A Community Health Worker Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasiblity
研究概览
简要总结
Lung cancer screening (LCS) can reduce lung cancer-related mortality by 20%, but only 5-10% of eligible individuals have received an initial LCS. The goal of this study is to partner with community stakeholders to jointly develop and pilot test a multi-component community health worker-delivered intervention targeting key barriers to improve LCS and tobacco treatment utilization. The proposed activities will lay the groundwork for a subsequent R01 grant, conducting a fully powered randomized clinical trial to establish CHWs as an evidence-based practice that will facilitate access to screening and tobacco treatment, to reduce lung cancer mortality.
详细描述
Lung cancer is the leading cause of cancer death, and lung cancer screening (LCS) can reduce lung cancer-related mortality by 20%. However, only 5-10% of eligible individuals have received an initial LCS exam. Community health worker (CHW) interventions have been effective at promoting screening in other cancer settings. Whether a CHW-delivered intervention can be effective in the context of LCS and address key barriers to receiving LCS remains unknown. The goal of this study is to develop and pilot test a four-part CHW-delivered intervention to improve LCS uptake, which includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) smoking cessation counseling, and 4) navigation of logistical barriers. Our central hypothesis, based on our qualitative work and informed by the expanded Health Belief Model, proposes that a CHW-delivered intervention can address key modifiable factors to improve LCS awareness, engagement, and barriers to accessing care, leading to increased LCS uptake. Our aims are to: Jointly "transcreate" a CHW-delivered intervention to increase LCS uptake among patients served by community health centers (Aim 1); conduct a pilot randomized controlled trial of the intervention (Aim 2a); and obtain empiric estimates of effect size in LCS and tobacco treatment utilization (Aim 2b). We first seek to jointly "transcreate" the intervention with our community advisory board, comprised of key stakeholders in LCS and patients with lived experience, applying the Transcreation Framework for Community-Engaged Behavioral Interventions. Then we will conduct a pilot randomized controlled trial of the CHW-delivered intervention at Baystate Health's three community health centers. We will randomize 80 LCS-eligible individuals (40 in each arm) to either the intervention or enhanced usual care (i.e., mailed LCS educational materials and usual LCS as per primary care provider). Primary pilot outcomes are focused on feasibility, including participant recruitment, measure completion, retention, fidelity, and acceptability. We will also conduct an evaluation of secondary trial outcomes, including LCS and tobacco treatment utilization, as well as explore potential mediators (e.g., knowledge, facilitation of logistical barriers). The proposed activities will provide me with crucial skills in community-engaged research, implementation science, and clinical trial design, and launch my career as a clinician-scientist dedicated to addressing lung cancer mortality. This work will also lay the groundwork for a subsequent R01 grant conducting a fully powered randomized controlled trial of the CHW-delivered intervention that directly addresses top priorities from the President's Cancer Moonshot and NCI's mission to develop multi-level interventions that facilitate access to cancer screening and reduce lung cancer mortality.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between the age of 50 and
- •Potentially eligible for LCS according to the Electronic Health Record smoking history.
- •Receive their primary care at Mason Square, High Street, or Brightwood community health centers.
- •English- or Spanish- speaking.
排除标准
- •Not eligible for lung cancer screening based on age (age < 50 or > 80 years) or smoking history (has not smoked more than 20 pack-years of tobacco cigarettes or quit more than 15 years ago).
- •Have received a lung cancer screen in the past.
研究组 & 干预措施
Enhanced Usual Care
Will receive educational materials about lung cancer screening and tobacco treatment.
干预措施: Enhanced Usual Care (Other)
Intervention
Will receive a four-part community health worker-delivered intervention to improve LCS uptake, which includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) smoking cessation counseling, and 4) navigation of logistical barriers
干预措施: Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation (Behavioral)
结局指标
主要结局
Feasiblity
时间窗: once a month until study trial ends, an average one year
Recruitment \& enrollment: # of participants approached, met eligibility, and randomized Baseline Measures (see Table 5): Completeness of data collection. Retention: Loss of follow-up, reason for discontinuation, completeness of post-intervention data
Fidelity
时间窗: once a month until study trial ends, an average of 1 year
Duration of SDM and Smoking cessation Navigation: amount of time spent per call
Acceptability
时间窗: 3 months post enrollment (for study participant) and through study completion, an average of 1 year (for CHW staff)
CHWs: Encounter logs documenting participant concerns and barriers to LCS Qualitative Interviews: Participants (N=15): Completed at the 3-month follow-up in a private setting, duration \~40-45 minutes, to assess the overall experience with the CHW intervention and barriers to LCS. CHWs (N=3): One 45-minute interview with each CHW after completing their last intervention delivery during the trial period.
Feasibility: Number of participants at each stage of the recruitment and retention cascade
时间窗: once a month until study trial ends, an average one year
Counts abstracted from the study screening and enrollment log at each of the following stages: approached, screened eligible, consented, randomized, completed baseline data collection, and completed post-intervention follow-up assessment.
Feasibility: Percentage of participants at each stage of the recruitment and retention cascade
时间窗: once a month until study trial ends, an average one year
Percentages calculated from the study screening and enrollment log. Eligibility rate = number screened eligible divided by number approached. Consent rate = number consented divided by number screened eligible. Randomization rate = number randomized divided by number consented. Baseline completion rate = number completing baseline data collection divided by number randomized. Retention rate = number completing post-intervention follow-up divided by number randomized.
Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter
时间窗: once a month until study trial ends, an average of 1 year
Time in minutes spent on SDM, recorded by community health workers (CHWs) in the encounter/call tracking log.
Fidelity: Duration in minutes of smoking cessation counseling per encounter
时间窗: once a month until study trial ends, an average of 1 year
Time in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) in the encounter/call tracking log.
Fidelity - SDM quality using OPTION Scale Observer OPTION Scale
时间窗: once a month until study trial ends, an average of 1 year
Mean total score on the OPTION Scale Observer OPTION Scale scored from audio-recorded SDM encounters; 12 items rated 0 ("not observed") to 4 ("exhibited at a very high standard"), total score 0-48, with higher scores indicating greater SDM competence.
Fidelity - Completion of SDM required elements
时间窗: once a month until study trial ends, an average of 1 year
Mean count of CMS SDM Elements completed during each encounter: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.
Fidelity: Percentage of participants with documented use of the SDM decision aid
时间窗: Monthly through study completion, an average of 1 year
Proportion of participants for whom the SDM decision aid was used, documented in the CHW encounter log.
Fidelity: Percentage of participants referred to tobacco treatment services, by type
时间窗: Monthly through study completion, an average of 1 year
Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW encounter log.
Acceptability of the CHW intervention to participants
时间窗: 3 months post-enrollment (participants) and through study completion, an average of 1 year (CHWs)
Qualitative themes regarding overall experience with the CHW intervention and barriers to lung cancer screening, identified through thematic analyses of semi-structured interviews using a study-specific interview guide. Participants (N=15), \~40-45 minutes, conducted in private at 3-month follow-up;
Acceptability of the CHW intervention to CHWs
时间窗: 3 months post-enrollment (participants) and through study completion, an average of 1 year (CHWs)
Qualitative themes regarding overall experience with the CHW intervention and barriers to lung cancer screening, identified through thematic analysis of CHW encounter logs and semi-structured interviews using a study-specific interview guide. CHWs (N=3), one 45-minute interview each after final intervention delivery.
Feasiblity
时间窗: once a month until study trial ends, an average one year
Recruitment \& enrollment: # of participants approached, met eligibility, and randomized Baseline Measures (see Table 5): Completeness of data collection. Retention: Loss of follow-up, reason for discontinuation, completeness of post-intervention data
Fidelity
时间窗: once a month until study trial ends, an average of 1 year
Referral to tobacco treatment services and type of referral (e.g., telephone quit line, in-person), nicotine replacement therapy.
Acceptability
时间窗: 3 months post enrollment (for study participant) and through study completion, an average of 1 year (for CHW staff)
CHWs: Encounter logs documenting participant concerns and barriers to LCS Qualitative Interviews: Participants (N=15): Completed at the 3-month follow-up in a private setting, duration \~40-45 minutes, to assess the overall experience with the CHW intervention and barriers to LCS. CHWs (N=3): One 45-minute interview with each CHW after completing their last intervention delivery during the trial period.
次要结局
- LCS uptake(Baseline and post intervention, 3 months post study enrollment)
- Tobacco Treatment receipt(3 months post study enrollment)
- Tobacco Treatment Duration(3 months post study enrollment)
- Tobacco Cessation(3 months post study enrollment)
- LCS referral(3 months post study enrollment)
- Percentage of participants with a lung cancer screening (LCS) referral order(3 months post study enrollment)
- Percentage of participants completing low-dose CT lung cancer screening (LCS uptake)(Baseline and post intervention, 3 months post study enrollment)
- Percentage of participants initiating tobacco treatment, by treatment type(3 months post study enrollment)
- Duration in weeks of tobacco treatment(3 months post study enrollment)
- Number of self-reported quit attempts per participant(3 months post study enrollment)
- LCS referral(3 months post study enrollment)
- LCS uptake(Baseline and post intervention, 3 months post study enrollment)
- Tobacco Treatment receipt(3 months post study enrollment)
- Tobacco Treatment Duration(3 months post study enrollment)
- Tobacco Cessation(3 months post study enrollment)
研究者
Eduardo
Assistant Professor Departments of Medicine and Healthcare Delivery and Population Sciences
Baystate Medical Center