Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Rectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

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 (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 (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.

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.

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.

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.

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.

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.

mPATH-CRC

The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

mPATH-Checkin

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

"high 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

"low touch" Implementation Strategy

David Miller, MD, MS

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

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.

Effectiveness and Implementation of mPATH-CRC

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

We will share de-identified participant data that underlie the results reported in peer-reviewed publications (text, tables, figures, and appendices).

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.

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)

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.

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

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

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

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

The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12

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.

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).

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.

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

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.

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.

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.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

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.

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.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

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 "low touch" implementation strategy in the 12 months after implementation.

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.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

Clinic Patients Eligible for CRC Screening 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 "high touch" implementation strategy in the 12 months after implementation.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

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 "low touch" implementation strategy in the 12 months after implementation.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

All Adult Clinic Patients 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 "high touch" implementation strategy in the 12 months after implementation.

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.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

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 "low touch" implementation strategy in the 12 months after implementation.

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.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

Clinic Personnel 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 "high touch" implementation strategy but in 8 months before implementation.

"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

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 "low touch" implementation strategy but in 8 months before implementation.

"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

Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Pre-Implementation)

Total

All Participants

Adult Clinic Patients Eligible for CRC Screening Post-Implementation

Demographics data are only available for clinic personnel who filled out a survey. "Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC.

Age, Continuous

"Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC.

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Insurance

Dr. David P. Miller, Jr

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.

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.

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.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

The analysis population for this outcome is in the sixth month after implementation, so this is a subset of the overall baseline population that includes patients eligible for CRC screening over the full12 months following implementation.

Percent of Patients Who Complete the mPATH-CRC Program

mPATH-CRC Reach (by Socioeconomic Strata)

mPATH-CRC Adoption

mPATH-CheckIn Reach

mPATH-CheckIn Adoption

mPATH-CRC Implementation Fidelity

mPATH-CRC Maintenance

mPATH-CheckIn Maintenance

CRC Screening Tests Ordered

mPATH-CRC Effectiveness

Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)

mPATH-CRC Reach (by Month)

mPATH-CRC Acceptability

mPATH-CRC Appropriateness

mPATH-CRC Feasibility

mPATH-CheckIn Acceptability

mPATH-CheckIn Appropriateness

mPATH-CheckIn Feasibility

Populations evaluated include: Patients Eligible for CRC Screening (Pre- and Post-Implementation), All Adult Patients (Post-Implementation), and Clinic Personnel (Post-Implementation) at clinics randomized to the "high touch" strategy.

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.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

"High Touch" Strategy

Populations evaluated include: Patients Eligible for CRC Screening (Pre- and Post-Implementation), All Adult Patients (Post-Implementation), and Clinic Personnel (Post-Implementation) at clinics randomized to the "low touch" strategy.

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.

mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.

"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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effectiveness and Implementation of mPATH-CRC	NCT03843957	Colorectal Canc... Cancer Rectum Cancer Colon Cancer	mPATH-CRC mPATH-Checkin "high touch" Im... "low touch" Imp...	18 Years -	Wake Forest University Health Sciences
Effectiveness and Implementation of mPATH-CRC	NCT03843957	Colorectal Canc... Cancer Rectum Cancer Colon Cancer	mPATH-CRC mPATH-Checkin "high touch" Im... "low touch" Imp...	18 Years -	Wake Forest University Health Sciences

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