Clinical trial NCT03224858: Ambulatory ICU Study for Medically and Socially Complex Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Services
Comorbidity
Primary Health Care
Keywords: Patient-Centered Care
Comorbidity
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pragmatic "wait-list" control design. Participants will be consented and baseline survey administered after which patient will be randomized by computer generated algorithm into 2 arms: immediate or 6-month 'wait-list.' Immediate group will start intervention and be followed at 6 month intervals for 12 months. 'Wait-list' group will resume usual care for 6-months, after which they will cross-over to the intervention group for 12 months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

• 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

And/OR:

• One or more of the following behavioral health diagnoses:

* psychotic disorder
* mood disorder
* post-traumatic stress disorder
* active substance use disorder

And/OR

• 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Medical Hospitalizations
timeFrame: 6 months
measure: Emergency Care visits
timeFrame: 6 months
measure: Primary care utilization
timeFrame: 6 months
measure: Patient Activation Measure (PAM)
timeFrame: 6 months
measure: Patient Experience (ambulatory CAHPS)
timeFrame: 6 months
Secondary outcomes:
measure: Life Chaos
timeFrame: 6 months
measure: inpatient costs of care
timeFrame: 6 months
measure: inpatient average length of stay
timeFrame: 6 months
measure: Functional status using Short Form (SF)-12 survey
timeFrame: 6 months
measure: number of falls
timeFrame: 6 months
measure: Edmonton Symptom Assessment Scale (ESAS) palliative measure
timeFrame: 6 months
measure: Medical Hospitalizations
timeFrame: 12 months
measure: Emergency Care visits
timeFrame: 12 months
measure: Patient Activation Measure (PAM)
timeFrame: 12 months
measure: Primary care utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Central City Concern
state: Oregon
Study officials:
affiliation: Assistant Professor
name: Brian Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan B, Edwards ST, Devoe M, Gil R, Mitchell M, Englander H, Nicolaidis C, Kansagara D, Saha S, Korthuis PT. The SUMMIT ambulatory-ICU primary care model for medically and socially complex patients in an urban federally qualified health center: study design and rationale. Addict Sci Clin Pract. 2018 Dec 14;13(1):27. doi: 10.1186/s13722-018-0128-y.
citation: Chan B, Hulen E, Edwards S, Mitchell M, Nicolaidis C, Saha S. "It's Like Riding Out the Chaos": Caring for Socially Complex Patients in an Ambulatory Intensive Care Unit (A-ICU). Ann Fam Med. 2019 Nov;17(6):495-501. doi: 10.1370/afm.2464.