Effectiveness and Implementation of mPATH-CRC

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

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

Study Overview

• Status: Completed
• Conditions: Cancer; Colorectal Cancer; Colon Cancer; Rectum Cancer
• Intervention / Treatment: Other: "high touch" Implementation strategy; Other: "low touch" Implementation Strategy; Other: mPATH-CRC; Other: mPATH-Checkin

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 Type: Interventional
• Enrollment (Actual): 77145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Miller, MD, MS; Phone Number: 336-713-5218; Email: dmiller@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation); 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.	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: 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.
Experimental: Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation); 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.	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; 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.
Experimental: Clinic personnel on "high touch" Strategy (Post-Implementation); 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.	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: 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.
Experimental: Clinic personnel on "low touch" Strategy (Post-Implementation); 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.	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; 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.
Experimental: All Adult Clinic Patients on "high touch" Strategy (Post-Implementation); 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.	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: mPATH-Checkin; The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.
Experimental: All Adult Clinic Patients on "low touch" Strategy (Post-Implementation); 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.	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; 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: Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation); 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.	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: Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation); 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Who Complete the mPATH-CRC Program	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.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mPATH-CRC Adoption	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.	up to month 6
mPATH-CheckIn Reach	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	up to month 6
mPATH-CheckIn Adoption	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	up to month 6
mPATH-CRC Implementation Fidelity	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	up to month 6
mPATH-CRC Maintenance	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	months 7-12
mPATH-CheckIn Maintenance	The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12	months 7-12
mPATH-CRC Effectiveness	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).	up to 16 weeks from index visit
mPATH-CRC Acceptability	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.	month 6
mPATH-CRC Appropriateness	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.	month 6
mPATH-CRC Feasibility	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.	month 6
mPATH-CheckIn Acceptability	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.	month 6
mPATH-CheckIn Appropriateness	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.	month 6
mPATH-CheckIn Feasibility	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.	month 6
mPATH-CRC Reach (by Socioeconomic Strata)	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)	up to month 6
CRC Screening Tests Ordered	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.	up to 16 weeks from index visit
Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)	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.	Month 12 or month of discontinuation of mPATH use
mPATH-CRC Reach (by Month)	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	Months 1-5

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David Miller, MD, MS, Wake Forest University Health Sciences

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mobile Health; Mortality; Implementation Science; Cancer Screening; Cancer Intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: IRB00048919; R01CA218416 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified participant data that underlie the results reported in peer-reviewed publications (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 6 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal to use the participant data in a meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No