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
About this trial
This is an interventional prevention trial for Smoking
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
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
NCT ID
NCT02764385
First Posted
April 14, 2016
Last Updated
July 26, 2021
Sponsor
Case Western Reserve University
Collaborators
Patient-Centered Outcomes Research Institute
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
Learn more about this trial
Using a Teachable Moment Communication Process to Improve Outcomes of Quitline Referrals
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