Cancer
Conditions
Keywords
Abnormal Screening Results
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.
Interventions
OTHERmFOCUS
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.
Sponsors
Brigham and Women's Hospital
Dartmouth-Hitchcock Medical Center
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
The intervention is not masked to the providers or the participants. Randomization status is masked to the participants but not the providers. Masking is not feasible because randomization will take place at the level of the practice and practices will need to be informed about intervention components that will be made available to patients in their practice and the health care team
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Follow-up Test | 120 days | Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment started in August 2020 and ended in December of 2021
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care standard of care | 2,702 |
| IT Platform Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
mFOCUS: 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. | 3,254 |
| IT Platform With Reminders Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.
mFOCUS: 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. | 2,569 |
| IT Platform and Patient Navigation the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.
mFOCUS: 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. | 3,455 |
| Total | 11,980 |
Baseline characteristics
| Characteristic | Standard of Care | IT Platform | IT Platform With Reminders | IT Platform and Patient Navigation | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 874 Participants | 1203 Participants | 1012 Participants | 1413 Participants | 4502 Participants |
| Age, Categorical Between 18 and 65 years | 1828 Participants | 2051 Participants | 1557 Participants | 2042 Participants | 7478 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 207 Participants | 316 Participants | 228 Participants | 344 Participants | 1095 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2310 Participants | 2642 Participants | 2137 Participants | 2913 Participants | 10002 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 185 Participants | 296 Participants | 204 Participants | 198 Participants | 883 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 7 Participants | 6 Participants | 12 Participants | 29 Participants |
| Race (NIH/OMB) Asian | 90 Participants | 89 Participants | 77 Participants | 101 Participants | 357 Participants |
| Race (NIH/OMB) Black or African American | 139 Participants | 265 Participants | 184 Participants | 201 Participants | 789 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 226 Participants | 346 Participants | 250 Participants | 357 Participants | 1179 Participants |
| Race (NIH/OMB) White | 2241 Participants | 2546 Participants | 2051 Participants | 2782 Participants | 9620 Participants |
| Region of Enrollment United States | 2702 participants | 3254 participants | 2569 participants | 3455 participants | 11980 participants |
| Sex: Female, Male Female | 1772 Participants | 2139 Participants | 1680 Participants | 2172 Participants | 7763 Participants |
| Sex: Female, Male Male | 930 Participants | 1115 Participants | 889 Participants | 1283 Participants | 4217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,702 | 0 / 3,254 | 0 / 2,569 | 0 / 3,455 |
| other Total, other adverse events | 0 / 2,702 | 0 / 3,254 | 0 / 2,569 | 0 / 3,455 |
| serious Total, serious adverse events | 0 / 2,702 | 0 / 3,254 | 0 / 2,569 | 0 / 3,455 |
Outcome results
Primary
Completion of Follow-up Test
Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Completion of Follow-up Test | 672 Participants |
| IT Platform | Completion of Follow-up Test | 796 Participants |
| IT Platform With Reminders | Completion of Follow-up Test | 831 Participants |
| IT Platform and Patient Navigation | Completion of Follow-up Test | 1062 Participants |
Secondary
Number of Participants Who Complete the Required Diagnostic Evaluation
How many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.
Time frame: up to 240 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Number of Participants Who Complete the Required Diagnostic Evaluation | 181-240 days | 113 Participants |
| Standard of Care | Number of Participants Who Complete the Required Diagnostic Evaluation | 61-120 days | 249 Participants |
| Standard of Care | Number of Participants Who Complete the Required Diagnostic Evaluation | Did not receive follow up | 1747 Participants |
| Standard of Care | Number of Participants Who Complete the Required Diagnostic Evaluation | 121-180 days | 170 Participants |
| Standard of Care | Number of Participants Who Complete the Required Diagnostic Evaluation | 0-60 days | 423 Participants |
| IT Platform | Number of Participants Who Complete the Required Diagnostic Evaluation | 121-180 days | 215 Participants |
| IT Platform | Number of Participants Who Complete the Required Diagnostic Evaluation | 181-240 days | 159 Participants |
| IT Platform | Number of Participants Who Complete the Required Diagnostic Evaluation | Did not receive follow up | 2084 Participants |
| IT Platform | Number of Participants Who Complete the Required Diagnostic Evaluation | 61-120 days | 332 Participants |
| IT Platform | Number of Participants Who Complete the Required Diagnostic Evaluation | 0-60 days | 464 Participants |
| IT Platform With Reminders | Number of Participants Who Complete the Required Diagnostic Evaluation | 121-180 days | 191 Participants |
| IT Platform With Reminders | Number of Participants Who Complete the Required Diagnostic Evaluation | 0-60 days | 514 Participants |
| IT Platform With Reminders | Number of Participants Who Complete the Required Diagnostic Evaluation | 61-120 days | 317 Participants |
| IT Platform With Reminders | Number of Participants Who Complete the Required Diagnostic Evaluation | 181-240 days | 100 Participants |
| IT Platform With Reminders | Number of Participants Who Complete the Required Diagnostic Evaluation | Did not receive follow up | 1447 Participants |
| IT Platform and Patient Navigation | Number of Participants Who Complete the Required Diagnostic Evaluation | 181-240 days | 153 Participants |
| IT Platform and Patient Navigation | Number of Participants Who Complete the Required Diagnostic Evaluation | 61-120 days | 409 Participants |
| IT Platform and Patient Navigation | Number of Participants Who Complete the Required Diagnostic Evaluation | 0-60 days | 653 Participants |
| IT Platform and Patient Navigation | Number of Participants Who Complete the Required Diagnostic Evaluation | 121-180 days | 255 Participants |
| IT Platform and Patient Navigation | Number of Participants Who Complete the Required Diagnostic Evaluation | Did not receive follow up | 1985 Participants |