AsthmaNCT00699439
A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department
A study testing Paper-based asthma flow diagram in people with Asthma and Medical Informatics, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The primary idea is that the use of a computerized reminder system to help with the guideline implementation will increase utilization and adherence of guideline-driven care, leading to improved patient outcomes. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Medical Informatics
- What is being tested?
- Paper-based asthma flow diagram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,102 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2015
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The study's inclusion criteria are:
- All patients aged 2-18 years;
- Emergency Severity Index 2 to 5; AND
- Availability of completed computerized triage documentation.
Who cannot join
- The exclusion criteria are:
- Critically ill patients (Emergency Severity Index 1)
- Patients who leave-without-being seen
- Patients who leave against-medical-advice
- Patients whose final diagnosis was not asthma (false positive identification by the detection system) or were determined not to be eligible for the guideline.
Trial locations and contacts
1 site in 1 country.
About this study
The primary idea is that the use of a computerized reminder system to help with the guideline implementation will increase utilization and adherence of guideline-driven care, leading to improved patient outcomes. The hypothesis we aim to address is that an automatic, computerized reminder system for detecting asthma patients in the pediatric ED will increase paper-based guideline utilization compared to paper-based guideline without the system.
We aim to implement a real-time, computerized asthma detection system and integrate the system with the pediatric emergency department information system, and evaluate the effect of the asthma detection system on reminding clinicians to use the paper-based asthma guideline.
Read the detailed description
Asthma is the leading chronic childhood disease affecting 9 million children (12.5%) under 18 years of age (1). Asthma exacerbations cause an estimated 14 million missed school days (2) and more than 1.8 million emergency department (ED) visits annually (2), and account for >60% of asthma-related costs (3). The chronic characteristic of asthma carries a considerable economic burden.
Uncontrolled asthma can lead to exacerbations requiring the patient to seek immediate care, frequently in an ED setting. Several asthma guidelines, including the nationally accepted guideline from the National Heart, Lung, and Blood Institute (NHLBI), exist to support clinicians in providing adequate treatment. Utilization of and adherence with asthma guidelines improves patients' clinical care (4, 5). However, guideline adherence remains suboptimal. In the ED, early recognition and accurate assessment of the severity of airway obstruction and response to therapy are fundamental to the improvement of health for patients with asthma. The NHLBI guidelines emphasize early recognition and treatment of asthma exacerbations, as well as appropriate treatment stratified by severity.
Computer applications for patient care can address barriers to optimal medical care. Computer systems have improved the use and adherence to practice guidelines, provide clinical alerts and reminders, and generate patient-specific treatment recommendations and educational material. Implementation of guideline-driven decision support is frequently paper-based or computerized. In either form a major barrier remains on the busy clinicians to remember to initiate the guideline a process and to embed the guideline tasks in the clinical workflow of the care team (5). The proposed study examines the benefits of a novel approach for reminding clinicians in an ED setting to use guideline-driven care. The approach will apply a workflow-embedded process taking advantage of an advanced information technology infrastructure. The informatics approach will include two elements: a) a computerized, real-time reminder system, which will automatically detect guideline-eligible patients without requiring additional data entry, and b) a computerized, workflow-embedded guideline implementation.
References
- Ref: QuickStats: Percentage of Children Aged <18 years Who Have Ever Had Asthma Diagnosed, by Age Group --- United States, 2003; MMWR April 29, 2005 / 54(16);412. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5416a5.htm
- Allergy \& Asthma Advocate. Quarterly patient newsletter of the American Academy of Allergy, Asthma and immunology. 2004.
- Grimshaw JM, Eccles MP, Walker AE, Thomas RE. Changing physicians' behavior: what works and thoughts on getting more things to work. J Contin Educ Health Prof. 2002;22:237-243.
- National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program. Expert Panel Report 2: Guidelines for the diagnosis and management of asthma. 1997.
- Scribano PV, Lerer T, Kennedy D, Cloutier MM. Provider adherence to a clinical practice guideline for acute asthma in a pediatric emergency department. Acad Emerg Med. 2001;8:1147-1152.
- Conditions
- Asthma, Medical Informatics
- Being tested
- Paper-based asthma flow diagram
- Keywords
- Medical Informatics, Asthma, Emergency Service, Hospital, Bayesian Method
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper-based asthma flow diagramOther
If a patient is identified as having an asthma exacerbation by the Bayesian Network, the patients will be randomized to either arm A or B. If in A, the paper-based flow-chart will be printed out to place on the chart.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | If a patient is identified as having an asthma exacerbation by the Bayesian Network, the paper-based flow-chart will be printed out to place on the chart. Receives: Other: Paper-based asthma flow diagram |
| B | No intervention | If a patient is identified as having an asthma exacerbation by the Bayesian Network, and assigned to the control group, no flow-chart will be printed out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline utilization. Guideline utilization will be defined as having used the guideline for the documentation of at least one assessment (asthma score).
Measured: Within 1 week after visit
Guideline Adherence. The measurement of guideline adherence includes three measures: a) asthma assessment (score); b) treatment compatible with assessment (or documentation of reason to deviate); and c) adherence to guideline schedule.
Measured: Within 1 week after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJul 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith W Dexheimer, MS, Principal investigator, Vanderbilt UniversityDominik Aronsky, MD, PhD, Principal investigator, Vanderbilt UniversityDonald H Arnold, MD, MPH, Study chair, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699439
- Sponsor's protocol ID
- 070206
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2008
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dexheimer JW, Brown LE, Leegon J, Aronsky D. Comparing decision support methodologies for identifying asthma exacerbations. Stud Health Technol Inform. 2007;129(Pt 2):880-4.
PubMed 17911842Sanders DL, Aronsky D. Prospective evaluation of a Bayesian Network for detecting asthma exacerbations in a Pediatric Emergency Department. AMIA Annu Symp Proc. 2006;2006:1085.
PubMed 17238704Sanders DL, Aronsky D. Detecting asthma exacerbations in a pediatric emergency department using a Bayesian network. AMIA Annu Symp Proc. 2006;2006:684-8.
PubMed 17238428Sanders DL, Gregg W, Aronsky D. Identifying asthma exacerbations in a pediatric emergency department: a feasibility study. Int J Med Inform. 2007 Jul;76(7):557-64. doi: 10.1016/j.ijmedinf.2006.03.003. Epub 2006 May 2.
PubMed 16647876
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00699439
- Acronym / sponsor ID
- 070206
- Conditions
- Asthma, Medical Informatics
- Keywords
- Medical Informatics, Asthma, Emergency Service, Hospital, Bayesian Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Jun 2008 (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 primary idea is that the use of a computerized reminder system to help with the guideline implementation will increase utilization and adherence of guideline-driven care, leading to improved patient outcomes. The hypothesis we aim to address is that an automatic, computerized reminder system for detecting asthma patients in the pediatric ED will increase paper-based guideline utilization compared to paper-based guideline without the system.
We aim to implement a real-time, computerized asthma detection system and integrate the system with the pediatric emergency department information system, and evaluate the effect of the asthma detection system on reminding clinicians to use the paper-based asthma guideline.
Detailed description
Asthma is the leading chronic childhood disease affecting 9 million children (12.5%) under 18 years of age (1). Asthma exacerbations cause an estimated 14 million missed school days (2) and more than 1.8 million emergency department (ED) visits annually (2), and account for >60% of asthma-related costs (3). The chronic characteristic of asthma carries a considerable economic burden.
Uncontrolled asthma can lead to exacerbations requiring the patient to seek immediate care, frequently in an ED setting. Several asthma guidelines, including the nationally accepted guideline from the National Heart, Lung, and Blood Institute (NHLBI), exist to support clinicians in providing adequate treatment. Utilization of and adherence with asthma guidelines improves patients' clinical care (4, 5). However, guideline adherence remains suboptimal. In the ED, early recognition and accurate assessment of the severity of airway obstruction and response to therapy are fundamental to the improvement of health for patients with asthma. The NHLBI guidelines emphasize early recognition and treatment of asthma exacerbations, as well as appropriate treatment stratified by severity.
Computer applications for patient care can address barriers to optimal medical care. Computer systems have improved the use and adherence to practice guidelines, provide clinical alerts and reminders, and generate patient-specific treatment recommendations and educational material. Implementation of guideline-driven decision support is frequently paper-based or computerized. In either form a major barrier remains on the busy clinicians to remember to initiate the guideline a process and to embed the guideline tasks in the clinical workflow of the care team (5). The proposed study examines the benefits of a novel approach for reminding clinicians in an ED setting to use guideline-driven care. The approach will apply a workflow-embedded process taking advantage of an advanced information technology infrastructure. The informatics approach will include two elements: a) a computerized, real-time reminder system, which will automatically detect guideline-eligible patients without requiring additional data entry, and b) a computerized, workflow-embedded guideline implementation.
References
- Ref: QuickStats: Percentage of Children Aged <18 years Who Have Ever Had Asthma Diagnosed, by Age Group --- United States, 2003; MMWR April 29, 2005 / 54(16);412. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5416a5.htm
- Allergy \& Asthma Advocate. Quarterly patient newsletter of the American Academy of Allergy, Asthma and immunology. 2004.
- Grimshaw JM, Eccles MP, Walker AE, Thomas RE. Changing physicians' behavior: what works and thoughts on getting more things to work. J Contin Educ Health Prof. 2002;22:237-243.
- National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program. Expert Panel Report 2: Guidelines for the diagnosis and management of asthma. 1997.
- Scribano PV, Lerer T, Kennedy D, Cloutier MM. Provider adherence to a clinical practice guideline for acute asthma in a pediatric emergency department. Acad Emerg Med. 2001;8:1147-1152.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Paper-based asthma flow diagramIf a patient is identified as having an asthma exacerbation by the Bayesian Network, the paper-based flow-chart will be printed out to place on the chart. |
| B | No intervention | –If a patient is identified as having an asthma exacerbation by the Bayesian Network, and assigned to the control group, no flow-chart will be printed out. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All patients aged 2-18 years;
- Emergency Severity Index 2 to 5; AND
- Availability of completed computerized triage documentation.
Key exclusion criteria (5 listed)
- Critically ill patients (Emergency Severity Index 1)
- Patients who leave-without-being seen
- Patients who leave against-medical-advice
- Patients whose final diagnosis was not asthma (false positive identification by the detection system) or were determined not to be eligible for the guideline.
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 |
|---|---|---|
| Paper-based asthma flow diagramIf a patient is identified as having an asthma exacerbation by the Bayesian Network, the patients will be randomized to either arm A or B. If in A, the paper-based flow-chart will be printed out to place on the chart. | Other | A |
Primary outcome
Guideline utilization. Guideline utilization will be defined as having used the guideline for the documentation of at least one assessment (asthma score).
Time frame: Within 1 week after visit
Guideline Adherence. The measurement of guideline adherence includes three measures: a) asthma assessment (score); b) treatment compatible with assessment (or documentation of reason to deviate); and c) adherence to guideline schedule.
Time frame: Within 1 week after visit
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 17 Aug 2018.
- Background: PubMed 17911842Dexheimer JW, Brown LE, Leegon J, Aronsky D. Comparing decision support methodologies for identifying asthma exacerbations. Stud Health Technol Inform. 2007;129(Pt 2):880-4.
- Background: PubMed 17238704Sanders DL, Aronsky D. Prospective evaluation of a Bayesian Network for detecting asthma exacerbations in a Pediatric Emergency Department. AMIA Annu Symp Proc. 2006;2006:1085.
- Background: PubMed 17238428Sanders DL, Aronsky D. Detecting asthma exacerbations in a pediatric emergency department using a Bayesian network. AMIA Annu Symp Proc. 2006;2006:684-8.
- Background: PubMed 16647876Sanders DL, Gregg W, Aronsky D. Identifying asthma exacerbations in a pediatric emergency department: a feasibility study. Int J Med Inform. 2007 Jul;76(7):557-64. doi: 10.1016/j.ijmedinf.2006.03.003. Epub 2006 May 2.
Related trials for Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
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.
Judith W Dexheimer, MS principal investigator
Vanderbilt University
Dominik Aronsky, MD, PhD principal investigator
Vanderbilt University
Donald H Arnold, MD, MPH study chair
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper-based asthma flow diagram in people with Asthma and Medical Informatics, run by Vanderbilt University Medical Center 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 4 inclusion and 5 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 17 Aug 2018. 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?
Guideline utilization. Guideline utilization will be defined as having used the guideline for the documentation of at least one assessment (asthma score). (time frame: Within 1 week after visit). The study lists 2 primary outcomes in all. 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 NCT00699439, which also lists 4 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 17 Aug 2018.