Population-Based Patient-Centric Care: Comprehensive Preventive Cancer Screening Using Health IT (TopCare)
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ClinicalTrials.gov Identifier: NCT01372527 |
Recruitment Status
:
Completed
First Posted
: June 14, 2011
Last Update Posted
: October 3, 2014
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Colorectal Cancer Cervical Cancer | Other: TopCare: Use of provider knowledge vs. automated system | Not Applicable |
In prior NIH-funded research, the investigators have demonstrated the efficacy of an IT-based population management system to improve breast cancer screening (NCI R21 CA121908). The investigators will expand our current IT platform from this single function (breast cancer screening) to a package of cancer prevention actions (breast, cervical, and colorectal cancer screening) and examine the added benefit of population-level preventive cancer care that is directed by specific clinician knowledge of individual patient needs. Moreover, rather than compare our system to currently sub-optimal "usual care" practice, our goal is to test whether the impact of our intervention exceeds the current state-of-the-art of IT-based population management. Therefore, control group practices will receive augmented standard care defined as a population-level reminder system with automated patient contacts.
In augmented standard care control practices, the investigators will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input. While not yet the standard of care nationwide, prior studies have proven the efficacy of such an approach. In intervention practices, the investigators will enhance augmented standard care by implementing a novel system that will enable physicians and clinical population managers to individualize care for each patient in their panel using tools to classify and organize patients by their clinical attributes. The investigators hypothesize that this personalized identification of patients by both their clinical outcome and clinical process risk status will improve the efficacy and efficiency of resource allocation decisions. The key additions to the health IT system for intervention practices will be: 1) a clinical systems IT platform to organize and present clinical data for each clinician's patient panel, 2) an accessible Web-based tool allowing clinicians (physicians and clinical population managers) to view, organize, and investigate their patient panels, and 3) a simple process where the clinician can make a tailored screening decision and designate the method of clinical intervention based upon the patient's risk profile.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103870 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Technology for Optimizing Population Care in a Resource-limited Environment |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
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Experimental: TopCare Intervention
The TOP-CARE intervention will be based on a medical informatics platform that:
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Other: TopCare: Use of provider knowledge vs. automated system
We will be evaluating the system in practices where providers are involved in determining to contact a patient, including the most appropriate outreach method, compared with practices where the system is fully automated without provider input.
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Active Comparator: Augmented Standard Care
In augmented standard care control practices, we will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input.
|
Other: TopCare: Use of provider knowledge vs. automated system
We will be evaluating the system in practices where providers are involved in determining to contact a patient, including the most appropriate outreach method, compared with practices where the system is fully automated without provider input.
|
- Cancer completion for all eligible cancers [ Time Frame: 1 year ]Average cancer screening test completion rate over the 1-year follow-up period for each eligible patient in all eligible cancers (breast, cervical, colorectal)
- % of patients completing all eligible cancer screenings [ Time Frame: 1 year ]Percentage of patients completing all eligible cancer screening modalities at 1-year follow-up will be compared between study arms
- Primary outcome in specified patient subgroups [ Time Frame: 1 year ]
- Eligible population: prevalent (overdue at baseline) or incident (become overdue during study) cancer screening rates will be compared between study arms.
- Patient-physician linkage status: Analyses will be stratified to compare PCP-linked patients between study arms and practice-linked patients between study arms.
- Patient risk status: Patients at high risk for not completing screening will be compared between study arms.
- TopCare system measures (intervention practices) [ Time Frame: 1 year ]
- Percentage of providers (PCPs and clinical population managers) in intervention practices using TOP-CARE system and percentage of eligible patients in clinician panel screened
- Percentage of providers (practice personnel and patient navigators) in intervention and control practices using TOP-CARE system and percentage of eligible patients assigned to provider who were contacted
- Percentage of eligible patients in clinician (PCP and clinical population manager) panel deferred and reasons selected

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Breast cancer: Women 42-74 years old
- Cervical cancer: Women 21-65 years old
- Colorectal cancer: Women and men 52-75 years old
Exclusion Criteria:
- Breast cancer: History of bilateral mastectomy in their EHR
- Cervical cancer: History of total hysterectomy in their EHR
- Colorectal cancer: History of total colectomy in their EHR

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372527
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven J Atlas, MD, MPH | Massachusetts General Hospital |
Publications of Results:
Responsible Party: | Steven Atlas, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01372527 History of Changes |
Other Study ID Numbers: |
R18HS018161 ( U.S. AHRQ Grant/Contract ) |
First Posted: | June 14, 2011 Key Record Dates |
Last Update Posted: | October 3, 2014 |
Last Verified: | October 2014 |
Keywords provided by Steven Atlas, Massachusetts General Hospital:
medical informatics health IT primary care screening cervical cancer |
colorectal cancer breast cancer mammography colonoscopy pap smear |
Additional relevant MeSH terms:
Colorectal Neoplasms Uterine Cervical Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |