NCT02764385

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,786

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.7 years

First QC Date

April 14, 2016

Results QC Date

February 23, 2021

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Patients With Documentation of Brief Advice

    Every visit until end of study, up to 6 months post TMCP implementation

Study Arms (2)

AAC only

OTHER

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

AAC + TMCP

OTHER

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: Teachable Moment Communication ProcessOther: AAC

Interventions

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

AAC + TMCP
AACOTHER

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 + TMCPAAC only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults age 18+ who present for visits at participating clinics

You may not qualify if:

  • Any individual under 18 years of age presenting for a clinic visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SmokingTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

Intent to treat analyses are presented. Of the 60 eligible clinicians, 44 had exposure to the Teachable Moment Communication Process training. Uptake and use of the communication process during patient visits was limited (less than 10% of eligible visits). This makes it difficult to evaluate the added value of the Teachable Moment Communication Process intervention over and above the Ask-Advise-Connect approach.

Results Point of Contact

Title
Sue Flocke
Organization
Oregon Health & Science University

Study Officials

  • Sue Flocke, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2016

First Posted

May 6, 2016

Study Start

August 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 27, 2021

Results First Posted

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share