Effectiveness and Implementation of mPATH-CRC: a Mobile Health System for Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77,145
- 试验地点
- 1
- 主要终点
- Percent of Patients Who Complete the mPATH-CRC Program
研究概览
简要总结
Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.
详细描述
The study team has developed mPATH-CRC (mobile PAtient Technology for Health-Colorectal Cancer), a patient-friendly iPad program used by individuals immediately before a routine primary care visit. mPATH-CheckIn is a module that is used in conjunction with mPATH-CRC that consists of questions asked of all adult patients at check-in. mPATH-CRC is a module specific for patients due for CRC screening.
To fully realize mPATH-CRC's potential to decrease CRC mortality, the program now must be implemented in primary care practices in a way that encourages routine and sustained use. However, while hundreds of mobile health (mHealth) tools have been developed in recent years, the optimal strategies for implementing and maintaining mHealth interventions in clinical practice are unknown. This study will compare the results of a "high touch" strategy to a "low touch" strategy using a Type III hybrid design and incorporating mixed methods to evaluate implementation, maintenance, and effectiveness of mPATH-CRC in a diverse sample of community-based practices.
The study will be conducted in three phases: 1) in a cluster-randomized controlled trial of 22 primary care clinics, the study team will compare the implementation outcomes of a "high touch" evidence-based mHealth implementation strategy with a "low touch" implementation strategy; 2) in a nested pragmatic study, the study team will estimate the effect of mPATH-CRC on completion of CRC screening within 16 weeks of a clinic visit; and 3) by surveying and interviewing clinic staff and providers after implementation is complete, the study team will determine the factors that facilitate or impede the maintenance of mHealth interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •This study will include three distinct populations of participants: 1) healthcare providers and staff at primary care practices, 2) patients aged 18 and older seen in the participating study sites, and 3) patients aged 50-74 seen in the participating study sites who are eligible for CRC screening
- •Patient Inclusion Criteria:
- •Due for routine CRC screening, defined as:
- •No colonoscopy within the prior 10 years
- •No flexible sigmoidoscopy within the prior 5 years
- •No CT colonography within the prior 5 years
- •No fecal DNA testing within the prior 3 years
- •No fecal blood testing (guaiac-based test with home kit or fecal immunochemical test) within the prior 12 months
排除标准
- •Personal history of CRC
- •First degree relative with CRC
- •Personal history of colorectal polyps
研究组 & 干预措施
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-CRC (Other)
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-Checkin (Other)
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: "high touch" Implementation strategy (Other)
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-CRC (Other)
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-Checkin (Other)
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: "low touch" Implementation Strategy (Other)
Clinic personnel on "high touch" Strategy (Post-Implementation)
Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-CRC (Other)
Clinic personnel on "high touch" Strategy (Post-Implementation)
Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-Checkin (Other)
Clinic personnel on "high touch" Strategy (Post-Implementation)
Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: "high touch" Implementation strategy (Other)
Clinic personnel on "low touch" Strategy (Post-Implementation)
Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-CRC (Other)
Clinic personnel on "low touch" Strategy (Post-Implementation)
Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-Checkin (Other)
Clinic personnel on "low touch" Strategy (Post-Implementation)
Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: "low touch" Implementation Strategy (Other)
All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: "high touch" Implementation strategy (Other)
All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-Checkin (Other)
All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: mPATH-Checkin (Other)
All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)
English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.
干预措施: "low touch" Implementation Strategy (Other)
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation.
干预措施: "high touch" Implementation strategy (Other)
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation)
English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation.
干预措施: "low touch" Implementation Strategy (Other)
结局指标
主要结局
Percent of Patients Who Complete the mPATH-CRC Program
时间窗: Month 6
mPATH-CRC Implementation: Percent of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 6th month following the implementation date.
次要结局
- mPATH-CRC Adoption(up to month 6)
- mPATH-CRC Reach (by Socioeconomic Strata)(up to month 6)
- mPATH-CRC Reach (by Month)(Months 1-5)
- mPATH-CRC Appropriateness(month 6)
- mPATH-CRC Maintenance(months 7-12)
- Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)(Month 12 or month of discontinuation of mPATH use)
- mPATH-CRC Feasibility(month 6)
- mPATH-CheckIn Reach(up to month 6)
- mPATH-CheckIn Adoption(up to month 6)
- mPATH-CRC Implementation Fidelity(up to month 6)
- mPATH-CheckIn Appropriateness(month 6)
- mPATH-CheckIn Maintenance(months 7-12)
- CRC Screening Tests Ordered(up to 16 weeks from index visit)
- mPATH-CRC Effectiveness(up to 16 weeks from index visit)
- mPATH-CRC Acceptability(month 6)
- mPATH-CheckIn Acceptability(month 6)
- mPATH-CheckIn Feasibility(month 6)