NCT01407367|CompletedResults
Safe Kidney Care Cohort Study
Does Under-recognition of Kidney Disease Affect Patient Safety?
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Does Under-recognition of Kidney Disease Affect Patient Safety?
Sponsor study identifier
Secondary identifiers
NIH
observational
350
1 country
2
Study Start
April 2011
Actual (reported)Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Actual (reported)April 26, 2011
Actual (reported)August 2, 2011
Actual (reported)July 2017
Actual (reported)July 2017
Actual (reported)November 6, 2018
Actual (reported)The Discrete Incidence of Any of the Chronic Kidney Disease Patient Safety Indicators (CKD-PSIs) Endorsed by the Consensus Expert Panel
The discrete incidence of any of the following CKD-PSIs endorsed by the consensus expert panel: Class I events: Incidence of patient reported adverse events related to medical care or medicines incuding: Falling, Bleeding, Edema, Angioedema, Confusion or altered mental status, Rhabdomyolysis Class II events: Incidence of adverse events detected at annual study visits such as: Hyperkalemia, Hypokalemia, Hypoglycemia, Hyperglycemia, Orthostatic Hypotension, Hypotension, Hypertension, Bradycardia Class III events: Incidence of usage of medications or agents to be avoided in CKD and Incidence of improperly dosed medications in CKD
at the end of study (up to 4.25 years, depending on participant enrollment date)
Rate of All-cause Hospitalization
at the end of study (up to 4.25 years, depending on participant enrollment date)
Change in Renal Function From Baseline
at the end of study (up to 4.25 years, depending on participant enrollment date)
Number of Participants With End-stage Renal Disease (ESRD) Defined as Need for Renal Replacement Therapy (Dialysis or Transplant)
at the end of study (up to 4.25 years, depending on participant enrollment date)
Number of Deaths Among Participants (All-cause)
at the end of study (up to 4.25 years, depending on participant enrollment date)
Phase I (First 100 participants): Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs Phase II (Next 250 participants): Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
Participants will be recruited from a variety of chronic kidney disease (CKD) management and primary care setting. Some participants will be self-referrals.
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Belkin MD, Doerfler RM, Wagner LA, Zhan M, Fink JC. Associations of Performance-Based Functional Assessments and Adverse Outcomes in CKD. Kidney360. 2021 Jan 19;2(4):629-638. doi: 10.34067/KID.0005802020. eCollection 2021 Apr 29.
Diamantidis CJ, Fink W, Yang S, Zuckerman MR, Ginsberg J, Hu P, Xiao Y, Fink JC. Directed use of the internet for health information by patients with chronic kidney disease: prospective cohort study. J Med Internet Res. 2013 Nov 15;15(11):e251. doi: 10.2196/jmir.2848.
At each yearly research clinic visit (up to 4), 30 cc (6 teaspoons) of blood will be processed and stored for future assays related to kidney function. At first research clinic visit, 9 cc urine will be processed and stored for future assays related to kidney function. At each yearly research clinic visit, 1 swab of both nares, 1 pharyngeal swab and 1 skin swab will be obtained, processed and stored with future testing for multiple antibiotic resistant (MAR) organisms.
Observational cohort with a sub-group to pilot a medical alert accessory; remainder of the cohort had no accessory. Bias cannot be excluded and direct group comparisons is not possible, nor can the accessory be formally evaluated as an intervention.
Jeffrey C Fink, MD, MS
University of Maryland, Baltimore
350 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2011
First Posted
August 2, 2011
Study Start
April 2011
Actual (reported)Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
Contact the study team to confirm eligibility.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
October 18, 2019
Results First Posted
November 6, 2018
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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