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Intervention, Control

Phase 3

Nurse Based Care Management | Unknown | Other |PLUS THERAPEUTICS, Inc.|Last Updated: Jul 29, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment65,500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02106221Transforming Outcomes for Patients Through Medical Home Evaluation & reDesignPHASE3 COMPLETED 65,500Jul 1, 2011Feb 1, 2015Jul 29, 20151 United States
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Study Endpoints
Primary Endpoints
Preventable utilization
12 months

Reduce by 15% ED visits and hospitalizations related to ambulatory care

Quality Measures Improvement
12 months

Select 3 standard measures related to the patient population and improve each by 20%. (An example of such a measure might be fall risk assessment. There are several quality measures that are included as part of the HIT tool that is provided to clinics.)

Patient Satisfaction
12 months

Improve patient experience with clinic and satisfaction with care coordination by 10% Patient satisfaction will be determined by a CAHPS patient satisfaction survey that is sent out at the start and end of the study.

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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
InterventionEXPERIMENTALFinancial incentives will be provided based on performance in areas determined to be of high-value.
ControlACTIVE_COMPARATORFinancial incentives are a flat rate which can be reduced if an appropriate amount of effort or improvement is not met
Interventions
NameTypeDescription
InterventionOTHERWill receive payments based on achievement in meeting goals based on specified high value elements as well as effort.
ControlOTHERWill receive payments based on achievement in meeting goals.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * clinics must be from the Oregon Rural Practice-based Research Network (ORPRN) * Primary care clinic meeting one of the following health care setting descriptions: 1) small clinics in rural area, 2) medium-sized clinics in rural area, 3) clinics in moderate-sized health system,...

Countries:United States
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