Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

NCT04737031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2146

Last updated 2024-02-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Cancer
  • Smoking
  • Tobacco Use
  • Nicotine Dependence

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Pennsylvania

    collaborator OTHER
  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737031 on ClinicalTrials.gov