Safe Kidney Care Cohort Study
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/8/2018 |
| Start Date: | April 2011 |
| End Date: | July 2017 |
Does Under-recognition of Kidney Disease Affect Patient Safety?
Chronic kidney disease (CKD) is common, but it is often over-looked in patients with this
disease when they are getting medical treatment. Patients with CKD have special needs for
their medical treatment. When these special needs are not considered their medical care may
lead to unintended harm (called safety events) which can cause hospitalization, more kidney
problems, and even death.
This research study has two purposes. The first purpose is to determine how participants feel
about wearing a medical alert bracelet or necklace that alerts health care workers that the
user of the bracelet or necklace has decreased kidney function. Medical alert bracelets are
often recommended for people who have other medical problems, such as diabetes. This medical
alert bracelet or necklace has an address to an informational website about the safe care of
patients with kidney problems. The investigators think that alerting health care workers that
a person has decreased kidney function may decrease their chances of having a medical injury
and improve the safety of their care.
The second purpose of this research study is to track how often people with kidney problems
may be exposed to medicines, tests, or procedures that might increase their chance of having
an accidental medical injury or safety event. Though some medical injuries can not be
prevented, the investigators want to find out what medical events in patients with kidney
problems might be preventable. The investigators also want to find out if other things might
increase a patient's chances of getting a medical injury, such as physical weakness or
medical instructions that might be confusing.
disease when they are getting medical treatment. Patients with CKD have special needs for
their medical treatment. When these special needs are not considered their medical care may
lead to unintended harm (called safety events) which can cause hospitalization, more kidney
problems, and even death.
This research study has two purposes. The first purpose is to determine how participants feel
about wearing a medical alert bracelet or necklace that alerts health care workers that the
user of the bracelet or necklace has decreased kidney function. Medical alert bracelets are
often recommended for people who have other medical problems, such as diabetes. This medical
alert bracelet or necklace has an address to an informational website about the safe care of
patients with kidney problems. The investigators think that alerting health care workers that
a person has decreased kidney function may decrease their chances of having a medical injury
and improve the safety of their care.
The second purpose of this research study is to track how often people with kidney problems
may be exposed to medicines, tests, or procedures that might increase their chance of having
an accidental medical injury or safety event. Though some medical injuries can not be
prevented, the investigators want to find out what medical events in patients with kidney
problems might be preventable. The investigators also want to find out if other things might
increase a patient's chances of getting a medical injury, such as physical weakness or
medical instructions that might be confusing.
Chronic kidney disease not requiring dialysis (CKD) is common, but under-recognized, among
patients who frequent the health care system, where improving patient safety is a high
priority. Poor recognition of the disease and several other features unique to CKD make it a
high-risk condition for adverse, patient-safety incidents (PSIs). In this context, PSIs refer
to events of unintended harm or injury related to medications or medical care. These adverse
safety events may include those usually cited for the general population (PSI), but also,
CKD-specific unsafe practices (CKD-PSI) all of which, in turn, can lead to frequent
hospitalization, accelerated loss of kidney function, increased risk of end-stage renal
disease (ESRD), and death - all common outcomes in CKD. CKD-PSIs have been established in
prior work by the investigators of this study with the help of an expert panel but it is not
known how commonly PSIs or CKD-PSIs occur or how to measure these reliably in the CKD
population. Furthermore, it is not known what role poor disease recognition plays in the
occurrence of such safety events. Finally, it remains to be determined whether CKD-PSIs
contribute to the high frequency of adverse outcomes so common in this disease. If CKD-PSIs
are common and account for a significant portion of the adverse events so common in this
population, then it is possible that by reducing the incidence of CKD-PSIs, through increased
disease recognition, outcomes can be improved in this patient population.
In this study, the investigators will enroll volunteers from the population with pre-dialysis
CKD for the purpose of observing the frequency of CKD-PSI in the target population detected
over time. The participants will be assessed annually for events that relate to CKD-PSI. The
first 100 participants (Phase I) will be provided with a standard medical alert accessory
(bracelet or necklace) which is commonly used to alert doctors and other providers of a
patient's disease state. In this case the medical alert accessory will state "Decreased
Kidney Function. For My Care, Please Visit (website) www.safekidneycare.org" Participants are
asked to log onto the website using unique 4-digit identifier (ID) assigned by the PI to
track the participant's use of the website and to further improve the website. Since all
information on the website is available to the public, participants are not required to use
the ID to access the content of the website. The website does not collect or store patient
health information, except for the Internet Protocol (IP) address which provides limited
information on the location of the computer used to access the website (city, state, zip, and
area code).
The volunteers in Phase I will be tracked over time as to whether they use and tolerate this
medical alert bracelet/necklace and for their incidence of CKD-PSI. Enrollment will continue
after Phase I in Phase II (n = 250) with participants tracked on an identical study schedule
for detection of CKD-PSI. All study procedures are the same for Phase II except for the
medical alert accessory. The overall goal of this study will be to determine: the frequency
of CKD-PSI in the target population, the acceptability of an alert device (Phase I only)
intended to increase the recognition of CKD, and the contribution of CKD-PSI to the high
incidence of adverse outcomes in CKD
patients who frequent the health care system, where improving patient safety is a high
priority. Poor recognition of the disease and several other features unique to CKD make it a
high-risk condition for adverse, patient-safety incidents (PSIs). In this context, PSIs refer
to events of unintended harm or injury related to medications or medical care. These adverse
safety events may include those usually cited for the general population (PSI), but also,
CKD-specific unsafe practices (CKD-PSI) all of which, in turn, can lead to frequent
hospitalization, accelerated loss of kidney function, increased risk of end-stage renal
disease (ESRD), and death - all common outcomes in CKD. CKD-PSIs have been established in
prior work by the investigators of this study with the help of an expert panel but it is not
known how commonly PSIs or CKD-PSIs occur or how to measure these reliably in the CKD
population. Furthermore, it is not known what role poor disease recognition plays in the
occurrence of such safety events. Finally, it remains to be determined whether CKD-PSIs
contribute to the high frequency of adverse outcomes so common in this disease. If CKD-PSIs
are common and account for a significant portion of the adverse events so common in this
population, then it is possible that by reducing the incidence of CKD-PSIs, through increased
disease recognition, outcomes can be improved in this patient population.
In this study, the investigators will enroll volunteers from the population with pre-dialysis
CKD for the purpose of observing the frequency of CKD-PSI in the target population detected
over time. The participants will be assessed annually for events that relate to CKD-PSI. The
first 100 participants (Phase I) will be provided with a standard medical alert accessory
(bracelet or necklace) which is commonly used to alert doctors and other providers of a
patient's disease state. In this case the medical alert accessory will state "Decreased
Kidney Function. For My Care, Please Visit (website) www.safekidneycare.org" Participants are
asked to log onto the website using unique 4-digit identifier (ID) assigned by the PI to
track the participant's use of the website and to further improve the website. Since all
information on the website is available to the public, participants are not required to use
the ID to access the content of the website. The website does not collect or store patient
health information, except for the Internet Protocol (IP) address which provides limited
information on the location of the computer used to access the website (city, state, zip, and
area code).
The volunteers in Phase I will be tracked over time as to whether they use and tolerate this
medical alert bracelet/necklace and for their incidence of CKD-PSI. Enrollment will continue
after Phase I in Phase II (n = 250) with participants tracked on an identical study schedule
for detection of CKD-PSI. All study procedures are the same for Phase II except for the
medical alert accessory. The overall goal of this study will be to determine: the frequency
of CKD-PSI in the target population, the acceptability of an alert device (Phase I only)
intended to increase the recognition of CKD, and the contribution of CKD-PSI to the high
incidence of adverse outcomes in CKD
Inclusion Criteria:
- estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 (using Modified Diet in
Renal Disease (MDRD) equation) based on the 2 out-patient serum creatinines obtained
within the last 18 months and at least 90 days apart
Exclusion Criteria:
- < 21 years of age,
- Expected to need dialysis within 12 months after time of enrollment,
- Expected to die within 12 months after time of enrollment,
- Unable to provide informed consent, or is a
- Prisoner
- Skin sensitivity or allergy to stainless steel and sterling silver (Phase 1 only)
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