mFOCUS (Multilevel FOllow-up of Cancer Screening)

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
IT platform	mFOCUS	Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
IT platform and patient navigation	mFOCUS	the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.
IT platform with reminders	mFOCUS	Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.

Primary Outcome Measures

Name	Time	Method
Completion of Follow-up Test	120 days	Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Complete the Required Diagnostic Evaluation	up to 240 days	How many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.

Locations (2): Massachusetts General Hospital
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Boston, Massachusetts, United States
Dartmouth Hitchcock
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Hanover, New Hampshire, United States