Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 主要终点
- Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
研究概览
简要总结
The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC) screening patient navigator program for patients with Mental Health (MH) and /or Substance Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study will involve randomly assigning eligible patients to early intervention or usual care/delayed intervention groups. The investigators believe this random assignment is ethical because Patient Navigation (PN) is an extremely limited resource, and all patients identified as eligible could not be contacted by the navigators in a short period of time. Thus the investigators will randomly assign access to PN during the study period, and then allow all patients to be navigated and screened after the study period is over. As a result, all eligible patients will be referred for PN, but the timing of the referral will be randomly assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients aged 50-75 years who are not up to date on CRC screening (did not have had CRCs colonoscopy in the last 10 years or sigmoidoscopy in the last 5 years or fecal occult blood within last 12 months)
- •receive care at MGH Charlestown
- •have documented history of MH or SUD in electronic medical record
排除标准
- •subsequently identified as having died prior to study intervention
- •patients with total colectomy
研究组 & 干预措施
patient navigation
PN will contact patients during their visits to health cancer or over the phone. During this initial contact, the PN will educate patients about CRC, screening and explore their barriers to screening. The PN will coordinate scheduling of CRC screening and remind patients about the tests. PN will explain preparation for colonoscopy and whenever feasible, accompany patient to obtain the test. Further interventions may include: reminding the patient about the test, helping with translation, insurance issues, transportation, and overcoming any other system barriers as needed.
干预措施: patient navigation (Behavioral)
usual care
patients randomly assigned to the control will receive usual care and be eligible for navigation after the study period.
结局指标
主要结局
Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
时间窗: 6 months
To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of colonoscopy results) we will perform EMR reviewed of trial participants.
次要结局
- Number of polys found in intervention polyps (histology)(1 year)
- As-treated primary outcomes among intervention patients contacted by patient navigator.(1 year)
- Number of cancers (stage) found in the intervention and control group during the study period(1 year)
研究者
Carolina Abuelo
Instructor
Massachusetts General Hospital