increases clinician referral to TUTS and/or the treatment of tobacco use. At this point, many clinicians are turning the referral order off and patients are not receiving treatment for tobacco use. A default to prescribe treatment may help override barriers to both.

Insights gained from this project form the basis of subsequent clinical trials assessing efficacy of novel implementation approaches improving uptake of evidence-based tobacco use treatment. This study is significant because the model for promoting physician behavior change is simple and pragmatic, yet has the potential to significantly impact cancer patient survival and morbidity. The study builds on previous observations made through NCI and C.U.R.E. investments, expanding the understanding of novel pharmacologic approaches to tobacco cessation.

Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

Defined as the number of orders signed by the clinician, divided by the total number pended orders (1-cancellation rate).

Defined as number of times the BPA is satisfied with any answer, divided by the total number of times the BPA fires

Defined as the number of pended orders accompanied by a signed prescription order for any of the 7 FDA-approved medications sent to pharmacy, divided by the total number of pended orders.

Defined as number of quit line referrals made, divided by the total number of TUT Service engaged patients.

Defined as the number of patients who make a pharmacologically-assisted quit attempt using any of 7 recommended tobacco dependence pharmacotherapies within 30 days of the initial ACC visit, divided by the total number of engaged patients.

Defined as the total number of patients who present for quit line counseling (i.e. telephone or electronic), divided by the total number of engaged patients

Defined as the number of engaged patients who make any quit attempt, divided by the total number of engaged patients

Defined as the total number of engaged patients self-reporting 7-day point prevalence abstinence at a 30-day follow-up assessment.

University of Pennsylvania

Abramson Cancer Center at Penn Medicine

Clinicians and patients will receive no further interventions beyond usual practice.

Clinicians will receive a nudge via Best Practice Alert within the EMR

Patients will receive a message sent through myPennMedicine following establishment of their smoking status.

Both strategies described above will be used.

Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.

Clinician Nudge

Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.

Patient Nudge

The main purpose of this research study is to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing Tobacco Use Treatment Service (TUTS) referral and engagement; and to explore clinician, patient, inner setting (e.g., clinic), and outer setting (e.g., payment structures) mechanisms related to TUTS referral and engagement. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms.

The investigators will conduct a four-arm pragmatic cluster randomize clinical trial to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing TUTS referral and engagement in cancer patients who smoke, vs. usual care (UC). The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to UC and that the combination of nudges to clinicians and to patients will be the most effective.

Continued tobacco smoking negatively impacts survival among patients with cancer. Routinely delivered evidence-based tobacco use treatment (TUT) would minimize cancer-specific and all-cause mortality, reduce treatment-related toxicity, and improve quality of life. About 50% of cancer patients who smoked prior to their diagnosis continue to smoke after diagnosis and during treatment. The National Comprehensive Cancer Network, American Society of Clinical Oncology, and American Association for Cancer Research, call for implementation of TUT within oncology care. In 2015, TUT received an "A" recommendation from the US Preventive Services Task Force, given the high level of certainty of resulting benefit. The approval specifically focused on clinicians asking all adults about smoking, prescribing FDA-approved cessation medications for smokers, and offering appropriate behavioral interventions.

Despite the importance of TUT, only half of cancer centers consistently identify patient tobacco use, and few cancer centers employ systematic mechanisms to refer patients to evidence-based cessation services. Acknowledging this gap, the National Cancer Institute (NCI) launched the Cancer Center Cessation Initiative (C3I) as part of the Moonshot to help centers develop effective ways to identify and engage patients who smoke. Penn ISC3 MPI Dr. Schnoll was a member of the NCI advisory board that developed this initiative, and Penn Medicine's Abramson Cancer Center (ACC) was in the first funded cohort. Because clinician expertise in TUT is a known barrier, the initial strategy used an automatic "default" electronic medical record (EMR) referral to the ACC Tobacco Use Treatment Service (TUTS). Engagement increased, but clinicians turned off the default 60% of the time, implicating additional important barriers to change.

This study aims to produce dramatic change within oncology by refining and testing implementation strategies informed by behavioral economics. The investigators' work has identified specific cognitive biases among clinicians and patients that prevent TUTS referral and engagement, including clinician pessimism regarding the ability to help patients stop using tobacco, misconceptions about patient resistance to treatment, and implicit biases regarding the capacity for patients to volitionally alter the course of illness. These motivators are related to clinician willingness to invest effort in help giving and may prevent acquisition of new knowledge and skills. From the patient perspective, several studies identify unique challenges that individuals with cancer face when engaging in tobacco cessation efforts, including low self-efficacy, low perceived benefits of quitting, and perceived risk of treatment. Thus, this study focuses on addressing these barriers, in a pragmatic and innovative way, to increase TUTS referral and engagement in cancer care.

The investigators' objectives are to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing in TUTS referral and engagement; and to explore clinician, patient, inner setting (e.g., clinic), and outer setting (e.g., payment structures) mechanisms related to TUTS referral and engagement. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms.

The investigators will conduct this study with at least 100 clinicians and at least 900 smokers across Penn Medicine's ACC (the clinician sample size may increase with additional clinicians joining Penn and the patient sample size may be higher given the pragmatic design and delay between determination of eligibility \[i.e., patient smokes\] and nudge delivery at a subsequent visit). They expect the study to yield essential insights into the effectiveness of nudges as an implementation strategy to speed the uptake of high value evidence-based TUT within cancer care, and to advance the understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how cancer care settings can ensure that patients with cancer who smoke are engaged with evidence-based TUT and may lead to a future R01 focused on scaling-up this approach across other cancer centers involved in the C3I.

Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

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 (i.e., nicotine replacement, varenicline, or bupropion)

Based on workflow issues and recommendations from the trial's Data and Safety Monitoring Board (DSMB), the primary outcome for this trial was adjusted to contain both referrals to TUTS and medication prescriptions.

Defined as the number of patients who make a pharmacologically-assisted quit attempt using any of the seven pharmacotherapies within 30 days of the initial oncology visit, divided by the total number of referred patients

Defined as the number of patients who receive a quit-line referral or in-person or telephone cessation counseling, divided by the total number of TUTS-engaged patients

Defined as the number of TUTS-referred patients who make any quit attempt, divided by the total number of TUTS-referred patients

Defined as the total number of TUTS-referred patients self-reporting 7-day point prevalence abstinence at a 90-day follow-up assessment, divided by the total number of TUTS-referred patients

National Cancer Institute (NCI)

Director, Comprehensive Smoking Treatment Program Professor, Critical Care and Pulmonology

Adverse events were only monitored for patients, not for clinicians.

Usual Care

Clinicians will receive a nudge via Best Practice Alert within the EMR

Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.

Patients will receive a message sent through myPennMedicine following establishment of their smoking status.

Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.

Both strategies described above will be used.

Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.

Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.

Clinician and Patient Nudge

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Marital Status

Clinician Type (seen by patients)

Clinician Specialty (seen by patients)

Days between arm assignment and engagement

The following baseline characteristics are for patients only.

Outcome measures were not collected for clinicians.

Penetration (Rate of Referral to TUTS or Medication Prescription)

This outcome was only assessed for patients who were referred to TUTS. Outcome measures were not collected for clinicians.

Treatment Engagement Rates (Medication)

Treatment Engagement Rate (Behavioral)

This outcome was assessed for patients with whom TUTS staff were able to successfully follow up. Outcome measures were not collected for clinicians.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Tobacco Treatment Rates for Cancer Patients Who Smoke	NCT04738643	Cancer Tobacco Use Smoking Nicotine Depend...	Tobacco Use Tre...	-	Abramson Cancer Center at Penn Medicine
Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke	NCT04737031	Cancer Smoking Tobacco Use Nicotine Depend...	Clinician Nudge Patient Nudge	-	Abramson Cancer Center at Penn Medicine
Improving Tobacco Treatment Rates for Cancer Patients Who Smoke	NCT04738643	Cancer Tobacco Use Smoking Nicotine Depend...	Tobacco Use Tre...	-	Abramson Cancer Center at Penn Medicine

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