- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02463838
San Francisco Health Plan Care Support Trial (SFHP_CBCM)
San Francisco Health Plan Care Support Intervention: A Randomized Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
San Francisco, California, Spojené státy, 94105
- San Francisco Health Plan
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Žádný zásah: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
ED visits
Časové okno: 9-18 months
|
Difference in the number of ED visits comparing intervention and usual care groups
|
9-18 months
|
Hospital admissions
Časové okno: 9-18 months
|
Difference in the number of hospital admissions comparing intervention and usual care groups
|
9-18 months
|
Hospital bed days
Časové okno: 9-18 months
|
Difference in the number of hospital bed days comparing intervention and usual care groups
|
9-18 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Primary care visits
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 14-14737
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Správa případů
-
Ohio State UniversityStaženoManagement medikamentózní terapie | Management léků | Odhadované vyhnutí se nákladům | MTM
-
Wolfson Medical CenterNeznámýOvládnutí bolesti | Postchirurgický management | Management zánětuIzrael
-
Vanderbilt University Medical CenterThe Gerber FoundationDokončeno
-
Schulthess KlinikZatím nenabírámeKrevní management pacienta
-
Geisinger ClinicStaženo
-
University Hospital, ToulouseDokončenoManagement medikamentózní terapieFrancie
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityAktivní, ne náborPDCA Circular ManagementČína
-
University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, FranceDokončenoManagement medikamentózní terapieFrancie
Klinické studie na Care Support Intervention
-
Rahel NaefSwiss National Science FoundationNáborKvalita života | Posttraumatická stresová porucha | Deprese, úzkost | Syndrom postintenzivní péče | Členové rodiny | Rodinná dynamikaŠvýcarsko
-
Duke UniversityNational Institute of Nursing Research (NINR)DokončenoObezita | Kardiovaskulární onemocnění | Rakovina | Diabetes typu II | Peer Support a Chronická nemocSpojené státy
-
Temple UniversityNational Institute of Mental Health (NIMH)Dokončeno
-
Shanghai 6th People's HospitalUniversity of North Carolina, Chapel Hill; Asian Center for Health Education; Shanghai Municipal Commission of Health and Family PlanningDokončenoDiabetes mellitus 2. typuČína
-
MRC/UVRI and LSHTM Uganda Research UnitKarolinska Institutet; University of California, San Francisco; European and... a další spolupracovníciNábor
-
Ohio State UniversityCambia Health FoundationZápis na pozvánkuDemence | Rodinný pečovatel | Peer SupportSpojené státy
-
Shared Decision Making ResourcesEMD Serono; Multiple Sclerosis Association of AmericaDokončenoRoztroušená sklerózaSpojené státy
-
McMaster UniversityNiagara Community Foundation; United Way Niagara; Niagara Poverty Reduction Network a další spolupracovníciUkončenoZdravotní chování | Využití zdravotní péče | Bezdomovectví | Chování při hledání zdravotní péčeKanada
-
University of ZimbabweDokončeno
-
University of TorontoQueen's UniversityDokončenoIschemická choroba srdečníKanada