Effectiveness and Implementation of mPATH-CRC
Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.
Inclusion 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03843957.
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationWake Forest University Health Sciences
- Primary IDIRB00048919
- Secondary IDsNCI-2020-02778, 10561, R01CA218416
- ClinicalTrials.gov IDNCT03843957