Safe Kidney Care Cohort Study

Does Under-recognition of Kidney Disease Affect Patient Safety?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01407367

Enrollment

350

Registered

2011-08-02

Start date

2011-04-30

Completion date

2017-07-31

Last updated

2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

patient safety, chronic kidney disease, medical errors

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 patient's 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 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
The Discrete Incidence of Any of the Chronic Kidney Disease Patient Safety Indicators (CKD-PSIs) Endorsed by the Consensus Expert Panel	at the end of study (up to 4.25 years, depending on participant enrollment date)	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

Secondary

Measure	Time frame	Description
Rate of All-cause Hospitalization	at the end of study (up to 4.25 years, depending on participant enrollment date)	Hospitalizations (following enrollment); including length of stay and safety events during hospitalization until time of end of study.
Change in Renal Function From Baseline	at the end of study (up to 4.25 years, depending on participant enrollment date)	Renal function with estimated glomerular filtration rate (eGFR) based on serum creatinine measured annually until time of end of study.
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)	ESRD defined as the need for renal replacement therapy with either dialysis (hemodialysis or peritoneal) for 3 months or more; or renal transplantation up until the time of end of study.
Number of Deaths Among Participants (All-cause)	at the end of study (up to 4.25 years, depending on participant enrollment date)	determined until end of study.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Phase I Phase I (first 108 participants enrolled): Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs	108
Phase II Phase II (subsequent 242 participants enrolled): Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs	242
Total	350

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	24	32
Overall Study	Lost to Follow-up	0	2
Overall Study	Renal Replacement Therapy (RRT)	12	29
Overall Study	Withdrawal by Subject	4	15

Baseline characteristics

Characteristic	Phase I	Total	Phase II
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	52 Participants	204 Participants	152 Participants
Age, Categorical Between 18 and 65 years	56 Participants	146 Participants	90 Participants
eGFR Stage 2 (60 ≤ eGFR ≤ 89 mL/min/1.73 m²)	12 Participants	35 Participants	23 Participants
eGFR Stage 3a (45 ≤ eGFR ≤ 59 mL/min/1.73 m²,)	32 Participants	115 Participants	83 Participants
eGFR Stage 3b (30 ≤ eGFR ≤ 44 mL/min/1.73 m²,)	46 Participants	137 Participants	91 Participants
eGFR Stage 4 (15 ≤ eGFR ≤ 29 mL/min/1.73 m²,)	15 Participants	50 Participants	35 Participants
eGFR Stage 5 (eGFR< 15 mL/min/1.73 m²,)	3 Participants	13 Participants	10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	4 Participants	4 Participants
Race (NIH/OMB) Black or African American	78 Participants	243 Participants	165 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	30 Participants	102 Participants	72 Participants
Region of Enrollment United States	108 Participants	350 Participants	242 Participants
Sex: Female, Male Female	38 Participants	99 Participants	61 Participants
Sex: Female, Male Male	70 Participants	251 Participants	181 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	24 / 108	32 / 242
other Total, other adverse events	0 / 108	0 / 242
serious Total, serious adverse events	0 / 108	0 / 242

Outcome results

Primary

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