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A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research

Primary Purpose

HIV, Smoking, Tobacco Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinician Nudge
Patient Nudge
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring Smoking, HIV, Tobacco Use, Nicotine Dependence, Tobacco Use Treatment Service, Behavioral Economics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinician participants must meet the following criteria for enrollment: Penn Division of Infectious Disease Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant) Clinical oversight of HIV patients for the past six months English-speaking (messages will be in English) Patient participants must be diagnosed with HIV and report current tobacco smoking (self-report daily smoking for last 6 months)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Usual Care

    Clinician Nudge

    Patient Nudge

    Combined Nudge: Clinician and Patient Nudge

    Arm Description

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

    Clinicians will receive a nudge via a Best Practice Alert within the electronic medical record.

    Patients will receive a message sent through the patient portal or via text.

    Both the clinician nudge and the patient nudge will be used.

    Outcomes

    Primary Outcome Measures

    Rate of referral to tobacco treatment
    Defined as the number of TUTS orders signed in the electronic medical record, divided by the total number of pended orders
    Rate of engagement in tobacco treatment
    Defined as the total number of patients who enroll in a tobacco treatment trial, complete at least one session with a tobacco treatment specialist from the investigators' cessation program, or use a tobacco medication divided by the total number of patients

    Secondary Outcome Measures

    Full Information

    First Posted
    May 1, 2023
    Last Updated
    May 1, 2023
    Sponsor
    University of Pennsylvania
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05852860
    Brief Title
    A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research
    Official Title
    A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research: Improving Tobacco Treatment Rates for People Living With HIV Who Smoke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2026 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to usual care and that the combination of nudges to clinicians and to patients will be the most effective.
    Detailed Description
    Treatments for tobacco use, including behavioral counseling and FDA-approved medications, increase the likelihood that smokers interested in quitting will make and succeed in a quit attempt. These medications are safe, including among smokers with psychiatric and medical comorbidities, including cancer, HIV, and cardiovascular disease. Yet, the majority of smokers who try to quit do not use FDA-approved medications or guideline-based counseling in their attempt. Data from Medicaid, Medicare, outpatient medical settings, and primary care show that, at best, only 25% of those interested in quitting use evidence-based tobacco treatments in their attempt. This reality may be worse for populations that traditionally show higher smoking rates and lower access to treatments; 40-75% of people with HIV (PWH) are current smokers, which is >2 times the general population rate. PWH also show very low rates of tobacco treatment utilization, including clinician-based treatments such as the 5As, NRT, and web-based treatments, and varenicline use among PWH is ~4%. The widespread use of antiretroviral therapy (ART) for PWH has substantially improved life expectancy but PWH now lose more life-years to tobacco use than to their HIV infection, primarily from cancer and cardiovascular disease, which account for almost one-quarter of all deaths among PWH. The investigators have shown that clinician willingness to treat patient smoking is related to clinician bias, including their perceived role in treating tobacco, patient culpability, and effectiveness. In 2 studies, the investigators showed that didactic instruction to counter these biases significantly increased clinician willingness to treat patient tobacco use. In a single-arm study, the researchers showed that a message delivered to oncologists through the EMR that addressed omission bias about tobacco treatment improved actual tobacco treatment rates for cancer patients from 0% to 36%. The study team recently completed a pragmatic RCT testing EMR-delivered patient and clinician nudges directed at omission and status quo biases to promote tobacco treatment in oncology (P50 CA244690). With 2,146 cancer patients accrued, a generalized estimating equation in an ITT analysis showed that the clinician nudge led to about a 3-fold increase in tobacco treatment engagement vs. usual care (35.6% vs. 13.5%; OR = 3.36, 95% CI: 2.12-5.32, p < 0.001). Advanced Practice Practitioners were significantly more likely than physicians to provide tobacco treatment and non-white patients were significantly more likely than white patients to engage in tobacco treatment (p's < 0.001). These findings were presented at the 15th Annual Conference on the Science of Dissemination and Implementation in Health and a manuscript is in preparation. While these data show a >3-fold increase in tobacco treatment rates from the clinician nudge (vs. usual care), the patient nudge did not increase tobacco treatment rates. Notably, however, the investigators in this study did not conduct a discrete choice experiment (DCE) to identify the patient bias to target with the patient nudge and the team relied on the EMR for patient nudge delivery (~25% of patients are not registered users of the patient portal). Conducting a DCE to identify the bias target and expanding patient nudge delivery to include text messages may affect the impact of the patient nudge in the proposed study. This study is particularly important because it will generate: 1) implementation strategies informed by behavioral economics and directed at clinicians and patients to increase tobacco use treatment for PWH; 2) optimal EHR-based infrastructure to facilitate tobacco use treatment; and 3) knowledge about which strategies are effective that can be tested more widely. New approaches to increasing tobacco treatment for PWH could lead to benefits at the patient and population levels. Insights from this study could be applied in other clinical settings to increase tobacco treatment, and thus improve patient outcomes in other populations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV, Smoking, Tobacco Use, Nicotine Dependence
    Keywords
    Smoking, HIV, Tobacco Use, Nicotine Dependence, Tobacco Use Treatment Service, Behavioral Economics

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Clinicians and patients will receive no further interventions beyond usual practice.
    Arm Title
    Clinician Nudge
    Arm Type
    Experimental
    Arm Description
    Clinicians will receive a nudge via a Best Practice Alert within the electronic medical record.
    Arm Title
    Patient Nudge
    Arm Type
    Experimental
    Arm Description
    Patients will receive a message sent through the patient portal or via text.
    Arm Title
    Combined Nudge: Clinician and Patient Nudge
    Arm Type
    Experimental
    Arm Description
    Both the clinician nudge and the patient nudge will be used.
    Intervention Type
    Other
    Intervention Name(s)
    Clinician Nudge
    Intervention Description
    The clinician nudge will use the BPA functionality within the electronic medical record to deliver a message with a defaulted option to refer to the health system's tobacco treatment program. Changing the default to "no referral" will require an explanation using the options provided or by entering free text.
    Intervention Type
    Other
    Intervention Name(s)
    Patient Nudge
    Intervention Description
    The patient nudge will deliver a message within 72 hours of a patient's next scheduled clinic visit. The message will be delivered through the Penn patient portal (MyPennMedicine) or by text with security measures for privacy.
    Primary Outcome Measure Information:
    Title
    Rate of referral to tobacco treatment
    Description
    Defined as the number of TUTS orders signed in the electronic medical record, divided by the total number of pended orders
    Time Frame
    through study completion, up to one year
    Title
    Rate of engagement in tobacco treatment
    Description
    Defined as the total number of patients who enroll in a tobacco treatment trial, complete at least one session with a tobacco treatment specialist from the investigators' cessation program, or use a tobacco medication divided by the total number of patients
    Time Frame
    through study completion, up to one year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinician participants must meet the following criteria for enrollment: Penn Division of Infectious Disease Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant) Clinical oversight of HIV patients for the past six months English-speaking (messages will be in English) Patient participants must be diagnosed with HIV and report current tobacco smoking (self-report daily smoking for last 6 months)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Schnoll, PhD
    Phone
    215.746.7143
    Email
    schnoll@pennmedicine.upenn.edu

    12. IPD Sharing Statement

    Learn more about this trial

    A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research

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