Standard Care Coordination Expansion Pilot

NCT04415515 | Terminated

• 2 other identifiers: UHC100023ADP006128
• Study Type: interventional
• Target: 592,023
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Total Cost

  Defined as total plan cost (medical and pharmacy) per member

  24 months

• Acute Inpatient Admission Rate

  Defined as acute inpatient admissions per 1,000 qualified members

  24 months

• Emergency Room Visit Rate

  Defined as the number of emergency room visits per 1,000 qualified members

  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)

  24 months

Secondary Outcomes (23)

• Risk of Acute Inpatient Admission

  12, 18, 24, 36, 48 months

• All-Cause 30-Day Readmission Risk

  12, 18, 24, 36, 48 months

• Outpatient Emergency Room Visit Rate

  12, 18, 24, 36, 48 months

• Risk of Emergency Room Visit

  12, 18, 24, 36, 48 months

• Primary Care Physician Visit Rate

  12, 18, 24, 36, 48 months

Study Arms (3)

Treatment 1

EXPERIMENTAL

RN Standard care coordination and disease management + RN Case Management

Behavioral: RN case management; Behavioral: RN Standard care coordination and disease management

Control

EXPERIMENTAL

RN Standard care coordination and disease management

Behavioral: RN Standard care coordination and disease management

Treatment 2

EXPERIMENTAL

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

Behavioral: Community Health Worker Case Management; Behavioral: RN Standard care coordination and disease management

Interventions

RN case management 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).

Treatment 1

Community Health Worker Case Management 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).

Treatment 2

RN Standard care coordination and disease management BEHAVIORAL

RN Standard care coordination and disease management

Control; Treatment 1; Treatment 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• : 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)

Sponsors & Collaborators

• UnitedHealthcare: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

UnitedHealthcare

Minnetonka, Minnesota, 55343, United States

Location

Related Publications (1)

• 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.

  PMID: 40553475 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Study Officials

• Anthony V Pirrello, MS

  UnitedHealthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director UHC E&I Healthcare Econ

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)