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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Health Care; Health Services; Comorbidity
• Intervention / Treatment: Other: SUMMIT intervention; Other: Enhanced usual care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97209
      • Central City Concern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: SUMMIT intervention; See description in experimental arm.; Other Names: intensive primary care team, complex care team
ACTIVE_COMPARATOR: 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.	Other: Enhanced usual care; See description in active comparator arm.; Other Names: usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Hospitalizations	Administrative data will be used to determine hospital admissions	6 months
Emergency Care visits	Administrative data will be used to determine Emergency Department (ED) visits over study period	6 months
Primary care utilization	Clinic administrative data will be used to determine primary care visits over study period	6 months
Patient Activation Measure (PAM)	Study survey of the PAM measure is a validated instrument to assess patient self-efficacy	6 months
Patient Experience (ambulatory CAHPS)	Study survey of patient reported assessment of patient experience	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Brian Chan, MD, Assistant Professor

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2016
• Primary Completion (ACTUAL): August 28, 2020
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Comorbidity; Patient-Centered Care
• Other Study ID Numbers: 15285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon request, the investigators can share de-identified, cleaned IPD for other researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No