Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations - Full Text View

Sponsor:	Brigham and Women's Hospital
Collaborator:	Massachusetts General Hospital
Information provided by (Responsible Party):	Jennifer S. Haas, MD, MSPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01156610

Sponsor:

Brigham and Women's Hospital

Collaborator:

Massachusetts General Hospital

Information provided by (Responsible Party):

Jennifer S. Haas, MD, MSPH, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT01156610

Purpose

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.

Condition	Intervention
Smoking Smoking Cessation	Behavioral: Tobacco Treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Use of any Tobacco Treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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).
Use of Community Resources to Facilitate Smoking Cessation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The difference between intervention and control patients who report using community resources.
Patient Report of Socio-cultural Barriers to Tobacco Cessation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The difference between the percentage of intervention and control patients who report key socio-cultural barriers to tobacco cessation.
Quit Attempts [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	875
Study Start Date:	November 2011
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Integrated Cessation Counseling IVR System: IVR will be used for two purposes: (1) to facilitate access to treatment for low-SES and minority smokers and (2) perform six-month outcome assessment. Tobacco Treatment Specialist Calls: A tobacco treatment specialist will make four attempts to contact the patient by phone within 14 days. On contacting the patient, the specialist will screen the patient for readiness to quit, provide brief (10 to 15 minutes) counseling tailored to the patient's readiness to quit, and provide information and support for use of medications that could be or were prescribed and about relevant community resources. NRT: Patients who do not have a contraindication and smoke > 10 cigarettes per day, will be offered a free 6-week kit of generic nicotine patches (2 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches). Individuals who smoke 5-10 cigarettes/day will be offered a 6-week course, starting with the 14 mg patch. Those with a contraindication will not get NRT.	Behavioral: Tobacco Treatment Comparison of integrated cessation counseling tools with the normal standard of care. Both the intervention and control clinics will be provided with tools for visit-based "best practices" for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline. Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).
Active Comparator: Usual Care IVR Call: Similar to the initial IVR call for the intervention arms, the initial control arm call will confirm the participant's identify and provide a brief description of the study (obtaining information about health behaviors), with the opportunity for the individual to accept or decline participation. Following this introduction, the IVR script will confirm smoking status. The phone script will collect specific information about current smoking (cigarettes/day), prior quit attempts, and motivation to quit during the next month. No further contact will be made with patients in the control clinics until the outcome assessment call. In the control practices, the IVR machine will also generate a text note documenting the information obtained for the patients' EHR for use by the patient's health care providers as part of their "visit-based" best practices.	Behavioral: Tobacco Treatment Comparison of integrated cessation counseling tools with the normal standard of care. Both the intervention and control clinics will be provided with tools for visit-based "best practices" for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline. Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).

Arms

Assigned Interventions

Experimental: Integrated Cessation Counseling

IVR System: IVR will be used for two purposes: (1) to facilitate access to treatment for low-SES and minority smokers and (2) perform six-month outcome assessment.

Tobacco Treatment Specialist Calls: A tobacco treatment specialist will make four attempts to contact the patient by phone within 14 days. On contacting the patient, the specialist will screen the patient for readiness to quit, provide brief (10 to 15 minutes) counseling tailored to the patient's readiness to quit, and provide information and support for use of medications that could be or were prescribed and about relevant community resources.

NRT: Patients who do not have a contraindication and smoke > 10 cigarettes per day, will be offered a free 6-week kit of generic nicotine patches (2 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches). Individuals who smoke 5-10 cigarettes/day will be offered a 6-week course, starting with the 14 mg patch. Those with a contraindication will not get NRT.

Behavioral: Tobacco Treatment

Comparison of integrated cessation counseling tools with the normal standard of care.

Both the intervention and control clinics will be provided with tools for visit-based "best practices" for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline.

Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).

Active Comparator: Usual Care

IVR Call: Similar to the initial IVR call for the intervention arms, the initial control arm call will confirm the participant's identify and provide a brief description of the study (obtaining information about health behaviors), with the opportunity for the individual to accept or decline participation. Following this introduction, the IVR script will confirm smoking status. The phone script will collect specific information about current smoking (cigarettes/day), prior quit attempts, and motivation to quit during the next month. No further contact will be made with patients in the control clinics until the outcome assessment call. In the control practices, the IVR machine will also generate a text note documenting the information obtained for the patients' EHR for use by the patient's health care providers as part of their "visit-based" best practices.

Behavioral: Tobacco Treatment

Comparison of integrated cessation counseling tools with the normal standard of care.

Show Detailed Description

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02110

Responsible Party:	Jennifer S. Haas, MD, MSPH, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01156610 History of Changes
Other Study ID Numbers:	2010P000405, P50CA148596
Study First Received:	July 1, 2010
Last Updated:	October 18, 2011
Health Authority:	United States: Institutional Review Board