Developing a Team-Delivered Intervention for Smoking and Hazardous Drinking for Primary Care Veterans With Cardiovascular Diseases (CDA 18-006)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Readiness to Change Drinking OR Smoking
研究概览
简要总结
In this study, the investigators are interested in learning how patients feel about and are impacted by a new approach for the primary care team to use to talk to patients about heart disease and health behaviors. The investigators were looking to recruit around 40 Veterans from Buffalo and Syracuse to be in this study. What it entailed is being randomly assigned to one of two conditions. If patients are assigned to the first condition, their upcoming primary care appointment will be extended by about 5 minutes because a Health Educator will join the end of that appointment. If they are assigned to the second condition they would have their typical primary care appointment. Beyond that, both conditions are quite similar. They will have an individual meeting following the primary care appointment with the Health Educator, two phone booster meetings at 2 and 4 weeks, and information about an optional app that they have the choice to use to help them track some health behaviors.
详细描述
Many Veterans (30.4%) with cardiovascular diseases (CVDs) continue to engage in behaviors that increase risk of cardiovascular events and early mortality, such as smoking or hazardous drinking. While the VA has several programs designed to help Veterans quit smoking or quit/reduce drinking, there is a gap in service for Veterans who are not ready for change-based treatments but continue to smoke or drink hazardously. VA Patient Aligned Care Teams (PACTs) screen all patients annually for alcohol and tobacco use, and thus the PACT platform is an ideal way to reach Veterans with CVDs who smoke and/or drink hazardously. Through the Primary Care Mental Health Integration (PCMHI) initiative, mental and behavioral health providers are embedded to provide effective, evidence-based, Veteran-centered, behavioral health interventions for a variety of co-occurring behavioral health concerns and medical problems. Educational and self-monitoring interventions are evidence-based and increase substance users' intentions to make a behavior change, and additionally improve patient factors including engagement, willingness to accept behavioral health referrals, and self-management strategies. This research proposal focuses on adapting elements of these evidence-based interventions specifically for a PACT-based VA setting to appeal to Veterans not yet ready to change smoking and/or drinking. This intervention aims to increase intention to change and may improve rates of cessation and engagement with change-based programs. The intervention will fill a gap in care and potentially improve the health and longevity of Veterans seen in PACT. The intervention, called CARE, will be piloted in two formats: 1) that includes a conjoint meeting between a PACT medical provider and a behavioral health provider; and 2) only with a behavioral health provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will not know which version of CARE that the patient receives.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veteran patients age 18 seen in PACT at the Buffalo and Syracuse VA Medical Center (VAMCs) and catchment areas
- •Upcoming PACT appointment
- •A diagnosis of cardiac disease, including coronary artery disease, hypertension, hyperlipidemia, OR ischemia
- •Positive alcohol or tobacco use screen for at least two consecutive years (including most recent) for:
- •a.Smoking (i.e., Answered "Yes" on the Annual Veteran's Health Administration (VHA) Tobacco Use Screening Questionnaire) AND/OR
- •b.Hazardous drinking (Alcohol Use Disorders-Consumption [AUD-C] 4 for men or 3 for women)
- •Currently smokes at least one cigarette per day OR currently scores in a range indicating hazardous drinking on the Alcohol Use Disorders Identification Test (AUDIT) OR both [telephone screen]
- •Currently reports on 1 to 10 scale having no greater than high-moderate (defined as 8) intention (i.e., 7) to change their drinking and/or smoking behavior [telephone screen]
排除标准
- •Disorientation at time of eligibility (i.e., delirium, acute psychosis, dementia, severe intoxication) [from the electronic medical record (EMR), telephone screen, or clinical judgment at the time of the in person appointment]
- •Unable to read or understand English [telephone screen]
- •Non-Veteran status [EMR]
结局指标
主要结局
Readiness to Change Drinking OR Smoking
时间窗: 6 weeks post intervention
Readiness to Change Questionnaire. This is a standardized measure (Heather and Rollnick, 1993) with 12 items measuring how ready an individual is to make a change to a behavior (e.g., drinking, smoking). The scale contains subscales that can indicate which Stage of Change (Precontemplation, Contemplation, or Action) an individual is in during the time of measurement. It is scored by seeing which subscale an individual is highest on at the time of measurement (i.e., their highest subscale score among the three stages; if two subscale scores are equal then the higher stage is chosen).
次要结局
- Cigarettes Per Day(6 weeks post intervention)
- Patient Satisfaction Survey(6 months post intervention)
- Drinking Days(6 weeks post intervention)
- Drinks Per Drinking Day(Six weeks post intervention)