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Case ManagementSFHP_CBCMNCT02463838

San Francisco Health Plan Care Support Trial

A study testing Care Support Intervention in people with Case Management and Managed Care Program, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Case Management, Managed Care Program
What is being tested?
Care Support Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
1 siteUnited States
Study dates
May 2015to Dec 2018
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

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

Who cannot join

  • Under age 18
  • Not a SFHP member

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Francisco Health Plan

    San Francisco, California, 94105

Other trials in United States

About this study

Official title: San Francisco Health Plan Care Support Intervention: A Randomized Trial

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.

Read the detailed description

Purpose: The purpose of the CareSupport intervention is to coordinate often-fragmented care for SFHP members with heavy use of acute health care services, reducing cost of care for the San Francisco safety net (the San Francisco Department of Health and San Francisco General Hospital) while increasing use of sustaining services including primary care.

The Program: The San Francisco Health Plan (SFHP) CareSupport program identifies high-utilizing SFHP members with high risk for mortality and morbidity due to factors that complicate underlying illness and care seeking patterns. These factors include housing instability, behavioral health issues, and complex medical illness. This population's medical, behavioral and social needs are not met by the existing delivery system, and while many issues they face may not be traditionally perceived as health care, they do impact this vulnerable population's health and care seeking patterns greatly.

CareSupport Community Coordinators each carry a caseload of 25-35 eligible members identified based on health services use in the prior 12 months. Each team of 5 Coordinators is supervised by a skilled master's level Social Worker. Community Coordinators outreach to eligible patients and conduct detailed assessments in order to develop a Care Plan that is then shared with other providers within and outside of SFHP. Community Coordinators provide patient-centered, community-based advocacy and navigation across systems of care, to improve coordination and unify health and treatment goals. The CareSupport program incorporates a focus on prevention and early intervention within a continuum of quality health care that includes disease management, advocacy, appointment reminders and accompaniment, home visits, and regular communication with primary care and other providers. Community Coordinators are accountable for coordinating and following through on all aspects of a member's needs, and their duties are as variable as reminder calls, accompaniment to medical appointments, assistance with housing placement, and help obtaining food and other services. Twice weekly team meetings involve complex case reviews and program troubleshooting as well as mini trainings led by social work supervisors. The staff is trained in trauma-informed care, motivational interviewing, harm reduction, and other areas of relevance to the intervention target population.

The investigators' composed of 3 groups of SFHP members, all of whom are heavy users of health care services: 1) members with a minimum of 2 hospitalizations in the year before enrollment 2) members with 5 ED visits and 1 hospitalization in the year before enrollment, and 3) members with 6 or more ED visits in the year before enrollment in the investigators' program.

The current CareSupport staff does not have the capacity to serve all SFHP members who are eligible for CareSupport. The investigators propose to ethically allocate limited resources and evaluate the impact of CareSupport using a randomly selected comparison group of non-enrolled, CareSupport eligible SFHP members.

Randomization

Randomization process: First, eligible members will be rank ordered by descending age, then based first on number of hospital admissions in the prior year, and finally by number of ED visits in the prior year. SFHP members falling into the CareSupport target population based on their utilization in the prior 12 months will be assigned using a standard "every other" technique to either the CareSupport program (the intervention) or to the comparison group that will not be offered enrollment. This technique will result in a "member pair," where one member from the pair will be randomly assigned to the CareSupport intervention and one member of the pair will be randomly assigned to the comparison group. For the purposes of the evaluation, the member pair will share the same engagement date (see below).

The investigators will use an intention to treat framework: all SFHP members assigned to CareSupport or the comparison group will remain in those groups for the analysis.

Outcomes and Evaluation Methods As mentioned above, SFHP has enrollment, demographic and encounter/claims data for all SFHP members and these data will be used to conduct the investigators' analysis. The investigators' primary outcomes can be tracked based on administrative encounter data, and will include member services use across San Francisco rather than being limited to a single hospital or small network of clinics.

A central goal of the investigators' evaluation is to determine whether the CareSupport demonstration project generates more savings to the delivery system than it costs to implement and sustain. The ability of the CareSupport program to succeed in this goal will help determine whether it is sustainable and exportable to other sites. The investigators anticipate that the CBCM model will produce cost-savings both by employing less expensive, more appropriately-trained staff, as well as by connecting vulnerable members more effectively to primary and preventive care, and social and behavioral resources, thereby reducing their use of acute care.

Being tested
Care Support Intervention
Keywords
Medi-Cal, Health Plan, Frequent Users, Heavy users, Care Coordination, Managed Care, Case Management, Mental Health, Substance Use, Emergency Department
Medical subject headings
Psychological Well-Being, Substance-Related Disorders, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care Support InterventionOther

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

Study groups in NCT02463838
Study groupRoleWhat they receive
Care Support InterventionExperimentalEligible 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.
Receives: Other: Care Support Intervention
Usual CareNo interventionAll 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ED visits

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

    Measured: 9-18 months

  2. Hospital admissions

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

    Measured: 9-18 months

  3. Hospital bed days

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

    Measured: 9-18 months

Secondary outcomes (6)
  1. Primary care visits

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

    Measured: 9-18 months

  2. Cost of health care services

    Difference in costs associated with ED visits, hospital admissions, and primary care visits comparing intervention and usual care groups, using standard Medi-Cal reimbursement rates

    Measured: 9-18 months

  3. Net program costs

    Comparative cost analysis that examines differences in Medi-Cal reimbursements in comparison to SFHP program costs (e.g. staffing, overhead). we plan to track not only the health service use costs outlined above (by assigning standard Medi-Cal reimbursement rates to each service), but also costs related to the CareSupport program such as staffing costs, supplies, and transportation via a comprehensive economic analysis.

    Measured: 9-18 months

  4. Mental health

    Depression will be evaluated for the intervention group only, and will include depression based on the PHQ-2. Changes in scores will be assessed at baseline and 6-month follow-up as a standard part of the CareSupport assessment and follow-up process conducted by the CareSupport Community Coordinators.

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

  5. Patient satisfaction

    Satisfaction will be evaluated for the intervention group only, and will include depression based on the PHQ-9. Changes in scores will be assessed at baseline and 6-month follow-up as a standard part of the CareSupport assessment and follow-up process conducted by the CareSupport Community Coordinators.

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

  6. Self-reported health

    Self reported health will be evaluated for the intervention group only and will include a question from the SF-8.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02463838
Sponsor's protocol ID
14-14737
Acronym
SFHP_CBCM
Status last verified
Jan 2019
First submitted
27 May 2015
Last updated
15 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Care Support Intervention in people with Case Management and Managed Care Program, run by University of California, San Francisco 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jan 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ED visits (time frame: 9-18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Jan 2019.

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