Clinical trial NCT03612895: Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers
Official title: Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Tobacco
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. Usual Care
timeFrame: 6 months
measure: Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing External Community Referral vs. Usual Care
timeFrame: 6 months
measure: Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. External Community Referral
timeFrame: 6 months
measure: Proportion of patients reporting cigarette abstinence for the past 7 days (point-prevalence abstinence measure)
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalkhoran S, Inman EM, Kelley JHK, Ashburner JM, Rigotti NA. Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network. J Gen Intern Med. 2019 Aug;34(8):1571-1577. doi: 10.1007/s11606-019-05079-3. Epub 2019 Jun 13.