Colorectal CancerNCT03843957
Effectiveness and Implementation of mPATH-CRC
A study testing mPATH-CRC, mPATH-Checkin and "high touch" Implementation strategy in people with Colorectal Cancer and Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Cancer, Rectum Cancer
- What is being tested?
- mPATH-CRC, mPATH-Checkin and "high touch" Implementation strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77,145 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Effectiveness and Implementation of mPATH-CRC: a Mobile Health System for Colorectal Cancer Screening
Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.
Read the 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. 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.
- Conditions
- Colorectal Cancer, Cancer, Rectum Cancer, Colon Cancer
- Being tested
- mPATH-CRC, mPATH-Checkin, "high touch" Implementation strategy, "low touch" Implementation Strategy
- Keywords
- Mortality, Cancer Screening, Cancer Intervention, Mobile Health, Implementation Science
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPATH-CRCOther
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-CheckinOther
The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.
"high touch" Implementation strategyOther
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 StrategyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: "low touch" Implementation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (17)
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: months 7-12
mPATH-CheckIn Maintenance
The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start31 Oct 2019
- Primary completion25 Aug 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Miller, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843957
- Sponsor's protocol ID
- IRB00048919
- Other IDs
- R01CA218416
- Status last verified
- Jan 2024
- First submitted
- 14 Feb 2019
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified participant data that underlie the results reported in peer-reviewed publications (text, tables, figures, and appendices).
Publications
Sharp L, Tilson L, Whyte S, O'Ceilleachair A, Walsh C, Usher C, Tappenden P, Chilcott J, Staines A, Barry M, Comber H. Cost-effectiveness of population-based screening for colorectal cancer: a comparison of guaiac-based faecal occult blood testing, faecal immunochemical testing and flexible sigmoidoscopy. Br J Cancer. 2012 Feb 28;106(5):805-16. doi: 10.1038/bjc.2011.580. Epub 2012 Feb 16.
PubMed 22343624Lin JS, Piper MA, Perdue LA, Rutter CM, Webber EM, O'Connor E, Smith N, Whitlock EP. Screening for Colorectal Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016 Jun 21;315(23):2576-94. doi: 10.1001/jama.2016.3332.
PubMed 27305422Knudsen AB, Zauber AG, Rutter CM, Naber SK, Doria-Rose VP, Pabiniak C, Johanson C, Fischer SE, Lansdorp-Vogelaar I, Kuntz KM. Estimation of Benefits, Burden, and Harms of Colorectal Cancer Screening Strategies: Modeling Study for the US Preventive Services Task Force. JAMA. 2016 Jun 21;315(23):2595-609. doi: 10.1001/jama.2016.6828.
PubMed 27305518Inadomi JM. Screening for Colorectal Neoplasia. N Engl J Med. 2017 Jan 12;376(2):149-156. doi: 10.1056/NEJMcp1512286. No abstract available.
PubMed 28076720US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989.
PubMed 27304597Qaseem A, Denberg TD, Hopkins RH Jr, Humphrey LL, Levine J, Sweet DE, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Screening for colorectal cancer: a guidance statement from the American College of Physicians. Ann Intern Med. 2012 Mar 6;156(5):378-86. doi: 10.7326/0003-4819-156-5-201203060-00010.
PubMed 22393133Smith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016 Mar-Apr;66(2):96-114. doi: 10.3322/caac.21336. Epub 2016 Jan 21.
PubMed 26797525Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017 Jul;112(7):1016-1030. doi: 10.1038/ajg.2017.174. Epub 2017 Jun 6.
PubMed 28555630White A, Thompson TD, White MC, Sabatino SA, de Moor J, Doria-Rose PV, Geiger AM, Richardson LC. Cancer Screening Test Use - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 3;66(8):201-206. doi: 10.15585/mmwr.mm6608a1.
PubMed 28253225Gupta S, Sussman DA, Doubeni CA, Anderson DS, Day L, Deshpande AR, Elmunzer BJ, Laiyemo AO, Mendez J, Somsouk M, Allison J, Bhuket T, Geng Z, Green BB, Itzkowitz SH, Martinez ME. Challenges and possible solutions to colorectal cancer screening for the underserved. J Natl Cancer Inst. 2014 Apr;106(4):dju032. doi: 10.1093/jnci/dju032. Epub 2014 Mar 28.
PubMed 24681602Yao N, Alcala HE, Anderson R, Balkrishnan R. Cancer Disparities in Rural Appalachia: Incidence, Early Detection, and Survivorship. J Rural Health. 2017 Sep;33(4):375-381. doi: 10.1111/jrh.12213. Epub 2016 Sep 7.
PubMed 27602545Doubeni CA, Laiyemo AO, Major JM, Schootman M, Lian M, Park Y, Graubard BI, Hollenbeck AR, Sinha R. Socioeconomic status and the risk of colorectal cancer: an analysis of more than a half million adults in the National Institutes of Health-AARP Diet and Health Study. Cancer. 2012 Jul 15;118(14):3636-44. doi: 10.1002/cncr.26677. Epub 2012 Jan 3.
PubMed 22898918James TM, Greiner KA, Ellerbeck EF, Feng C, Ahluwalia JS. Disparities in colorectal cancer screening: a guideline-based analysis of adherence. Ethn Dis. 2006 Winter;16(1):228-33.
PubMed 16599375Morgan JW, Cho MM, Guenzi CD, Jackson C, Mathur A, Natto Z, Kazanjian K, Tran H, Shavlik D, Lum SS. Predictors of delayed-stage colorectal cancer: are we neglecting critical demographic information? Ann Epidemiol. 2011 Dec;21(12):914-21. doi: 10.1016/j.annepidem.2011.09.002. Epub 2011 Oct 13.
PubMed 22000327Siegel R, Desantis C, Jemal A. Colorectal cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):104-17. doi: 10.3322/caac.21220. Epub 2014 Mar 17.
PubMed 24639052
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of mPATH-CRC: a Mobile Health System for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT03843957
- Acronym / sponsor ID
- IRB00048919
- Conditions
- Colorectal Cancer, Cancer, Rectum Cancer, Colon Cancer
- Keywords
- Mortality, Cancer Screening, Cancer Intervention, Mobile Health, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77,145 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 31 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.
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. 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation) | Experimental | Other: mPATH-CRC, Other: mPATH-Checkin, Other: "high touch" Implementation strategyEnglish 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. |
| Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation) | Experimental | Other: mPATH-CRC, Other: mPATH-Checkin, Other: "low touch" Implementation StrategyEnglish 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. |
| Clinic personnel on "high touch" Strategy (Post-Implementation) | Experimental | Other: mPATH-CRC, Other: mPATH-Checkin, Other: "high touch" Implementation strategyClinic 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. |
| Clinic personnel on "low touch" Strategy (Post-Implementation) | Experimental | Other: mPATH-CRC, Other: mPATH-Checkin, Other: "low touch" Implementation StrategyClinic 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. |
| All Adult Clinic Patients on "high touch" Strategy (Post-Implementation) | Experimental | Other: mPATH-Checkin, Other: "high touch" Implementation strategyEnglish 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. |
| All Adult Clinic Patients on "low touch" Strategy (Post-Implementation) | Experimental | Other: mPATH-Checkin, Other: "low touch" Implementation StrategyEnglish 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. |
| Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation) | Other | Other: "high touch" Implementation strategyEnglish 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. |
| Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation) | Other | Other: "low touch" Implementation StrategyEnglish 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mPATH-CRCmPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. | Other | 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-CheckinThe mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. | Other | 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 strategyThe "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 | Other | 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 StrategyClinics 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 | Other | 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) |
Primary outcome
Percent of Patients Who Complete the mPATH-CRC Program
Time frame: Month 6
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.
17 secondary outcomes
mPATH-CRC Reach (by Socioeconomic Strata)
Time frame: up to month 6
mPATH-CRC Adoption
Time frame: up to month 6
mPATH-CheckIn Reach
Time frame: up to month 6
mPATH-CheckIn Adoption
Time frame: up to month 6
mPATH-CRC Implementation Fidelity
Time frame: up to month 6
mPATH-CRC Maintenance
Time frame: months 7-12
mPATH-CheckIn Maintenance
Time frame: months 7-12
CRC Screening Tests Ordered
Time frame: up to 16 weeks from index visit
mPATH-CRC Effectiveness
Time frame: up to 16 weeks from index visit
Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)
Time frame: Month 12 or month of discontinuation of mPATH use
mPATH-CRC Reach (by Month)
Time frame: Months 1-5
mPATH-CRC Acceptability
Time frame: month 6
mPATH-CRC Appropriateness
Time frame: month 6
mPATH-CRC Feasibility
Time frame: month 6
mPATH-CheckIn Acceptability
Time frame: month 6
mPATH-CheckIn Appropriateness
Time frame: month 6
mPATH-CheckIn Feasibility
Time frame: month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22343624Sharp L, Tilson L, Whyte S, O'Ceilleachair A, Walsh C, Usher C, Tappenden P, Chilcott J, Staines A, Barry M, Comber H. Cost-effectiveness of population-based screening for colorectal cancer: a comparison of guaiac-based faecal occult blood testing, faecal immunochemical testing and flexible sigmoidoscopy. Br J Cancer. 2012 Feb 28;106(5):805-16. doi: 10.1038/bjc.2011.580. Epub 2012 Feb 16.
- Background: PubMed 27305422Lin JS, Piper MA, Perdue LA, Rutter CM, Webber EM, O'Connor E, Smith N, Whitlock EP. Screening for Colorectal Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016 Jun 21;315(23):2576-94. doi: 10.1001/jama.2016.3332.
- Background: PubMed 27305518Knudsen AB, Zauber AG, Rutter CM, Naber SK, Doria-Rose VP, Pabiniak C, Johanson C, Fischer SE, Lansdorp-Vogelaar I, Kuntz KM. Estimation of Benefits, Burden, and Harms of Colorectal Cancer Screening Strategies: Modeling Study for the US Preventive Services Task Force. JAMA. 2016 Jun 21;315(23):2595-609. doi: 10.1001/jama.2016.6828.
- Background: PubMed 28076720Inadomi JM. Screening for Colorectal Neoplasia. N Engl J Med. 2017 Jan 12;376(2):149-156. doi: 10.1056/NEJMcp1512286. No abstract available.
- Background: PubMed 27304597US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989.
- Background: PubMed 22393133Qaseem A, Denberg TD, Hopkins RH Jr, Humphrey LL, Levine J, Sweet DE, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Screening for colorectal cancer: a guidance statement from the American College of Physicians. Ann Intern Med. 2012 Mar 6;156(5):378-86. doi: 10.7326/0003-4819-156-5-201203060-00010.
- Background: PubMed 26797525Smith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016 Mar-Apr;66(2):96-114. doi: 10.3322/caac.21336. Epub 2016 Jan 21.
- Background: PubMed 28555630Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017 Jul;112(7):1016-1030. doi: 10.1038/ajg.2017.174. Epub 2017 Jun 6.
- Background: PubMed 28253225White A, Thompson TD, White MC, Sabatino SA, de Moor J, Doria-Rose PV, Geiger AM, Richardson LC. Cancer Screening Test Use - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 3;66(8):201-206. doi: 10.15585/mmwr.mm6608a1.
- Background: PubMed 24681602Gupta S, Sussman DA, Doubeni CA, Anderson DS, Day L, Deshpande AR, Elmunzer BJ, Laiyemo AO, Mendez J, Somsouk M, Allison J, Bhuket T, Geng Z, Green BB, Itzkowitz SH, Martinez ME. Challenges and possible solutions to colorectal cancer screening for the underserved. J Natl Cancer Inst. 2014 Apr;106(4):dju032. doi: 10.1093/jnci/dju032. Epub 2014 Mar 28.
- Background: PubMed 27602545Yao N, Alcala HE, Anderson R, Balkrishnan R. Cancer Disparities in Rural Appalachia: Incidence, Early Detection, and Survivorship. J Rural Health. 2017 Sep;33(4):375-381. doi: 10.1111/jrh.12213. Epub 2016 Sep 7.
- Background: PubMed 22898918Doubeni CA, Laiyemo AO, Major JM, Schootman M, Lian M, Park Y, Graubard BI, Hollenbeck AR, Sinha R. Socioeconomic status and the risk of colorectal cancer: an analysis of more than a half million adults in the National Institutes of Health-AARP Diet and Health Study. Cancer. 2012 Jul 15;118(14):3636-44. doi: 10.1002/cncr.26677. Epub 2012 Jan 3.
- 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 \[cited 2015 Sep 23\];Link provided by the sponsor.
- 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 \[Internet\]. \[cited 2017 Jun 16\].Link provided by the sponsor.
- Monegain B. Cerner still leads in EHR marketshare, though smaller vendors are making moves. Healthc IT News \[Internet\]. 2017 Apr 28 \[cited 2017 Jun 22\];Link provided by the sponsor.
- 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).Link provided by the sponsor.
- Maher L, Gustafson D, Evans A. Sustainability Model and Guide \[Internet\]. British National Health Service Modernization Agency; 2004 \[cited 2017 Jun 9\].Link provided by the sponsor.
- Soo S, Baker WB and GR. Role of Champions in the Implementation of Patient Safety Practice Change. Healthc Q \[Internet\]. 2009 Aug 15 \[cited 2017 May 8\];Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share de-identified participant data that underlie the results reported in peer-reviewed publications (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Miller, MD, MS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPATH-CRC, mPATH-Checkin and "high touch" Implementation strategy in people with Colorectal Cancer and Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients Who Complete the mPATH-CRC Program (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843957, which also lists 70 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.