Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers

NCT03612895 | Completed

• 1 other identifier: 2015P0021111
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Tobacco

Outcome Measures

Primary Outcomes (1)

• 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

  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

  6 months

Secondary Outcomes (4)

• Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. Usual Care

  6 months

• Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing External Community Referral vs. Usual Care

  6 months

• Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. External Community Referral

  6 months

• Proportion of patients reporting cigarette abstinence for the past 7 days (point-prevalence abstinence measure)

  6 months

Study Arms (3)

Internal Care Coordination

EXPERIMENTAL

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.

Behavioral: Internal Care Coordination

External Community Referral

EXPERIMENTAL

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.

Behavioral: External Community Referral

Usual Care

OTHER

Passive referral to quitline and referral to primary care physician.

Behavioral: Usual Care

Interventions

Internal Care Coordination BEHAVIORAL

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.

Internal Care Coordination

External Community Referral BEHAVIORAL

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.

External Community Referral

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 31197730 DERIVED

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Officials

• Nancy Rigotti, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: August 2, 2018
• Study Start: April 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)