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Trial record 16 of 22 for:    counseling | Recruiting, Not yet recruiting, Available Studies | "Tobacco Use Disorder"

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

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ClinicalTrials.gov Identifier: NCT02764385
Recruitment Status : Not yet recruiting
First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Susan Flocke, Case Western Reserve University

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.


Condition or disease Intervention/treatment Phase
Smoking Tobacco Dependence Other: Teachable Moment Communication Process Other: AAC Not Applicable

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 use a stepped wedge design to first implement the AAC system change intervention and then 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  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using a Teachable Moment Communication Process to Improve Outcomes of Quitline Referrals
Study Start Date : June 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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

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: Teachable Moment Communication Process
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




Primary Outcome Measures :
  1. Number of currently smoking participants receiving a referral to the Quitline [ Time Frame: Every 6 months until end of study, up to 31 months ]
    The number of participants that receive a referral to the quitline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Susan Flocke, Director, Research Division, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02764385     History of Changes
Other Study ID Numbers: RES206807
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders