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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00853619
Other study ID # HHSA290200810010
Secondary ID
Status Enrolling by invitation
Phase N/A
First received February 26, 2009
Last updated February 27, 2012
Start date March 2008
Est. completion date July 2013

Study information

Verified date February 2012
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goal of the Clinical Decision Support (CDS) Consortium research study is to assess, define, demonstrate, and evaluate best practices for knowledge management (KM) and CDS in healthcare information technology across multiple ambulatory care settings and electronic health records (EHR) technology platforms.

There are seven specific research objectives focusing on two practical areas of implementation for clinical decision support services: a) healthcare maintenance and preventive care screening, and b) two chronic disease conditions: Coronary Artery Disease (CAD), and Adult-onset Diabetes Mellitus (AODM). The research objectives are: 1) Knowledge management lifecycle, 2) Knowledge specification, 3) Knowledge portal and repository, 4) CDS knowledge content and public web services, 5) CDS Dashboard, 6)Evaluation, and 7) Dissemination.


Description:

Investigators and developers of electronic health records from both academe and industry have come together to form the Clinical Decision Support (CDS) Consortium. Members of the CDS Consortium are intimately involved in creating and providing CDS tools and services in electronic health records used in both academic settings as well as community-based physician office practices. These investigators share a common interest and goal of enhancing the wide-spread adoption of CDS tools and services to improve the delivery of healthcare both domestically and world-wide.

Our approach to the project is iterative and cyclical: we will begin with a survey of the knowledge management lifecycle and supporting infrastructure (such as knowledge management systems, terminology services and data standards) at the participating clinical sites. We will then work together to define best practices for translating knowledge into a multi-layered array of human readable knowledge artifacts and public web services. At each point in this process, we will conduct careful evaluation, documenting lessons learned from each site. The ultimate work products will fall into three main categories:

First, tangible, actionable knowledge artifacts such as the shareable, human-readable and computable forms of clinical practice guidelines (CPGs) under study, public web-services for CDS demonstrations, and a CDS Knowledge Portal and Repository to facilitate widespread adoption of these artifacts.

Second, detailed guidance and recommendations, based on what we learn from our combined efforts, for external parties such as the Certification Commission for Health Information Technology (CCHIT), the Health Information Technology Standards Panel (HITSP), and the clinical practice guideline developer community.

Third, a set of knowledge and best practices, such as methods for the knowledge management lifecycle, development of both human readable knowledge artifacts and machine-interpretable knowledge, and management of decision-support related organizational change. We will share this knowledge through a variety of channels, such as presentations and academic papers.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 70
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- PHS clinics using the LMR (Partners electronic health record system). These clinics include Massachusetts General Hospital Back Bay, Brigham Primary Physicians at Faulkner Hospital, Brigham PCA in Brookline, and Brigham and Women's Hospital at Foxboro.

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Other:
Service based decision support intervention
Delivering CDS via services

Locations

Country Name City State
United States Partners HealthCare - Information Systems, Wellesley Gateway Wellesley Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Middleton B. The clinical decision support consortium. Stud Health Technol Inform. 2009;150:26-30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance with guideline 6 months Yes
Secondary Patient outcomes 6 months Yes
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