Multilevel Health System Intervention to Increase Guideline-Concordant Surveillance Colonoscopy for High Risk Colon Polyps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,680
- 试验地点
- 2
- 主要终点
- Cost effectiveness (Aim 3b)
研究概览
简要总结
This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.
详细描述
PRIMARY OBJECTIVE:
I. To increase completion of surveillance colonoscopy within 3.5 years of high risk neoplasia (HRN) diagnosis.
OUTLINE:
AIM 1: Participants complete an interview over 20-30 minutes.
AIM 2: Primary care clinics are randomized to 1 of 2 arms.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AIM 1 PATIENTS: Patients between age 45 and 75 with a HRN diagnosis in the past 5 years
- •AIM 1 PATIENTS: 12 patients who did and 12 patients who did not have surveillance colonoscopy
- •AIM 1 PROVIDERS: Primary care providers (PCPs) and gastroenterologists (GIs)
- •AIM 1 ADMINISTRATORS: Administrators who are involved in care processes related to CRC screening, HRN surveillance, and/or colonoscopy scheduling
- •AIM 2: Patients age 45 to 75 diagnosed with a HRN during the pre-specified two-year HRN diagnosis period
排除标准
- •AIM 2: Individuals with a personal history of colorectal carcinoma (CRC), inflammatory bowel disease (Crohn's, ulcerative colitis), or polyposis syndrome
- •AIM 2: HRN cases not confirmed by chart review (human-in-the-loop)
结局指标
主要结局
Cost effectiveness (Aim 3b)
时间窗: Up to 3 years
Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the natural language processing-based electronic health record intervention compared to usual care office outreach.
Stakeholder perspectives on the multilevel intervention (Aim 1)
时间窗: At time of interview
The Investigators will conduct 1-on-1 in-depth interviews with patients, advocates, providers, and administrators. these interviews will provide data in closer proximity to intervention implementation to optimize composition, timing, and acceptability of each component. Interview content is guided by the multiple health outcomes framework (MHOF) and addresses major barriers (patient, provider, system) to surveillance and challenges (patient, provider, system) to the planned implementation of intervention components.
Completion of surveillance colonoscopy (Aim 2)
时间窗: At 3.5 years
Will analyze rates during the study period using a generalized linear mixed model with a logit link that includes an indicator for study arm and random effects for clinic and primary care provider to account for the multilevel data structure.
Implementation quality (Aim 3a)
时间窗: Up to 3 years
The Investigators will assess implementation quality and outcomes through stakeholder interviews (patients, providers, administrators) and chart reviews. The information gained will guide adaptations of the intervention for future use so that clinicians maximize effectiveness, feasibility, acceptability, sustainability, and impact. Findings will also determine the resources needed to successfully scale the intervention to different settings
次要结局
- Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2)(From HRN diagnosis to colonoscopy, up to 3 years)