Trial Outcomes & Findings for Improving Tobacco Treatment Rates for Cancer Patients Who Smoke (NCT NCT04738643)
NCT ID: NCT04738643
Last Updated: 2025-05-08
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
685 participants
Primary outcome timeframe
Up to 30 days after Initial Visit
Results posted on
2025-05-08
Participant Flow
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.
Participant milestones
| Measure |
Usual Care
TUT Service Only
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
425
|
260
|
|
Overall Study
Patients Who Received Any Tobacco Use Treatment
|
113
|
60
|
|
Overall Study
COMPLETED
|
425
|
260
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Tobacco Treatment Rates for Cancer Patients Who Smoke
Baseline characteristics by cohort
| Measure |
Usual Care
n=397 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=238 Participants
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.
|
Total
n=635 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.66 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
57.99 years
STANDARD_DEVIATION 14.02 • n=7 Participants
|
56.53 years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
383 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
614 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
294 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
475 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
397 participants
n=5 Participants
|
238 participants
n=7 Participants
|
635 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after Initial VisitPopulation: Outcome measures were only assessed for patients.
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
| Measure |
Usual Care
n=397 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=238 Participants
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.
|
|---|---|---|
|
Intervention Ordering Rate
|
113 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after Initial VisitPopulation: Outcomes were only assessed for patients.
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
Outcome measures
| Measure |
Usual Care
n=397 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=238 Participants
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.
|
|---|---|---|
|
Inpatient Medication Ordering Rate
|
73 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after Initial VisitPopulation: Outcomes were only assessed for patients.
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
Outcome measures
| Measure |
Usual Care
n=397 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=238 Participants
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.
|
|---|---|---|
|
Outpatient/Discharge Medication Ordering Rate
|
26 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after Initial VisitPopulation: Outcomes were only assessed for patients.
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
Outcome measures
| Measure |
Usual Care
n=397 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=238 Participants
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.
|
|---|---|---|
|
TUTS Referral Rate
|
13 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 30 Day Follow-up AssessmentPopulation: This outcome was only assessed for patients who were referred to the Smoking Cessation Program.
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
Outcome measures
| Measure |
Usual Care
n=10 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=23 Participants
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.
|
|---|---|---|
|
Quit Line Rate
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 Day Follow-up AssessmentPopulation: This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult.
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
Outcome measures
| Measure |
Usual Care
n=5 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=5 Participants
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.
|
|---|---|---|
|
Medication Recommendation Rate
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 Day Follow-up AssessmentPopulation: This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult.
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
Outcome measures
| Measure |
Usual Care
n=5 Participants
TUT Service Only
|
Tobacco Use Treatment Service + Varenicline Management
n=5 Participants
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.
|
|---|---|---|
|
Follow-up Recommendation Rate
|
4 Participants
|
5 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tobacco Use Treatment Service + Varenicline Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place