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Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers

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ClinicalTrials.gov Identifier: NCT03612895
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Nancy A. Rigotti, 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.


Condition or disease Intervention/treatment Phase
Smoking, Tobacco Behavioral: Internal Care Coordination Behavioral: External Community Referral Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: 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.
Behavioral: Internal Care Coordination
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.

Experimental: 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.
Behavioral: External Community Referral
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.

Usual Care
Passive referral to quitline and referral to primary care physician.
Behavioral: Usual Care
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.




Primary Outcome Measures :
  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 [ Time Frame: 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 :
  1. Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. Usual Care [ Time Frame: 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

  2. Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing External Community Referral vs. Usual Care [ Time Frame: 6 months ]
    Treatment defined as above

  3. Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. External Community Referral [ Time Frame: 6 months ]
    Treatment defined as above

  4. Proportion of patients reporting cigarette abstinence for the past 7 days (point-prevalence abstinence measure) [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612895


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Nancy Rigotti, MD Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nancy A. Rigotti, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03612895    
Other Study ID Numbers: 2015P0021111
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders