Otitis MediaPhase 3OMHITNCT00581711
Improving Otitis Media Care With Clinical Decision Support
A Phase 3 study testing 3-Part Intervention, 4-Part Intervention and 1-part intervention in people with Otitis Media, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes Otitis Media (OM) care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT… Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- 3-Part Intervention, 4-Part Intervention and 1-part intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55,779 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Sep 2010
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All CHOP primary care pediatric and ENT practice sites are eligible for inclusion in this study. We expect 35,000 patients to receive care for otitis media by CHOP clinicians at these sites during the study period however, they are not the subjects of this research.
Who cannot join
- There are no exclusion criteria. All CHOP primary care pediatric and ENT sites are eligible for participation. Data for all clinicians providing OM care and data on all OM encounters will be included in our data set.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback
This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes Otitis Media (OM) care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians.
Read the detailed description
Context The high prevalence of Otitis Media (OM) and its enormous cost make it a prime target for cost-effective and evidence-based strategies for disease management.
Objectives
This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes OM care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians. The specific aims are:
Aim 1: To develop and pilot test the OM health IT intervention; Aim 2: To examine the overall effect of the health IT intervention and the independent contribution of physician feedback on quality of OM care (primary outcomes); Aim 3: To assess the effects of the intervention on the secondary outcomes of health care resource utilization and clinician adoption of the health IT.
Study Design/Settings/Participants A cluster randomized trial and multi-level statistical modeling will be used to estimate health IT intervention effects on study outcomes. The proposed project will be conducted in the Children's Hospital of Philadelphia's (CHOP) health care system. The heath IT intervention will be tested in the Pediatric Research Consortium (PeRC), which includes 28 primary care practices in the CHOP network, both urban and suburban, and the CHOP ENT clinical sites. Randomization and implementation of the intervention will occur at the practice level. Study outcomes of quality of care and resource utilization will be reported at the levels of the practice, individual practitioner, and episode-of-care (patient-level).
Study Measures Our main study measures include the quality of otitis media care provided during episodes of OM.
Our secondary outcomes include measurement of clinician adoption of the health IT intervention and resource use.
- Conditions
- Otitis Media
- Being tested
- 3-Part Intervention, 4-Part Intervention, 1-part intervention
- Keywords
- Electronic Health Record, Clinical Decision Support, Otitis Media
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Part InterventionOther
A combination of training, an otitis media episode grouper, and clinical decision support.
4-Part InterventionOther
A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.
1-part interventionOther
Provision of feedback on otitis media quality indicators
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care |
| HIT Intervention without feedback | Experimental | 3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support Receives: Other: 3-Part Intervention |
| HIT Intervention with feedback | Experimental | 4-Part Intervention: Training, Episode Grouper, Clinical Decision Support, and Physician Feedback. Receives: Other: 4-Part Intervention |
| Feedback only | Experimental | 1 part intervention: Physician Feedback Receives: Other: 1-part intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of otitis media care.
Measured: 18 Months
Secondary outcomes (1)
Clinician adoption of intervention and Resource Utilization
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionSep 2010
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 Otitis MediaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Christopher B Forrest, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581711
- Sponsor's protocol ID
- 2007-10-5555
- Other IDs
- 1R18HS017042-01
- Acronym
- OMHIT
- Status last verified
- Jun 2012
- First submitted
- 19 Dec 2007
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Forrest CB, Fiks AG, Bailey LC, Localio R, Grundmeier RW, Richards T, Karavite DJ, Elden L, Alessandrini EA. Improving adherence to otitis media guidelines with clinical decision support and physician feedback. Pediatrics. 2013 Apr;131(4):e1071-81. doi: 10.1542/peds.2012-1988. Epub 2013 Mar 11.
PubMed 23478860
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback
- ClinicalTrials.gov ID
- NCT00581711
- Acronym / sponsor ID
- OMHIT / 2007-10-5555
- Conditions
- Otitis Media
- Keywords
- Electronic Health Record, Clinical Decision Support, Otitis Media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55,779 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Dec 2007 (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 protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes Otitis Media (OM) care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians.
Detailed description
Context The high prevalence of Otitis Media (OM) and its enormous cost make it a prime target for cost-effective and evidence-based strategies for disease management.
Objectives
This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes OM care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians. The specific aims are:
Aim 1: To develop and pilot test the OM health IT intervention; Aim 2: To examine the overall effect of the health IT intervention and the independent contribution of physician feedback on quality of OM care (primary outcomes); Aim 3: To assess the effects of the intervention on the secondary outcomes of health care resource utilization and clinician adoption of the health IT.
Study Design/Settings/Participants A cluster randomized trial and multi-level statistical modeling will be used to estimate health IT intervention effects on study outcomes. The proposed project will be conducted in the Children's Hospital of Philadelphia's (CHOP) health care system. The heath IT intervention will be tested in the Pediatric Research Consortium (PeRC), which includes 28 primary care practices in the CHOP network, both urban and suburban, and the CHOP ENT clinical sites. Randomization and implementation of the intervention will occur at the practice level. Study outcomes of quality of care and resource utilization will be reported at the levels of the practice, individual practitioner, and episode-of-care (patient-level).
Study Measures Our main study measures include the quality of otitis media care provided during episodes of OM.
Our secondary outcomes include measurement of clinician adoption of the health IT intervention and resource use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care |
| HIT Intervention without feedback | Experimental | Other: 3-Part Intervention3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support |
| HIT Intervention with feedback | Experimental | Other: 4-Part Intervention4-Part Intervention: Training, Episode Grouper, Clinical Decision Support, and Physician Feedback. |
| Feedback only | Experimental | Other: 1-part intervention1 part intervention: Physician Feedback |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All CHOP primary care pediatric and ENT practice sites are eligible for inclusion in this study. We expect 35,000 patients to receive care for otitis media by CHOP clinicians at these sites during the study period however, they are not the subjects of this research.
Key exclusion criteria (1 listed)
- There are no exclusion criteria. All CHOP primary care pediatric and ENT sites are eligible for participation. Data for all clinicians providing OM care and data on all OM encounters will be included in our data set.
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 |
|---|---|---|
| 3-Part InterventionA combination of training, an otitis media episode grouper, and clinical decision support. | Other | HIT Intervention without feedback |
| 4-Part InterventionA combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback. | Other | HIT Intervention with feedback |
| 1-part interventionProvision of feedback on otitis media quality indicators | Other | Feedback only |
Primary outcome
Quality of otitis media care.
Time frame: 18 Months
1 secondary outcome
Clinician adoption of intervention and Resource Utilization
Time frame: 18 months
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 Jun 2012.
- Derived from this study: PubMed 23478860Forrest CB, Fiks AG, Bailey LC, Localio R, Grundmeier RW, Richards T, Karavite DJ, Elden L, Alessandrini EA. Improving adherence to otitis media guidelines with clinical decision support and physician feedback. Pediatrics. 2013 Apr;131(4):e1071-81. doi: 10.1542/peds.2012-1988. Epub 2013 Mar 11.
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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.
Christopher B Forrest, MD, PhD principal investigator
Children's Hospital of Philadelphia
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 3-Part Intervention, 4-Part Intervention and 1-part intervention in people with Otitis Media, run by Children's Hospital of Philadelphia 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 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 Jun 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 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?
Quality of otitis media care. (time frame: 18 Months). 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 NCT00581711, 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 Jun 2012.