Safe Kidney Care Cohort Study

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT01407367
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 350
• Locations: 2
• Actual Duration (Months): 75
• Patients Per Site: 175
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease

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

Study Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Does Under-recognition of Kidney Disease Affect Patient Safety?
• Actual Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Phase I and Phase II 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baltimore VA Medical Center	Baltimore	Maryland	United States	21201
2	University of Maryland Medical System	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Jeffrey C Fink, MD, MS, University of Maryland, Baltimore

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 17, 2018

More Information

Publications

None provided.

• Responsible Party: Jeffrey Fink, Associate Professor, Nephrology, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01407367
• Other Study ID Numbers: HP-00048532; R01DK084017
• First Posted: Aug 2, 2011
• Last Update Posted: Oct 18, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Jeffrey Fink, Associate Professor, Nephrology, University of Maryland, Baltimore: patient safety; chronic kidney disease; medical errors
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

Participant Flow

Arm/Group Title	Phase I	Phase II
Arm/Group Description	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	Phase II (subsequent 242 participants enrolled) Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
Period Title: Overall Study
STARTED	108	242
COMPLETED	68	164
NOT COMPLETED	40	78

Baseline Characteristics

Arm/Group Title	Phase I	Phase II	Total
Arm/Group Description	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	Phase II (subsequent 242 participants enrolled): Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs	Total of all reporting groups
Overall Participants	108	242	350
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	56 51.9%	90 37.2%	146 41.7%
>=65 years	52 48.1%	152 62.8%	204 58.3%
Sex: Female, Male (Count of Participants)
Female	38 35.2%	61 25.2%	99 28.3%
Male	70 64.8%	181 74.8%	251 71.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.4%	1 0.3%
Asian	0 0%	4 1.7%	4 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	78 72.2%	165 68.2%	243 69.4%
White	30 27.8%	72 29.8%	102 29.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	108 100%	242 100%	350 100%
eGFR (Count of Participants)
Stage 2 (60 ≤ eGFR ≤ 89 mL/min/1.73 m²)	12 11.1%	23 9.5%	35 10%
Stage 3a (45 ≤ eGFR ≤ 59 mL/min/1.73 m²,)	32 29.6%	83 34.3%	115 32.9%
Stage 3b (30 ≤ eGFR ≤ 44 mL/min/1.73 m²,)	46 42.6%	91 37.6%	137 39.1%
Stage 4 (15 ≤ eGFR ≤ 29 mL/min/1.73 m²,)	15 13.9%	35 14.5%	50 14.3%
Stage 5 (eGFR< 15 mL/min/1.73 m²,)	3 2.8%	10 4.1%	13 3.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety events reported in this outcome measure are from 6 months prior to participant's annual in-center visits

Arm/Group Title	Phase I	Phase II
Arm/Group Description	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	Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
Measure Participants	108	242
Class I	108.7	100.6
Class II	38.3	41.2

2. Secondary Outcome

Title	Rate of All-cause Hospitalization
Description	Hospitalizations (following enrollment); including length of stay and safety events during hospitalization until time of end of study.
Time Frame	at the end of study (up to 4.25 years, depending on participant enrollment date)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase I	Phase II
Arm/Group Description	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	Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
Measure Participants	108	242
Number [events per patient-years]	0.51	0.44

3. Secondary Outcome

Title	Change in Renal Function From Baseline
Description	Renal function with estimated glomerular filtration rate (eGFR) based on serum creatinine measured annually until time of end of study.
Time Frame	at the end of study (up to 4.25 years, depending on participant enrollment date)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase I	Phase II
Arm/Group Description	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	Phase II (subsequent 242 participants enrolled) Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
Measure Participants	108	242
Median (Inter-Quartile Range) [ml/min per 1.73m^2 per month]	-0.12	-0.06

4. Secondary Outcome

Title	Number of Participants With End-stage Renal Disease (ESRD) Defined as Need for Renal Replacement Therapy (Dialysis or Transplant)
Description	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.
Time Frame	at the end of study (up to 4.25 years, depending on participant enrollment date)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase I	Phase II
Arm/Group Description	Phase I Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs	Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
Measure Participants	108	242
Number [participants]	12 11.1%	29 12%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase I, Phase II
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments	calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.38
	Confidence Interval	(2-Sided) 95%; 0.16 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Deaths Among Participants (All-cause)
Description	determined until end of study.
Time Frame	at the end of study (up to 4.25 years, depending on participant enrollment date)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase I	Phase II
Arm/Group Description	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	Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
Measure Participants	108	242
Number [participants]	24 22.2%	32 13.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase I, Phase II
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.86
	Comments	calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.53 to 1.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	up to 4.25 years, depending on participant enrollment date
Arm/Group Title	Phase I		Phase II
Arm/Group Description	Phase I Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs		Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
All Cause Mortality
	Phase I		Phase II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/108 (22.2%)		32/242 (13.2%)
Serious Adverse Events
	Phase I		Phase II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		0/242 (0%)
Other (Not Including Serious) Adverse Events
	Phase I		Phase II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		0/242 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.