N/A
N=350
Safe Kidney Care Cohort Study
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01407367 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: The Discrete Incidence of Any of the Chronic Kidney Disease Patient Safety Indicators (CKD-PSIs) Endorsed by the Consensus Expert Panel — 108.7; 100.6; 38.3; 41.2 events per 100 patient-visits
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Discrete Incidence of Any of the Chronic Kidney Disease Patient Safety Indicators (CKD-PSIs) Endorsed by the Consensus Expert Panel |
108.7; 100.6; 38.3; 41.2 | — |
| SECONDARY Rate of All-cause Hospitalization |
0.51; 0.44 | — |
| SECONDARY Change in Renal Function From Baseline |
-0.12; -0.06 | — |
| SECONDARY Number of Participants With End-stage Renal Disease (ESRD) Defined as Need for Renal Replacement Therapy (Dialysis or Transplant) |
12; 29 | .04 sig |
| SECONDARY Number of Deaths Among Participants (All-cause) |
24; 32 | 0.86 |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01407367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.