ID

35303

Beschreibung

Shared Decision Making and Renal Supportive Care; ODM derived from: https://clinicaltrials.gov/show/NCT02405312

Link

https://clinicaltrials.gov/show/NCT02405312

Stichworte

Versionen (1)
  1. 27.02.19 27.02.19 -
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See clinicaltrials.gov

Hochgeladen am

27. Februar 2019

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT02405312

Englisch

Eligibility Chronic Kidney Disease NCT02405312

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
high-risk patients, as defined by falling within the high-risk category of our validated prognostic instrument and have approximately 50% 18-month mortality.
Beschreibung

High risk Patients | Mortality Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C0030705
UMLS CUI [2,1]
C0026565
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
english- and spanish-speaking patients will be included (estimated to be 95% of this population).
Beschreibung

Able to speak English Language | Able to speak Spanish Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
patients who receive hemodialysis at one of our 16 research dialysis sites during the data collection period.
Beschreibung

Hemodialysis | Data Collection Period

Datentyp

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2,1]
C0010995
UMLS CUI [2,2]
C1948053
patients must be willing and able to sign the consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patients who are lack the capacity to meaningfully participate in medical decisions must have a surrogate who is willing to sign the informed consent.
Beschreibung

Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030701
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
children 18 years of age. children constitute 2% of the dialysis population, and our preliminary survey of the study sites found no children were active patients. in any case, the renal and other physical factors of children with esrd are not directly comparable to those of adults.
Beschreibung

Children | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0001779
does not belong to the population's high-mortality risk quintile according to our prognostic instrument
Beschreibung

Mortality High risk Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026565
UMLS CUI [1,2]
C4319571
UMLS CUI [1,3]
C0332197
severe psychiatric disorders including schizophrenia, bipolar disorder which would interfere with participation in the study (severity determined by psychiatric hospitalization in the past month or actively suicidal)
Beschreibung

Severe Mental Disorder Interferes with Study Subject Participation Status | Schizophrenia | Bipolar Disorder | Psychiatric hospitalization | Suicidal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4046029
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0748061
UMLS CUI [5]
C0438696
active substance abuse (active abuse is defined as using alcohol or recreational drugs in the past 30 days in a way that interferes with their ability to function in daily life)
Beschreibung

Substance Use Disorder Interferes with Activities of Daily Living

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0001288
expectation of native kidney recovery
Beschreibung

Expectation Recovery Kidney Native

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679138
UMLS CUI [1,2]
C2004454
UMLS CUI [1,3]
C0022646
UMLS CUI [1,4]
C0302891
history of poor adherence to thrice-weekly hemodialysis (poor adherence defined by missing 4 treatments in the past month)
Beschreibung

Poor compliance Hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0019004
unable to communicate in english or spanish
Beschreibung

Lacking Able to communicate English Language | Lacking Able to communicate Spanish Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2364293
UMLS CUI [2,3]
C0037750
scheduled for living donor kidney transplant, conversion to peritoneal dialysis, or plans to relocate to another hemodialysis unit
Beschreibung

Live donor renal transplant Scheduled | Conversion Peritoneal Dialysis | Hemodialysis unit Other Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0401177
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0439836
UMLS CUI [2,2]
C0031139
UMLS CUI [3,1]
C1552759
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C1301732
current pregnancy or actively planning to become pregnant
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
currently a prisoner
Beschreibung

Prisoners

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
unable or unwilling to follow the study protocol
Beschreibung

Protocol Compliance Unable | Protocol Compliance Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
unable or unwilling to provide informed consent or sign institutional review board (irb)-approval or lack of a surrogate/proxy
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
exclusion by primary nephrologist or social worker due to risk of harm
Beschreibung

Exclusion Due to Risk Harm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C3658342
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Ähnliche Modelle

Eligibility Chronic Kidney Disease NCT02405312

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
High risk Patients | Mortality Percentage Timespan
Item
high-risk patients, as defined by falling within the high-risk category of our validated prognostic instrument and have approximately 50% 18-month mortality.
boolean
C4319571 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0026565 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Able to speak English Language | Able to speak Spanish Language
Item
english- and spanish-speaking patients will be included (estimated to be 95% of this population).
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Hemodialysis | Data Collection Period
Item
patients who receive hemodialysis at one of our 16 research dialysis sites during the data collection period.
boolean
C0019004 (UMLS CUI [1])
C0010995 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
Informed Consent
Item
patients must be willing and able to sign the consent form.
boolean
C0021430 (UMLS CUI [1])
Informed Consent Patient Representative
Item
patients who are lack the capacity to meaningfully participate in medical decisions must have a surrogate who is willing to sign the informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0030701 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Children | Age
Item
children 18 years of age. children constitute 2% of the dialysis population, and our preliminary survey of the study sites found no children were active patients. in any case, the renal and other physical factors of children with esrd are not directly comparable to those of adults.
boolean
C0008059 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Mortality High risk Absent
Item
does not belong to the population's high-mortality risk quintile according to our prognostic instrument
boolean
C0026565 (UMLS CUI [1,1])
C4319571 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Severe Mental Disorder Interferes with Study Subject Participation Status | Schizophrenia | Bipolar Disorder | Psychiatric hospitalization | Suicidal
Item
severe psychiatric disorders including schizophrenia, bipolar disorder which would interfere with participation in the study (severity determined by psychiatric hospitalization in the past month or actively suicidal)
boolean
C4046029 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0748061 (UMLS CUI [4])
C0438696 (UMLS CUI [5])
Substance Use Disorder Interferes with Activities of Daily Living
Item
active substance abuse (active abuse is defined as using alcohol or recreational drugs in the past 30 days in a way that interferes with their ability to function in daily life)
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
Expectation Recovery Kidney Native
Item
expectation of native kidney recovery
boolean
C0679138 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
Poor compliance Hemodialysis
Item
history of poor adherence to thrice-weekly hemodialysis (poor adherence defined by missing 4 treatments in the past month)
boolean
C0032646 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
Lacking Able to communicate English Language | Lacking Able to communicate Spanish Language
Item
unable to communicate in english or spanish
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2364293 (UMLS CUI [2,2])
C0037750 (UMLS CUI [2,3])
Live donor renal transplant Scheduled | Conversion Peritoneal Dialysis | Hemodialysis unit Other Planned
Item
scheduled for living donor kidney transplant, conversion to peritoneal dialysis, or plans to relocate to another hemodialysis unit
boolean
C0401177 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0439836 (UMLS CUI [2,1])
C0031139 (UMLS CUI [2,2])
C1552759 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
Pregnancy | Pregnancy, Planned
Item
current pregnancy or actively planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Prisoners
Item
currently a prisoner
boolean
C0033167 (UMLS CUI [1])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
unable or unwilling to follow the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to provide informed consent or sign institutional review board (irb)-approval or lack of a surrogate/proxy
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Exclusion Due to Risk Harm
Item
exclusion by primary nephrologist or social worker due to risk of harm
boolean
C2828389 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C3658342 (UMLS CUI [1,4])
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