Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

NCT04737031 | Completed Results DMC

• 3 other identifiers: UPCC 01921P50CA244690843062
• Study Type: interventional
• Target: 2,146
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Cancer; Smoking; Tobacco Use; Nicotine Dependence; Tobacco Use Treatment Service

Outcome Measures

Primary Outcomes (1)

• Penetration (Rate of Referral to TUTS or Medication Prescription)

  Defined as the proportion of patients who received either a treatment referral (via the BPA or elsewhere in the EHR workflow) or a prescription for tobacco treatment medication (i.e., nicotine replacement, varenicline, or bupropion) Based on workflow issues and recommendations from the trial's Data and Safety Monitoring Board (DSMB), the primary outcome for this trial was adjusted to contain both referrals to TUTS and medication prescriptions.

  through study completion, up to one year

Secondary Outcomes (4)

• Treatment Engagement Rates (Medication)

  Up to 30 days following baseline

• Treatment Engagement Rate (Behavioral)

  Up to 90 days after Repeat Visit

• Quit Attempt Rate

  Up to 90 days after Repeat Visit

• Abstinence Rate

  Up to 90 days after Repeat Visit

Study Arms (4)

Usual Care

NO INTERVENTION

Clinicians and patients will receive no further interventions beyond usual practice.

Clinician Nudge

EXPERIMENTAL

Clinicians will receive a nudge via Best Practice Alert within the EMR

Other: Clinician Nudge

Patient Nudge

EXPERIMENTAL

Patients will receive a message sent through myPennMedicine following establishment of their smoking status.

Other: Patient Nudge

Clinician and Patient Nudge

EXPERIMENTAL

Both strategies described above will be used.

Other: Clinician Nudge; Other: Patient Nudge

Interventions

Clinician Nudge OTHER

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.

Clinician Nudge; Clinician and Patient Nudge

Patient Nudge OTHER

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.

Clinician and Patient Nudge; Patient Nudge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Related Publications (2)

• Jenssen BP, Schnoll R, Beidas RS, Bekelman J, Bauer AM, Evers-Casey S, Fisher T, Scott C, Nicoloso J, Gabriel P, Asch DA, Buttenheim AM, Chen J, Melo J, Grant D, Horst M, Oyer R, Shulman LN, Clifton ABW, Lieberman A, Salam T, Rendle KA, Chaiyachati KH, Shelton RC, Fayanju O, Wileyto EP, Ware S, Blumenthal D, Ragusano D, Leone FT. Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke. J Clin Oncol. 2023 Oct 1;41(28):4511-4521. doi: 10.1200/JCO.23.00355. Epub 2023 Jul 19.

  PMID: 37467454 DERIVED

• Jenssen BP, Schnoll R, Beidas R, Bekelman J, Bauer AM, Scott C, Evers-Casey S, Nicoloso J, Gabriel P, Asch DA, Buttenheim A, Chen J, Melo J, Shulman LN, Clifton ABW, Lieberman A, Salam T, Zentgraf K, Rendle KA, Chaiyachati K, Shelton R, Wileyto EP, Ware S, Leone F. Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke. Implement Sci. 2021 Jul 15;16(1):72. doi: 10.1186/s13012-021-01139-7.

  PMID: 34266468 DERIVED

MeSH Terms

Conditions

Neoplasms; Smoking; Tobacco Use; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Robert Schnoll, PhD
• Organization: University of Pennsylvania

schnoll@pennmedicine.upenn.edu

215.746.7143

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Comprehensive Smoking Treatment Program Professor, Critical Care and Pulmonology

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: May 18, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 13, 2024
• Results First Posted: December 26, 2023

Record last verified: 2024-02

Locations

US (3)