Ambulatory ICU Study for Medically and Socially Complex Patients

NCT ID: NCT03224858

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-27
• Study Completion Date: 2021-12-30

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.

Conditions

Health Services; Comorbidity; Primary Health Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

SUMMIT intervention group

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.

Group Type: EXPERIMENTAL

SUMMIT intervention

Intervention Type: OTHER

See description in experimental arm.

enhanced usual care group

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.

Group Type: ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type: OTHER

See description in active comparator arm.

Interventions

SUMMIT intervention

See description in experimental arm.

Intervention Type: OTHER

Enhanced usual care

See description in active comparator arm.

Intervention Type: OTHER

Other Intervention Names

intensive primary care team, complex care team; usual care

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Brian L Chan

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Central City Concern

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30547847 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31712287 (View on PubMed)

Chan B, Cook R, Levander X, Wiest K, Hoffman K, Pertl K, Petluri R, McCarty D, Korthuis PT, Martin SA. Buprenorphine discontinuation in telehealth-only treatment for opioid use disorder: A longitudinal cohort analysis. J Subst Use Addict Treat. 2024 Dec;167:209511. doi: 10.1016/j.josat.2024.209511. Epub 2024 Sep 5.

Reference Type: DERIVED

PMID: 39243979 (View on PubMed)

Chan B, Edwards ST, Srikanth P, Mitchell M, Devoe M, Nicolaidis C, Kansagara D, Korthuis PT, Solotaroff R, Saha S. Ambulatory Intensive Care for Medically Complex Patients at a Health Care Clinic for Individuals Experiencing Homelessness: The SUMMIT Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342012. doi: 10.1001/jamanetworkopen.2023.42012.

Reference Type: DERIVED

PMID: 37948081 (View on PubMed)

Other Identifiers

15285

Identifier Type: -

Identifier Source: org_study_id