Ambulatory ICU Study for Medically and Socially Complex Patients

NCT03224858 | Completed DMC

• 1 other identifier: 15285
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Services; Comorbidity; Primary Health Care

Keywords

Patient-Centered Care; Comorbidity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Life Chaos

  6 months

• inpatient costs of care

  6 months

• inpatient average length of stay

  6 months

• Functional status using Short Form (SF)-12 survey

  6 months

• number of falls

  6 months

Study Arms (2)

SUMMIT intervention group

EXPERIMENTAL

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

enhanced usual care group

ACTIVE COMPARATOR

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

Interventions

SUMMIT intervention OTHER

See description in experimental arm.

Also known as: intensive primary care team, complex care team

SUMMIT intervention group

Enhanced usual care OTHER

See description in active comparator arm.

Also known as: usual care

enhanced usual care group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Central City Concern

Portland, Oregon, 97209, United States

Location

Related Publications (4)

• 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.

  PMID: 30547847 BACKGROUND

• 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.

  PMID: 31712287 BACKGROUND

• 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.

  PMID: 39243979 DERIVED

• 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.

  PMID: 37948081 DERIVED

Study Officials

• Brian Chan, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, care providers, investigator, and initial trained research assistant will be blinded initially during consent and baseline interview survey procedures. Once, randomization has occurred, the participants, care provider, investigator, and subsequent outcomes assessor will not be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 21, 2017
• Study Start: September 27, 2016
• Primary Completion: August 28, 2020
• Study Completion: December 30, 2021
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)