Clinical trial · Interventional
Population-Based Patient-Centric Care: Comprehensive Preventive Cancer Screening Using Health IT
Technology for Optimizing Population Care in a Resource-limited Environment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TopCare: Use of provider knowledge vs. automated system | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TopCare Intervention
- description
- 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
- interventionNames
- Other: TopCare: Use of provider knowledge vs. automated system
- type
- ACTIVE_COMPARATOR
- label
- Augmented Standard Care
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAtlas 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 25002002
- RESULTZai 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 24043318