Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings (SMARTER CRC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,696
- 试验地点
- 2
- 主要终点
- Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients)
研究概览
简要总结
This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.
详细描述
PRIMARY OBJECTIVE:
I. Adapt, pilot, then test the implementation and scale-up of targeted direct mail and patient navigation programs.
OUTLINE:
This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening. Eligible patients will be mailed a fecal immunochemical test (FIT). The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic. Outcomes are tracked using reports from direct mail vendors, claims data from participating Medicaid health plans, clinic data from the electronic health record, chart review, and data from a REDCap database. The hypotheses will be tested using a two-arm cluster randomized trial design. Participating clinics will be randomized into two groups: Intervention and Usual Care. Medicaid health plans/ Coordinated care organizations (CCO) and clinic leadership participate in interviews and complete surveys.
The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months. Data will be collected at 6 time points: baseline, 6-months, 12-months, 18-months, 24-months, and 36-months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CCOs/CCO STAFF: Serving a majority of counties that are predominantly rural based on 2010 Rural-Urban Commuting Area (RUCA) codes (codes 4-10)
- •CCOs/CCO STAFF: Willing to participate in data collection activities (e.g., producing claims data, interviews)
- •CLINICS: Clinics will be eligible for the cluster randomization if there are 30 or more patients eligible for screening
- •CLINICS: Are classified as rural according to RUCA (Codes 4-10) or Oregon Office of Rural Health designations
- •CLINICS: Are served by CCOs agreeing to participate in the project
- •CLINICS: Willing to implement the intervention into their clinic for the study
- •CLINIC STAFF/PROVIDERS: Employed as a clinician or ancillary staff member in a participating clinic
- •CLINIC STAFF/PROVIDERS: Willing to participate in data collection activities (e.g., interviews, observation, surveys)
- •PATIENTS: Attributed to participating clinic
- •PATIENTS: Are enrolled in Medicaid or dual eligible
- •PATIENTS: Eligible for colorectal cancer (CRC) screening
- •PATIENTS: For the subset of patients that will be invited to participate in key informant interviews, a 5th eligibility criteria is consented to participate
- •COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: (Includes endoscopy providers, community-based outreach workers, or leaders from regional or national organizations who participate in the pilot, pragmatic trial, or scale-up study)
- •COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Involved in study activities (training, care delivery)
- •COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Willing to participate in data collection activities (e.g., trainings, interviews, surveys)
- •Elderly - Yes - we anticipate that a limited number of clinic and CCO staff, or community organization representatives may be elderly; we limit our patient recruitment to those aged 45-75
- •Rural - Yes
- •Inner city - No
- •Low income - Yes
- •Disabled - Yes
- •Chronic care - Yes
- •End of life - Yes - This is possible, but we predict limited numbers because of the types of individuals we are recruiting: clinic and CCO staff, and patients who are not currently in hospice care
- •Minorities - Yes
排除标准
- •CLINICS: Clinics are excluded if they have current or ongoing participating in other mailed fecal testing research projects in the Medicaid population
- •PATIENTS: Are current for screening
- •PATIENTS: Comorbid conditions that make patients poor candidates for screening based on clinical judgment (e.g., end-stage renal disease, enrollment in hospice)
- •PATIENTS: Are not an established patient or for other reasons documented by the clinics
- •All patients that we recruit will be at least 45 years of age or older
结局指标
主要结局
Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients)
时间窗: Primary outcome at 6 months following CCO eligible patient list pull date,
Adjusted 6-month any CRC screening for enrollees in clinic units. These values are predicted estimates rather than crude number \[%\] generated using marginal standardization and accounting for clustering and covariates (i.e., sex, age, and Medicaid health plan). Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, we used the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.
次要结局
- Rate of CRC Screening Among the Intervention-eligible Population(6 months)
- Time to Screening From Study-eligible Patient List Pull(Up to 12 months)
- Follow-up Colonoscopy Completion(Up to 12 months)
- Completion of CRC Screening(Up to 12 months)
- Patient Navigation Completed (Intervention Group)(Up to 12 months)
- Adenomas or Cancers Detected(Up to 12 months)
- Key Implementation Barriers(Up to 36 months)
- Abnormal FIT Results(6 months)
- Patient Navigation Trainings (Intervention Group)(Up to 12 months)
- Time to Colonoscopy From Abnormal FIT Result(Up to 12 months)
研究者
Melinda Davis
Principal Investigator
OHSU Knight Cancer Institute