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出境医 / 临床实验 / mFOCUS (Multilevel FOllow-up of Cancer Screening) (mFOCUS)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Cancer Other: mFOCUS Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
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
Primary Purpose: Screening
Official Title: mFOCUS (Multilevel FOllow-up of Cancer Screening)
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Arm Intervention/treatment
No Intervention: Standard of care
standard of care
Active Comparator: IT platform
Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
 Other: 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.
Active Comparator: 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.
 Other: 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.
Active Comparator: 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.
 Other: 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.
Outcome Measures
Primary Outcome Measures :
  1. Completion of follow-up test [ Time Frame: 120 days ]
    Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)


Secondary Outcome Measures :
  1. Amount of time to complete the required diagnostic evaluation [ Time Frame: 120 days ]
    How many days are need for the completion of required diagnostic evaluation (EHR)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
United States, New Hampshire
Dartmouth Hitchcock
Hanover, New Hampshire, United States, 03755
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Dartmouth-Hitchcock Medical Center
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE August 24, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Completion of follow-up test [ Time Frame: 120 days ]
Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Amount of time to complete the required diagnostic evaluation [ Time Frame: 120 days ]
How many days are need for the completion of required diagnostic evaluation (EHR)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE mFOCUS (Multilevel FOllow-up of Cancer Screening)
Official Title  ICMJE mFOCUS (Multilevel FOllow-up of Cancer Screening)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
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
Primary Purpose: Screening
Condition  ICMJE Cancer
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • No Intervention: Standard of care
    standard of care
  • Active Comparator: IT platform
    Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
    Intervention: Other: mFOCUS
  • Active Comparator: 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.
    Intervention: Other: mFOCUS
  • Active Comparator: 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.
    Intervention: Other: mFOCUS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		3324
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979495
Other Study ID Numbers  ICMJE 2019P000341
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer S Haas, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Dartmouth-Hitchcock Medical Center
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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