DiabetesCDSCNCT00853619
Clinical Decision Support Consortium
A study testing Service based decision support intervention in people with Diabetes and Coronary Artery Disease, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Coronary Artery Disease, Hypertension
- What is being tested?
- Service based decision support intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners HealthCare - Information Systems, Wellesley Gateway
Wellesley, Massachusetts, 02481
About this study
Official title: Clinical Decision Support Consortium for AHRQ CDS Research
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.
Read the detailed 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.
- Conditions
- Diabetes, Coronary Artery Disease, Hypertension
- Being tested
- Service based decision support intervention
- Keywords
- clinical decision support, knowledge management, knowledge representation, clinical guidelines, coronary artery disease, myocardial ischemia, diabetes mellitus, hypertension
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease, Hypertension, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service based decision support interventionOther
Also called Clinical Decision Support,, CDS Consortium,, Enterprise Clinical Rules Services
Delivering CDS via services
| Study group | Role | What they receive |
|---|---|---|
| Services Demo at PHS and RI | Experimental | Service based CDS intervention at PHS. Receives: Other: Service based decision support intervention |
| Normal CDS interventions at PHS and RI | Active comparator | Normal CDS intervention at both PHS and RI hospitals Receives: Other: Service based decision support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with guideline
Measured: 6 months
Secondary outcomes (1)
Patient outcomes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blackford Middleton, MD, MPH, Brigham and Women's Hospital
- Investigators
- Blackford Middleton, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853619
- Sponsor's protocol ID
- HHSA290200810010
- Acronym
- CDSC
- Status last verified
- Feb 2012
- First submitted
- 26 Feb 2009
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Middleton B. The clinical decision support consortium. Stud Health Technol Inform. 2009;150:26-30.
PubMed 19745260
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support Consortium for AHRQ CDS Research
- ClinicalTrials.gov ID
- NCT00853619
- Acronym / sponsor ID
- CDSC / HHSA290200810010
- Conditions
- Diabetes, Coronary Artery Disease, Hypertension
- Keywords
- clinical decision support, knowledge management, knowledge representation, clinical guidelines, coronary artery disease, myocardial ischemia, diabetes mellitus, hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Services Demo at PHS and RI | Experimental | Other: Service based decision support interventionService based CDS intervention at PHS. |
| Normal CDS interventions at PHS and RI | Active comparator | Other: Service based decision support interventionNormal CDS intervention at both PHS and RI hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Service based decision support interventionAlso: Clinical Decision Support,, CDS Consortium,, Enterprise Clinical Rules ServicesDelivering CDS via services | Other | Normal CDS interventions at PHS and RI, Services Demo at PHS and RI |
Primary outcome
Compliance with guideline
Time frame: 6 months
1 secondary outcome
Patient outcomes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
- Background: PubMed 19745260Middleton B. The clinical decision support consortium. Stud Health Technol Inform. 2009;150:26-30.
- Clinical Decision Support Consortium WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blackford Middleton, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Service based decision support intervention in people with Diabetes and Coronary Artery Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with guideline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00853619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.