NCT03843957

Effectiveness and Implementation of mPATH-CRC

Effectiveness and Implementation of mPATH-CRC: a Mobile Health System for Colorectal Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77,145 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Colorectal Cancer
• Cancer
• Rectum Cancer
• Colon Cancer

Interventions

Type	Name	Description
OTHER	mPATH-CRC	mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.
OTHER	mPATH-Checkin	The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.
OTHER	"high touch" Implementation strategy	The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities * Clinic champion identified. * Study team meeting with clinic champion * Implementation adaptations as needed for clinic flow Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard * Monthly program usage report sent to clinic champions * Scheduled phone-calls with clinic champion to review QA data and explore potential barriers. * Implementation adaptations as needed for clinic flow * Goal-triggered follow-up on-site trainings * Additional on-site trainings as requested. Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard
OTHER	"low touch" Implementation Strategy	Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard

Timeline

• Start date: 2019-10-31
• Primary completion: 2022-08-25
• Completion: 2023-03-10
• First posted: 2019-02-18
• Last updated: 2024-01-31
• Results posted: 2024-01-31

Locations

1 site across 1 country: United States