- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02463838
San Francisco Health Plan Care Support Trial (SFHP_CBCM)
San Francisco Health Plan Care Support Intervention: A Randomized Trial
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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California
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San Francisco, California, Соединенные Штаты, 94105
- San Francisco Health Plan
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: 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.
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Case management and care coordination intervention delivered in person to SFHP members who are frequent users of emergency department and inpatient hospital services.
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Без вмешательства: 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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
ED visits
Временное ограничение: 9-18 months
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Difference in the number of ED visits comparing intervention and usual care groups
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9-18 months
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Hospital admissions
Временное ограничение: 9-18 months
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Difference in the number of hospital admissions comparing intervention and usual care groups
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9-18 months
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Hospital bed days
Временное ограничение: 9-18 months
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Difference in the number of hospital bed days comparing intervention and usual care groups
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9-18 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Primary care visits
Временное ограничение: 9-18 months
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Difference in the number of primary care visits comparing intervention and usual care groups
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9-18 months
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Cost of health care services
Временное ограничение: 9-18 months
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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
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9-18 months
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Net program costs
Временное ограничение: 9-18 months
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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.
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9-18 months
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Mental health
Временное ограничение: Baseline, 6 month follow-up, 12 month follow up if still enrolled
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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.
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Baseline, 6 month follow-up, 12 month follow up if still enrolled
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Patient satisfaction
Временное ограничение: Baseline, 6 month follow-up, 12 month follow up if still enrolled
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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.
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Baseline, 6 month follow-up, 12 month follow up if still enrolled
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Self-reported health
Временное ограничение: Baseline, 6 month follow-up, 12 month follow up if still enrolled
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Self reported health will be evaluated for the intervention group only and will include a question from the SF-8.
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Baseline, 6 month follow-up, 12 month follow up if still enrolled
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 14-14737
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Care Support Intervention
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University of MinnesotaMayo Clinic; Minneapolis Veterans Affairs Medical Center; United States Department...РекрутингБремя воспитателя | Стрессовый синдром опекуна | Выгорание опекунаСоединенные Штаты
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Butler HospitalNational Institute of Mental Health (NIMH)ЗавершенныйПсихотическое расстройствоСоединенные Штаты
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Butler HospitalNational Institute of Mental Health (NIMH)ЗавершенныйПсихотические расстройстваСоединенные Штаты
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Karolinska InstitutetЗавершенный
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Brigham and Women's HospitalNational Institute on Aging (NIA)ЗавершенныйРевматические заболевания | Красная волчанка, системная | Приверженность, лекарства | ПодаграСоединенные Штаты
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Meghan MarsacChildren's Hospital of PhiladelphiaЗавершенный
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Seton Healthcare FamilyUniversity of Texas at AustinЗавершенныйКачество жизни | Хроническое заболевание | Хроническое заболеваниеСоединенные Штаты
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University Medical Center GroningenGGZ Drenthe Mental Health InstitutionРекрутингСердечно-сосудистый риск | Депрессия, униполярная | Депрессия, биполярное расстройствоНидерланды
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Kessler FoundationUniversity of Southern California; VA Office of Research and Development; Kessler Institute... и другие соавторыНеизвестныйТравматическое повреждение мозгаСоединенные Штаты
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University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)РекрутингДоконтактная профилактика ВИЧСоединенные Штаты