Standard Care Coordination Expansion Pilot

Study Overview
=================
Brief Summary
-----------------
The Standard Care Coordination (SCC) solution integrates aspects of case management & care coordination & was designed by UnitedHealth Group for high-cost, complex, at-risk consumers to facilitate health care access and decisions that can have a dramatic impact on the quality and affordability of the consumer's health care. Currently members only receive the SCC if they are: 1) identified as high risk for readmission upon discharge from the hospital, 2) are self-referred, or 3) are directly referred to the program by their physician. The current quality improvement study was designed as a randomized controlled trial to determine if the expansion of the SCC program to commercially insured members identified via a proprietary administrative algorithms as being at high risk would significantly impact rates of acute inpatient admissions.

Official Title
-----------------
Standard Care Coordination Expansion Pilot - A Quality Improvement Study

Conditions
-----------------
Superutilizers, Health Care Utilization

Intervention / Treatment
-----------------
* Behavioral: RN case management
* Behavioral: Community Health Worker Case Management
* Behavioral: RN Standard care coordination and disease management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UnitedHealthcare commercial Fully Insured members; all states; 18+ years old; actively enrolled in the health plan as of randomization identified via proprietary administrative algorithm as being at high risk for persistent super utilizer status. Exclusion Criteria: : pregnant women, individuals prescribed medications for infertility, members with evidence of dementing disorders, members indicated as do not contact  for program outreach, and Members in the following products and plans: legacy UHC ASO groups (populations for which UHC provides administrative services only), legacy Oxford health plan members (all members receive the SCC program), legacy PacifiCare members, legacy River Valley/NHP members, and Public Sector clients the PHS 2.0 intervention (a small population within Fully Insured) assignment to a clinically activated Accountable Care Organization (ACO)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>RN Standard care coordination and disease management + RN Case Management | Behavioral: RN case management<br>* A Registered Nurse (RN) case manager makes phone contact with the member to review medications, health risks, care gaps/barriers, & to develop a case management plan that focuses on improving medication adherence & reconciliation, condition-based measures & outcomes, addressing psycho-social needs, & intensive post-admission care transition. RNs may refer the member to social workers,specialist providers, & support programs (including to more intense case management where the primary care physician is notified that RNs may contact them to support treatment & coordinate services).<br>Behavioral: RN Standard care coordination and disease management<br>* RN Standard care coordination and disease management<br>|
| Experimental: Control<br>RN Standard care coordination and disease management | Behavioral: RN Standard care coordination and disease management<br>* RN Standard care coordination and disease management<br>|
| Experimental: Treatment 2<br>RN Standard care coordination and disease management + Community Health Worker Case Management | Behavioral: Community Health Worker Case Management<br>* In selected UHC markets for defined time periods, members randomized to the treatment arm also received an enhanced version of the SCC that included in-home case management support from non-clinical Community Health Workers (CHW).<br>Behavioral: RN Standard care coordination and disease management<br>* RN Standard care coordination and disease management<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cost | Defined as total plan cost (medical and pharmacy) per member | 24 months | 
| Acute Inpatient Admission Rate | Defined as acute inpatient admissions per 1,000 qualified members | 24 months | 
| Emergency Room Visit Rate | Defined as the number of emergency room visits per 1,000 qualified members | 24 months | 
| Diabetes-Related Complications | Defined as the Diabetes Complications Severity Index (DCSI) composite score. The composite DCSI score ranges between 0 to 13 (sum of scores from 7 diabetes complication categories [cardiovascular disease, cerebrovascular disease/stroke, peripheral vascular disease, nephropathy, retinopathy, neuropathy, and metabolic complications such as ketoacidosis, hyperosmolar, or other coma] which are each scored from 0 to 2 [0=no complication, 1=non-severe complication, 2=severe complication], except for neuropathy which is scored from 0 to 1) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of Acute Inpatient Admission | Defined as time to first acute inpatient admission | 12, 18, 24, 36, 48 months | 
| All-Cause 30-Day Readmission Risk | Defined as first acute inpatient readmission for all-causes within 30 days of index acute inpatient discharge | 12, 18, 24, 36, 48 months | 
| Outpatient Emergency Room Visit Rate | Defined as emergency room visits per 1,000 qualified members per year | 12, 18, 24, 36, 48 months | 
| Risk of Emergency Room Visit | Defined as time to first emergency room visit | 12, 18, 24, 36, 48 months | 
| Primary Care Physician Visit Rate | Defined as primary care physician visits per qualified member | 12, 18, 24, 36, 48 months | 
| Specialist Physician Visit Rate | Defined as specialist physician visits per qualified member | 12, 18, 24, 36, 48 months | 
| Cardiovascular Disease | Defined as percentage of members with cardiovascular disease | 12, 18, 24, 36, 48 months | 
| Diabetes-related complications (DCSI) |  | 12, 18, 24, 36, 48 months | 
| Amputations | Defined as lower extremity amputations per 1,000 qualified members | 12, 18, 24, 36, 48 months | 
| Chronic Kidney Disease | Defined as attenuated decline of eGFR, for members with baseline eGFR below 60mL/min | 12, 18, 24, 36, 48 months | 
| Glycemic Control | Defined as number of members with A1c below 7%, below 8%, and/or above 9%, per 100 qualified members with diabetes | 12, 18, 24, 36, 48 months | 
| Adherence to Diabetes-Related Medications | Defined as number of members with medication possession ratio (MPR) values of 80% or higher, per 100 qualified members with diabetes | 12, 18, 24, 36, 48 months | 
| Adherence to Diabetes-Related Processes of Care | Defined as rates of microalbuminuria screening, retinal/eye exams, A1c test frequency, LDL test frequency, Statin use, ACE/ARB use | 12, 18, 24, 36, 48 months | 
| Total Plan and Member Cost | Defined as total (plan+member) cost per member | 12, 18, 24, 36, 48 months | 
| Diabetes Complications Count | Defined as the Diabetes Complications Severity Index (DCSI) count. The DCSI count ranges from 0 to 7 (count of the 7 diabetes complication categories [cardiovascular disease, cerebrovascular disease/stroke, peripheral vascular disease, nephropathy, retinopathy, neuropathy, and metabolic complications such as ketoacidosis, hyperosmolar, or other coma]). | 12, 18, 24, 36, 48 months | 
| Any Acute Inpatient Admission | Defined as the number of members with any Acute Inpatient Admission per 1,000 qualified members | 12, 18, 24, 36, 48 months | 
| Any Emergency Room Visit | Defined as the number of members with any emergency room visit per 1,000 qualified members | 12, 18, 24, 36, 48 months | 
| Cerebrovascular disease/stroke | Defined as percentage of members with Cerebrovascular disease/stroke | 12, 18, 24, 36, 48 months | 
| Peripheral vascular disease | Defined as percentage of members with Peripheral vascular disease | 12, 18, 24, 36, 48 months | 
| Nephropathy | Defined as percentage of members with Nephropathy | 12, 18, 24, 36, 48 months | 
| Retinopathy | Defined as percentage of members with Retinopathy | 12, 18, 24, 36, 48 months | 
| Neuropathy | Defined as percentage of members with Neuropathy | 12, 18, 24, 36, 48 months | 
| Metabolic complications such as ketoacidosis, hyperosmolar, or other coma | Defined as percentage of members with metabolic complications | 12, 18, 24, 36, 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Care coordination, case management, superutilizers, health care utilization