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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
The investigators specifically aim to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAC only | Other | 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. |
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| AAC + TMCP | Other | The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teachable Moment Communication Process | Other | A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Every visit until end of study, up to 6 months post TMCP implementation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Documentation of Brief Advice | The number of patients that use tobacco with documentation of brief advice | Every visit until end of study, up to 6 months post TMCP implementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Flocke, PhD | Oregon Health and Science University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33947346 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AAC Only | 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. AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants |
| FG001 | AAC + TMCP | The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AAC Only | 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. AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | unit is the patient; among referrals received by the quitline, documented as contacted. | Posted | Count of Participants | Participants | Every visit until end of study, up to 6 months post TMCP implementation |
|
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All cause mortality, serious and other adverse events were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AAC Only | 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. AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants |
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Intent to treat analyses are presented. Of the 60 eligible clinicians, 44 had exposure to the Teachable Moment Communication Process training. Uptake and use of the communication process during patient visits was limited (less than 10% of eligible visits). This makes it difficult to evaluate the added value of the Teachable Moment Communication Process intervention over and above the Ask-Advise-Connect approach.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sue Flocke | Oregon Health & Science University | 5034946697 | flocke@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2020 | Mar 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| AAC | Other | A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants |
|
| BG001 | AAC + TMCP | The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 |
| AAC + TMCP |
The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants |
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| Secondary | Number of Patients With Documentation of Brief Advice | The number of patients that use tobacco with documentation of brief advice | number of smokers | Posted | Count of Participants | Participants | Every visit until end of study, up to 6 months post TMCP implementation |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | AAC + TMCP | The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits. AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants | 0 | 0 | 0 | 0 | 0 | 0 |
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