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San Francisco Health Plan Care Support Trial (SFHP_CBCM)

14 de enero de 2019 actualizado por: Maria Raven, MD, University of California, San Francisco

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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

292

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • San Francisco, California, Estados Unidos, 94105
        • San Francisco Health Plan

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

  • Under age 18
  • Not a SFHP member

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Care Support Intervention
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.
Case management and care coordination intervention delivered in person to SFHP members who are frequent users of emergency department and inpatient hospital services.
Sin intervención: Usual Care
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ED visits
Periodo de tiempo: 9-18 months
Difference in the number of ED visits comparing intervention and usual care groups
9-18 months
Hospital admissions
Periodo de tiempo: 9-18 months
Difference in the number of hospital admissions comparing intervention and usual care groups
9-18 months
Hospital bed days
Periodo de tiempo: 9-18 months
Difference in the number of hospital bed days comparing intervention and usual care groups
9-18 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Primary care visits
Periodo de tiempo: 9-18 months
Difference in the number of primary care visits comparing intervention and usual care groups
9-18 months
Cost of health care services
Periodo de tiempo: 9-18 months
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
9-18 months
Net program costs
Periodo de tiempo: 9-18 months
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.
9-18 months
Mental health
Periodo de tiempo: Baseline, 6 month follow-up, 12 month follow up if still enrolled
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.
Baseline, 6 month follow-up, 12 month follow up if still enrolled
Patient satisfaction
Periodo de tiempo: Baseline, 6 month follow-up, 12 month follow up if still enrolled
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.
Baseline, 6 month follow-up, 12 month follow up if still enrolled
Self-reported health
Periodo de tiempo: Baseline, 6 month follow-up, 12 month follow up if still enrolled
Self reported health will be evaluated for the intervention group only and will include a question from the SF-8.
Baseline, 6 month follow-up, 12 month follow up if still enrolled

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2015

Finalización primaria (Actual)

1 de diciembre de 2018

Finalización del estudio (Actual)

1 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

27 de mayo de 2015

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2015

Publicado por primera vez (Estimar)

4 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de enero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

14 de enero de 2019

Última verificación

1 de enero de 2019

Más información

Términos relacionados con este estudio

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