Effectiveness and Implementation of mPATH-CRC
Study Details
Study Description
Brief Summary
Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Clinic Patients on "high touch" Strategy 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
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.
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
|
| Experimental: Clinic Patients on "low touch" Strategy 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
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.
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
|
| Experimental: Clinic personnel on "high touch" Strategy 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
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
|
| Experimental: Clinic personnel on "low touch" Strategy 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
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
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients who complete the mPATH-CRC program [Month 6]
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.
Secondary Outcome Measures
- The proportion of patients who are given mPATH-CRC by varying socioeconomic strata [up to month 6]
mPATH-CRC Reach: The proportion of patients, ages 50 - 74, who are given mPATH-CRC by varying socioeconomic strata (Describe strata)
- The proportion of clinic personnel who use mPATH-CRC with their patients [up to month 6]
mPATH-CRC Adoption: The proportion of staff and providers who use mPATH-CRC with their patients
- The proportion of patients who are given mPATH-CheckIn by varying socioeconomic strata [up to month 6]
mPATH-CRC Reach: The proportion of patients, ages 18+m who are given mPATH-CheckIn by varying socioeconomic strata (Describe strata)
- The proportion of clinic personnel who use mPATH-CheckIn with their patients [up to month 6]
mPATH-CheckIn Adoption: The proportion of staff and providers who use mPATH-CheckIn with their patients
- The proportion of times the ability of patients to "self-order" tests is used as designed [up to month 6]
mPATH-CRC Implementation Fidelity: The proportion of times this feature of the mPATH-CRC program is used as designed.
- The proportion of visits in which mPATH-CRC is used [up to month 12]
mPATH-CRC Maintenance: The proportion of visits for patients ages 50 - 74 in which mPATH-CRC is used. Data will be obtained from the mPATH-CRC database (capturing the numerator) and the clinics appointment schedules (the denominator).
- The proportion of visits in which mPATH-CheckIn is used [up to month 12]
mPATH-CRC Maintenance: The proportion of visits for patients ages 18 and older in which mPATH-CRC is used. Data will be obtained from the mPATH-Check In database (capturing the numerator) and the clinics appointment schedules (the denominator).
- Proportion of patients meeting study inclusion/exclusion criteria who have a CRC screening test ordered [up to 16 weeks from index visit]
Proportion of patients meeting study inclusion/exclusion criteria who have a CRC screening test ordered (colonoscopy, flexible sigmoidoscopy, fecal testing for blood, or fecal DNA testing)
- Proportion of patients meeting study inclusion/exclusion criteria who complete CRC screening [up to 16 weeks from index visit]
mPATH-CRC Effectiveness: Proportion of patients meeting study inclusion/exclusion criteria who complete CRC screening within 16 weeks of their index visit to the clinic. Effectiveness will be 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 Implementation Cost [start of the study up to 5 years]
Cost to implement usage of mPATH program will be calculated from the perspective of a health care system considering implementation, including hardware, cloud data storage fees, training, and technical support.
- Qualitative facilitator and barriers to maintenance [end of the study up to 5 years]
Semi-structured interviews with clinic staff to 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 transcribed and analyzed thematically. Themes will be compared among clinics with high/low/erratic levels of maintenance to determine any differences.
- Proportion of patients who complete mPATH-CRC [Month 1]
mPATH-CRC Implementation: Proportion of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 1st month following the implementation date.
- Proportion of patients who complete mPATH-CRC [Month 2]
mPATH-CRC Implementation: Proportion of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 2nd month following the implementation date.
- Proportion of patients who complete mPATH-CRC [Month 3]
mPATH-CRC Implementation: Proportion of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 3rd month following the implementation date.
- Proportion of patients who complete mPATH-CRC [Month 4]
mPATH-CRC Implementation: Proportion of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 4th month following the implementation date.
- Proportion of patients who complete mPATH-CRC [Month 5]
mPATH-CRC Implementation: Proportion of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 5th month following the implementation date.
- Proportion of patients using mPATH-CheckIn [Month 6]
The proportion of all clinic patients aged 18+ who have used the mPATH-CheckIn module.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: David Miller, MD, MS, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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- IRB00048919
- R01CA218416