Clinical trial NCT02764385: 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
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Dependence
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-05-06
Enrollment: 15786
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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:

1. Improve delivery and documentation of smoking cessation advice and assistance to socially and economically disadvantaged patients using an AAC approach integrated into the EHR.
2. Test the effect of combining the TMCP with AAC on process, Quitline referral and smoking outcomes.
3. 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.

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

Primary outcomes:
measure: Number of Patients Contacted for Quitline Enrollment
timeFrame: Every visit until end of study, up to 6 months post TMCP implementation
Secondary outcomes:
measure: Number of Patients With Documentation of Brief Advice
timeFrame: Every visit until end of study, up to 6 months post TMCP implementation
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Sue Flocke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.