mFOCUS (Multilevel FOllow-up of Cancer Screening)

Study Overview
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Brief Summary
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To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal cancer screening test.

Detailed Description
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Standard care consists of well-characterized existing decision support and systems for follow-up in these three participating primary care networks and their affiliated integrated delivery systems (Brigham and Women's Hospital, Massachusetts General Hospital, and Dartmouth Hitchcock Health, the largest health care provider in New Hampshire). The primary outcome will be whether an individual receives follow-up, defined based on the type of screening abnormality and organ type (breast, cervical, lung or colorectal cancer), within 120 days of becoming eligible for mFOCUS. Secondary comparisons will assess multi- and cross-level (individual, team, system) outcomes. The study design will allow us to examine the marginal effectiveness of system, team and individual-level enhancements, and exploratory analyses will address subgroups defined by race/ ethnicity, socioeconomic status and cancer type.

Official Title
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mFOCUS (Multilevel FOllow-up of Cancer Screening)

Conditions
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Cancer

Intervention / Treatment
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* Other: mFOCUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals who have an abnormal screen that is due for follow-up including: Breast: women 40-80 years with an incident (i.e., newly detected) abnormal screening mammogram or digital breast tomosynthesis (DBT) exam. Cervical: women 21-65 years with an incident abnormal screening Pap. Colorectal: adults 40-80 years with an abnormal screen, including incident FOBT (Fecal Occult Blood Test) / FIT (Fecal Immunochemical Test), or prevalent colonoscopy. Because of the long periods of time required for follow-up of colonoscopies, we will look back over a 5-year period and will therefore find prevalent abnormalities that become due for follow-up. Lung: adults 55-80 years, current and former smokers, with an incident abnormal LDCT (Low Dose Computed Topography) result. Exclusion Criteria: We will exclude patients who: are not English or Spanish-speaking have had prior cancer of the organ for each screening test (i.e., women with prior breast cancer will not be tracked for breast cancer screening abnormalities) as these individuals may have non-standard follow-up care recommendations.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All individuals in this study will receive the current standard of care at Massachusetts General Hospital, Brigham and Women's Hospital, and Dartmouth Hitchcock for the follow-up of abnormal cancer screening tests (Arms 1-4). In addition to this standard of care, we will test 3 additional arms of increasing intensity of intervention: Arm 2-access to an IT platform to facilitate updates to HM modifiers and problem lists for visit-based reminders; Arm 3- the IT platform in addition to automated reminders to patients between visits and the care team; Arm 4-the IT platform, automated reminders, and administrative outreach and navigation to help with scheduling and to address social barriers to care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>standard of care | |
| Active Comparator: IT platform<br>Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results | Other: mFOCUS<br>* To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.<br>|
| Active Comparator: IT platform with reminders<br>Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results. | Other: mFOCUS<br>* To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.<br>|
| Active Comparator: IT platform and patient navigation<br>the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care. | Other: mFOCUS<br>* To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of follow-up test | Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR) | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time to complete the required diagnostic evaluation | How many days are need for the completion of required diagnostic evaluation (EHR) | 120 days | 
| Amount of time to complete the required diagnostic evaluation | How many days are need for the completion of required diagnostic evaluation (EHR) | 240 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abnormal Screening Results