TRIAL INFORMATION SHEET
ACRIN PA 4007
Pennsylvania Quality Initiative for CT Radiation Dose Reduction (QI_CTDR)
<To be provided to all certified CT technologists conducting
CT studies and radiologists prescribing or reading CT scans at participating institutions.>
[Note: The American College of Radiology Imaging Network (ACRIN) complies with the privacy measures put forth by the Health Insurance Portability and Accountability Act (HIPAA).
However, ACRIN does not monitor compliance with HIPAA; that is the responsibility of
the local institutions and their Institutional Review Boards (IRBs).]
The ACRIN PA 4007 Pennsylvania Quality Initiative for CT Radiation Dose Reduction (QI_CTDR) clinical trial is a quality initiative funded by the Pennsylvania Department of Health. The goal of the trial is to reduce the radiation doses of computed tomography (CT) imaging techniques commonly used in Pennsylvania. Researchers will test a series of reports and other interventions to assist participating sites in reducing patient risk by educating their technologists and radiologists concerning current practices and techniques for reducing CT radiation doses. This information will aid in development of tools that can be applied state-wide or nationally to improve practices in CT radiation exposure.
Your participation in this quality improvement (QI) project is part of your employment at your institution, and subject to your institutional policies concerning participation in quality improvement/assurance projects. For this study, de-identified radiation dose data from the CT scanners used at yours and other facilities will be collected and analyzed. The QI_CTDR investigators will provide you with feedback on the radiation dose information collected from your site. Participating sites will be randomized to one of four interventions aimed at informing the technologists and radiologists at the institution about radiation dose reduction techniques and their application to CT protocols.
The research team is going to talk with you about the study and give you this informational document to read. Keep this form; in it you will find contact information and answers to questions about the study. You may ask to have this form read to you.
What is the purpose of the study?
There are two purposes of this study:
1. To evaluate the distribution of CT radiation doses across a wide variety of practices throughout Pennsylvania and analyze socioeconomic, geographic, technical, and other factors leading to variability.
2. To evaluate the effects of four approaches to educate technologists and radiologists concerning radiation dose reduction methods for CT. A tested, and future validated, method of informing sites of their trends in radiation exposure with CT will help to encourage best practices and offer tools in quality initiatives in Pennsylvania and across the United States.
The software being used in this study is called eXposure from Radimetrics, Inc., and it will collect and transmit de-identified technical and CT radiation dose data from your institution’s systems. This process should be seamless and you will not need to interrupt your routine workflow to complete forms or other trial-related procedures. The developer of the software being used in the study is hoping to show the value of their system in providing radiation dose data to institutions to promote quality improvement and protect patients by encouraging the lowest radiation doses possible for the best quality images.
What am I being asked to do for the project?
You are being asked to participate in this project because you are a CT technologist or a radiologist who reads CT images. Your site is affiliated with a large healthcare system in Pennsylvania. The leadership of your institution has agreed to participate in this quality improvement project and trial in hopes of identifying areas where radiation exposure can be reduced when imaging patients. All radiologists and technologists employed at your institution will participate.
You are being asked to participate in educational sessions and apply the knowledge provided to you during the intervention period of the trial to your daily work in CT imaging in an attempt to reduce the average dose of radiation to your patients based on manufacturer and other information on radiation dose-reduction techniques. If you are a radiologist, you will receive reports with analysis of doses at your institution compared to the other participating sites and ACR standards.
How long will I be in the study? What will happen during the study?
The study will take place over a period of 24 months, broken into three blocks of time for either data collection or intervention at the site.
First six months. The first six months will be a data collection period where CT-related technical and dosing data will be collected directly through your PACS or other systems. These data will be used to analyze the radiation doses given during CT at your site and provide a report to your department of the radiation doses at your site compared to the other participating sites as well as ACR recommended radiation doses. All radiologists will participate in dose reduction education at their site at the end of the 6 month baseline period.
Second six months. The second six-month period will be the intervention period. Each independent group of technologists will be randomized to one of two educational interventions, either web-based instruction in radiation dose reduction techniques available for your scanners or on-site education with review of cases and protocols. Each independent group of radiologists will also be randomized to receive a report analyzing radiation doses at your site either monthly or every 6 months.
Follow-up 12 months. The 12-month period will be similar to the initial six-month period where radiation dose data is collected and will then be analyzed to see if and how the interventions worked over time. Your site will receive dose reporting every 6 months during this period.
In addition, if you are a technologist supervisor or radiologist who is responsible for creating scan protocols, you will be asked to keep a record of any hardware or software changes that occur at your site during all three time periods.
What are the risks?
There are no known risks of participating in this type of study. You may find participating in this study, viewing web-based educational content, attending meetings associated with the randomized intervention, applying the interventions and keeping a record of hardware/software/protocol changes for the study to be additional work added to your clinical CT responsibilities. The information collected for the study will be de-identified when ACRIN collects it and for all trial-related purposes. At the close of the study, data will be provided to your institution that may allow for individualized analyses of the data collected.
How will I benefit from the study?
There may be no direct benefit to you. However, you may benefit from increased knowledge about CT radiation dose reduction techniques and your participation could help reduce the potential adverse side effects, including cancer in your patients stemming from CT radiation exposure. In the future, the knowledge learned during this study could help other institutions reduce the radiation doses associated with common CT scans by using tested and validated tools designed during this trial.
What happens if I do not choose to join the study?
As this is a quality improvement project in which your department/group has agreed to participate, the decision to participate or not is between you and your employer and is governed by their rules concerning participation in quality improvement/assurance projects. The agreement for the trial is that data will be collected for all technologists and radiologists at the participating healthcare system, and we hope that you will participate fully in this important project.
How will my privacy be protected?
We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.
How will confidentiality be maintained?
The eXposure software will replace your name and your patient’s name associated with any CT images with a unique study number before it is sent to ACRIN to protect people’s identities. The study investigators will not know your identity and will not provide specific analyses by technologist or radiologist to your employer. However, the dose data acquired from your site will remain with identifiers on the Radimetrics workstation at your site; if your site chooses to continue to use the eXposure software after the end of the trial, they would be able to analyze doses by technologist or radiologist at that time.
Who will be allowed to see de-identified data?
The principal investigator<site PI name> , and members of the IRB at the <institution name> will have access to the records. De-identified data may be reviewed by ACRIN monitors and auditors during quality assurance procedures. De-identified information may be provided as required by law.
Who can I call with questions, complaints, or if I’m concerned about my rights as a research subject?
If you have questions, concerns, or complaints regarding your participation in this research study, or if you have any questions about your rights as a research subject, you should speak with the Principal Investigator listed on page one of this form. If a member of the research team cannot be reached or you want to talk to someone other than those working on the study, you may contact ACRIN’s Department of Protocol Development and Regulatory Compliance or the Regulatory Office at <institution name> by calling <contact phone number>.
December 17, 2012