Cancer, Nicotine Dependence, Smoking, Tobacco Use
Conditions
Keywords
Cancer, Smoking, Tobacco Use, Nicotine Dependence, Tobacco Use Treatment Service
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Currently in active practice within Medical and Radiation Oncology divisions of ACC, 2. Prescribing authority in Pennsylvania (i.e. physician, nurse practitioner, physician assistant), 3. Nonsmoker, 4. Has cared for at least one patient with tobacco use disorder in the 30 days prior to recruitment, 5. English speaking, and 6. Willing to provide informed consent to participate.
Exclusion criteria
1. Unwillingness to prescribe varenicline, or 2. Unwillingness to assign varenicline management to TUT Service providers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Ordering Rate | Up to 30 days after Initial Visit | Defined as the number of patients for whom any inpatient tobacco use treatment order is signed by a participating clinician, divided by the total number of patients in each arm for whom an order was pended and the alert fired |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outpatient/Discharge Medication Ordering Rate | Up to 30 days after Initial Visit | Defined as the number of patients for whom any tobacco use treatment medication was ordered upon patient discharge from the hospital, divided by the total number of patients in each arm for whom an order was pended and the alert fired |
| TUTS Referral Rate | Up to 30 days after Initial Visit | Defined as the number of inpatients for whom a referral to the health system's Smoking Cessation Program was placed, divided by the total number of patients in each arm for whom an order was pended and the alert fired |
| Inpatient Medication Ordering Rate | Up to 30 days after Initial Visit | Defined as the number of patients for whom any inpatient tobacco use treatment medication was ordered, divided by the total number of patients in each arm for whom an order was pended and the alert fired |
| Medication Recommendation Rate | 30 Day Follow-up Assessment | Defined as the number of patients who are recommended to receive a tobacco use treatment medication by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling |
| Follow-up Recommendation Rate | 30 Day Follow-up Assessment | Defined as the number of patients who are recommended to receive a tobacco use treatment medication or a follow-up appointment by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling |
| Quit Line Rate | 30 Day Follow-up Assessment | Defined as the total number of patients who present for quit line counseling (i.e. telephone or electronic), divided by the total number of patients referred to the Smoking Cessation Program |
Countries
United States
Participant flow
Pre-assignment details
635 patients accrued to the study, and the 50 clinicians who saw these patients received either the intervention alert or the usual care alert depending on the arm to which they were randomized. In total, this resulted in 685 individuals who were involved in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care TUT Service Only | 397 |
| Tobacco Use Treatment Service + Varenicline Management TUTS + Varenicline Management
Tobacco Use Treatment Service and Varenicline Management: 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. | 238 |
| Total | 635 |
Baseline characteristics
| Characteristic | Usual Care | Total | Tobacco Use Treatment Service + Varenicline Management |
|---|---|---|---|
| Age, Continuous | 55.66 years STANDARD_DEVIATION 13.73 | 56.53 years STANDARD_DEVIATION 13.87 | 57.99 years STANDARD_DEVIATION 14.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 14 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 383 Participants | 614 Participants | 231 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 294 Participants | 475 Participants | 181 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 28 Participants | 11 Participants |
| Race (NIH/OMB) White | 82 Participants | 125 Participants | 43 Participants |
| Region of Enrollment United States | 397 participants | 635 participants | 238 participants |
| Sex: Female, Male Female | 175 Participants | 272 Participants | 97 Participants |
| Sex: Female, Male Male | 222 Participants | 363 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 397 | 0 / 238 |
| other Total, other adverse events | 0 / 397 | 0 / 238 |
| serious Total, serious adverse events | 0 / 397 | 0 / 238 |
Outcome results
Intervention Ordering Rate
Defined as the number of patients for whom any inpatient tobacco use treatment order is signed by a participating clinician, divided by the total number of patients in each arm for whom an order was pended and the alert fired
Time frame: Up to 30 days after Initial Visit
Population: Outcome measures were only assessed for patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Intervention Ordering Rate | 113 Participants |
| Tobacco Use Treatment Service + Varenicline Management | Intervention Ordering Rate | 60 Participants |
Follow-up Recommendation Rate
Defined as the number of patients who are recommended to receive a tobacco use treatment medication or a follow-up appointment by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling
Time frame: 30 Day Follow-up Assessment
Population: This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Follow-up Recommendation Rate | 4 Participants |
| Tobacco Use Treatment Service + Varenicline Management | Follow-up Recommendation Rate | 5 Participants |
Inpatient Medication Ordering Rate
Defined as the number of patients for whom any inpatient tobacco use treatment medication was ordered, divided by the total number of patients in each arm for whom an order was pended and the alert fired
Time frame: Up to 30 days after Initial Visit
Population: Outcomes were only assessed for patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Inpatient Medication Ordering Rate | 73 Participants |
| Tobacco Use Treatment Service + Varenicline Management | Inpatient Medication Ordering Rate | 41 Participants |
Medication Recommendation Rate
Defined as the number of patients who are recommended to receive a tobacco use treatment medication by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling
Time frame: 30 Day Follow-up Assessment
Population: This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Medication Recommendation Rate | 4 Participants |
| Tobacco Use Treatment Service + Varenicline Management | Medication Recommendation Rate | 4 Participants |
Outpatient/Discharge Medication Ordering Rate
Defined as the number of patients for whom any tobacco use treatment medication was ordered upon patient discharge from the hospital, divided by the total number of patients in each arm for whom an order was pended and the alert fired
Time frame: Up to 30 days after Initial Visit
Population: Outcomes were only assessed for patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Outpatient/Discharge Medication Ordering Rate | 26 Participants |
| Tobacco Use Treatment Service + Varenicline Management | Outpatient/Discharge Medication Ordering Rate | 17 Participants |
Quit Line Rate
Defined as the total number of patients who present for quit line counseling (i.e. telephone or electronic), divided by the total number of patients referred to the Smoking Cessation Program
Time frame: 30 Day Follow-up Assessment
Population: This outcome was only assessed for patients who were referred to the Smoking Cessation Program.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Quit Line Rate | 5 Participants |
| Tobacco Use Treatment Service + Varenicline Management | Quit Line Rate | 5 Participants |
TUTS Referral Rate
Defined as the number of inpatients for whom a referral to the health system's Smoking Cessation Program was placed, divided by the total number of patients in each arm for whom an order was pended and the alert fired
Time frame: Up to 30 days after Initial Visit
Population: Outcomes were only assessed for patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | TUTS Referral Rate | 13 Participants |
| Tobacco Use Treatment Service + Varenicline Management | TUTS Referral Rate | 20 Participants |