Smoking Cessation Clinical Trial
Official title:
Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Verified date | March 2014 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The objectives of this project are to develop and evaluate a multi-level approach to tobacco
treatment for low-SES and minority patients. The components of this intervention would
include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco
treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and
integration of this program with both an individual's primary care physician through an
electronic health record (EHR), as well as referral to community resources to address the
socio-contextual barriers to tobacco cessation. To achieve these objectives, this
intervention will test an innovative model of systematic outreach to low-SES and minority
smokers using systematic phone outreach (including cell phones which are particularly
prevalent among minority and low-SES groups), coordinated with the PCP, using both a
cost-effective technology and a dedicated tobacco treatment specialist to increase smoking
cessation in these populations. The proposed intervention will have multiple levels of
influence (patient, PCP) and provide linkages to community resources. If successful, this
model could be generalized to other health systems with an EHR, which are increasingly being
promoted to improve the safety and quality of health care.
Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment
program for low-SES and minority smokers can reach these patients to increase quit rates and
use of tobacco treatment effectively.
Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized
treatment program for low-SES and minority smokers can be adopted across a variety of
practice settings and be consistently implemented across diverse patient populations.
Status | Completed |
Enrollment | 706 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must be 18 years of age or older. - Must be a current smoker. - Must receive primary care at one of the participating clinics. - Must have had a PCP visit within the last month at a participating clinic. - Must have a working phone number listed in Partner's database. - Must report race /ethnicity as African American or Hispanic or live in a low-SES block group (a census block group with a median income of < $65,000). - Must speak English or Spanish. Exclusion Criteria: - Hearing impaired patients who cannot use the telephone. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Massachusetts General Hospital |
United States,
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* Note: There are 133 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). | The difference between intervention and control patients ("smokers") who report nine months after randomization that they are now quitters (i.e., that they have not smoked for the past seven days but did smoke on enrollment). Self-reported smoking status has established validity when compared with measured serum cotinine levels and yields similar population prevalence estimates. | 2 years | No |
Secondary | Use of any Tobacco Treatment | The difference between intervention and control patients who report using any pharmacologic tobacco treatment (NRT replacement, bupropion, varenicline) or any behavioral treatment (state quitline, local tobacco program). | 2 years | No |
Secondary | Use of Community Resources to Facilitate Smoking Cessation | The difference between intervention and control patients who report using community resources. | 2 years | No |
Secondary | Patient Report of Socio-cultural Barriers to Tobacco Cessation | The difference between the percentage of intervention and control patients who report key socio-cultural barriers to tobacco cessation. | 2 years | No |
Secondary | Quit Attempts | The difference between intervention and control patients who report making one or more quit attempts lasting >= 1 day during the nine months after randomization. An increasing number of quit attempts is related to ultimately quitting smoking. We will also examine difference in the number of quit attempts reported by the intervention and control groups within the nine months after randomization. | 2 years | No |
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