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Using a Teachable Moment Communication Process to Improve Outcomes of Quitline Referrals

Primary Purpose

Smoking, Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Teachable Moment Communication Process
AAC
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All adults age 18+ who present for visits at participating clinics

Exclusion Criteria:

  • Any individual under 18 years of age presenting for a clinic visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    AAC only

    AAC + TMCP

    Arm Description

    This is a system-based intervention that involves changes in the EHR regarding documenting tobacco assessment and the capability to order an eReferral to the Quitline. This system-based intervention also changes the role of the medical technical assistant.

    The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.

    Outcomes

    Primary Outcome Measures

    Number of Patients Contacted for Quitline Enrollment
    The number of patients contacted by the Quitline among those ready to quit and who accepted a referral to the quitline

    Secondary Outcome Measures

    Number of Patients With Documentation of Brief Advice
    The number of patients that use tobacco with documentation of brief advice

    Full Information

    First Posted
    April 14, 2016
    Last Updated
    July 26, 2021
    Sponsor
    Case Western Reserve University
    Collaborators
    Patient-Centered Outcomes Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02764385
    Brief Title
    Using a Teachable Moment Communication Process to Improve Outcomes of Quitline Referrals
    Official Title
    Using a Teachable Moment Communication Process to Improve Outcomes of Quitline Referrals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    April 2019 (Actual)
    Study Completion Date
    April 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Case Western Reserve University
    Collaborators
    Patient-Centered Outcomes Research Institute

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study will compare the effectiveness of two approaches for delivering smoking cessation advice in the primary care setting. Ask-Advise-Connect (AAC) is a strategy that uses the electronic health record (EHR) to prompt clinical staff to Ask if the patient smokes, Advise them to quit and, if they're interested, Connect them to Quitline (QL) counseling services. The connection occurs when a QL counselor is notified of the patient's interest, and then calls the patient to enroll in treatment. AAC has been shown to be very effective at enrolling patients, however, it was found that less than 42% of patients who agreed to be referred were successfully contacted by the QL after 5 call attempts. This indicates that many patients that are referred are not ready for cessation, but may feel obligated to accept the referral from their primary care team. This presents an opportunity to improve the patient centeredness of the referral process. To overcome these limitations, the investigators propose pairing it with a patient-centered smoking cessation approach called the Teachable Moments Communication Process (TMCP). The investigators' team developed this communication strategy, which incorporates patients' concerns into a partnership-oriented discussion about smoking cessation. The investigators propose that combining these two approaches could increase appropriate referrals to the QL, increase the likelihood of successful patient contact and enrollment, and increase the patient's rating of the value of the experience.
    Detailed Description
    The investigators specifically aim to: Improve delivery and documentation of smoking cessation advice and assistance to socially and economically disadvantaged patients using an AAC approach integrated into the EHR. Test the effect of combining the TMCP with AAC on process, Quitline referral and smoking outcomes. Examine the narratives of subgroups of individuals to better understand the referral experience and identify ways to improve it. The investigative research team will conduct a randomized trial to implement these strategies with 8 clinics serving more than 25,000 patients who smoke. The investigators first implement the AAC system change intervention and then use a stepped wedge design to implement the TMCP in 8 clinics that are randomly assigned to a time point (step) for receiving the TMCP intervention. The investigators will collect data via patient survey, EHR and Quitline. The investigators also will conduct in-depth interviews with sub-groups of patients to inform ways to improve the referral process. With mounting demand for systems-based solutions for providing tobacco cessation assistance, it is urgent to understand how to use a systems approach like the AAC in a way that attends to the patient experience. The findings from this study will be useful to clinicians, patients, healthcare systems, and health insurance plans.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking, Tobacco Dependence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15786 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AAC only
    Arm Type
    Other
    Arm Description
    This is a system-based intervention that involves changes in the EHR regarding documenting tobacco assessment and the capability to order an eReferral to the Quitline. This system-based intervention also changes the role of the medical technical assistant.
    Arm Title
    AAC + TMCP
    Arm Type
    Other
    Arm Description
    The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.
    Intervention Type
    Other
    Intervention Name(s)
    Teachable Moment Communication Process
    Intervention Description
    A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.
    Intervention Type
    Other
    Intervention Name(s)
    AAC
    Intervention Description
    A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants
    Primary Outcome Measure Information:
    Title
    Number of Patients Contacted for Quitline Enrollment
    Description
    The number of patients contacted by the Quitline among those ready to quit and who accepted a referral to the quitline
    Time Frame
    Every visit until end of study, up to 6 months post TMCP implementation
    Secondary Outcome Measure Information:
    Title
    Number of Patients With Documentation of Brief Advice
    Description
    The number of patients that use tobacco with documentation of brief advice
    Time Frame
    Every visit until end of study, up to 6 months post TMCP implementation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All adults age 18+ who present for visits at participating clinics Exclusion Criteria: Any individual under 18 years of age presenting for a clinic visit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sue Flocke, PhD
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33947346
    Citation
    Flocke SA, Albert EL, Lewis SA, Love TE, Rose JC, Kaelber DC, Seeholzer EL. A cluster randomized trial evaluating a teachable moment communication process for tobacco cessation support. BMC Fam Pract. 2021 May 4;22(1):85. doi: 10.1186/s12875-021-01423-x.
    Results Reference
    derived

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    Using a Teachable Moment Communication Process to Improve Outcomes of Quitline Referrals

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