Ambulatory ICU Study for Medically and Socially Complex Patients

Primary Health Care Clinical Trial

— SUMMIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224858
• Other study ID #: 15285
• Status: Completed
• Phase: N/A
• Start date: September 27, 2016
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2021
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Comorbidity
• Health Services
• Primary Health Care

Intervention

Other:
• SUMMIT intervention
See description in experimental arm.
• Enhanced usual care
See description in active comparator arm.

Locations

Country	Name	City	State
United States	Central City Concern	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Hospitalizations	Administrative data will be used to determine hospital admissions	6 months
Primary	Emergency Care visits	Administrative data will be used to determine Emergency Department (ED) visits over study period	6 months
Primary	Primary care utilization	Clinic administrative data will be used to determine primary care visits over study period	6 months
Primary	Patient Activation Measure (PAM)	Study survey of the PAM measure is a validated instrument to assess patient self-efficacy	6 months
Primary	Patient Experience (ambulatory CAHPS)	Study survey of patient reported assessment of patient experience	6 months
Secondary	Life Chaos	Study survey of a validated instrument to assess self-reported life chaos	6 months
Secondary	inpatient costs of care	claims data for patients will be used to determine costs of inpatient care	6 months
Secondary	inpatient average length of stay	Administrative data will be used to determine average length of stay each hospitalization	6 months
Secondary	Functional status using Short Form (SF)-12 survey	patient reported survey of functional status	6 months
Secondary	number of falls	Study survey with question asking how many falls over the last 6 months	6 months
Secondary	Edmonton Symptom Assessment Scale (ESAS) palliative measure	Study survey with one question from the ESAS questionaire	6 months
Secondary	Medical Hospitalizations	Administrative data will be used to determine hospital admissions	12 months
Secondary	Emergency Care visits	Administrative data will be used to determine ED visits	12 months
Secondary	Patient Activation Measure (PAM)	Study survey of the PAM measure is a validated instrument to assess patient self-efficacy	12 months
Secondary	Primary care utilization	Clinic administrative data will be used to determine primary care visits over study period	12 months