Clinical Trials Directory

Trials / Completed

CompletedNCT03612895

Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers

Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
234 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Health care systems are key channels for delivering tobacco cessation treatment to the smokers in a population. Current health care system approaches require busy clinicians with many competing demands on their time to initiate treatment in the course of clinical encounter. A population-based approach is an alternative that could complement office-based care and offload busy clinicians. The ongoing evolution of the health care system is making this more feasible with adoption of electronic health records (EHR) that document patients' smoking status in a coded field. This facilitates the creation of a registry of smokers who can be offered tobacco treatment proactively. However, the optimal way to implement a proactive population health strategy for tobacco users is unclear. The goal of the project is to implement a population-based proactive outreach program to current smokers in a health care system's primary care practices. The program will 1. Proactively contact smokers independent of their health care visits and 2. Connect smokers who respond to evidence-based tobacco cessation resources available in the health care system and/or community. The study aims of the study are to: Aim 1: To determine the feasibility and reach of the program. Aim 2a: To determine whether the two intervention arms combined increase the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up, compared to those receiving usual clinical care. Aim 2b: To determine whether each of the two interventions increases the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up, compared to those receiving usual clinical care. Exploratory aim: To compare the 7-day point prevalence smoking cessation rate in each intervention arm to usual care.

Conditions

Interventions

TypeNameDescription
BEHAVIORALInternal Care CoordinationThis 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.
BEHAVIORALExternal Community ReferralMassachusetts (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.
BEHAVIORALUsual CareParticipants will be given the number to the MA Smokers Helpline and advised to contact their primary care provider for additional assistance in quitting smoking.

Timeline

Start date
2016-04-01
Primary completion
2017-08-01
Completion
2017-08-01
First posted
2018-08-02
Last updated
2018-08-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03612895. Inclusion in this directory is not an endorsement.