Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers

Mass General Brigham

Status: Completed

Conditions: Smoking, Tobacco

Treatments: Behavioral: External Community Referral; Behavioral: Internal Care Coordination; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03612895

2015P0021111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Seen at a participating Massachusetts General Hospital (MGH) Primary Care practice within the linkage cohort time period
• "Current Smoker" as reported within the year based upon structured field in the health monitoring section of the electronic health record, or problem list term
• Listed telephone number

Exclusion criteria

• Excluded by primary care provider
• No telephone in electronic health record or at primary care provider's office
• Non-English speaking
• Problem list has a diagnosis of dementia, psychosis, schizophrenia, Alzheimer's disease, delirium, schizoaffective disorder, or suicidal tendencies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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234 participants in 3 patient groups

Internal Care Coordination

Experimental group

Description:

The smoker will be connected to a Tobacco Care Coordinator who is based centrally within the health care system but has ready access via EHR, email, and telephone with staff in each primary care practice.

Treatment:

Behavioral: Internal Care Coordination

External Community Referral

Experimental group

Description:

This intervention will connect the smoker directly via "warm transfer" to a the Massachusetts Smokers Helpline operated by National Jewish Health, which will provide its standard services to smokers.

Treatment:

Behavioral: External Community Referral

Usual Care

Other group

Description:

Passive referral to quitline and referral to primary care physician.

Treatment:

Behavioral: Usual Care