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| ID | Type | Description | Link |
|---|---|---|---|
| SAP#4100083101 | Other Grant/Funding Number | Commonwealth of Pennsylvania | |
| 832404 | Other Identifier | University of Pennsylvania Institutional Review Board |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | TUT Service Only | |
| Tobacco Use Treatment Service + Varenicline Management | Experimental | TUTS + Varenicline Management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco Use Treatment Service and Varenicline Management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 30 days after Initial Visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 30 days after Initial Visit |
| Outpatient/Discharge Medication Ordering Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40570180 | Derived | Schnoll R, Blumenthal D, Wileyto EP, Bauer AM, Evers-Casey S, Stevens N, Fisher T, Ware S, Jenssen BP, Wollack C, Schwartz S, Leone FT. Pilot Trial of a Behavioral Economics-Informed Clinical Decision Support Alert to Improve Inpatient Tobacco Use Treatment Rates. Nicotine Tob Res. 2025 Nov 23;27(12):2265-2272. doi: 10.1093/ntr/ntaf129. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | TUT Service Only |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline information was only collected for the 635 patients who accrued to the trial, not for the 50 clinicians.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | TUT Service Only |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Outcome measures were only assessed for patients. | Posted | Count of Participants | Participants | Up to 30 days after Initial Visit |
|
Duration of patient's stay, which averaged as approximately 11 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | TUT Service Only | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Schnoll, PhD | University of Pennsylvania | 215-746-7143 | schnoll@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2024 | Dec 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D064424 | Tobacco Use |
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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 |
| Up to 30 days after Initial Visit |
| 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 | Up to 30 days after Initial Visit |
| 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 | 30 Day Follow-up Assessment |
| 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 | 30 Day Follow-up Assessment |
| 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 | 30 Day Follow-up Assessment |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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 | Outcomes were only assessed for patients. | Posted | Count of Participants | Participants | Up to 30 days after Initial Visit |
|
|
|
| Secondary | 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 | Outcomes were only assessed for patients. | Posted | Count of Participants | Participants | Up to 30 days after Initial Visit |
|
|
|
| Secondary | 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 | Outcomes were only assessed for patients. | Posted | Count of Participants | Participants | Up to 30 days after Initial Visit |
|
|
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| Secondary | 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 | This outcome was only assessed for patients who were referred to the Smoking Cessation Program. | Posted | Count of Participants | Participants | 30 Day Follow-up Assessment |
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| Secondary | 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 | This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult. | Posted | Count of Participants | Participants | 30 Day Follow-up Assessment |
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| Secondary | 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 | This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult. | Posted | Count of Participants | Participants | 30 Day Follow-up Assessment |
|
|
|
| 397 |
| 0 |
| 397 |
| 0 |
| 397 |
| EG001 | 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. | 0 | 238 | 0 | 238 | 0 | 238 |
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