Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02764385
Enrollment
15786
Registered
2016-05-06
Start date
2016-08-31
Completion date
2019-04-30
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Tobacco Dependence

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.

Interventions

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

OTHERAAC

A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Case Western Reserve University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients Contacted for Quitline EnrollmentEvery visit until end of study, up to 6 months post TMCP implementationThe number of patients contacted by the Quitline among those ready to quit and who accepted a referral to the quitline

Secondary

MeasureTime frameDescription
Number of Patients With Documentation of Brief AdviceEvery visit until end of study, up to 6 months post TMCP implementationThe number of patients that use tobacco with documentation of brief advice

Participant flow

Participants by arm

ArmCount
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. 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
9,145
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. 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
6,641
Total15,786

Baseline characteristics

CharacteristicAAC OnlyAAC + TMCPTotal
Age, Customized
18-34 years
1697 Participants1123 Participants2820 Participants
Age, Customized
35-64 years
6532 Participants4675 Participants11207 Participants
Age, Customized
65+ years
916 Participants843 Participants1759 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
4194 Participants3177 Participants7371 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
617 Participants471 Participants1088 Participants
Race (NIH/OMB)
White
4334 Participants2993 Participants7327 Participants
Sex: Female, Male
Female
5300 Participants3885 Participants9185 Participants
Sex: Female, Male
Male
3845 Participants2756 Participants6601 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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

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

Population: unit is the patient; among referrals received by the quitline, documented as contacted.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AAC OnlyNumber of Patients Contacted for Quitline Enrollment273 Participants
AAC + TMCPNumber of Patients Contacted for Quitline Enrollment59 Participants
95% CI: [1.73, 2.01]
p-value: 0.0595% CI: [0.45, 1.02]Regression, Logistic
Secondary

Number of Patients With Documentation of Brief Advice

The number of patients that use tobacco with documentation of brief advice

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

Population: number of smokers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AAC OnlyNumber of Patients With Documentation of Brief Advice7086 Participants
AAC + TMCPNumber of Patients With Documentation of Brief Advice5579 Participants
95% CI: [1.73, 2.1]

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026