AgedPhase 1/2NCT00281450
An Intervention to Reduce Inappropriate Prescriptions for Elderly Patients in General Practice
A Phase 1/2 study testing Educational intervention in people with Aged and Family Practice, run by University of Oslo.
Trial summary
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to reduce inappropriate prescription patterns for elderly patients > 70 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aged, Family Practice
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 85,836 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Mar 2007
- 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
- General practitioner
- Specialist in general practice
Who cannot join
None listed.
About this study
Official title: A Cluster Randomized Educational Intervention to Reduce Inappropriate Prescription Patterns for Elderly Patients in General Practice
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to reduce inappropriate prescription patterns for elderly patients > 70 years.
- Conditions
- Aged, Family Practice
- Being tested
- Educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
We developed a set of explicit criteria for pharmacological inappropriateness for Norwegian GPs' prescribing to elderly patients. The main purpose of the criteria was to serve as quality indicators during an educational intervention: the Prescription Peer Academic Detailing (Rx-PAD) Study, aimed at improving GPs' prescribing for elderly patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients
Prescription data for 1 year were retrospectively retrieved from the Norwegian Prescription Database (NorPD) and assessed in relation to 13 prescription quality indicators.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2007
- Study completionMar 2007
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 AgedStudies 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
- None (open label)
- Enrolment
- 85,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Investigators
- Sture Rognstad, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281450
- Sponsor's protocol ID
- 850652
- Status last verified
- Dec 2005
- First submitted
- 3 Jan 2006
- Last updated
- 28 Apr 2010
- Results posted
- No
Publications
Straand J, Fetveit A, Rognstad S, Gjelstad S, Brekke M, Dalen I. A cluster-randomized educational intervention to reduce inappropriate prescription patterns for elderly patients in general practice--The Prescription Peer Academic Detailing (Rx-PAD) study [NCT00281450]. BMC Health Serv Res. 2006 Jun 11;6:72. doi: 10.1186/1472-6963-6-72.
PubMed 16764734
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Educational Intervention to Reduce Inappropriate Prescription Patterns for Elderly Patients in General Practice
- ClinicalTrials.gov ID
- NCT00281450
- Acronym / sponsor ID
- 850652
- Conditions
- Aged, Family Practice
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85,836 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 24 Jan 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.
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to reduce inappropriate prescription patterns for elderly patients > 70 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- General practitioner
- Specialist in general practice
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Educational interventionWe developed a set of explicit criteria for pharmacological inappropriateness for Norwegian GPs' prescribing to elderly patients. The main purpose of the criteria was to serve as quality indicators during an educational intervention: the Prescription Peer Academic Detailing (Rx-PAD) Study, aimed at improving GPs' prescribing for elderly patients. | Behavioural | – |
Primary outcome
Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients
Time frame: 1 year
Prescription data for 1 year were retrospectively retrieved from the Norwegian Prescription Database (NorPD) and assessed in relation to 13 prescription quality indicators.
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 28 Apr 2010.
- Derived from this study: PubMed 16764734Straand J, Fetveit A, Rognstad S, Gjelstad S, Brekke M, Dalen I. A cluster-randomized educational intervention to reduce inappropriate prescription patterns for elderly patients in general practice--The Prescription Peer Academic Detailing (Rx-PAD) study [NCT00281450]. BMC Health Serv Res. 2006 Jun 11;6:72. doi: 10.1186/1472-6963-6-72.
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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.
Sture Rognstad, MD principal investigator
University of Oslo
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Educational intervention in people with Aged and Family Practice, run by University of Oslo.
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 0 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 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (time frame: 1 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 NCT00281450, 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 28 Apr 2010.