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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | standard of care | |
| IT platform | Active Comparator | Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results |
|
| IT platform with reminders | Active Comparator | Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results. |
|
| IT platform and patient navigation | Active Comparator | the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mFOCUS | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Follow-up Test | Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR) | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 240 days |
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Inclusion Criteria:
individuals who have an abnormal screen that is due for follow-up including:
Exclusion Criteria:
We will exclude patients who:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dartmouth Hitchcock |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39424768 | Derived | Atlas SJ, Gallagher KL, McGovern SE, Wint AJ, Smith RE, Aman DG, Zhao W, Burdick TE, Orav EJ, Zhou L, Wright A, Tosteson ANA, Haas JS. Patient Perceptions on the Follow-Up of Abnormal Cancer Screening Test Results. J Gen Intern Med. 2025 May;40(6):1280-1287. doi: 10.1007/s11606-024-09128-4. Epub 2024 Oct 18. | |
| 37815566 | Derived |
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Recruitment started in August 2020 and ended in December of 2021
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard care/no changes to usual care |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | standard of care |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion of Follow-up Test | Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR) | Posted | Count of Participants | Participants | 120 days |
|
240 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | standard of care | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Haas | Massachusetts General Hospital | 617-724-1832 | jhaas@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2023 | Jan 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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.
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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
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| Hanover |
| New Hampshire |
| 03755 |
| United States |
| Atlas SJ, Tosteson ANA, Wright A, Orav EJ, Burdick TE, Zhao W, Hort SJ, Wint AJ, Smith RE, Chang FY, Aman DG, Thillaiyapillai M, Diamond CJ, Zhou L, Haas JS. A Multilevel Primary Care Intervention to Improve Follow-Up of Overdue Abnormal Cancer Screening Test Results: A Cluster Randomized Clinical Trial. JAMA. 2023 Oct 10;330(14):1348-1358. doi: 10.1001/jama.2023.18755. |
| 34375748 | Derived | Haas JS, Atlas SJ, Wright A, Orav EJ, Aman DG, Breslau ES, Burdick TE, Carpenter E, Chang F, Dang T, Diamond CJ, Feldman S, Harris KA, Hort SJ, Housman ML, Mecker A, Lehman CD, Percac-Lima S, Smith R, Wint AJ, Yang J, Zhou L, Tosteson ANA. Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results. Contemp Clin Trials. 2021 Oct;109:106533. doi: 10.1016/j.cct.2021.106533. Epub 2021 Aug 8. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
| OG003 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | up to 240 days |
|
|
|
| 2,702 |
| 0 |
| 2,702 |
| 0 |
| 2,702 |
| EG001 | 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. | 0 | 3,254 | 0 | 3,254 | 0 | 3,254 |
| EG002 | 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. | 0 | 2,569 | 0 | 2,569 | 0 | 2,569 |
| EG003 | 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. | 0 | 3,455 | 0 | 3,455 | 0 | 3,455 |
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| 61-120 days |
|
| 121-180 days |
|
| 181-240 days |
|
| Did not receive follow up |
|