Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers

NCT03612895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2018-08-02

No results posted yet for this study

Summary

Health care systems are key channels for delivering tobacco cessation treatment to the smokers in a population. A population-based approach could complement office-based care and offload busy clinicians. The project will conduct population-based proactive outreach to current smokers in a health care system's primary care practices and randomize smokers who respond to the outreach to 3 groups: 2 alternative evidence-based cessation resources or to usual care.

Specific Aims:

Aim 1: To determine the feasibility and reach of the program

Aim 2a: To determine whether the 2 intervention arms combined increase the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up compared to those randomized to usual clinical care.

Aim 2b: To determine whether each of the two intervention arms increases the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up, compared to those receiving usual clinical care.

Conditions

  • Smoking, Tobacco

Interventions

BEHAVIORAL

Internal Care Coordination

This individual will primarily initiate, guide, and optimize adherence to the care that others deliver, rather than providing direct care his or herself. S/he will call the smoker to conduct a brief assessment of tobacco use and readiness to quit, offer brief counseling and motivational intervention, describe the available pharmacologic and behavioral options, help the smoker to choose among them, and link the smoker to chosen resources. The resources offered will include both internal (health care system based) and external (community based) tobacco cessation resources.

BEHAVIORAL

External Community Referral

Massachusetts (MA) Helpline services include an assessment of smoking history and readiness to quit, advice to quit, self-help materials and telephone counseling. For smokers who set a quit date in the next 30 days, the Helpline offers up to 5 proactive telephone counseling calls with options for text messaging and web-based resources. It also provides eligible smokers 4 weeks of free nicotine patch or gum mailed to their home.

BEHAVIORAL

Usual Care

Participants will be given the number to the MA Smokers Helpline and advised to contact their primary care provider for additional assistance in quitting smoking.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Nancy Rigotti, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612895 on ClinicalTrials.gov