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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
592023

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eileen Birmingham
  • Phone Number: 800-842-3225

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment 1
RN Standard care coordination and disease management + RN Case Management
Behavioral: 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).
Behavioral: RN Standard care coordination and disease management
RN Standard care coordination and disease management
Experimental: Control
RN Standard care coordination and disease management
Behavioral: 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
Behavioral: RN Standard care coordination and disease management
RN Standard care coordination and disease management
Behavioral: Community Health Worker Case 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UnitedHealthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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