Effectiveness and Implementation of mPATH-CRC

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

Detailed Description
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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. 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. This record refers to the cluster-randomized controlled trial of 22 primary care clinics.

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

Conditions
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Colorectal Cancer, Cancer, Rectum Cancer, Colon Cancer

Intervention / Treatment
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* Other: mPATH-CRC
* Other: high touch Implementation strategy
* Other: low touch Implementation Strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinic Patients on high touch Strategy<br>English-speaking patients aged 50-74 who are seen in the study clinics randomized to mPATH-CRC utilizing the high touch Implementation strategy. | Other: mPATH-CRC<br>* mPATH-CRC is a self-administered iPad program that patients use in primary care clinics to help them receive CRC screening. The mPATH-CRC program also includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.<br>Other: high touch Implementation strategy<br>* 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<br>|
| Experimental: Clinic Patients on low touch Strategy<br>English-speaking patients aged 50-74 who are seen in the study clinics randomized to mPATH-CRC utilizing the low touch Implementation Strategy | Other: mPATH-CRC<br>* mPATH-CRC is a self-administered iPad program that patients use in primary care clinics to help them receive CRC screening. The mPATH-CRC program also includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.<br>Other: low touch Implementation Strategy<br>* 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<br>|
| Experimental: Clinic personnel on high touch Strategy<br>Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH-CRC utilizing the high touch Implementation strategy. | Other: high touch Implementation strategy<br>* 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<br>|
| Experimental: Clinic personnel on low touch Strategy<br>Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH-CRC utilizing the low touch Implementation Strategy | Other: low touch Implementation Strategy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who complete the mPATH-CRC program | mPATH-CRC Implementation: Proportion 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 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mortality, Cancer Screening, Cancer Intervention, Mobile Health, Implementation Science