Effectiveness and Implementation of mPATH-CRC

NCT03843957 | Completed Results DMC

• 2 other identifiers: IRB00048919R01CA218416
• Study Type: interventional
• Target: 77,145
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer; Cancer; Rectum Cancer; Colon Cancer

Keywords

Mortality; Cancer Screening; Cancer Intervention; Mobile Health; Implementation Science

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• mPATH-CRC Reach (by Socioeconomic Strata)

  up to month 6

• mPATH-CRC Adoption

  up to month 6

• mPATH-CheckIn Reach

  up to month 6

• mPATH-CheckIn Adoption

  up to month 6

• mPATH-CRC Implementation Fidelity

  up to month 6

Study Arms (8)

Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)

EXPERIMENTAL

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.

Other: mPATH-CRC; Other: mPATH-Checkin; Other: "high touch" Implementation strategy

Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)

EXPERIMENTAL

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.

Other: mPATH-CRC; Other: mPATH-Checkin; Other: "low touch" Implementation Strategy

Clinic personnel on "high touch" Strategy (Post-Implementation)

EXPERIMENTAL

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.

Other: mPATH-CRC; Other: mPATH-Checkin; Other: "high touch" Implementation strategy

Clinic personnel on "low touch" Strategy (Post-Implementation)

EXPERIMENTAL

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.

Other: mPATH-CRC; Other: mPATH-Checkin; Other: "low touch" Implementation Strategy

All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)

EXPERIMENTAL

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.

Other: mPATH-Checkin; Other: "high touch" Implementation strategy

All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)

EXPERIMENTAL

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.

Other: mPATH-Checkin; Other: "low touch" Implementation Strategy

Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation)

OTHER

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.

Other: "high touch" Implementation strategy

Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation)

OTHER

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.

Other: "low touch" Implementation Strategy

Interventions

mPATH-CRC OTHER

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.

Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation); Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation); Clinic personnel on "high touch" Strategy (Post-Implementation); Clinic personnel on "low touch" Strategy (Post-Implementation)

mPATH-Checkin OTHER

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

All Adult Clinic Patients on "high touch" Strategy (Post-Implementation); All Adult Clinic Patients on "low touch" Strategy (Post-Implementation); Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation); Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation); Clinic personnel on "high touch" Strategy (Post-Implementation); Clinic personnel on "low touch" Strategy (Post-Implementation)

"high touch" Implementation strategy OTHER

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); Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation); Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation); Clinic personnel on "high touch" Strategy (Post-Implementation)

"low touch" Implementation Strategy OTHER

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 Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation); Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation); Clinic personnel on "low touch" Strategy (Post-Implementation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Personal history of CRC
• First degree relative with CRC
• Personal history of colorectal polyps

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

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Related Links

• 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 \[cited 2016 Sep 30\].

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Rectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. David P. Miller, Jr
• Organization: Wake Forest University School of Medicine

dmiller@wakehealth.edu

336-713-5218

Study Officials

• David Miller, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: October 31, 2019
• Primary Completion: August 25, 2022
• Study Completion: March 10, 2023
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 5 years following article publication.
• Access Criteria: Investigators who provide a methodologically sound proposal to use the participant data in a meta-analysis.

Locations

US (1)