Results Summary
What was the research about?
Tobacco use is the leading cause of preventable death in the United States. Primary care teams, such as doctors, nurses, and medical assistants, can help patients quit using tobacco. But clinic staff don’t always have the support they need to talk with patients about tobacco or refer patients to quitlines. Quitlines are services people can call to get telephone counseling for tobacco addiction.
In this study, the research team compared two ways to help primary care clinic staff identify patients who use tobacco and offer them help:
- Ask-Advise-Connect, or AAC. AAC changes the role of medical assistants to ask patients about tobacco use. They also give brief advice and use the electronic health record, or EHR, to refer patients who want help to a quitline.
- AAC plus the Teachable Moments Communication Process, or TMCP. TMCP trains clinicians, like doctors and nurses, on how to talk with patients based on their concerns about tobacco use.
What were the results?
One year after AAC changes happened at the clinics, medical assistants were more likely to
- Ask patients if they used tobacco
- Advise patients to quit tobacco
- See how ready patients were to quit
Also, patients at these clinics were more likely to accept a referral to a quitline.
After adding TMCP, patients at the clinics were more likely to receive advice to quit tobacco.
Clinicians only used TMCP with 8 percent of patients. When they used TMCP, clinicians were more likely to prescribe medicine to help quit tobacco. Other outcomes did not improve.
Who was in the study?
The study used EHR data from 224,079 visits by 176,061 adult patients. Patients were from eight clinics in one health system in the Cleveland area. Of these patients, 50 percent were white, 46 percent were African American, and 4 percent were other races; 12 percent were Hispanic or Latino. Also, 57 percent were ages 35–65, 70 percent were women, and 26 percent were tobacco users.
What did the research team do?
The research team first worked with the health system to make changes to their EHR system, including
- Adding an electronic referral between clinics and a quitline in Ohio
- Adding AAC guidance to EHR systems
- Using a team-based approach to tobacco screening and training staff to use the new EHR system
Next, the research team trained clinicians in TMCP.
The research team looked at patient care at the clinics at three time periods: before making any changes, after putting AAC in place in clinics, and after adding TMCP.
Clinicians, clinic staff, Ohio’s health department staff, quitline staff, and patients who use tobacco helped design the study and review results.
What were the limits of the study?
Only eight percent of clinicians used TMCP to talk with patients. Results might differ if more clinicians used this approach.
Future research could look at ways to increase how often clinicians use TMCP.
How can people use the results?
Clinics and health systems can use the results when deciding how to help patients quit tobacco.
Professional Abstract
Objective
To compare the effectiveness of health system infrastructure changes using the Ask-Advise-Connect (AAC) approach alone versus AAC plus the Teachable Moments Communication Process (TMCP)—a clinician-led counseling method—on improving tobacco cessation support and patient engagement with a quitline and increasing tobacco cessation medication prescriptions
Study Design
Design Elements | Description |
---|---|
Design | Cluster randomized trial |
Population | 224,079 visits by 176,061 adults receiving care at 8 primary care community health clinics in the Cleveland metropolitan area |
Interventions/ Comparators |
|
Outcomes | Percentage of visits where patients were asked about tobacco use status, advised to quit, and assessed readiness to quit; percentage of patients offered quitline referrals and percentage of patients who accepted a referral; percentage of patients who engaged with the quitline and percentage of patients who were prescribed medication to quit tobacco |
Timeframe | At least 1-year follow-up for study outcomes |
This stepped-wedge cluster randomized trial compared the effectiveness of two interventions—health system infrastructure changes alone or infrastructure changes plus a clinician-led counseling method—in improving tobacco cessation support outcomes.
Eight primary care community health clinics from one health system participated in the study. Researchers first led implementation of health system infrastructure changes at the clinics using the AAC approach, which included adding electronic referrals between clinics and an Ohio tobacco cessation quitline and expanding the role of medical assistants. Researchers trained medical assistants to ask about tobacco use, provide brief advice, and ask about readiness to quit and willingness to receive a referral to quitline counseling. After at least six months of the AAC approach, researchers trained clinicians in the TMCP counseling method. This method used patient concerns about tobacco to help clinicians guide discussions about behavior change. By the end of the study, all clinics received both interventions.
Researchers examined patients’ electronic health record (EHR) data for the 3 months before each clinic implemented the AAC, a minimum of 6 months of implementing the AAC only, and 12 months after the TMCP intervention to assess the effectiveness of the AAC approach and the added value of the TMCP approach.
The study included 224,079 EHR-recorded visits by 176,061 adult patients in the Cleveland metropolitan area. Of these patients, 50% were white, 46% were African American, and 4% were other races; also, 12% were Hispanic or Latino. The majority (57%) were ages 35–65, 70% were female, and 26% were tobacco users.
Primary care clinicians, clinic staff, Ohio’s health department staff, quitline staff, and patients who use tobacco helped design the study and review results.
Results
Implementation of the AAC approach showed increases in asking about tobacco use (27% vs. 50%), providing brief advice to quit (45% vs. 85%), asking about readiness to quit (13% vs. 66%), and referrals to quitline counseling (0% vs. 31%), (all p<0.05).
Compared with the AAC-only period, the AAC+TMCP period showed increases in providing brief advice to quit (85% vs. 91%, p<0.05). Overall, clinicians used the TMCP approach in only 8% of visits by tobacco users. When clinicians used the TMCP approach, prescriptions for tobacco cessation medication were higher (12% vs. 32%; p<0.05). Other outcomes did not improve significantly.
Limitations
The low clinician uptake of TMCP made it difficult to determine the effectiveness of this approach.
Conclusions and Relevance
Infrastructure changes increased assessments of tobacco use and advising patients to quit, assessing patient readiness to quit, and having patients accept quitline referrals. The counseling intervention, when used, increased clinician prescriptions for tobacco cessation medication.
Future Research Needs
Future research could look at ways to better integrate the two approaches and increase clinicians’ use of the counseling intervention.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked why the study design chosen, a cluster randomized trial with a stepped-wedge design, was well suited to address the study’s aims. They suggested that it was a flaw in the study that the Teachable Moments Communication Process (TMCP) was used at clinicians’ discretion and that intervention uptake was inconsistent across sites. The researchers explained that the participating health system wanted all clinics to eventually receive the intervention rather than some just serving as control clinics. The stepped-wedge design allowed the researchers to start each clinic with the control condition and then implement the TMCP intervention in each clinic at randomly assigned time points. The researchers said they did not view the variability in clinicians’ communication styles or the site uptake of the intervention as faults of the study. They noted that this was a pragmatic trial, and the site variability in uptake and use of the TMCP intervention demonstrated the need for future research to provide performance feedback to clinicians. The researchers did acknowledge that they could have improved the study by proactively and systematically collecting site-level data to help explain the observed variability.
- The reviewers asked for clarity about whether the researchers performed intent-to-treat analyses on the data. The researchers explained that they analyzed the data in three ways: (1) intent-to-treat analyses based on when the clinic site should have received the TMCP training, regardless of whether the clinicians attended the training; (2) per-protocol analyses using only the sample of clinicians who attended the training; and (3) analyses comparing when trained clinicians used and did not use the intervention.
- The reviewers noted that very small numbers of patients who were referred to the two smoking cessation programs that the study used as interventions, completed those programs. The reviewers asked how these rates compared with what was seen in past studies and to what extent participation in such programs is associated with successfully quitting smoking. The researchers said their study focused on success in improving the referral process to such programs, not engagement with the programs after referral. They chose to include the data on intervention engagement because few studies presented these data, but they could be useful for future studies. However, this was not the focus of the study.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^This project was originally affiliated with Case Western Reserve University.