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临床试验/NCT03612895
NCT03612895已完成不适用

Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
234
试验地点
2
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Internal Care Coordination (Behavioral)

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.

干预措施: External Community Referral (Behavioral)

Usual Care

Other

Passive referral to quitline and referral to primary care physician.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

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

时间窗: 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

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy A. Rigotti

Professor of Medicine, Harvard Medical School

Massachusetts General Hospital

研究点 (2)

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