Clinician Patient CommunicationNCT01575886
Enhancing Teachable Moment Communication for Smoking Cessation and Weight Management
A study testing Teachable Moment Communication Process in people with Clinician Patient Communication and Smoking Cessation, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinician Patient Communication, Smoking Cessation, Weight Management
- What is being tested?
- Teachable Moment Communication Process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Enhancing Teachable Moment Communication for Smoking Cessation and Weight
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.
Read the 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.
- Being tested
- Teachable Moment Communication Process
- Keywords
- clinician patient communication, smoking cessation, weight management, primary care, health behavior change advice
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teachable Moment Communication ProcessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Teachable Moment Communication Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
duration of the visit
the amount of time spent face to face with the clinician during the observed visit.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinician Patient CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Flocke, Case Western Reserve University
- Investigators
- Susan A Flocke, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575886
- Sponsor's protocol ID
- R01CA105292_ETM
- Other IDs
- R01CA105292
- Status last verified
- Dec 2021
- First submitted
- 6 Apr 2012
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22554310
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Teachable Moment Communication for Smoking Cessation and Weight
- ClinicalTrials.gov ID
- NCT01575886
- Acronym / sponsor ID
- R01CA105292_ETM
- Keywords
- clinician patient communication, smoking cessation, weight management, primary care, health behavior change advice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation intervention | Experimental | Other: Teachable Moment Communication ProcessThis group receives the teachable moment communication process intervention focused on smoking cessation and contributes data at baseline (Time 1) and post intervention (Time 2). |
| Delayed intervention group | Other | Other: Teachable Moment Communication ProcessThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teachable Moment Communication ProcessThe 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, Smoking cessation intervention |
Primary outcome
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.
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.
1 secondary outcome
duration of the visit
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 22554310Flocke 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan A Flocke, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teachable Moment Communication Process in people with Clinician Patient Communication and Smoking Cessation, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01575886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.