Standard Care Coordination Expansion Pilot

Sponsor

UnitedHealthcare (Other)

Overall Status

Recruiting

CT.gov ID

NCT04415515

Collaborator

University of California, Los Angeles (Other)

592,023

Enrollment

Location

Arms

Anticipated Duration (Months)

7047.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Superutilizers, Health Care Utilization	Behavioral: RN case management Behavioral: Community Health Worker Case Management Behavioral: RN Standard care coordination and disease management	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

592023 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Standard Care Coordination Expansion Pilot - A Quality Improvement Study

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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: 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). Behavioral: RN Standard care coordination and disease management RN Standard care coordination and disease management

Arm

Intervention/Treatment

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: 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).

Behavioral: RN Standard care coordination and disease management

RN Standard care coordination and disease management

Outcome Measures

Primary Outcome Measures

Total Cost [24 months]
Defined as total plan cost (medical and pharmacy) per member
Acute Inpatient Admission Rate [24 months]
Defined as acute inpatient admissions per 1,000 qualified members
Emergency Room Visit Rate [24 months]
Defined as the number of emergency room visits per 1,000 qualified members
Diabetes-Related Complications [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)

Secondary Outcome Measures

Risk of Acute Inpatient Admission [12, 18, 24, 36, 48 months]
Defined as time to first acute inpatient admission
All-Cause 30-Day Readmission Risk [12, 18, 24, 36, 48 months]
Defined as first acute inpatient readmission for all-causes within 30 days of index acute inpatient discharge
Outpatient Emergency Room Visit Rate [12, 18, 24, 36, 48 months]
Defined as emergency room visits per 1,000 qualified members per year
Risk of Emergency Room Visit [12, 18, 24, 36, 48 months]
Defined as time to first emergency room visit
Primary Care Physician Visit Rate [12, 18, 24, 36, 48 months]
Defined as primary care physician visits per qualified member
Specialist Physician Visit Rate [12, 18, 24, 36, 48 months]
Defined as specialist physician visits per qualified member
Cardiovascular Disease [12, 18, 24, 36, 48 months]
Defined as percentage of members with cardiovascular disease
Diabetes-related complications (DCSI) [12, 18, 24, 36, 48 months]
Amputations [12, 18, 24, 36, 48 months]
Defined as lower extremity amputations per 1,000 qualified members
Chronic Kidney Disease [12, 18, 24, 36, 48 months]
Defined as attenuated decline of eGFR, for members with baseline eGFR below 60mL/min
Glycemic Control [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
Adherence to Diabetes-Related Medications [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
Adherence to Diabetes-Related Processes of Care [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
Total Plan and Member Cost [12, 18, 24, 36, 48 months]
Defined as total (plan+member) cost per member
Diabetes Complications Count [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]).
Any Acute Inpatient Admission [12, 18, 24, 36, 48 months]
Defined as the number of members with any Acute Inpatient Admission per 1,000 qualified members
Any Emergency Room Visit [12, 18, 24, 36, 48 months]
Defined as the number of members with any emergency room visit per 1,000 qualified members
Cerebrovascular disease/stroke [12, 18, 24, 36, 48 months]
Defined as percentage of members with Cerebrovascular disease/stroke
Peripheral vascular disease [12, 18, 24, 36, 48 months]
Defined as percentage of members with Peripheral vascular disease
Nephropathy [12, 18, 24, 36, 48 months]
Defined as percentage of members with Nephropathy
Retinopathy [12, 18, 24, 36, 48 months]
Defined as percentage of members with Retinopathy
Neuropathy [12, 18, 24, 36, 48 months]
Defined as percentage of members with Neuropathy
Metabolic complications such as ketoacidosis, hyperosmolar, or other coma [12, 18, 24, 36, 48 months]
Defined as percentage of members with metabolic complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UnitedHealthcare	Minnetonka	Minnesota	United States	55343

Sponsors and Collaborators

UnitedHealthcare
University of California, Los Angeles

Investigators

Principal Investigator: Ayae Yamamoto, PhD, UnitedHealthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayae Yamamoto, Director Healthcare Economics, UnitedHealthcare

ClinicalTrials.gov Identifier:

NCT04415515

Other Study ID Numbers:

UHC100023A
DP006128

First Posted:

Jun 4, 2020

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayae Yamamoto, Director Healthcare Economics, UnitedHealthcare

Care coordination, case management, superutilizers, health care utilization

Study Results

No Results Posted as of Oct 26, 2021