Information Sheet
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Our institution is committed to improving the care of our patients through implementation of best care
practices.
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This clinic is participating in a National Institute of Health (NIH) sponsored research study being
conducted by University of Texas Southwestern and Parkland Center for Clinical Innovation investigators
called, “Improving Chronic Disease with Pieces” (ICD-Pieces) Trial.
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The purpose of this study is to learn how to assist physicians to provide the best care for patients with a
combination of chronic kidney disease, diabetes and hypertension. This clinic is participating in the trial
along with other clinics/practice sites in four large health care systems.
Patients eligible for the study will be identified through the electronic health record (EHR) of each
institution and information for recommended care will be provided to their physicians. If you are one of
the candidate patients, your doctor will consider the appropriateness of the recommended care, taking
into account your individual health characteristics. If your doctor feels any of the recommended care is
not appropriate for you, he/she will not prescribe it to you. As always, you should talk to your doctor
about treatment options.
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As part of this study, investigators will review your data collected in your institution’s EHR to monitor
and assess your progress towards treatment goals. There will be no additional information collected or
extra test done as a result of the ICD-Pieces trial. Even if you were not offered the recommended care
by your doctor, your information will still be important for this research. To protect your confidentiality,
all personal information will be accessed in a safe and secure manner by only members of the study
team who need to know. At the end of the study, all data will be de-identified before analysis i.e. we will
destroy all patient identifiers. Your confidential information (such as name, address, or date of birth)
will not be distributed.
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Thank you for reading this information about the ICD-Pieces trial. On the other side of this paper are
answers to frequently asked question that might be helpful to you. If you would like more information
about the ICD-Pieces trial or if you do not want your data reported to the study team, please call this
number and a member of the study team will get back to you answer your questions: 214-590-3073.
What is a clinical trial?
A clinical trial is a research study in which treatments are evaluated to determine what is best for patients. In
order to best compare treatments, clinical trials often involve assignment of patients or treatment centers to a
specific treatment approach. Clinical trials help doctors answer a variety of questions about diseases and their
treatments.
Why is this clinical trial being conducted?
This trial is being done to determine whether assisting physicians to provide the best care for patients with a
combination of chronic kidney disease, diabetes and hypertension will improve hospitalization within twelve
months.
Why am I being included in this clinical trial?
You are being included in this trial because your institution chose to participate has agreed to participate and
you may be a candidate for this trial. Like all other candidate patients in this clinic site, you will be included in
this trial, but you can opt out from us using your data in the study.
How will this clinical trial affect my care?
This trial is designed to assist your doctor to provide the best care for you. We expect that the study will help
improve the care being provided to you and would likely have a positive result on your health. If you opt out of
your data being used for the study, you will still receive the same quality standard of care being offered to all
eligible patients.
How long will my participation in this clinical trial last?
Your participation will be for approximately one year after enrollment in the clinic
What if I move and attend a clinic that is not taking part in this clinical trial?
If you move to Clinic with the ______ health system, information about your treatments and results of lab tests
that are done as part of your medical care will continue to be included as trial data even if the clinic is not part of
the trial. Your doctor will continue to provide care for you as usual, but will not receive assistance from the trial.
You should call the number shown below if you do not want your information included as trial data after you
move to a new facility.
Are there risks related to this clinical trial?
Since the purpose of the ICD-Pieces trial is assist physicians in providing the best care for patients with a
combination of chronic kidney disease, diabetes and hypertension, we do not anticipate any add risk as a result
of the trial. However, there is a very low risk that your information accessed through the EHR could be seen by
people other than the researchers. The confidentiality of your data is very important to us and we will make
every effort to keep all information collected in this trial strictly confidential.
Are there benefits to taking part in this clinical trial?
This study has a potential for individual benefits of improved health and reduced hospitalization and reduced
healthcare cost for the society. Findings may also help to better take care of patients in future.
Whom can I contact if I have questions about this clinical trial?
If at any time you have questions or concerns about this trial, please contact the research team at 214590-3073