Decision Support Systems, ClinicalNCT00348751
CholGate - The Effect of Alerting Versus on Demand Computer Based Decision Support on Treatment of Dyslipidaemia by General Practitioners
A study testing CholGate in people with Decision Support Systems, Clinical, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decision Support Systems, Clinical
- What is being tested?
- CholGate
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Jun 2004to Nov 2005
- 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 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- All general practices using only Elias electronic patient records (ISOFT b.V)
- All patients meeting the screening and treatment criteria of the Dutch college of general practitioners cholesterol guideline
Who cannot join
- Practices that used paper based records
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Medical informatics, ErasmusMC
Rotterdam, South Holland, 3000DR
About this study
Official title: The Effect of Alerting Versus on Demand Computer Based Decision Support on Treatment of Dyslipidaemia by General Practitioners - The CholGate Randomized Trial
Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners.
Read the detailed description
Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners, using a clinical decsion support system called CholGate. This system has the functionality to provide both Alerting and On-Demand decision support. Users are free to negate the advise provided by the decision support system. The trial will have a cluster randomized structure.
- Conditions
- Decision Support Systems, Clinical
- Being tested
- CholGate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholGateDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of correctly screened patients using anonymous patient record data.
The percentage of correctly treated patients using anonymous patient record data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJun 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Decision Support Systems, ClinicalStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Investigators
- Jacobus T van Wyk, MD, PhD, Principal investigator, ErasmusMC University Medical Centre Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348751
- Sponsor's protocol ID
- 2000B161
- Status last verified
- Jun 2006
- First submitted
- 29 Jun 2006
- Last updated
- 8 May 2008
- Results posted
- No
Publications
Van Wyk JT, Van Wijk MA, Moorman PW, Mosseveld M, Van Der Lei J. Cholgate - a randomized controlled trial comparing the effect of automated and on-demand decision support on the management of cardiovascular disease factors in primary care. AMIA Annu Symp Proc. 2003;2003:1040.
PubMed 14728543Van Wyk JT, Van Wijk MA. Assessment of the possibility to classify patients according to cholesterol guideline screening criteria using routinely recorded electronic patient record data. Stud Health Technol Inform. 2002;93:39-46.
PubMed 15058412Van Wyk JT, Van Wijk MA. Analysis of Dutch general practice guidelines for inconsistencies with respect to the management of cardiovascular disease risk factors. Stud Health Technol Inform. 2004;107(Pt 1):179-86.
PubMed 15360799van Wyk JT, Picelli G, Dieleman JP, Mozaffari E, Kramarz P, van Wijk MA, van der Lei J, Sturkenboom MC. Management of hypertension and hypercholesterolaemia in primary care in The Netherlands. Curr Med Res Opin. 2005 Jun;21(6):839-48. doi: 10.1185/030079905X46368.
PubMed 15969884Dieleman JP, van Wyk JT, van Wijk MA, van Herpen G, Straus SM, Dunselman H, Sturkenboom MC. Differences between statins on clinical endpoints: a population-based cohort study. Curr Med Res Opin. 2005 Sep;21(9):1461-8. doi: 10.1185/030079905X61866.
PubMed 16197665van Wyk JT, van Wijk MA, Sturkenboom MC, Moorman PW, van der Lei J. Identification of the four conventional cardiovascular disease risk factors by Dutch general practitioners. Chest. 2005 Oct;128(4):2521-7. doi: 10.1378/chest.128.4.2521.
PubMed 16236918van Wyk JT, van Wijk MA, Moorman PW, van der Lei J. Cross-sectional analysis of guidelines on cardiovascular disease risk factors: going to meet the inconsistencies. Med Decis Making. 2006 Jan-Feb;26(1):57-62. doi: 10.1177/0272989X05284104.
PubMed 16495201van Wyk JT, van Wijk MA, Moorman PW, Mosseveld M, van der Lei J. User requirements rating and knowledge-level of general practitioners at the start of CholGate - a lipid management decision support project. AMIA Annu Symp Proc. 2005;2005:1146.
PubMed 16779432
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alerting Versus on Demand Computer Based Decision Support on Treatment of Dyslipidaemia by General Practitioners - The CholGate Randomized Trial
- ClinicalTrials.gov ID
- NCT00348751
- Acronym / sponsor ID
- 2000B161
- Conditions
- Decision Support Systems, Clinical
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- Jun 2004
- Study completion
- Nov 2005
- First posted
- 6 Jul 2006 (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.
Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners.
Detailed description
Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners, using a clinical decsion support system called CholGate. This system has the functionality to provide both Alerting and On-Demand decision support. Users are free to negate the advise provided by the decision support system. The trial will have a cluster randomized structure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All general practices using only Elias electronic patient records (ISOFT b.V)
- All patients meeting the screening and treatment criteria of the Dutch college of general practitioners cholesterol guideline
Key exclusion criteria (1 listed)
- Practices that used paper based records
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 |
|---|---|---|
| CholGate | Device | – |
Primary outcome
The percentage of correctly screened patients using anonymous patient record data.
The percentage of correctly treated patients using anonymous patient record data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2008.
- Background: PubMed 14728543Van Wyk JT, Van Wijk MA, Moorman PW, Mosseveld M, Van Der Lei J. Cholgate - a randomized controlled trial comparing the effect of automated and on-demand decision support on the management of cardiovascular disease factors in primary care. AMIA Annu Symp Proc. 2003;2003:1040.
- Background: PubMed 15058412Van Wyk JT, Van Wijk MA. Assessment of the possibility to classify patients according to cholesterol guideline screening criteria using routinely recorded electronic patient record data. Stud Health Technol Inform. 2002;93:39-46.
- Background: PubMed 15360799Van Wyk JT, Van Wijk MA. Analysis of Dutch general practice guidelines for inconsistencies with respect to the management of cardiovascular disease risk factors. Stud Health Technol Inform. 2004;107(Pt 1):179-86.
- Background: PubMed 15969884van Wyk JT, Picelli G, Dieleman JP, Mozaffari E, Kramarz P, van Wijk MA, van der Lei J, Sturkenboom MC. Management of hypertension and hypercholesterolaemia in primary care in The Netherlands. Curr Med Res Opin. 2005 Jun;21(6):839-48. doi: 10.1185/030079905X46368.
- Background: PubMed 16197665Dieleman JP, van Wyk JT, van Wijk MA, van Herpen G, Straus SM, Dunselman H, Sturkenboom MC. Differences between statins on clinical endpoints: a population-based cohort study. Curr Med Res Opin. 2005 Sep;21(9):1461-8. doi: 10.1185/030079905X61866.
- Background: PubMed 16236918van Wyk JT, van Wijk MA, Sturkenboom MC, Moorman PW, van der Lei J. Identification of the four conventional cardiovascular disease risk factors by Dutch general practitioners. Chest. 2005 Oct;128(4):2521-7. doi: 10.1378/chest.128.4.2521.
- Background: PubMed 16495201van Wyk JT, van Wijk MA, Moorman PW, van der Lei J. Cross-sectional analysis of guidelines on cardiovascular disease risk factors: going to meet the inconsistencies. Med Decis Making. 2006 Jan-Feb;26(1):57-62. doi: 10.1177/0272989X05284104.
- Background: PubMed 16779432van Wyk JT, van Wijk MA, Moorman PW, Mosseveld M, van der Lei J. User requirements rating and knowledge-level of general practitioners at the start of CholGate - a lipid management decision support project. AMIA Annu Symp Proc. 2005;2005:1146.
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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.
Jacobus T van Wyk, MD, PhD principal investigator
ErasmusMC University Medical Centre Rotterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CholGate in people with Decision Support Systems, Clinical, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 8 May 2008. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage of correctly screened patients using anonymous patient record data.. The study lists 2 primary outcomes in all. 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 NCT00348751, which also lists 8 linked publications.
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 8 May 2008.