ID

28397

Description

Aetna_Intel Medicare Home Biomonitoring Study; ODM derived from: https://clinicaltrials.gov/show/NCT01105572

Link

https://clinicaltrials.gov/show/NCT01105572

Keywords

Versions (1)
  1. 1/10/18 1/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT01105572

English

Eligibility Congestive Heart Failure NCT01105572

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aetna medicare (pffs, hmo/ppo fully insured) individual members, plus medicare members from any plan sponsor that has agreed it would like its members to be included
Description

Medicare member

Data type

boolean

Alias
UMLS CUI [1,1]
C0018717
UMLS CUI [1,2]
C0680022
member meets aetna health profile database criteria for chronic heart failure (disease management eligibility = y) with a disease risk stratification score of 3 -
Description

Chronic heart failure | At risk of disease Score

Data type

boolean

Alias
UMLS CUI [1]
C0264716
UMLS CUI [2,1]
C1281905
UMLS CUI [2,2]
C0449820
5 (moderately severe to severe). these proprietary criteria yield a group of individuals for whom historical claims data estimates a substantial risk of hospital readmission within the coming 6 months.
Description

High risk of Hospital Readmission

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0600290
acute inpatient admission or 2 or more emergency room visits within 6 months prior to identification
Description

Hospital admission | Emergency department visit Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0184666
UMLS CUI [2,1]
C0586082
UMLS CUI [2,2]
C1265611
residence in the designated geographic areas selected for the study (the planned source population is all new jersey, new york, pennsylvania and north central aetna individual medicare members and north central. if members identified from these states have not filled the study within three months, the source population may be expanded to include aetna's north central region members in illinois and ohio. these north central members would include all aetna medicare individual members in these areas, plus any group medicare members from groups whose plan sponsors agree that the study may be offered to the members.)
Description

Residence Geographic area Designated

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0017446
UMLS CUI [1,3]
C1524084
member may be currently open/ active in case management
Description

Member Active Case management

Data type

boolean

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0085971
responds telephonic outreach to offer study participation, or to interactive voice response outreach call, and confirms each of:
Description

Telephone Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0039457
UMLS CUI [1,2]
C0470187
their own identity {secure health insurance portability accountability act (hipaa) compliant acknowledgement to caller}
Description

PATIENT IDENTITY Confirmation

Data type

boolean

Alias
UMLS CUI [1,1]
C0747303
UMLS CUI [1,2]
C0750484
that they have been told of having a heart condition
Description

Heart condition

Data type

boolean

Alias
UMLS CUI [1]
C3842523
interest in hearing more and possibly participating in the study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
member had case management and this was closed within the 30 days prior to identification for the study
Description

Member Case management Stop

Data type

boolean

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0085971
UMLS CUI [1,3]
C2746065
end-of life, terminal cancer, end stage renal disease, hospice, late stage alzheimer's disease, dementia, ventricular assist device, heart transplant or active in heart transplant program. excluded diagnoses or conditions will be identified where it is evident through aetna's health profile data diagnoses in claims, or upon case management assessment.
Description

Cessation of life | End stage cancer | Kidney Failure, Chronic | Hospice patient | Alzheimer's Disease Late stage | Dementia | Artificial Ventricle | Heart Transplantation | Heart Transplantation Program

Data type

boolean

Alias
UMLS CUI [1]
C0011065
UMLS CUI [2]
C0741884
UMLS CUI [3]
C0022661
UMLS CUI [4]
C0745035
UMLS CUI [5,1]
C0002395
UMLS CUI [5,2]
C0683337
UMLS CUI [6]
C0497327
UMLS CUI [7]
C0085842
UMLS CUI [8]
C0018823
UMLS CUI [9,1]
C0018823
UMLS CUI [9,2]
C3484370
chronic or ongoing intravenous heart failure medication
Description

Intravenous medication Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0812149
UMLS CUI [1,2]
C0018801
any response to interactive voice response outreach call other than "yes, i am interested"
Description

Telephone call Response Interest Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C2911692
UMLS CUI [1,3]
C0543488
UMLS CUI [1,4]
C0332268
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Similar models

Eligibility Congestive Heart Failure NCT01105572

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Medicare member
Item
aetna medicare (pffs, hmo/ppo fully insured) individual members, plus medicare members from any plan sponsor that has agreed it would like its members to be included
boolean
C0018717 (UMLS CUI [1,1])
C0680022 (UMLS CUI [1,2])
Chronic heart failure | At risk of disease Score
Item
member meets aetna health profile database criteria for chronic heart failure (disease management eligibility = y) with a disease risk stratification score of 3 -
boolean
C0264716 (UMLS CUI [1])
C1281905 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
High risk of Hospital Readmission
Item
5 (moderately severe to severe). these proprietary criteria yield a group of individuals for whom historical claims data estimates a substantial risk of hospital readmission within the coming 6 months.
boolean
C0332167 (UMLS CUI [1,1])
C0600290 (UMLS CUI [1,2])
Hospital admission | Emergency department visit Quantity
Item
acute inpatient admission or 2 or more emergency room visits within 6 months prior to identification
boolean
C0184666 (UMLS CUI [1])
C0586082 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Residence Geographic area Designated
Item
residence in the designated geographic areas selected for the study (the planned source population is all new jersey, new york, pennsylvania and north central aetna individual medicare members and north central. if members identified from these states have not filled the study within three months, the source population may be expanded to include aetna's north central region members in illinois and ohio. these north central members would include all aetna medicare individual members in these areas, plus any group medicare members from groups whose plan sponsors agree that the study may be offered to the members.)
boolean
C0237096 (UMLS CUI [1,1])
C0017446 (UMLS CUI [1,2])
C1524084 (UMLS CUI [1,3])
Member Active Case management
Item
member may be currently open/ active in case management
boolean
C0680022 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0085971 (UMLS CUI [1,3])
Telephone Available
Item
responds telephonic outreach to offer study participation, or to interactive voice response outreach call, and confirms each of:
boolean
C0039457 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
PATIENT IDENTITY Confirmation
Item
their own identity {secure health insurance portability accountability act (hipaa) compliant acknowledgement to caller}
boolean
C0747303 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Heart condition
Item
that they have been told of having a heart condition
boolean
C3842523 (UMLS CUI [1])
Study Subject Participation Status
Item
interest in hearing more and possibly participating in the study
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Member Case management Stop
Item
member had case management and this was closed within the 30 days prior to identification for the study
boolean
C0680022 (UMLS CUI [1,1])
C0085971 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
Cessation of life | End stage cancer | Kidney Failure, Chronic | Hospice patient | Alzheimer's Disease Late stage | Dementia | Artificial Ventricle | Heart Transplantation | Heart Transplantation Program
Item
end-of life, terminal cancer, end stage renal disease, hospice, late stage alzheimer's disease, dementia, ventricular assist device, heart transplant or active in heart transplant program. excluded diagnoses or conditions will be identified where it is evident through aetna's health profile data diagnoses in claims, or upon case management assessment.
boolean
C0011065 (UMLS CUI [1])
C0741884 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
C0745035 (UMLS CUI [4])
C0002395 (UMLS CUI [5,1])
C0683337 (UMLS CUI [5,2])
C0497327 (UMLS CUI [6])
C0085842 (UMLS CUI [7])
C0018823 (UMLS CUI [8])
C0018823 (UMLS CUI [9,1])
C3484370 (UMLS CUI [9,2])
Intravenous medication Heart failure
Item
chronic or ongoing intravenous heart failure medication
boolean
C0812149 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Telephone call Response Interest Lacking
Item
any response to interactive voice response outreach call other than "yes, i am interested"
boolean
C0302186 (UMLS CUI [1,1])
C2911692 (UMLS CUI [1,2])
C0543488 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
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