- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03064724
Practice-based Intervention for Vietnamese and Korean Patients
February 22, 2017 updated by: Thu Quach, Asian Health Services
This pilot project examined the feasibility of an multilingual interactive video education intervention "an interactive Mobile Doctor intervention (iMD)" to promote patient-provider discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care settings.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
While California has made significant strides in tobacco control and is leading the nation in reducing smoking use, the decline is not observed in all groups.
Select groups still have much higher smoking rates and thus bear an unequal burden of tobacco-related illnesses and deaths.
Of important note, Asian American men as a combined group have a higher smoking rate than non-Hispanic Whites (22% vs. 18%, respectively); in particular, the highest smoking prevalence has been observed in Vietnamese (31%) and Korean (30%) men among major Asian subgroups.
Research also shows that smoking rates are higher for Asian American men with low acculturation (e.g., immigrant status, low English proficiency) than for those who are more acculturated; yet the reverse trend is observed in Asian American women.
These findings underscore the need for more targeted tobacco control efforts.
The scientific literature suggests that provider advice to quit smoking can influence a smoker's decision to quit.
However, research has shown that Asian Americans are less likely to receive such provider advice.
Providers often have very limited face-time with patients during the short clinic visit, which presents a challenge as to whether they can incorporate smoking cessation messages during the visit.
Overall, little research has focused on smoking cessation in the clinic setting, particularly research that focuses on Asian Americans.
The purpose of the pilot study was to develop a more streamlined smoking cessation intervention that can be integrated into the clinic visit, especially to maximize the time when patients are waiting to see their providers.
The research question was whether providing culturally appropriate video education that includes provider advice and was tailored to a patient's readiness for quitting smoking will increase whether a patient receives smoking cessation education according to the recommended Clinical Practice Guideline and whether this results in a decrease in tobacco use in low-income Vietnamese and Korean patients.
Using a community-based participatory research approach, the investigators created the iMD that delivers tailored in-language video messages via a mobile tablet to Korean and Vietnamese male smokers right before their clinic visit with a provider.
iMD delivers the "5 A's" and generates a bilingual tailored printout.
Participants were Korean- and Vietnamese-speaking patients who self-identify as daily smokers and receive primary care at a federally-qualified health center.
This study evaluated the feasibility and acceptability of iMD from the patients' perspectives.
This study examined patient-provider discussion on tobacco use from patients' self-report and electronic health record (EHR), and self-reported quit attempts and smoking abstinence at 3 months post iMD visit.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- current smokers identified on electronic health records (EHR)
- have a scheduled primary care visit during the recruitment period
Exclusion Criteria:
- already quit smoking or not smoking daily in the past 7 days
- had already quit smoking or not smoking daily in the past 7 days
- had canceled or rescheduled their primary care visit outside of the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smoking Cessation Group
Patients received the interactive mobile doctor (iMD) intervention.
|
iMD delivers tailored interactive video education via a mobile tablet to smoking patients right before their clinic visit with a provider.
iMD delivers the "5 A's" (ask, advise, assess, assist, and arrange) and generates a bilingual tailored printout, which aims to increase patient-provider discussion on tobacco use and to promote smoking cessation.
This version of iMD delivers the intervention in Korean or Vietnamese languages as preferred by the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation Rate
Time Frame: Baseline
|
proportion of eligible participants consent to participate
|
Baseline
|
|
Acceptability
Time Frame: through study completion, an average of 1 year
|
proportion of participants who rated the intervention as moderately to extremely satisfied
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-provider discussion
Time Frame: "through study completion, an average of 1 year
|
self-reported by patient whether discussion on tobacco use took place at the indexed clinical encounter
|
"through study completion, an average of 1 year
|
|
Physician delivery of 5As
Time Frame: "through study completion, an average of 1 year
|
EHR-documented physician's delivery of assess, advice, assist, or arrange at the indexed clinical encounter
|
"through study completion, an average of 1 year
|
|
Quit attempt
Time Frame: 3-month
|
self-reported at least one or more 24 hour quit attempts
|
3-month
|
|
Abstinence
Time Frame: 3-month
|
self-reported 7-day point prevalent smoking abstinence
|
3-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thu Quach, PhD, MPH, Asian Health Services
- Principal Investigator: Janice Tsoh, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
February 20, 2017
First Submitted That Met QC Criteria
February 22, 2017
First Posted (Actual)
February 27, 2017
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 21BT-0056
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.
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