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Completed

NCT Number: NCT03843957

Effectiveness and Implementation of mPATH-CRC

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

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Key information

Conditions

Colorectal Cancer Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Rectum Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

mPATH-Checkin

Other

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

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

"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

Primary outcomes

  1. 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.

Secondary outcomes

  1. mPATH-CRC Reach (by Socioeconomic Strata)

    Time frame: up to month 6

    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)

  2. mPATH-CRC Adoption

    Time frame: up to month 6

    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.

  3. mPATH-CheckIn Reach

    Time frame: up to month 6

    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

  4. mPATH-CheckIn Adoption

    Time frame: up to month 6

    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

  5. mPATH-CRC Implementation Fidelity

    Time frame: up to month 6

    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

  6. mPATH-CRC Maintenance

    Time frame: months 7-12

    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

  7. mPATH-CheckIn Maintenance

    Time frame: months 7-12

    The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12

  8. CRC Screening Tests Ordered

    Time frame: up to 16 weeks from index visit

    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.

  9. mPATH-CRC Effectiveness

    Time frame: up to 16 weeks from index visit

    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).

  10. Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)

    Time frame: Month 12 or month of discontinuation of mPATH use

    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.

  11. mPATH-CRC Reach (by Month)

    Time frame: Months 1-5

    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

  12. mPATH-CRC Acceptability

    Time frame: month 6

    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.

  13. mPATH-CRC Appropriateness

    Time frame: month 6

    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.

  14. mPATH-CRC Feasibility

    Time frame: month 6

    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.

  15. mPATH-CheckIn Acceptability

    Time frame: month 6

    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.

  16. mPATH-CheckIn Appropriateness

    Time frame: month 6

    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.

  17. mPATH-CheckIn Feasibility

    Time frame: month 6

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 18, 2019
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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