AsthmaNCT01522144
An Electronic Decision Support Tool to Improve Outpatient Asthma Care
A study testing Computerized Decision support in people with Asthma, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
The Children's Hospital of Philadelphia's ambulatory network uses an electronic health record (EHR) to document clinical information. Using the EHR, a clinical decision support tool will be designed to help the primary care physician's in caring for children with asthma. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Computerized Decision support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Aug 2008
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with the diagnosis of asthma
- Children enrolled in one of 10 selected primary care practices in the PeRC practice-based research network
Who cannot join
None listed.
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: EHR Decision Support to Improve Outpatient Asthma Care
The Children's Hospital of Philadelphia's ambulatory network uses an electronic health record (EHR) to document clinical information. Using the EHR, a clinical decision support tool will be designed to help the primary care physician's in caring for children with asthma. The goal will be to improve the primary care physician's use of the national Institutes of Health guidelines for the best care for asthma. To study this EHR decision support tool, it will be introduced into 5 practices while 5 other practices will have the existing asthma care information. It will be determined whether the physicians in the practices with the decision support tool are better at following the asthma guidelines. If the decision support tool works...then it will be offered to others to use with their EHR systems.
Read the detailed description
National Asthma Education and Prevention Program guidelines (NAEPP) exist, but are under used in Primary Care. In addition, implementation of the guidelines has been shown to be vary according to the location of practice and other contextual factors.
The Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC), a practice-based research network will determine whether an innovative clinical decision support system embedded in an existing electronic health record (EHR) will improve provider adherence to the existing NAEPP guidelines.
After receiving a standardized education module based on NAEPP guidelines, 10 primary care pediatric practices (both urban and suburban) will be randomized to receive either a passive EHR (control sites) or an interactive decision support sytem (intervention sites).
The primary outcome of interest will be the proportion of patient son appropriate asthma controller medication compared over time. Secondary outcomes include the proportion of asthma patients with: 1) an updated asthma action plan 2) documentation of spirometry performed (6 to 17years) and 3) an updated problem list reflecting current asthma severity. After hours calls to providers and types of office visits related to to asthma will be tracked. Contextual factors at the clinic and patient level will be examined to assess their association with the outcomes of interest. In addition, measurement of asthma-related quality of life and missed school and work in a sample of 200 subjects from each group will be performed
If shown to be successful, this type of clinical decision support, embedded within the EHR, has the potential to be a powerful tool to improve the implementation of asthma guidelines and clinical practice guidelines for other conditions and illnesses.
- Conditions
- Asthma
- Being tested
- Computerized Decision support
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Decision supportBehavioural
Also called electronic health record
Using a clustered randomized method, computerized decision support, embedded in the electronic health record, was offered to selected primary care practices and outcomes of asthma care were compared to those practices without the computerized decision support.
| Study group | Role | What they receive |
|---|---|---|
| Asthma clinical decision support | Experimental | decision support compared to no decision support in a cluster-randomized trial by practise Receives: Behavioral: Computerized Decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients on appropriate asthma controller medication at the end of the trial
each patient who is classified as having persistant asthma should be on at least one appropriate controller medication for asthma.
Measured: assessed at each visit
Secondary outcomes (3)
1) an updated asthma action plan
Each patient should have an asthma care plan updated once per year
Measured: updated at least once per year
2)documentation of spirometry(6 to 18 yrs)in those with asthma
Each patient should have had spirometry at least once per year.
Measured: spirometry should be done once per year
3) an updated problem list that reflects an assessment of asthma severity
each patient should have their asthma severity classification on the thier chart
Measured: tthe asthma severity should be on the problem list
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, lbell, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Louis M Bell, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522144
- Sponsor's protocol ID
- R21HS014873
- Status last verified
- Jan 2012
- First submitted
- 19 Jan 2012
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Asthma mortality and hospitalization among children and young adults--United States, 1980-1993. From the Centers for Disease Control and Prevention. JAMA. 1996 May 22-29;275(20):1535-7. No abstract available.
PubMed 8622235Lieu TA, Quesenberry CP Jr, Capra AM, Sorel ME, Martin KE, Mendoza GR. Outpatient management practices associated with reduced risk of pediatric asthma hospitalization and emergency department visits. Pediatrics. 1997 Sep;100(3 Pt 1):334-41. doi: 10.1542/peds.100.3.334.
PubMed 9282702Landry P, Tremblay S, Darioli R, Genton B. Inactivated hepatitis A vaccine booster given >/=24 months after the primary dose. Vaccine. 2000 Oct 15;19(4-5):399-402. doi: 10.1016/s0264-410x(00)00188-2.
PubMed 11027799
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHR Decision Support to Improve Outpatient Asthma Care
- ClinicalTrials.gov ID
- NCT01522144
- Acronym / sponsor ID
- R21HS014873
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 31 Jan 2012 (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 Children's Hospital of Philadelphia's ambulatory network uses an electronic health record (EHR) to document clinical information. Using the EHR, a clinical decision support tool will be designed to help the primary care physician's in caring for children with asthma. The goal will be to improve the primary care physician's use of the national Institutes of Health guidelines for the best care for asthma. To study this EHR decision support tool, it will be introduced into 5 practices while 5 other practices will have the existing asthma care information. It will be determined whether the physicians in the practices with the decision support tool are better at following the asthma guidelines. If the decision support tool works...then it will be offered to others to use with their EHR systems.
Detailed description
National Asthma Education and Prevention Program guidelines (NAEPP) exist, but are under used in Primary Care. In addition, implementation of the guidelines has been shown to be vary according to the location of practice and other contextual factors.
The Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC), a practice-based research network will determine whether an innovative clinical decision support system embedded in an existing electronic health record (EHR) will improve provider adherence to the existing NAEPP guidelines.
After receiving a standardized education module based on NAEPP guidelines, 10 primary care pediatric practices (both urban and suburban) will be randomized to receive either a passive EHR (control sites) or an interactive decision support sytem (intervention sites).
The primary outcome of interest will be the proportion of patient son appropriate asthma controller medication compared over time. Secondary outcomes include the proportion of asthma patients with: 1) an updated asthma action plan 2) documentation of spirometry performed (6 to 17years) and 3) an updated problem list reflecting current asthma severity. After hours calls to providers and types of office visits related to to asthma will be tracked. Contextual factors at the clinic and patient level will be examined to assess their association with the outcomes of interest. In addition, measurement of asthma-related quality of life and missed school and work in a sample of 200 subjects from each group will be performed
If shown to be successful, this type of clinical decision support, embedded within the EHR, has the potential to be a powerful tool to improve the implementation of asthma guidelines and clinical practice guidelines for other conditions and illnesses.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma clinical decision support | Experimental | Behavioral: Computerized Decision supportdecision support compared to no decision support in a cluster-randomized trial by practise |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with the diagnosis of asthma
- Children enrolled in one of 10 selected primary care practices in the PeRC practice-based research network
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 |
|---|---|---|
| Computerized Decision supportAlso: electronic health recordUsing a clustered randomized method, computerized decision support, embedded in the electronic health record, was offered to selected primary care practices and outcomes of asthma care were compared to those practices without the computerized decision support. | Behavioural | Asthma clinical decision support |
Primary outcome
The proportion of patients on appropriate asthma controller medication at the end of the trial
Time frame: assessed at each visit
each patient who is classified as having persistant asthma should be on at least one appropriate controller medication for asthma.
3 secondary outcomes
1) an updated asthma action plan
Time frame: updated at least once per year
2)documentation of spirometry(6 to 18 yrs)in those with asthma
Time frame: spirometry should be done once per year
3) an updated problem list that reflects an assessment of asthma severity
Time frame: tthe asthma severity should be on the problem list
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 31 Jan 2012.
- Background: PubMed 8622235Asthma mortality and hospitalization among children and young adults--United States, 1980-1993. From the Centers for Disease Control and Prevention. JAMA. 1996 May 22-29;275(20):1535-7. No abstract available.
- Background: PubMed 9282702Lieu TA, Quesenberry CP Jr, Capra AM, Sorel ME, Martin KE, Mendoza GR. Outpatient management practices associated with reduced risk of pediatric asthma hospitalization and emergency department visits. Pediatrics. 1997 Sep;100(3 Pt 1):334-41. doi: 10.1542/peds.100.3.334.
- Background: PubMed 11027799Landry P, Tremblay S, Darioli R, Genton B. Inactivated hepatitis A vaccine booster given >/=24 months after the primary dose. Vaccine. 2000 Oct 15;19(4-5):399-402. doi: 10.1016/s0264-410x(00)00188-2.
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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.
Louis M Bell, MD 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 study testing Computerized Decision support in people with Asthma, run by Agency for Healthcare Research and Quality (AHRQ) 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 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 31 Jan 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.
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 proportion of patients on appropriate asthma controller medication at the end of the trial (time frame: assessed at each visit). 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 NCT01522144, which also lists 3 linked publications.
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 31 Jan 2012.