- Who is conducting this study?
The study is being conducted by researchers at the University of Washington in Seattle, WA, under contract with the Agency for Healthcare Research and Quality (AHRQ). The principal investigators are James W. Stout, a Professor of Pediatrics at the University of Washington and leader of QI Partners, and Rita Mangione-Smith, a pediatrician and Associate Professor at the University of Washington.
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- Who is eligible to participate?
We are looking for pediatric practices in New York State that have a high interest in improving asthma care quality thru the use of office spirometry and written asthma action plans. We can enroll any doctor (MD), nurse (RN), and/or medical assistant (MA) from you office who wants to participate, but we need a minimum of one MD – RN/MA pair to enroll. Interested pairs should contact the project's research coordinator at the University of Washington, Alison Long at (206) 616-3917.
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- What's involved in the enrollment process?
If you decide to enroll, you will be contacted by Ms. Peterson at a time of your choice. She will answer any questions you have and ask you for information about your practice and computer equipment that will help us determine your eligibility. Practice members who are interested in the study will be able to download and print a Consent Form from our website and fax it to the research office to complete enrollment. Your participation is completely voluntary.
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- What happens after I enroll?
After we receive your faxed consent form, we will be sending you a new ndd EasyOne spirometer that you will keep after the study is completed. You will receive standard training as well as ongoing technical support from ndd when your new spirometer is delivered at no cost to your practice. Any spirometry tests you do during the study will be at your discretion as clinically indicated.
We will also be sending you a software program called EasyData. EasyData allows you to transmit spirometry curves from your EasyOne spirometer via the internet to a secure central data warehouse for the study. EasyData only uploads spirometry curve data, so any information that identifies who your patients are (names, ages, medical record #s, etc.) will not be transmitted to us. We will provide you with directions and any technical support you need to install the software and send us data. Throughout the 15 months of the study we will ask you to transmit spirometry curves to us on a weekly basis using EasyData.
In October 2007, we will invite you to attend an optional introductory meeting in Albany, NY. Attendance at this meeting is not mandatory for study participation although we will encourage all participants to attend. At this meeting, you will have the opportunity to meet project faculty and research staff and have your questions addressed. Following this meeting, we would ask you to agree to being randomly assigned to either the intervention or control group for the study. The research team will use a computer program to randomly assign each pair to either the control or intervention group.
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- I'm in the intervention group, what do I have to do?
As a member of the intervention group we will ask you to send us your spirometry curve data once per week for all 15 months of the study. In month 5, you will be asked to begin participating in the distance learning asthma quality improvement program. This will include: viewing the Spirometry Fundamentals™ CD-ROM at a time that is convenient for you and attending a series of 5 WebEx conference call learning sessions. Each learning session call will last about 1-2 hours depending on the asthma topic covered. The first 3 calls will occur during months 5 and 6 of the study with approximately 1 call taking place every 2 weeks. The last 2 calls will occur during month 9 of the study and will also take place at 2 week intervals. We know you are busy practitioners and we will work with all enrolled practices to schedule these learning session conference calls at the most convenient times possible.
As part of the program, we will send you monthly feedback reports regarding your practice's spirometry curve quality via a secure internet reporting system. You will also have access to research team experts for short (15 minute), scheduled "office hours" calls to help trouble-shoot around particular issues you are having related to performing and interpreting spirometry tests. These calls are optional.
During the last month of the study, we will ask you to randomly select a sample of 35 medical records of children aged 5 to 18 years who had at least one visit for asthma during the prior 20 months. You will be asked to de-identify and photocopy these records and then send them to us for abstraction. We will supply you with pre-paid Fed-Ex boxes to mail us the chart copies.
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- I'm in the control group, what do I have to do?
As a member of the control group we will also ask you to send us your spirometry curve data once per week for all 15 months of the study. In month 10, you will be asked to begin participating in the distance learning asthma quality improvement program. This will include: viewing the Spirometry Fundamentals™ CD-ROM at a time that is convenient for you and attending a series of 5 WebEx conference call learning sessions. Each learning session call will last about 1-2 hours depending on the asthma topic covered. The first 3 calls will occur during months 9 and 10 of the study with approximately 1 call taking place every 2 weeks. The last 2 calls will occur during month 15 of the study and will also take place at 2 week intervals.
As part of the program, we will send you monthly feedback reports regarding your practice's spirometry curve quality via a secure internet reporting system. You will also have access to research team experts for short (15 minute), scheduled "office hours" calls to help trouble-shoot around particular issues you are having related to performing and interpreting spirometry tests. These calls are optional.
During the last month of the study, we will ask you to randomly select a sample of 35 medical records of children aged 5 to 18 years who had at least one visit for asthma during the prior 20 months. You will be asked to de-identify and photocopy these records and then send them to us for abstraction. We will supply you with pre-paid Fed-Ex boxes to mail us the chart copies.
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- Will I need to obtain local IRB approval?
You will not need separate additional local IRB approval to participate since all patient information you provide to us will be anonymous. We will however request that you conduct a HIPAA privacy review of our protocol for removing identifying information from medical records before sending them to us. A brief letter stating you have reviewed the protocol and have determined it is consistent with your local HIPAA privacy policies will be sufficient.
We will also request that you review and sign a Data Use Agreement that we will provide. Once you send us your HIPAA approval letter and signed Data Use Agreement, we will forward copies of them to the University of Washington IRB to keep on file.
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- What do I get out of participating?
Each participating practice will receive $300 to compensate them for time spent pulling, de-identifying, and copying 35 medical records for the research team.
Each participating practice will also receive an EasyOne Diagnostic spirometer, EasyData software, and multiple copies of the Spirometry Fundamentals CD-ROM training course for free.
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- How long will the study last?
We will ask you to transmit spirometry data weekly for a total of 15 months after you receive your spirometer. Your participation will end after 15 months of transmitting data to us.
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- How much time is involved if I decide to participate?
Delivery and set up of your spirometer will include an in service training session from ndd that will last 1 hour. Loading the software and setting up your computer to transmit data will take between 1-3 hours. Uploading the spirometry curve data from the EasyOne spirometer can be done at the end of each week and should take less than 10 minutes.
The introductory meeting in October 2007, in Albany New York will last for one day.
Watching the CD should take no more than 2-3 hours and each of the 5 WebEx sessions will last 1-2 hours.
The distance learning quality improvement program is designed to take no more than 10 hours of your time over a 5 month period. As described above, the learning sessions will occur at different time points along the 15 month timeline depending on whether you are in the intervention or control group.
Selection, de-identification, and copying of the 35 medical records will take between 5 -10 hours.
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- What are the benefits of taking part in this study?
We believe you will benefit from taking part in this distance learning quality improvement program and that the quality of care you provide to your asthma patients will be enhanced.
From a global point of view, if shown to be effective, widespread dissemination and use of this program by primary care providers and their staff will likely produce higher-quality of care for asthmatic children on a societal level. By implementing office-based spirometry into the care of asthmatic patients, providers will improve their ability to accurately diagnose asthma, resulting in faster, more effective treatment for these children.
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- Whom should I contact with questions?
Alison Long, the Study Coordinator, can be contacted by phone at (206) 616-3917 or by email at
alison2@u.washington.edu.
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