NCT01575886

Brief Summary

The goal of this study is to test an intervention that teaches clinicians to integrate the use of 'teachable moments' with the key skills of motivational interviewing tailored to address smoking and weight management in the primary care outpatient visit setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

April 6, 2012

Last Update Submit

December 23, 2021

Conditions

Keywords

clinician patient communicationsmoking cessationweight managementprimary carehealth behavior change advice

Outcome Measures

Primary Outcomes (2)

  • performance of the elements of the teachable moment communication process

    Analysis of the audio recorded visit is used to assess the performance of each of the key elements of the teachable moment communication process.

    evaluated at time of observed/audio recorded visit; visits are evaluated between 2 weeks and 3 months after clinician exposure to the educational intervention

  • incremental behavior change for smoking

    A 15-item self report measure of small behavior changes antecedent to smoking cessation. The measure is assessed prior to the visit and then 6-weeks after the observed visit and a change score is computed.

    6 weeks

Secondary Outcomes (1)

  • duration of the visit

    immediate

Study Arms (2)

Smoking cessation intervention

EXPERIMENTAL

This group receives the teachable moment communication process intervention focused on smoking cessation and contributes data at baseline (Time 1) and post intervention (Time 2).

Other: Teachable Moment Communication Process

Delayed intervention group

OTHER

This group serves as the comparison group for the evaluation of the smoking cessation intervention at Time 1 and Time 2 data collection to complete the group randomized trial. This group of clinicians then has Time 3 data collection focused on weight management receives a revised intervention focused on teachable moment communication for weight management and has Time 4 data collected to evaluate the teachable moment for weight management training as a pre-post design.

Other: Teachable Moment Communication Process

Interventions

The Teachable Moment Communication Process intervention is designed to teach clinicians: (1) the skills necessary to recognize and foster teachable moments in clinical encounters, (2) strategies to effectively elicit the patients' perspective on health behavior change, and express their alignment with that perspective, and (3) the ability to respond to the patient in a non-confrontational manner while providing brief advice appropriate to the patient's expressed level of readiness to change. The Teachable Moment Communication Process intervention consists of two, 3-hour educational training sessions including didactic presentation, skill demonstration through video examples, skills practices with standardized patients, and feedback from peers and the trainers.

Delayed intervention groupSmoking cessation intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients visiting a clinician participating in the study on data collection days.
  • For data collection Time 1 and 2, patients who report smoking at least 1 cigarette per day.
  • For data collect times 3 and 4, patients who have a BMI \> 30 or patients who have a BMI \>25 and self-reporting any one of the following chronic conditions: high blood pressure, high cholesterol, heart disease or diabetes.

You may not qualify if:

  • Inability to comprehend the invitation to participate in the study in English or Spanish
  • No access to a telephone and no mailing address to complete follow up surveys.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Flocke SA, Antognoli E, Step MM, Marsh S, Parran T, Mason MJ. A Teachable Moment Communication Process for smoking cessation talk: description of a group randomized clinician-focused intervention. BMC Health Serv Res. 2012 May 3;12:109. doi: 10.1186/1472-6963-12-109.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Susan A Flocke, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Family Medicine and Community Health

Study Record Dates

First Submitted

April 6, 2012

First Posted

April 12, 2012

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2013

Last Updated

January 12, 2022

Record last verified: 2021-12

Locations