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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Dependence
• Intervention / Treatment: Other: AAC; Other: Teachable Moment Communication Process

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.

• Study Type: Interventional
• Enrollment (Actual): 15786
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: 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
OTHER: 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.	Other: 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; Other: Teachable Moment Communication Process; A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Sue Flocke, PhD, Oregon Health and Science University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): April 1, 2019

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (ESTIMATE): May 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: RES206807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No