Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers
- Conditions
- Smoking, Tobacco
- Interventions
- Behavioral: Usual CareBehavioral: External Community ReferralBehavioral: Internal Care Coordination
- Registration Number
- NCT03612895
- Lead Sponsor
- Massachusetts General Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual Care Passive referral to quitline and referral to primary care physician. External Community Referral External Community Referral 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. Internal Care Coordination Internal Care Coordination 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.
- Primary Outcome Measures
Name Time Method Proportion of patients who are provided any evidence-based tobacco cessation treatment (as defined below), comparing pooled intervention groups (Internal Care Coordination + External Community Referral) vs Usual Care 6 months Any tobacco cessation treatment was defined as any of the following: (1) in-person visit with the practice-based tobacco counselor; (2) completion of \>1 Quitline counseling call (excluding the initial registration call in which the participant was transferred from the interactive voice response \[IVR\] system); (3) telephone contact with the study's Tobacco Coach (excluding the initial call after enrollment); (4) outpatient prescription for nicotine replacement, bupropion, or varenicline in the EHR; or (5) provision of nicotine replacement by the Quitline. Information was obtained from the EHR, research program records, practice-based tobacco counselor records, and the Quitline provider, National Jewish Health
- Secondary Outcome Measures
Name Time Method Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. External Community Referral 6 months Treatment defined as above
Proportion of patients reporting cigarette abstinence for the past 7 days (point-prevalence abstinence measure) 6 months Proportion of patients who report that they have not smoked a cigarette in the past 7 days on a telephone survey (point-prevalence abstinence measure)
Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. Usual Care 6 months Any tobacco cessation treatment was defined as any of the following: (1) in-person visit with the practice-based tobacco counselor; (2) completion of \>1 Quitline counseling call (excluding the initial registration call in which the participant was transferred from the IVR system); (3) telephone contact with the study's Tobacco Coach (excluding the initial call after enrollment); (4) outpatient prescription for nicotine replacement, bupropion, or varenicline in the EHR; or (5) provision of nicotine replacement by the Quitline. Information was obtained from the EHR, research program records, practice-based tobacco counselor records, and the Quitline provider, National Jewish Health
Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing External Community Referral vs. Usual Care 6 months Treatment defined as above
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States