跳至主要内容
临床试验/NCT03224858
NCT03224858已完成不适用

Does a Clinic Based Complex Care Coordination Intervention Improve Patient Quality Outcomes in an Underserved Clinic Population? the Streamlined, Unified, Meaningfully Managed Interdisciplinary Team (SUMMIT) Ambulatory ICU Study

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Emergency Care visits

研究概览

简要总结

This is a prospective randomized wait-list control study to determine whether a stand-alone, co-located team of physician, mental health behaviorist, and care coordinators with decreased panel size (aka "intensive primary care") will reduce inpatient and emergency care utilization, inpatient costs of care, and improve patient activation and experience for medically and socially complex patients, compared to enhanced usual care at 6 and 12 months. Participants with multiple co-morbidities, and meet utilization criteria will have the opportunity to enroll; half the participants will start the intervention immediately, while half will continue enhanced usual care for 6 months before beginning the intervention.

详细描述

The goal of this study is to conduct an evaluation of an "Ambulatory-ICU" model of primary care for "high utilizer" patients with medical, behavioral, and social complexity. A small proportion of patients use > 50 % of healthcare resources. It is currently unknown what interventions can help reduce inappropriate utilization due to lack of studies with rigorous study design, particularly in patients with high rates of homelessness, mental illness and substance use. The use of high-risk teams for select patients is a promising model of primary care that removes barriers to accessing usual care services by centralizing medical and behavioral clinical services, promotes ability to outreach beyond the clinic, and promote continuity of care and trust-building between patient and provider teams.

This study will test the hypothesis that a stand-alone clinic based intervention of a multidisciplinary, co-located physician, mental health behaviorist, nursing, pharmacist, and care coordinators with reduced panel size, and focus on patient capacity building and decreasing treatment burden will improve health outcomes at 6 and 12 months in a low-income high utilizer population with history of homelessness.

Enhanced usual care comprises of care delivered at Old Town Clinic (OTC) a Federally Qualified Health Center (FQHC) that is modeled on the Patient Centered Medical Home (PCMH) model. Patients have a designated primary care physician and care team with access to chronic disease education, mental health, social work, and substance abuse programs through referral system. In addition, participants thought to have difficulty engaging in primary care have access to a Health Resilience Specialist, a community health worker intervention who conducts outreach and assists the patient in care navigation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Participants, care providers, investigator, and initial trained research assistant will be blinded initially during consent and baseline interview survey procedures. Once, randomization has occurred, the participants, care provider, investigator, and subsequent outcomes assessor will not be blinded.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • One or more of the following medical diagnoses:
  • congestive heart failure
  • uncontrolled diabetes
  • end stage liver disease
  • chronic kidney disease (stage III or higher)
  • chronic obstructive pulmonary disease (group C or D)
  • chronic or severe soft tissue infections or ulcers
  • osteomyelitis
  • failure to thrive
  • One or more of the following behavioral health diagnoses:
  • psychotic disorder
  • mood disorder
  • post-traumatic stress disorder
  • active substance use disorder
  • One or more of the following utilization patterns:
  • 1+ medical hospital admission in prior 6 months
  • frequent missed appointments (cancel or no-show for >5 primary care or specialty appointments in previous 12 months

排除标准

  • Non-English speaking
  • Patients on hospice, nursing home, rehabilitation, or other institutional or long term care facility
  • Inability to consent (as demonstrated by teach back of the consent process)
  • Diagnosis of metastatic brain cancer
  • Inability to participate in follow up phone due to aphasia, severe hearing impairment, or lack of access to telephone

结局指标

主要结局

Emergency Care visits

时间窗: 6 months

Administrative data will be used to determine Emergency Department (ED) visits over study period

Primary care utilization

时间窗: 6 months

Clinic administrative data will be used to determine primary care visits over study period

Patient Activation Measure (PAM)

时间窗: 6 months

Study survey of the PAM measure is a validated instrument to assess patient self-efficacy

Patient Experience (ambulatory CAHPS)

时间窗: 6 months

Study survey of patient reported assessment of patient experience

Medical Hospitalizations

时间窗: 6 months

Administrative data will be used to determine hospital admissions

次要结局

  • Life Chaos(6 months)
  • Medical Hospitalizations(12 months)
  • Functional status using Short Form (SF)-12 survey(6 months)
  • Emergency Care visits(12 months)
  • inpatient costs of care(6 months)
  • inpatient average length of stay(6 months)
  • Edmonton Symptom Assessment Scale (ESAS) palliative measure(6 months)
  • Patient Activation Measure (PAM)(12 months)
  • number of falls(6 months)
  • Primary care utilization(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian L Chan

assistant professor

Oregon Health and Science University

研究点 (2)

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