CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55,999
- 试验地点
- 2
- 主要终点
- Screening up-to-date (primary)
研究概览
简要总结
Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.
The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.
The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.
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
- 否
入选标准
- •Patient had an office visit within the last 12 months at one or more of your health centers. (Use Uniform Data System [UDS] criteria for an office visit.)
- •Not up to date with colorectal cancer screening according to the standard UDS query
- •Male or Female
- •50 - 75 years old
- •Current VALID address in San Diego or Riverside Counties (addresses with a PO box or General Delivery are acceptable)
- •Valid Phone Number
- •Insured patients only (e.g., Medicare, Medi-Cal, or private insurance)
排除标准
- •Absence of a phone number listed in the Electronic Health Record/Electronic Medical Record (EMR)
- •Absence of a valid mailing address (e.g. blank field)
- •Uninsured
- •Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
- •Duplicate patients within a health center organization. (If a patient was seen at multiple locations within the past year, only include the patient in the sample for the site where the patient was seen last)
- •Care Coordination for Abnormal FIT results, add the following to the inclusion criteria:
- •Completion of a FIT for Colorectal Cancer Screening during the designated time period
- •Abnormal FIT result received and documented in EMR during the designated time period
结局指标
主要结局
Screening up-to-date (primary)
时间窗: Three years
Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years).
Colonoscopy after abnormal FIT (primary)
时间窗: Six months
Proportion of patients with abnormal FIT who complete colonoscopy within 6 months
次要结局
- FIT Completion(Twelve months)
- Follow-up process(From date of abnormal FIT results until the date of follow-up process is completed if a CRC is found, assessed up to 3 years)
- Time to colonoscopy after abnormal FIT(From date of abnormal FIT results until the date of colonoscopy completion, assessed up to 3 years)
研究者
Elena Martinez
Professor
University of California, San Diego