Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers
Primary Purpose
Smoking, Tobacco
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internal Care Coordination
External Community Referral
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Smoking, Tobacco
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Internal Care Coordination
External Community Referral
Usual Care
Arm 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.
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.
Passive referral to quitline and referral to primary care physician.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination 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 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
Treatment defined as above
Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. External Community Referral
Treatment defined as above
Proportion of patients reporting cigarette abstinence for the past 7 days (point-prevalence abstinence measure)
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)
Full Information
NCT ID
NCT03612895
First Posted
July 21, 2018
Last Updated
July 27, 2018
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03612895
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Proactively contact smokers independent of their health care visits and
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internal Care Coordination
Arm Type
Experimental
Arm 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.
Arm Title
External Community Referral
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Passive referral to quitline and referral to primary care physician.
Intervention Type
Behavioral
Intervention Name(s)
Internal Care Coordination
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
External Community Referral
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
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
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. Usual Care
Description
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
Time Frame
6 months
Title
Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing External Community Referral vs. Usual Care
Description
Treatment defined as above
Time Frame
6 months
Title
Proportion of patients who are provided any evidence-based tobacco cessation treatment (defined below), comparing Internal Care Coordination vs. External Community Referral
Description
Treatment defined as above
Time Frame
6 months
Title
Proportion of patients reporting cigarette abstinence for the past 7 days (point-prevalence abstinence measure)
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Rigotti, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31197730
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.
Results Reference
derived
Learn more about this trial
Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers
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