NCT01156610

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
706

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

July 1, 2010

Last Update Submit

March 4, 2014

Conditions

SmokingSmoking Cessation

Keywords

SmokingSmoking CessationElectronic Health RecordTelephone

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Use of any Tobacco Treatment

    2 years

  • Use of Community Resources to Facilitate Smoking Cessation

    2 years

  • Patient Report of Socio-cultural Barriers to Tobacco Cessation

    2 years

  • Quit Attempts

    2 years

Study Arms (2)

Integrated Cessation Counseling

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Tobacco TreatmentBEHAVIORAL

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).

Integrated Cessation CounselingUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hearing impaired patients who cannot use the telephone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02110, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

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MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Jennifer Haas, MD, MSPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 5, 2010

Study Start

November 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

US(2)