A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
- 试验地点
- 5
- 主要终点
- 7-day point-prevalence smoking abstinence at 18 months
研究概览
简要总结
This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey.
- •Currently smoke >1 cigarette over the past 30 days
- •Must have address or telephone number in the electronic health record
排除标准
- •Electronic health record documented cognitive impairment or legal guardianship
- •Patients who have opted out of reserach studies
研究组 & 干预措施
Enhanced Usual Care: Ask-Advice-Connect (AAC)
AAC participants will receive care through their primary care provider as usual (with the caveat that providers in the clinics will be trained to provide AAC). AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.
干预措施: Ask-Advice-Connect (AAC) (Behavioral)
AAC + Longitudinal Proactive Outreach (LPO)
AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment. AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.
干预措施: Ask-Advice-Connect (AAC) (Behavioral)
AAC + Longitudinal Proactive Outreach (LPO)
AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment. AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.
干预措施: Longitudinal Proactive Outreach (LPO). (Behavioral)
结局指标
主要结局
7-day point-prevalence smoking abstinence at 18 months
时间窗: 18 months
7-day point prevalence abstinence from combustible tobacco will be verified at 18 months post-enrollment. Surveys to self-report abstinence will be provided at 6, 12, and 18 months. Self-reported smoking abstinence will be verified using expired carbon monoxide as the primary method with salivary cotinine as an alternative method at the 18-month follow-up. Participants with a CO of \< 6 ppm will be considered abstinent. Participants with a salivary cotinine \< 10 ng/ml will be considered abstinent.
次要结局
- Change in Overall Quality of Life(0, 6, 12, and 18 months)
- Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score(0, 6, 12, and 18 months)
- Change in Treatment utilization.(6, 12, and 18 months)