- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415515
Standard Care Coordination Expansion Pilot
November 10, 2025 updated by: Anthony Pirrello, UnitedHealthcare
Standard Care Coordination Expansion Pilot - A Quality Improvement Study
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
592023
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minnetonka, Minnesota, United States, 55343
- UnitedHealthcare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment 1
RN Standard care coordination and disease management + RN Case Management
|
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).
RN Standard care coordination and disease management
|
|
Experimental: Control
RN Standard care coordination and disease management
|
RN Standard care coordination and disease management
|
|
Experimental: Treatment 2
RN Standard care coordination and disease management + Community Health Worker Case Management
|
RN Standard care coordination and disease management
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Cost
Time Frame: 24 months
|
Defined as total plan cost (medical and pharmacy) per member
|
24 months
|
|
Acute Inpatient Admission Rate
Time Frame: 24 months
|
Defined as acute inpatient admissions per 1,000 qualified members
|
24 months
|
|
Emergency Room Visit Rate
Time Frame: 24 months
|
Defined as the number of emergency room visits per 1,000 qualified members
|
24 months
|
|
Diabetes-Related Complications
Time Frame: 24 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as time to first acute inpatient admission
|
12, 18, 24, 36, 48 months
|
|
All-Cause 30-Day Readmission Risk
Time Frame: 12, 18, 24, 36, 48 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as emergency room visits per 1,000 qualified members per year
|
12, 18, 24, 36, 48 months
|
|
Risk of Emergency Room Visit
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as time to first emergency room visit
|
12, 18, 24, 36, 48 months
|
|
Primary Care Physician Visit Rate
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as primary care physician visits per qualified member
|
12, 18, 24, 36, 48 months
|
|
Specialist Physician Visit Rate
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as specialist physician visits per qualified member
|
12, 18, 24, 36, 48 months
|
|
Cardiovascular Disease
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as percentage of members with cardiovascular disease
|
12, 18, 24, 36, 48 months
|
|
Diabetes-related complications (DCSI)
Time Frame: 12, 18, 24, 36, 48 months
|
12, 18, 24, 36, 48 months
|
|
|
Amputations
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as lower extremity amputations per 1,000 qualified members
|
12, 18, 24, 36, 48 months
|
|
Chronic Kidney Disease
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as attenuated decline of eGFR, for members with baseline eGFR below 60mL/min
|
12, 18, 24, 36, 48 months
|
|
Glycemic Control
Time Frame: 12, 18, 24, 36, 48 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as total (plan+member) cost per member
|
12, 18, 24, 36, 48 months
|
|
Diabetes Complications Count
Time Frame: 12, 18, 24, 36, 48 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
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
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as percentage of members with Cerebrovascular disease/stroke
|
12, 18, 24, 36, 48 months
|
|
Peripheral vascular disease
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as percentage of members with Peripheral vascular disease
|
12, 18, 24, 36, 48 months
|
|
Nephropathy
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as percentage of members with Nephropathy
|
12, 18, 24, 36, 48 months
|
|
Retinopathy
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as percentage of members with Retinopathy
|
12, 18, 24, 36, 48 months
|
|
Neuropathy
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as percentage of members with Neuropathy
|
12, 18, 24, 36, 48 months
|
|
Metabolic complications such as ketoacidosis, hyperosmolar, or other coma
Time Frame: 12, 18, 24, 36, 48 months
|
Defined as percentage of members with metabolic complications
|
12, 18, 24, 36, 48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anthony V Pirrello, MS, UnitedHealthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
January 28, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
November 12, 2025
Last Update Submitted That Met QC Criteria
November 10, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHC100023A
- DP006128 (Other Grant/Funding Number: CDC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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