PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 682
- 试验地点
- 2
- 主要终点
- Rate of colonoscopy completion within 6 months
研究概览
简要总结
This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.
详细描述
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling.
GROUP II: Patients receive usual care as described in Group I and additionally receive a quick response (QR) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse.
After completion of study intervention, patients are followed up for 18 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
- Single (Care Provider)
盲法说明
The program navigator will be blinded to randomization assignments.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS: Age >= 45 years old and =< 75 years old
- •PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic
- •PATIENTS: >= 1 month from documented abnormal FIT result
- •PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment
- •CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care
- •CLINIC STAFF: Staff in the Fred Hutchinson (Fred Hutch)/UW Medicine Population Health Program that provide colorectal cancer screening and navigation
排除标准
- 未提供
研究组 & 干预措施
Group I (usual care)
Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling.
干预措施: Best Practice (Other)
Group I (usual care)
Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling.
干预措施: Electronic Health Record Review (Other)
Group II (usual care, video, rideshare transportation)
Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.
干预措施: Best Practice (Other)
Group II (usual care, video, rideshare transportation)
Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.
干预措施: Electronic Health Record Review (Other)
Group II (usual care, video, rideshare transportation)
Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.
干预措施: Interview (Other)
Group II (usual care, video, rideshare transportation)
Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.
干预措施: Educational Intervention (Other)
Group II (usual care, video, rideshare transportation)
Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.
干预措施: Supportive Care (Other)
Group II (usual care, video, rideshare transportation)
Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Rate of colonoscopy completion within 6 months
时间窗: At 6 months after randomization
Will descriptively compare the rates of colonoscopy completion at 6 months. Will fit a generalized mixed effects model with a logit link and a random effect for clinic. Will include an indicator variable for the randomized group (usual care versus (vs.) multilevel intervention) and adjust for patient-level clinical and demographic factors (e.g., age, sex, race, ethnicity, primary language, marital status, last primary care visit, insurance) and clinic-level factors (e.g., clinic size, average full-time equivalent providers per clinic, average provider panel size, primary care provider mix (Doctor of Medicine/Doctor of Osteopathic Medicine vs. other advanced degree).
Time to colonoscopy completion
时间窗: Beginning 6 months after randomization until study completion
Will assess the time to colonoscopy completion in days and compare these times across individual clinics.
次要结局
- Rate of colonoscopy completion > 6 months(At 9 and 12 months after randomization)
- Colonoscopy referral: Number of participants referred for a colonoscopy(Up to 18 months after randomization)
- Time to colonoscopy referral (days)(Up to 18 months after randomization)
- Number of participants who schedule a colonoscopy(Up to 18 months after randomization)
- Time to scheduling a colonoscopy (days)(Up to 18 months after randomization)
- Time from abnormal fecal immunochemical test (FIT) result to colonoscopy completion(Up to 18 months after randomization)
- Rates of colorectal cancer or advanced adenoma(Up to 18 months after randomization)
- Proportion and demographic characteristics of individuals who are eligible and receive the multilevel intervention after randomization (Reach)(6-24 months post randomization)
- Perception that the intervention components are suitable to address identified barriers (Acceptability)(6-24 months post randomization)
- Degree to which the intervention is used as intended (Fidelity)(6-24 months post randomization)
- Average cost per patient to deliver the intervention(Weekly, for up to 8 months)
- Average cost per clinic to deliver the intervention(Weekly, for up to 8 months)
- Proportion of costs per intervention activity(Weekly, for up to 8 months)
- Number of participants served per intervention component(Weekly, for up to 8 months)
- Average cost per participant by intervention component(Weekly, for up to 8 months)