Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01407367
Status:
COMPLETED
Last Update Posted:
2019-10-18
First Post:
2011-04-26
Brief Title:
Safe Kidney Care Cohort Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Does Under-recognition of Kidney Disease Affect Patient Safety
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients chances of getting a medical injury such as physical weakness or medical instructions that might be confusing
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 patients chances of getting a medical injury such as physical weakness or medical instructions that might be confusing
Detailed Description:
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 patients disease state In this case the medical alert accessory will state Decreased Kidney Function For My Care Please Visit website wwwsafekidneycareorg Participants are asked to log onto the website using unique 4-digit identifier ID assigned by the PI to track the participants 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 braceletnecklace 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
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 patients disease state In this case the medical alert accessory will state Decreased Kidney Function For My Care Please Visit website wwwsafekidneycareorg Participants are asked to log onto the website using unique 4-digit identifier ID assigned by the PI to track the participants 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 braceletnecklace 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK084017 | NIH | None | httpsreporternihgovquickSearchR01DK084017 |