Ambulatory ICU Study for Medically and Socially Complex Patients (SUMMIT)

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Primary Health Care; Health Services; Comorbidity

Treatments: Other: Enhanced usual care; Other: SUMMIT intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03224858

15285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

SUMMIT intervention group

Experimental group

Description:

This group will transfer primary care to the SUMMIT team, which consists of: 1 primary care provider, 1 clinical nurse, 1 team manager, 2 care-coordinators, 2 behavioralists, 1 clinical pharmacist. This interdisciplinary team will have reduced patient panel load and increased flexibility in time and scheduling in order to foster trust and continuity with the patient with a goal of decreasing treatment burden and increasing patient capacity. Specific activities that participants will receive include: 1) comprehensive initial intake and care plan development that incorporates patient goal setting; 2) flexible scheduling of appointments with outreach; 3) transitional care coordination; 4) built-in behavioural counselling and case management; 5) regular review of care plan by team members.

Treatment:

Other: SUMMIT intervention

enhanced usual care group

Active Comparator group

Description:

This group will continue to receive primary care as usual for 6 months. This includes care provided by the patient's existing primary care provider, access to a clinic's Health Resilience outreach worker, mental health consultation, and other services provided by usual care. After 6 months, the baseline survey is administered and the participant will transfer care to the intervention as described above in the SUMMIT intervention group.

Treatment:

Other: Enhanced usual care