Superutilizers, Health Care UtilizationNCT04415515
Standard Care Coordination Expansion Pilot
A study testing RN case management and Community Health Worker Case Management in people with Superutilizers, Health Care Utilization, run by UnitedHealthcare at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superutilizers, Health Care Utilization
- What is being tested?
- RN case management and Community Health Worker Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592,023 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- : 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Superutilizers, Health Care Utilization
- Being tested
- RN case management, Community Health Worker Case Management, RN Standard care coordination and disease management
- Keywords
- Care coordination, case management, superutilizers, health care utilization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN case managementBehavioural
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).
Community Health Worker Case ManagementBehavioural
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).
RN Standard care coordination and disease managementBehavioural
RN Standard care coordination and disease management
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | RN Standard care coordination and disease management + RN Case Management Receives: Behavioral: RN case management; Behavioral: RN Standard care coordination and disease management |
| Control | Experimental | RN Standard care coordination and disease management Receives: Behavioral: RN Standard care coordination and disease management |
| Treatment 2 | Experimental | RN Standard care coordination and disease management + Community Health Worker Case Management Receives: Behavioral: Community Health Worker Case Management; Behavioral: RN Standard care coordination and disease management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cost
Defined as total plan cost (medical and pharmacy) per member
Measured: 24 months
Acute Inpatient Admission Rate
Defined as acute inpatient admissions per 1,000 qualified members
Measured: 24 months
Emergency Room Visit Rate
Defined as the number of emergency room visits per 1,000 qualified members
Measured: 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)
Measured: 24 months
Secondary outcomes (23)
Risk of Acute Inpatient Admission
Defined as time to first acute inpatient admission
Measured: 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
Measured: 12, 18, 24, 36, 48 months
Outpatient Emergency Room Visit Rate
Defined as emergency room visits per 1,000 qualified members per year
Measured: 12, 18, 24, 36, 48 months
Risk of Emergency Room Visit
Defined as time to first emergency room visit
Measured: 12, 18, 24, 36, 48 months
Primary Care Physician Visit Rate
Defined as primary care physician visits per qualified member
Measured: 12, 18, 24, 36, 48 months
Specialist Physician Visit Rate
Defined as specialist physician visits per qualified member
Measured: 12, 18, 24, 36, 48 months
Cardiovascular Disease
Defined as percentage of members with cardiovascular disease
Measured: 12, 18, 24, 36, 48 months
Diabetes-related complications (DCSI)
Measured: 12, 18, 24, 36, 48 months
Amputations
Defined as lower extremity amputations per 1,000 qualified members
Measured: 12, 18, 24, 36, 48 months
Chronic Kidney Disease
Defined as attenuated decline of eGFR, for members with baseline eGFR below 60mL/min
Measured: 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
Measured: 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
Measured: 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
Measured: 12, 18, 24, 36, 48 months
Total Plan and Member Cost
Defined as total (plan+member) cost per member
Measured: 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]).
Measured: 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
Measured: 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
Measured: 12, 18, 24, 36, 48 months
Cerebrovascular disease/stroke
Defined as percentage of members with Cerebrovascular disease/stroke
Measured: 12, 18, 24, 36, 48 months
Peripheral vascular disease
Defined as percentage of members with Peripheral vascular disease
Measured: 12, 18, 24, 36, 48 months
Nephropathy
Defined as percentage of members with Nephropathy
Measured: 12, 18, 24, 36, 48 months
Retinopathy
Defined as percentage of members with Retinopathy
Measured: 12, 18, 24, 36, 48 months
Neuropathy
Defined as percentage of members with Neuropathy
Measured: 12, 18, 24, 36, 48 months
Metabolic complications such as ketoacidosis, hyperosmolar, or other coma
Defined as percentage of members with metabolic complications
Measured: 12, 18, 24, 36, 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study startOct 2015
- Primary completionDec 2023
- Study completionDec 2023
Why it stopped: Academic partnership between UHC and UCLA was terminated effective December 31, 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Superutilizers, Health Care UtilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 592,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealthcare
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Anthony Pirrello, UnitedHealthcare
- Investigators
- Anthony V Pirrello, MS, Principal investigator, UnitedHealthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415515
- Sponsor's protocol ID
- UHC100023A
- Other IDs
- DP006128
- Status last verified
- Nov 2025
- First submitted
- 28 Jan 2020
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saju R, Harwood JM, Tseng CH, Moin T, Mangione C, Duru OK, Takada S, Onufrak S. The effectiveness of care coordination on medication adherence among high-need, high-cost commercially insured beneficiaries: A randomized controlled trial. J Manag Care Spec Pharm. 2026 May;32(5):540-550. doi: 10.18553/jmcp.2026.32.5.540.
PubMed 42043924Duru OK, Harwood J, Moin T, Takada S, Tseng CH, Saju R, Lee E, Fatehpuria A, Mangione CM. Care Coordination for High-Need, High-Cost Commercially Insured Patients: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2511804. doi: 10.1001/jamanetworkopen.2025.11804.
PubMed 40553475
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Care Coordination Expansion Pilot - A Quality Improvement Study
- ClinicalTrials.gov ID
- NCT04415515
- Acronym / sponsor ID
- UHC100023A
- Conditions
- Superutilizers, Health Care Utilization
- Keywords
- Care coordination, case management, superutilizers, health care utilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Academic partnership between UHC and UCLA was terminated effective December 31, 2023
- Enrolment
- 592,023 participants (actual)
- Lead sponsor
- UnitedHealthcareUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Behavioral: RN case management, Behavioral: RN Standard care coordination and disease managementRN Standard care coordination and disease management + RN Case Management |
| Control | Experimental | Behavioral: RN Standard care coordination and disease managementRN Standard care coordination and disease management |
| Treatment 2 | Experimental | Behavioral: Community Health Worker Case Management, Behavioral: RN Standard care coordination and disease managementRN Standard care coordination and disease management + Community Health Worker Case Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- : 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RN case managementA 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). | Behavioural | Treatment 1 |
| Community Health Worker Case ManagementIn 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). | Behavioural | Treatment 2 |
| RN Standard care coordination and disease managementRN Standard care coordination and disease management | Behavioural | Control, Treatment 1, Treatment 2 |
Primary outcome
Total Cost
Time frame: 24 months
Defined as total plan cost (medical and pharmacy) per member
Acute Inpatient Admission Rate
Time frame: 24 months
Defined as acute inpatient admissions per 1,000 qualified members
Emergency Room Visit Rate
Time frame: 24 months
Defined as the number of emergency room visits per 1,000 qualified members
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)
23 secondary outcomes
Risk of Acute Inpatient Admission
Time frame: 12, 18, 24, 36, 48 months
All-Cause 30-Day Readmission Risk
Time frame: 12, 18, 24, 36, 48 months
Outpatient Emergency Room Visit Rate
Time frame: 12, 18, 24, 36, 48 months
Risk of Emergency Room Visit
Time frame: 12, 18, 24, 36, 48 months
Primary Care Physician Visit Rate
Time frame: 12, 18, 24, 36, 48 months
Specialist Physician Visit Rate
Time frame: 12, 18, 24, 36, 48 months
Cardiovascular Disease
Time frame: 12, 18, 24, 36, 48 months
Diabetes-related complications (DCSI)
Time frame: 12, 18, 24, 36, 48 months
Amputations
Time frame: 12, 18, 24, 36, 48 months
Chronic Kidney Disease
Time frame: 12, 18, 24, 36, 48 months
Glycemic Control
Time frame: 12, 18, 24, 36, 48 months
Adherence to Diabetes-Related Medications
Time frame: 12, 18, 24, 36, 48 months
Adherence to Diabetes-Related Processes of Care
Time frame: 12, 18, 24, 36, 48 months
Total Plan and Member Cost
Time frame: 12, 18, 24, 36, 48 months
Diabetes Complications Count
Time frame: 12, 18, 24, 36, 48 months
Any Acute Inpatient Admission
Time frame: 12, 18, 24, 36, 48 months
Any Emergency Room Visit
Time frame: 12, 18, 24, 36, 48 months
Cerebrovascular disease/stroke
Time frame: 12, 18, 24, 36, 48 months
Peripheral vascular disease
Time frame: 12, 18, 24, 36, 48 months
Nephropathy
Time frame: 12, 18, 24, 36, 48 months
Retinopathy
Time frame: 12, 18, 24, 36, 48 months
Neuropathy
Time frame: 12, 18, 24, 36, 48 months
Metabolic complications such as ketoacidosis, hyperosmolar, or other coma
Time frame: 12, 18, 24, 36, 48 months
Results and safety
The study was stopped early (reason given: Academic partnership between UHC and UCLA was terminated effective December 31, 2023). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Derived from this study: PubMed 42043924Saju R, Harwood JM, Tseng CH, Moin T, Mangione C, Duru OK, Takada S, Onufrak S. The effectiveness of care coordination on medication adherence among high-need, high-cost commercially insured beneficiaries: A randomized controlled trial. J Manag Care Spec Pharm. 2026 May;32(5):540-550. doi: 10.18553/jmcp.2026.32.5.540.
- Derived from this study: PubMed 40553475Duru OK, Harwood J, Moin T, Takada S, Tseng CH, Saju R, Lee E, Fatehpuria A, Mangione CM. Care Coordination for High-Need, High-Cost Commercially Insured Patients: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2511804. doi: 10.1001/jamanetworkopen.2025.11804.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony V Pirrello, MS principal investigator
UnitedHealthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RN case management and Community Health Worker Case Management in people with Superutilizers, Health Care Utilization, run by UnitedHealthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Academic partnership between UHC and UCLA was terminated effective December 31, 2023). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cost (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415515, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025; AzTrials last refreshed its copy on 4 Nov 2026.