Safe Kidney Care Cohort Study

NCT01407367 | Completed Results

• 2 other identifiers: HP-00048532R01DK084017
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Disease

Keywords

patient safety; chronic kidney disease; medical errors

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• 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)

Study Arms (1)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from a variety of chronic kidney disease (CKD) management and primary care setting. Some participants will be self-referrals.

You may qualify if:

• 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

You may not qualify if:

• \<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)

Sponsors & Collaborators

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

Study Sites (2)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• 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.

  PMID: 35373040 DERIVED

• 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.

  PMID: 24240617 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and 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.

Results Point of Contact

• Title: Jeffrey C. Fink MD, MS; Principal Investigator
• Organization: University of Maryland Baltimore

jfink@som.umaryland.edu

410-382-4822

Study Officials

• Jeffrey C Fink, MD, MS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Nephrology

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: August 2, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 18, 2019
• Results First Posted: November 6, 2018

Record last verified: 2019-10

Locations

US (2)