Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
77145 participants
INTERVENTIONAL
2019-10-31
2023-03-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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 "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.
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 "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.
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 "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.
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
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.
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 "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.
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 "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.
"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 "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.
"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
Interventions
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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
"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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* First degree relative with CRC
* Personal history of colorectal polyps
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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David Miller, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Kutner M, Greenburg E, Jin Y, Paulsen C. The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy. NCES 2006-483. Natl Cent Educ Stat \[Internet\]. 2006 \[cited 2015 Sep 23\];
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. Summary Health Statistics: National Health Interview Survey, 2015 \[Internet\]. \[cited 2017 Jun 16\].
Monegain B. Cerner still leads in EHR marketshare, though smaller vendors are making moves. Healthc IT News \[Internet\]. 2017 Apr 28 \[cited 2017 Jun 22\];
Berta W, Cranley L, Dearing JW, Dogherty EJ, Squires JE, Estabrooks CA. Why (we think) facilitation works: insights from organizational learning theory. Implement Sci \[Internet\]. 2015 Dec \[cited 2017 May 8\];10(1).
Maher L, Gustafson D, Evans A. Sustainability Model and Guide \[Internet\]. British National Health Service Modernization Agency; 2004 \[cited 2017 Jun 9\].
Soo S, Baker WB and GR. Role of Champions in the Implementation of Patient Safety Practice Change. Healthc Q \[Internet\]. 2009 Aug 15 \[cited 2017 May 8\];
Behavioral Risk Factor Surveillance System, 2015 Questionnaire \[Internet\]. Centers for Disease Control and Prevention (US); 2014 \[cited 2016 Sep 30\].
Other Identifiers
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IRB00048919
Identifier Type: -
Identifier Source: org_study_id
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