- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575886
Enhancing Teachable Moment Communication for Smoking Cessation and Weight Management
Enhancing Teachable Moment Communication for Smoking Cessation and Weight
Study Overview
Status
Intervention / Treatment
Detailed Description
A large burden of cancer morbidity and mortality is potentially preventable by changes in personal health behaviors. Health behavior advice (HBA) by primary care physicians, who provide basic health care to most Americans, holds great promise as a strategy to alter cancer-related health behaviors and to reduce morbidity and mortality. One potentially powerful strategy is the use of illness visits as a 'teachable moment'(TM) for health behavior change. Our in-depth analysis of audio recorded physician-patient interactions has led to new discoveries of the communication elements of a TM. First, effective TM's involve linking a health behavior to a salient patient problem and positioning the health behavior as a problem. Persuasion is accomplished by suggesting that changing the health behavior will improve the patient's salient concern. If done skillfully, the patient accepts the portrayal of the health behavior as a relevant problem and exhibits uptake of the health behavior change talk, possibly expressing a commitment to change. Our data reveal that TMs occur in 20% of health behavior discussions between physician and patient. More frequent (43%) , however, are TM 'attempts' which fail to engage the patient. These attempts lack two essential aspects of good patient-centered advice 1) eliciting the patient's readiness to change and 2) responding in alignment with the patient's expressed stage of change. We also observed 'missed opportunities' (20%) where the health behavior advice failed to link to a salient patient concern.
Therefore, the goal of this randomized trial is to test an intervention that teaches clinicians to integrate the use of TMs with the key skills of motivational interviewing tailored to address smoking and weight management in the outpatient visit setting. This goal will be accomplished using a group randomized trial of 32 clinicians (1152 patients). The initial Teachable Moment Communication Process (TMCP) intervention will focus on smoking cessation as the health behavior topic. After the initial intervention is evaluated, the clinicians assigned to the control group will receive a revised TMCP intervention with a focus on weight management. The TMCP intervention involves multiple modalities including skills-based training, practice with standardized patients and on-site coaching. Audio recordings of visits with patients who smoke or are obese will be used to assess both intervention and control clinicians' health behavior change strategies at baseline and post intervention. Patient surveys will be used to assess the effect of the observed health behavior change strategies on immediate and short-term patient outcomes. Leveraging clinicians' naturally-occurring health behavior change strategies by fostering the development of more effective communication skills has great potential to enhance patient health behavior change. This study will test this strategy and generate rich data about its effectiveness and how it is tailored by physicians in practice for both smoking and weight management; two important risk factors for cancer and other devastating chronic diseases.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smoking cessation intervention
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).
|
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.
|
|
Other: Delayed intervention group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
performance of the elements of the teachable moment communication process
Time Frame: evaluated at time of observed/audio recorded visit; visits are evaluated between 2 weeks and 3 months after clinician exposure to the educational intervention
|
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
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
duration of the visit
Time Frame: immediate
|
the amount of time spent face to face with the clinician during the observed visit.
|
immediate
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan A Flocke, PhD, Case Western Reserve University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01CA105292_ETM
- R01CA105292 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
The University of Hong KongCompletedSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
Clinical Trials on Teachable Moment Communication Process
-
Case Western Reserve UniversityPatient-Centered Outcomes Research InstituteCompletedSmoking | Tobacco Dependence
-
Louisville VA Medical CenterUniversity of LouisvilleCompletedSuicide, AttemptedUnited States
-
Western Kentucky UniversityVanderbilt UniversityCompletedSuicide AttemptUnited States
-
University of TulsaTerminatedSuicide, AttemptedUnited States
-
Hartford HospitalNational Cancer Institute (NCI)Completed
-
Assistance Publique - Hôpitaux de ParisCompletedPatients Died in Intensive Care Unit (ICU)France
-
University of MinnesotaNational Institute of Mental Health (NIMH)CompletedParent-Child Relations | Parents | Behavior Problem | Behavior, ChildUnited States
-
Agency for Healthcare Research and Quality (AHRQ)University of Illinois at ChicagoCompletedInterprofessional Relations | Information DisseminationUnited States
-
Saint Francis CareAmerican Cancer Society, Inc.; Northwestern University Feinberg School of MedicineCompletedColorectal CancerUnited States
-
University of MinnesotaRecruiting