Evidence-Based Medicine Electronic Decision Support Study (EBMeDS)
This study has been completed.
Sponsor:
University of Tampere
Collaborators:
The Finnish Medical Society Duodecim
National Institute for Health and Welfare, Finland
Duodecim Medical Publications Ltd.
ProWellness Ltd.
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Tiina Kortteisto, University of Tampere
ClinicalTrials.gov Identifier:
NCT00915304
First received: June 5, 2009
Last updated: December 17, 2012
Last verified: December 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 5, 2009 | ||||||||
| Last Updated Date | December 17, 2012 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The number of reminders triggered (in relation to the number of eligible patients, Ri/Ni) during repeated Virtual Health Checks (VHCs) [ Time Frame: Follow-up time max one and half year ] [ Designated as safety issue: Yes ] VHC will be performed once a week for the whole study population, beginning at baseline and before randomisation. The main outcome measure is Ri/Ni at follow-up time after commencement of the study where Ri is the total number of reminders triggered by the patient record data in intervention and in control group at the time of analysis, and Ni is the total number of patients. |
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| Original Primary Outcome Measures ICMJE |
The number of reminders triggered (in relation to the number of eligible patients) during repeated Virtual Health Checks (VHCs) [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT00915304 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Specific clinical measures compared to an intervention and a control group [ Designated as safety issue: Yes ] Clinical measures as mean values of laboratory parameters, for example a mean level of HbA1c, a mean level of total cholesterol. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evidence-Based Medicine Electronic Decision Support Study | ||||||||
| Official Title ICMJE | Patient Specific Automatic Reminders in Primary Care - the EBMeDS Randomised Trial | ||||||||
| Brief Summary | The purpose of this study is to analyze the effect of the Evidence-Based Medicine electronic Decision Support (EBMeDS) automatic reminders in primary health care. Hypothesis (1)is that in the intervention group the total number of EBMeDS reminders will decrease compared to the control group. Hypothesis (2) is that in the intervention group the quality measures will increase faster compared to the control group at follow-up time. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
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| Condition ICMJE | Decision Support Systems, Clinical | ||||||||
| Intervention ICMJE | Behavioral: The EBMeDS reminders
Phase I: EBMeDS reminders specific to the visiting or caring patient and his/her clinical problem are generated when the practitioner uses the electronic patient record. During visits of intervention group patients the EBMeDS reminders will be shown on screen to the practitioner. Phase II: As phase I and in addition, results of the Virtual Health Check (VHC) of all the intervention group patients will be shown to the practitioners.Phase II will be fulfilled in Autumn 2010 and follow-up time will be about 3 months. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 12101 | ||||||||
| Completion Date | February 2011 | ||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Finland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00915304 | ||||||||
| Other Study ID Numbers ICMJE | EBMeDS-40344-06 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Tiina Kortteisto, University of Tampere | ||||||||
| Study Sponsor ICMJE | University of Tampere | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Tampere | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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