Effectiveness and Implementation of mPATH-CRC

Wake Forest University (WFU)

Status: Completed

Conditions: Rectum Cancer; Colon Cancer; Cancer; Colorectal Cancer

Treatments: Other: mPATH-Checkin; Other: "low touch" Implementation Strategy; Other: mPATH-CRC; Other: "high touch" Implementation strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03843957

R01CA218416 (U.S. NIH Grant/Contract)

IRB00048919

Details and patient eligibility

About

Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.

Full description

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.

Enrollment: 77,145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Patient Exclusion Criteria:

• Personal history of CRC
• First degree relative with CRC
• Personal history of colorectal polyps

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

77,145 participants in 8 patient groups

Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)

Experimental group

Description:

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.

Treatment:

Other: mPATH-CRC

Other: "high touch" Implementation strategy

Other: mPATH-Checkin

Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)

Experimental group

Description:

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.

Treatment:

Other: mPATH-CRC

Other: "low touch" Implementation Strategy

Other: mPATH-Checkin

Clinic personnel on "high touch" Strategy (Post-Implementation)

Experimental group

Description:

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.

Treatment:

Other: mPATH-CRC

Other: "high touch" Implementation strategy

Other: mPATH-Checkin

Clinic personnel on "low touch" Strategy (Post-Implementation)

Experimental group

Description:

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.

Treatment:

Other: mPATH-CRC

Other: "low touch" Implementation Strategy

Other: mPATH-Checkin

All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)

Experimental group

Description:

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.

Treatment:

Other: "high touch" Implementation strategy

Other: mPATH-Checkin

All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)

Experimental group

Description:

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.

Treatment:

Other: "low touch" Implementation Strategy

Other: mPATH-Checkin

Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation)

Other group

Description:

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.

Treatment:

Other: "high touch" Implementation strategy

Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation)

Other group

Description:

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.

Treatment:

Other: "low touch" Implementation Strategy