NCT02463838

Brief Summary

This study will expand and evaluate an existing pilot program to improve care for frequent users of acute emergency and inpatient services by providing care coordination and management for eligible San Francisco Health Plan members. SF Health Plan's Community-Based Care Management pilot program ("Program") known as "CareSupport" serves vulnerable SF Health Plan members who are high utilizers of hospital inpatient and emergency departments and at extremely high risk for mortality and morbidity due to factors such as housing instability, mental illness, and addiction. Care managers, called community coordinators, are trained bachelor-level social workers or outreach workers and each have a panel of 30-35 members who they directly engage in the community where the members tend to live or congregate (shelters, bus stops, coffee shops, community agencies, and by cell phone) to help them improve their health and navigate through the health care and social services systems. The number of San Francisco Health Plan members who would be eligible for Care Support services far outstrips the capacity the San Francisco Health Plan to provide these additional services, and the investigators will thus evaluate the intervention using a randomized trial design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

May 27, 2015

Last Update Submit

January 14, 2019

Conditions

Keywords

Medi-CalHealth PlanFrequent UsersHeavy usersCare CoordinationManaged CareCase ManagementMental HealthSubstance UseEmergency Department

Outcome Measures

Primary Outcomes (3)

  • ED visits

    Difference in the number of ED visits comparing intervention and usual care groups

    9-18 months

  • Hospital admissions

    Difference in the number of hospital admissions comparing intervention and usual care groups

    9-18 months

  • Hospital bed days

    Difference in the number of hospital bed days comparing intervention and usual care groups

    9-18 months

Secondary Outcomes (6)

  • Primary care visits

    9-18 months

  • Cost of health care services

    9-18 months

  • Net program costs

    9-18 months

  • Mental health

    Baseline, 6 month follow-up, 12 month follow up if still enrolled

  • Patient satisfaction

    Baseline, 6 month follow-up, 12 month follow up if still enrolled

  • +1 more secondary outcomes

Study Arms (2)

Care Support Intervention

EXPERIMENTAL

Eligible members are assigned a CareSupport Coordinator who carries a caseload of 25-35 members. A team of 5 Coordinators is supervised by a master's level Social Worker. Community Coordinators work with members to conduct standardized assessments to develop a Care Plan shared with other providers within and outside of SFHP. Coordinators provide members advocacy and navigation across systems of care, to improve coordination focus on treatment goals. Coordinator focus on prevention and early intervention around disease management, advocacy, appointment reminders and accompaniment, home visits, and regular communication with primary care and other providers. Coordinators are encouraged to be accountable for coordinating and following through on all aspects of a member's needs.

Other: Care Support Intervention

Usual Care

NO INTERVENTION

All eligible SFHP members randomized to usual care will receive medical and health plan by virtue of enrollment in the SFHP and Medi-Cal. Services include assignment to a primary care physician and access to all services available through Medi-Cal in the county of San Francisco.

Interventions

Case management and care coordination intervention delivered in person to SFHP members who are frequent users of emergency department and inpatient hospital services.

Care Support Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible, SFHP members must have one of three health service use patterns in the prior 12 months:
  • or more hospital admissions
  • ED visits and 1 hospital admission
  • or more ED visits
  • Must be aged 18 or older

You may not qualify if:

  • Under age 18
  • Not a SFHP member

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Health Plan

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Psychological Well-BeingSubstance-Related DisordersEmergencies

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 4, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations