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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01575886
Other study ID # R01CA105292_ETM
Secondary ID R01CA105292
Status Completed
Phase N/A
First received
Last updated
Start date July 2010
Est. completion date February 2013

Study information

Verified date December 2021
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 840
Est. completion date February 2013
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
Teachable Moment Communication Process
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.

Locations

Country Name City State
United States Case Western Reserve University Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 duration of the visit the amount of time spent face to face with the clinician during the observed visit. immediate
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