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临床试验/NCT03452371
NCT03452371已完成不适用

Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication

研究概览

简要总结

In a pilot randomized controlled trial (RCT), smokers hospitalized on the general internal medicine or family medicine service will be randomized to: 1) enhanced traditional care (ETC), or 2) patient navigation (PN). Patients will be assessed at 3 months for self-report of quitting, use of smoking cessation medications, and use of counseling in the outpatient setting. Medical charts will be reviewed to ascertain if a prescription for smoking cessation medications was sent to the participants' pharmacy (primary outcome), if participants received inpatient tobacco counseling from the Tobacco Treatment Service (TTS), and whether they had a diagnosis of mental health and substance use.

详细描述

An Electronic Privacy Information Center(EPIC programmer who works with the Inpatient Tobacco Treatment Program will identify potential participants using electronic health record (EHR) data each week.

Eligible patients who are interested in the study and provide informed consent will be randomized and informed of the randomization assignment by the research assistant. We will stratify randomization by participants' response regarding their plan to quit smoking ("in the next month" or "more than a month from now"). A computer-generated sequence of random numbers will assign treatment groups. Participants will be randomized to one of two treatment arms: (1) standard of care, or (2) PN: a patient navigator to coordinate tobacco treatment with the smoker's outpatient healthcare team and address any underlying social determinants of health that are barriers to cessation (identified using a validated social determinants of health screening tool).

Assessments. A trained research assistant will administer these assessments either in-person or over the phone. The assessments require under 30 minutes to complete. The PI will also conduct an in-depth interview with the patient navigator to explore barriers to successful navigation. Outcome assessments will be conducted at baseline (prior to randomization) and at 3-months after randomization. Participants will be assessed at 3-months, for self-report of quitting, use of smoking cessation medications, and use of counseling in the outpatient setting.

Enhanced Traditional Care: Participants randomized to this group will receive a resource card that has information on quitlines, Boston Medical Center (BMC) outpatient program number, and websites for smoking cessation.

Patient Navigation Intervention: This intervention is based on the Social Contextual Model, a multi-level approach to health education which stresses the influence of life experiences (e.g. stress and financial problems) and social relationships (e.g. social networks and family roles) on the practice of health behaviors. Participants randomized into this group will meet the trained navigator in person if she is available, or will be introduced by telephone. Participants will receive up to ten hours of patient navigation, in person or over the phone, over a three-month period. Patient navigation contacts will involve individual counseling to help the patient achieve abstinence from smoking. Navigators will also screen participants for social determinants of health which may be preventing them from quitting smoking, using an adapted version of a validated social determinants of health screening tool. Patient navigation intervention calls will use motivational interviewing (MI) strategies to do the following: (1) Assess stage of change for smoking cessation; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce or quit smoking; (3) Explore the patient's motivation to quit smoking, drawing on recent illness, financial situation, and family situation as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications (e.g. lack of trust, cost, misconceptions about treatment (e.g. that nicotine replacement therapy (NRT) is more harmful than cigarettes); (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • ≥ 18 years of age
  • Hospitalized on the General Internal Medicine or Family Medicine service
  • Have a primary care provider at BMC
  • Smoked ≥1 cigarettes/day in the past month
  • Must have plans to quit smoking
  • Read, understand, speak English
  • Possession of a telephone (home or cell)
  • Able to consent

排除标准

  • Cannot give informed consent or participate in counseling due to psychiatric or cognitive impairment or communication barrier
  • Admitted to surgical, obstetric or psychiatric units
  • Estimated life expectancy of <12 months
  • Medical instability

结局指标

主要结局

Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication

时间窗: Three months

Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)

次要结局

  • Number of Participants With Stage of Change for Smoking Cessation(Three months)
  • Number of Participants With Self-reported Smoking Cessation(Three months)
  • Number of Participants With Utilization of Smoking Cessation Medication(Three months)
  • Use of Other Tobacco Treatment Support(Three months)
  • Mean Fagerstrom Test Score for Nicotine Dependence(Three months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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