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

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.

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

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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