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

NCT ID: NCT02764385

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15786 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-04-30

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.

Conditions

Smoking; Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

AAC

Intervention Type: 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

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.

Group Type: OTHER

Teachable Moment Communication Process

Intervention Type: OTHER

A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.

AAC

Intervention Type: 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

Interventions

Teachable Moment Communication Process

A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Susan Flocke

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sue Flocke, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

References

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.

Reference Type: DERIVED

PMID: 33947346 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RES206807

Identifier Type: -

Identifier Source: org_study_id