Effectiveness and Implementation of mPATH-CRC

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843957
• Other study ID #: IRB00048919
• Secondary ID: R01CA218416
• Status: Completed
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: March 10, 2023

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77145
• Est. completion date: March 10, 2023
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Colon Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Neoplasms
• Rectum Cancer

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	mPATH-CheckIn Maintenance	The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12	months 7-12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Behavioral Risk Factor Surveillance System, 2015 Questionnaire [Internet]. Centers for Disease Control and Prevention (US); 2014 [cited 2016 Sep 30].
•   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).
•   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];
•   Maher L, Gustafson D, Evans A. Sustainability Model and Guide [Internet]. British National Health Service Modernization Agency; 2004 [cited 2017 Jun 9].
•   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];
•   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];
•   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].