Standard Care Coordination Expansion Pilot

NCT ID: NCT04415515

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 592023 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2023-12-31

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.

Conditions

Superutilizers, Health Care Utilization

Keywords

Care coordination, case management, superutilizers, health care utilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment 1

RN Standard care coordination and disease management + RN Case Management

Group Type: EXPERIMENTAL

RN case management

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

RN Standard care coordination and disease management

Control

RN Standard care coordination and disease management

Group Type: EXPERIMENTAL

RN Standard care coordination and disease management

Intervention Type: BEHAVIORAL

RN Standard care coordination and disease management

Treatment 2

RN Standard care coordination and disease management + Community Health Worker Case Management

Group Type: EXPERIMENTAL

Community Health Worker Case Management

Intervention Type: BEHAVIORAL

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 management

Intervention Type: BEHAVIORAL

RN Standard care coordination and disease management

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

RN Standard care coordination and disease management

RN Standard care coordination and disease management

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

UnitedHealthcare

OTHER

Sponsor Role: lead

Responsible Party

Anthony Pirrello

Director UHC E&I Healthcare Econ

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony V Pirrello, MS

Role: PRINCIPAL_INVESTIGATOR

UnitedHealthcare

Locations

UnitedHealthcare

Minnetonka, Minnesota, United States

Countries

United States

References

Duru 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.

Reference Type: DERIVED

PMID: 40553475 (View on PubMed)

Other Identifiers

DP006128

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UHC100023A

Identifier Type: -

Identifier Source: org_study_id