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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02764385
Other study ID # RES206807
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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