Effectiveness and Implementation of mPATH-CRC

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.

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
28 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.

This record refers to the cluster-randomized controlled trial of 28 primary care clinics.

This study will include two distinct populations of participants: 1) healthcare providers
and staff at primary care practices, and 2) patients seen in the participating study sites

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