Asthma ExacerbationPhase 3NCT00952471
Reduction in Clinical Variance Using Targeted Design Changes in Computerized Provider Order Entry Order (CPOE) Sets
A Phase 3 study testing Evidence Based Intervention to order set in people with Asthma Exacerbation, run by Brian Jacobs at 1 site in United States.
Trial summary
Selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma Exacerbation
- What is being tested?
- Evidence Based Intervention to order set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted using an acute asthma exacerbation order set.
Who cannot join
- Patients who did not have either an admission or discharge diagnosis of asthma exacerbation.
- In addition, patients admitted to the intensive care unit directly or transferred to the intensive care unit within 24-hours were excluded from analysis.
- Finally, patients were excluded from analysis if asthma was not the presenting problem.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance.
Read the detailed description
Variance in ordering of care can be characterized as the lack of uniform use of specific treatments by clinicians for a given medical condition. Unwarranted variance in healthcare has been associated with prolonged length of stay, diminished health and increased cost. Practice variation in the management of asthma can be significant and few investigators have evaluated strategies to reduce this variation. We hypothesized that selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance.
- Conditions
- Asthma Exacerbation
- Being tested
- Evidence Based Intervention to order set
- Keywords
- Asthma, Children, CPOE, Decision Support, Framing, Heuristic, Order Sets
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence Based Intervention to order setOther
The order set was altered to include evidence based care items
| Study group | Role | What they receive |
|---|---|---|
| Baseline Period | No intervention | Patients in the baseline period were cared for using the standard historical electronic order set. |
| Post Intervention Period | Active comparator | Patients in the Post intervention period were cared for with evidence-bsed modified order set changes Receives: Other: Evidence Based Intervention to order set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced variation from in evidence-based care through integrating evidence into the clinician workflow in the EMR system.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ExacerbationStudies 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 3
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian Jacobs
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical
- Responsible party
- Sponsor-investigator, Brian Jacobs, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952471
- Sponsor's protocol ID
- 05-11-34
- Status last verified
- May 2015
- First submitted
- 24 Jul 2009
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Clinical Variance Using Targeted Design Changes in Computerized Provider Order Entry Order (CPOE) Sets
- ClinicalTrials.gov ID
- NCT00952471
- Acronym / sponsor ID
- 05-11-34
- Conditions
- Asthma Exacerbation
- Keywords
- Asthma, Children, CPOE, Decision Support, Framing, Heuristic, Order Sets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Brian JacobsUniversity, hospital or other
- Collaborators
- Siemens Medical
- Study start
- Sep 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 6 Aug 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.
Selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance.
Detailed description
Variance in ordering of care can be characterized as the lack of uniform use of specific treatments by clinicians for a given medical condition. Unwarranted variance in healthcare has been associated with prolonged length of stay, diminished health and increased cost. Practice variation in the management of asthma can be significant and few investigators have evaluated strategies to reduce this variation. We hypothesized that selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Period | No intervention | –Patients in the baseline period were cared for using the standard historical electronic order set. |
| Post Intervention Period | Active comparator | Other: Evidence Based Intervention to order setPatients in the Post intervention period were cared for with evidence-bsed modified order set changes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted using an acute asthma exacerbation order set.
Key exclusion criteria (3 listed)
- Patients who did not have either an admission or discharge diagnosis of asthma exacerbation.
- In addition, patients admitted to the intensive care unit directly or transferred to the intensive care unit within 24-hours were excluded from analysis.
- Finally, patients were excluded from analysis if asthma was not the presenting problem.
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 |
|---|---|---|
| Evidence Based Intervention to order setThe order set was altered to include evidence based care items | Other | Post Intervention Period |
Primary outcome
Reduced variation from in evidence-based care through integrating evidence into the clinician workflow in the EMR system.
Time frame: 2 years
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 21 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evidence Based Intervention to order set in people with Asthma Exacerbation, run by Brian Jacobs at 1 site 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 1 inclusion and 3 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 21 May 2015. 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 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?
Reduced variation from in evidence-based care through integrating evidence into the clinician workflow in the EMR system. (time frame: 2 years). 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 21 May 2015.