# Clinical Coordination Core

> **NIH NIH P01** · TUFTS UNIVERSITY BOSTON · 2024 · $1,680,494

## Abstract

ABSTRACT- CLINICAL COORDINATION CORE
The Clinical Coordination Core (CCC) provides oversight for efficient and optimal enrollment of patients with
early Lyme disease as manifested by erythema migrans (and/or other features of disseminated early Lyme
disease) and for an antibody-based prevalence study of patient populations at high risk of exposure to Ixodes
scapularis transmitted tickborne infections. The CCC provides the centerpiece for successful completion of the
Aims outlined in Projects 1-3. The CCC directs the collection of clinical information and blood and tissue
samples, supports the practice infrastructure for subject retention and follow-up and co-ordinates efficient
distribution of samples to the Diagnostics Core. We will develop and maintain an integrated system for data
management among the three medical institutions at MaineHealth, Tufts University School of Medicine, and
MassGeneral Brigham (MGB). The CCC supports, monitors and, if appropriate, modifies operations for our
outpatient –based network of front-line providers of care in high incidence areas for Lyme disease. Our
enrollment sites include hospital-based practices, independent primary care sites, and urgent care centers over
large geographic areas in New England. Our enrollment strategy incorporates an iterative approach to
successful practice site engagement that will maximize enrollment of subjects with early Lyme disease through
ongoing interaction with the capacity to augment support if needed. Contingencies for practice site expansion
are in place if needed. Detailed protocols for subject enrollment, skin biopsies, phlebotomy and specimen
handling will be overseen by the CCC teams at MaineHealth, Tufts and MGB. In addition to our outpatient
based networks for enrollment of subjects with erythema migrans in Maine and Massachusetts, the CCC
oversees hospital-based enrollment within our network of subjects with early disseminated Lyme disease, i.e.
Lyme meningitis and/or other acute neurologic presentations and Lyme carditis. The CCC is closely linked to
the Diagnostic Core for integration of subject data, sample distribution and storage. We have created an
organizational structure of the CCC that facilitates integration of Project and Core leadership while providing for
continuous interaction with our outpatient practice leaders.

## Key facts

- **NIH application ID:** 10862289
- **Project number:** 1P01AI181934-01
- **Recipient organization:** TUFTS UNIVERSITY BOSTON
- **Principal Investigator:** Robert Pease Smith
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,680,494
- **Award type:** 1
- **Project period:** 2024-09-05 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10862289

## Citation

> US National Institutes of Health, RePORTER application 10862289, Clinical Coordination Core (1P01AI181934-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10862289. Licensed CC0.

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