NCT01372527

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103,870

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 3, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

June 10, 2011

Last Update Submit

October 2, 2014

Conditions

Breast CancerColorectal CancerCervical Cancer

Keywords

medical informaticshealth ITprimary carescreeningcervical cancercolorectal cancerbreast cancermammographycolonoscopypap smear

Outcome Measures

Primary Outcomes (1)

  • Cancer completion for all eligible cancers

    Average cancer screening test completion rate over the 1-year follow-up period for each eligible patient in all eligible cancers (breast, cervical, colorectal)

    1 year

Secondary Outcomes (3)

  • % of patients completing all eligible cancer screenings

    1 year

  • Primary outcome in specified patient subgroups

    1 year

  • TopCare system measures (intervention practices)

    1 year

Study Arms (2)

TopCare Intervention

EXPERIMENTAL

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

Augmented Standard Care

ACTIVE COMPARATOR

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

Interventions

TopCare: Use of provider knowledge vs. automated systemOTHER

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.

Augmented Standard CareTopCare Intervention

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer: Women 42-74 years old
  • Cervical cancer: Women 21-65 years old
  • Colorectal cancer: Women and men 52-75 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Atlas SJ, Zai AH, Ashburner JM, Chang Y, Percac-Lima S, Levy DE, Chueh HC, Grant RW. Non-visit-based cancer screening using a novel population management system. J Am Board Fam Med. 2014 Jul-Aug;27(4):474-85. doi: 10.3122/jabfm.2014.04.130319.

    PMID: 25002002RESULT

  • Zai AH, Kim S, Kamis A, Hung K, Ronquillo JG, Chueh HC, Atlas SJ. Applying operations research to optimize a novel population management system for cancer screening. J Am Med Inform Assoc. 2014 Feb;21(e1):e129-35. doi: 10.1136/amiajnl-2013-001681. Epub 2013 Sep 16.

    PMID: 24043318RESULT

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Steven J Atlas, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 14, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

January 1, 2013

Last Updated

October 3, 2014

Record last verified: 2014-10

Locations

US(1)