Effectiveness and Implementation of mPATH-CRC

Not Applicable

Completed

• Conditions: Colorectal Cancer; Cancer; Rectum Cancer; Colon Cancer
• Interventions: Other: mPATH-Checkin; Other: mPATH-CRC; Other: "high touch" Implementation strategy; Other: "low touch" Implementation Strategy

• Registration Number: NCT03843957
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Study Start: 2019-10-31
• Primary Completion: 2022-08-25
• Study Completion: 2023-03-10
• Results First Submitted: 2023-09-19
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Results First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77145

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)	mPATH-Checkin	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.
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)	mPATH-CRC	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.
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)	mPATH-Checkin	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.
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)	mPATH-CRC	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.
Clinic personnel on "high touch" Strategy (Post-Implementation)	mPATH-CRC	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.
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)	"high touch" Implementation strategy	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.
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)	mPATH-Checkin	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.
Clinic personnel on "high touch" Strategy (Post-Implementation)	mPATH-Checkin	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.
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)	"low touch" Implementation Strategy	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.
Clinic personnel on "high touch" Strategy (Post-Implementation)	"high touch" Implementation strategy	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.
Clinic personnel on "low touch" Strategy (Post-Implementation)	mPATH-CRC	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.
Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation)	"high touch" Implementation strategy	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.
Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation)	"low touch" Implementation Strategy	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.
Clinic personnel on "low touch" Strategy (Post-Implementation)	mPATH-Checkin	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.
All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)	"high touch" Implementation strategy	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.
Clinic personnel on "low touch" Strategy (Post-Implementation)	"low touch" Implementation Strategy	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.
All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)	mPATH-Checkin	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.
All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)	"low touch" Implementation Strategy	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.

Primary Outcome Measures

Name	Time	Method
Percent of Patients Who Complete the mPATH-CRC Program	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.

Secondary Outcome Measures

Name	Time	Method
mPATH-CRC Adoption	up to month 6	The mean usage of mPATH-CRC among staff and providers over the first 6 months following implementation; usage is calculated for each staff/provider as the proportion of times mPATH-CRC is completed out of the total times mPATH-CRC should have been launched.
mPATH-CRC Reach (by Socioeconomic Strata)	up to month 6	mPATH-CRC Reach: The proportion of patients, ages 50 - 74, who are given mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-6 by varying socioeconomic strata (Describe strata)
mPATH-CRC Reach (by Month)	Months 1-5	The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-5 following implementation
mPATH-CRC Appropriateness	month 6	The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness.
mPATH-CRC Maintenance	months 7-12	The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 7-12
Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)	Month 12 or month of discontinuation of mPATH use	These will be identified through semi-structured interviews. Interviews will explore how mPATH-CRC was incorporated in the clinic's work flow and factors that affected maintenance such as intervention adaptations, organizational characteristics, and the champion's role. Interviews will be conducted with four members of each selected clinic: the clinic champion, one clinician, one front desk team member, and one medical assistant/nursing team member.
mPATH-CRC Feasibility	month 6	The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility.
mPATH-CheckIn Reach	up to month 6	The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 1-6; this outcome will be calculated overall and within socioeconomic strata
mPATH-CheckIn Adoption	up to month 6	The mean usage of mPATH-CheckIn among staff and providers over the first 6 months following implementation; usage is calculated for front desk staff as the proportion of times mPATH-CheckIn is completed out of the total times mPATH-CheckIn should have been handed out; usage is calculated for nurses/providers as the proportion of times mPATH-CheckIn is completed and data is transmitted to the EHR out of the total times mPATH-CheckIn should have been handed out
mPATH-CRC Implementation Fidelity	up to month 6	The proportion of patients who use mPATH-CRC and request a CRC screening test who have a test ordered or have the order dismissed (i.e., "self-order" feature is used as designed) in months 1-6
mPATH-CheckIn Appropriateness	month 6	The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness.
mPATH-CheckIn Maintenance	months 7-12	The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12
CRC Screening Tests Ordered	up to 16 weeks from index visit	The outcome is defined as the proportion of patients aged 50-74 who are eligible for CRC screening who have a CRC screening test ordered (colonoscopy, flexible sigmoidoscopy, fecal testing for blood, or fecal DNA testing) within 16 weeks of their index visit to the clinic. This outcome will also be compared between the pre- and post-implementation cohorts.
mPATH-CRC Effectiveness	up to 16 weeks from index visit	The proportion of patients aged 50-74 who are eligible for CRC screening who complete CRC screening within 16 weeks of their index visit to the clinic. Effectiveness is determined by comparing the proportion who complete screening in a pre-implementation cohort (months 12 - 4 before implementation) to a post-implementation cohort (months 1 - 8 after implementation).
mPATH-CRC Acceptability	month 6	The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.
mPATH-CheckIn Acceptability	month 6	The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.
mPATH-CheckIn Feasibility	month 6	The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States