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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764385
• Other study ID #: RES206807
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2019

Study information

• Verified date: July 2021
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15786
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Every visit until end of study, up to 6 months post TMCP implementation
Secondary	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