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Data collection, Data Collection

Phase 3

Nurse Based Care Management | Unknown | Other |PLUS THERAPEUTICS, Inc.|Last Updated: Jul 2, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment60,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01890603Enhancing Complex Care Through an Integrated Care Coordination Information SystemPHASE3 COMPLETED 60,000Sep 1, 2008Jun 1, 2011Jul 2, 20131 United States
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Study Endpoints
Primary Endpoints
Rate of Utilization
up to 18 months

Utilization includes Emergency Department visits and hospitalizations for this high risk group.

Secondary Endpoints
Patient Satisfaction/Experience
0, 18 months
Reduce Costs
0, 12, 18 months
Improve quality of care
0,3,6,9,12,15,18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Care Coordination ArmEXPERIMENTAL -
Quality Measure ImprovementACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Data collectionOTHERResearch involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Six Clinics participating whom Care Management Plus team has worked with before * Patients belonging to one of these six clinics * Picked based on an algorithm designed to identify high risk patients. * Clinic will review potential patients list and issue a survey with consent...

Countries:United States
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