Decision Support Systems, ClinicalPhase 1/2EBMeDSNCT00915304
Evidence-Based Medicine Electronic Decision Support Study
A Phase 1/2 study testing The EBMeDS reminders in people with Decision Support Systems, Clinical, run by Tampere University at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Decision Support Systems, Clinical
- What is being tested?
- The EBMeDS reminders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12,101 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2009to Feb 2011
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All residents of Sipoo who have patient ID number in the Mediatri electronic patient record system in Sipoo Health Centre
Who cannot join
- Those residents who's occupational health care is produced by Sipoo Health Centre
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Tampere; School of Health Sciences
Tampere, Finland, 33014
About this study
Official title: Patient Specific Automatic Reminders in Primary Care - the EBMeDS Randomised Trial
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.
- Conditions
- Decision Support Systems, Clinical
- Being tested
- The EBMeDS reminders
- Keywords
- Clinical Decision Support System, Automatic reminder, Primary care, Evidence-Based Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EBMeDS remindersBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of reminders triggered (in relation to the number of eligible patients, Ri/Ni) during repeated Virtual Health Checks (VHCs)
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.
Measured: Follow-up time max one and half year
Secondary outcomes (1)
Specific clinical measures compared to an intervention and a control group
Clinical measures as mean values of laboratory parameters, for example a mean level of HbA1c, a mean level of total cholesterol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2011
- Study completionFeb 2011
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 Decision Support Systems, ClinicalStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- The Finnish Medical Society Duodecim, Finnish Institute for Health and Welfare, Duodecim Medical Publications Ltd., ProWellness Ltd., The Finnish Funding Agency for Technology and Innovation
- Responsible party
- Principal investigator, Tiina Kortteisto, Tampere University
- Investigators
- Pekka Rissanen, Professor, Study director, University of Tampere; School of Health SciencesTiina Kortteisto, MSc, Principal investigator, University of Tampere; School of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915304
- Sponsor's protocol ID
- EBMeDS-40344-06
- Acronym
- EBMeDS
- Status last verified
- Dec 2012
- First submitted
- 5 Jun 2009
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kortteisto T, Raitanen J, Komulainen J, Kunnamo I, Makela M, Rissanen P, Kaila M; EBMeDS (Evidence-Based Medicine electronic Decision Support) Study Group. Patient-specific computer-based decision support in primary healthcare--a randomized trial. Implement Sci. 2014 Jan 20;9:15. doi: 10.1186/1748-5908-9-15.
PubMed 24444113
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Automatic Reminders in Primary Care - the EBMeDS Randomised Trial
- ClinicalTrials.gov ID
- NCT00915304
- Acronym / sponsor ID
- EBMeDS / EBMeDS-40344-06
- Conditions
- Decision Support Systems, Clinical
- Keywords
- Clinical Decision Support System, Automatic reminder, Primary care, Evidence-Based Medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,101 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- The Finnish Medical Society Duodecim, Finnish Institute for Health and Welfare, Duodecim Medical Publications Ltd., ProWellness Ltd., The Finnish Funding Agency for Technology and Innovation
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Jun 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All residents of Sipoo who have patient ID number in the Mediatri electronic patient record system in Sipoo Health Centre
Key exclusion criteria (1 listed)
- Those residents who's occupational health care is produced by Sipoo Health Centre
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 |
|---|---|---|
| The EBMeDS remindersPhase 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. | Behavioural | – |
Primary outcome
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
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.
1 secondary outcome
Specific clinical measures compared to an intervention and a control group
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 18 Dec 2012.
- Derived from this study: PubMed 24444113Kortteisto T, Raitanen J, Komulainen J, Kunnamo I, Makela M, Rissanen P, Kaila M; EBMeDS (Evidence-Based Medicine electronic Decision Support) Study Group. Patient-specific computer-based decision support in primary healthcare--a randomized trial. Implement Sci. 2014 Jan 20;9:15. doi: 10.1186/1748-5908-9-15.
- Click here for more information about this study and EDMeDSLink 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.
Pekka Rissanen, Professor study director
University of Tampere; School of Health Sciences
Tiina Kortteisto, MSc principal investigator
University of Tampere; School of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing The EBMeDS reminders in people with Decision Support Systems, Clinical, run by Tampere University at 1 site in Finland.
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: finished, as of the sponsor's last update on 18 Dec 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 Finland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 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). 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 NCT00915304, 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 18 Dec 2012.