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Population-Based Patient-Centric Care: Comprehensive Preventive Cancer Screening Using Health IT (TopCare)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Atlas, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01372527
First received: June 10, 2011
Last updated: October 2, 2014
Last verified: October 2014
History of Changes
  Purpose

Although there is considerable evidence that current health IT can improve certain elements of care, the most effective and efficient implementation of health IT systems for primary care population management are not currently known. Indeed, while many systems currently take a "case-management" approach to identify and address clinical care issues for high risk patients, no systems to our knowledge apply a risk-based approach that accounts both for adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific patient will ignore a reminder letter and would therefore benefit from direct phone or in person contact). The investigators propose to directly test the hypothesis that implementing a health IT platform that 1) provides novel risk-based decision support using data derived from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge of his or her patient panel will result in more effective and more efficient population-based primary care. The investigators will test this hypothesis in a practice-randomized clinical trial of preventive cancer screening within our primary care Practice-Based Research Network (PBRN).


Condition Intervention
Breast Cancer
Colorectal Cancer
Cervical Cancer
 Other: TopCare: Use of provider knowledge vs. automated system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Technology for Optimizing Population Care in a Resource-limited Environment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Cancer completion for all eligible cancers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Average cancer screening test completion rate over the 1-year follow-up period for each eligible patient in all eligible cancers (breast, cervical, colorectal)


Secondary Outcome Measures:
  • % of patients completing all eligible cancer screenings [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    1. Eligible population: prevalent (overdue at baseline) or incident (become overdue during study) cancer screening rates will be compared between study arms.
    2. Patient-physician linkage status: Analyses will be stratified to compare PCP-linked patients between study arms and practice-linked patients between study arms.
    3. 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 ] [ Designated as safety issue: No ]
    1. Percentage of providers (PCPs and clinical population managers) in intervention practices using TOP-CARE system and percentage of eligible patients in clinician panel screened
    2. 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
    3. Percentage of eligible patients in clinician (PCP and clinical population manager) panel deferred and reasons selected
Enrollment: 103870
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TopCare Intervention

The TOP-CARE intervention will be based on a medical informatics platform that:

  1. Identifies all patients eligible for any of the three cancer screening programs
  2. Links patients with a specific clinician
  3. Offers a visit-independent method for clinicians to review panels of their eligible patients

  4. For patients due for one or more cancer screenings, clinicians will access a web-based informatics tool to:

    1. Screen their panel based upon risk
    2. Defer patients, document exclusions, and update the EHR

    3. Order a screening test with patient information material based upon the patient's risk profile and automatically initiate the process of:

      1. Informing the patient by letter of the need to schedule a test, educating the patient with respect to the benefits of cancer screening, and properly documenting the transaction in the patient's EHR, or
      2. Referral to a patient navigator for patients most likely to benefit from this more intensive approach
 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.
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.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372527

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven J Atlas, MD, MPH Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Steven Atlas, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01372527     History of Changes
Other Study ID Numbers: R18HS018161
Study First Received: June 10, 2011
Last Updated: October 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
medical informatics
health IT
primary care
screening
cervical cancer
 colorectal cancer
breast cancer
mammography
colonoscopy
pap smear

ClinicalTrials.gov processed this record on March 03, 2015