N/A N=2,146 Randomized Prevention

Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

Cancer · Smoking · Tobacco Use · Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT04737031 ↗

Enrolled (actual)

2,146

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Penetration (Rate of Referral to TUTS or Medication Prescription) — 66; 180; 40; 222 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clinician Nudge (Other); Patient Nudge (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Abramson Cancer Center at Penn Medicine
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Penetration (Rate of Referral to TUTS or Medication Prescription)	66; 180; 40; 222	—
SECONDARY Treatment Engagement Rates (Medication)	52; 66; 28; 88	—
SECONDARY Treatment Engagement Rate (Behavioral)	0; 131; 0; 133	—
SECONDARY Quit Attempt Rate	0; 14; 0; 18	—
SECONDARY Abstinence Rate	0; 2; 0; 1	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Clinician participants must meet the following criteria for inclusion:

Currently in practice at an Implementation Lab site (UPHS)
Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant)
Cared for at least 1 tobacco-using patient in 30 days prior to recruitment
English-speaking (messages will be in English)

Patient participants must be diagnosed with cancer and report current tobacco smoking (as assessed by an by any staff collecting vital signs or initially rooming the patients such as nurses, front desk staff, MAs, nursing assistants or technicians during an Index Visit). Patients are considered in the analyzable dataset after their Index Visit and after they have a clinic visit with a clinician in the study at which point a nudge may have been delivered (see steps below).

The process by which patients become eligible for inclusion involves a 3-step algorithm employed in the EMR:

Step 1 - All patients seeking care within the participating Abramson Cancer Center programs are screened for tobacco use status in order to ascertain relevance to the project (i.e., tobacco exposure). This screening encounter need not be a visit with a clinician who is in the cluster randomization.

Step 2 - This step occurs at the first visit with a clinician within the cluster randomization. Note that this might be the same encounter in which screening occurs, but does not have to be. At this visit, all patients identified as current smokers are assigned a hidden (i.e., system) variable, the value of which is based on the clinician they are scheduled to meet during that visit (i.e., cluster membership).

Step 3 - The logic is engaged at the next (third in series) visit, wherein the system variable is used to guide the intervention based on the clinician's cohort. There must be this visit to permit the delivery of the nudges (or not, if in usual care arm). The primary outcome is clinician referral for tobacco cessation through the EHR at this visit. Thus, patients eligible for this study are only those who are screened (and positive for tobacco use) and have completed the two visits in their randomly assigned cluster (clinician clusters are the unit of randomization) during the study period.

Outcomes are assessed at the patient level.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04737031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.