Acute Otitis MediaPhase 3NCT00368823
A Trial of Point of Care Information in Ambulatory Pediatrics
A Phase 3 study testing Electronic point-of-care delivery system in people with Acute Otitis Media and Allergic Rhinitis, run by University of Washington at 2 sites in United States.
Trial summary
Does presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics? Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media, Allergic Rhinitis, Sinusitis
- What is being tested?
- Electronic point-of-care delivery system
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 1999to Dec 2003
- Phase
- Phase 3
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roosevelt Pediatric Clinic
Seattle, Washington
Skagit Valley Pediatrics
Skagit Valley, Washington
About this study
Official title: A Randomized Clinical Trial to Improve Prescribing Patterns in Ambulatory Pediatrics
Does presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics?
Read the detailed description
We showed previously that an electronic prescription writer and decision support system improved pediatric prescribing behavior for otitis media in an academic clinic setting. This study assessed whether point-of-care evidence delivery could demonstrate similar effects for a wide range of other common pediatric conditions. We performed a randomized controlled trial in a teaching clinic/clinical practice site and a primary care pediatric clinic serving a rural and semi-urban patient mix. There were 36 providers at the teaching clinic/practice site, and 8 providers at the private primary pediatric clinic, and an evidence-based message system presented real time evidence to providers based on prescribing practices for acute otitis media, allergic rhinitis, sinusitis, constipation, pharyngitis, croup, urticaria, and bronchiolitis. We measured the proportion of prescriptions dispensed in accordance with evidence.
- Conditions
- Acute Otitis Media, Allergic Rhinitis, Sinusitis, Constipation, Pharyngitis, Croup
- Being tested
- Electronic point-of-care delivery system
- Keywords
- point of care, evidence based medicine
- Medical subject headings
- Otitis Media, Rhinitis, Allergic, Sinusitis, Constipation, Pharyngitis, Croup, Urticaria, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic point-of-care delivery systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
prescribing practices for acute otitis media,
allergic rhinitis,
sinusitis,
constipation,
pharyngitis,
croup,
urticaria,
bronchiolitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startNov 1999
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Robert L Davis, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368823
- Sponsor's protocol ID
- HS10516-03
- Status last verified
- Aug 2006
- First submitted
- 24 Aug 2006
- Last updated
- 29 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Improve Prescribing Patterns in Ambulatory Pediatrics
- ClinicalTrials.gov ID
- NCT00368823
- Acronym / sponsor ID
- HS10516-03
- Conditions
- Acute Otitis Media, Allergic Rhinitis, Sinusitis, Constipation, Pharyngitis, Croup
- Keywords
- point of care, evidence based medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Nov 1999
- Study completion
- Dec 2003
- First posted
- 29 Aug 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.
Does presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics?
Detailed description
We showed previously that an electronic prescription writer and decision support system improved pediatric prescribing behavior for otitis media in an academic clinic setting. This study assessed whether point-of-care evidence delivery could demonstrate similar effects for a wide range of other common pediatric conditions. We performed a randomized controlled trial in a teaching clinic/clinical practice site and a primary care pediatric clinic serving a rural and semi-urban patient mix. There were 36 providers at the teaching clinic/practice site, and 8 providers at the private primary pediatric clinic, and an evidence-based message system presented real time evidence to providers based on prescribing practices for acute otitis media, allergic rhinitis, sinusitis, constipation, pharyngitis, croup, urticaria, and bronchiolitis. We measured the proportion of prescriptions dispensed in accordance with evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 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 |
|---|---|---|
| Electronic point-of-care delivery system | Device | – |
Primary outcome
prescribing practices for acute otitis media,
allergic rhinitis,
sinusitis,
constipation,
pharyngitis,
croup,
urticaria,
bronchiolitis
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 29 Aug 2006.
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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.
Robert L Davis, MD, MPH principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electronic point-of-care delivery system in people with Acute Otitis Media and Allergic Rhinitis, run by University of Washington at 2 sites 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 0 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 29 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
prescribing practices for acute otitis media,. The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2006.