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Completed

NCT Number: NCT03224858

Ambulatory ICU Study for Medically and Socially Complex Patients

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central City Concern

Portland, Oregon, 97209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SUMMIT intervention

Other

See description in experimental arm.

Other names: intensive primary care team, complex care team

Enhanced usual care

Other

See description in active comparator arm.

Other names: usual care

Primary outcomes

  1. Medical Hospitalizations

    Time frame: 6 months

    Administrative data will be used to determine hospital admissions

  2. Emergency Care visits

    Time frame: 6 months

    Administrative data will be used to determine Emergency Department (ED) visits over study period

  3. Primary care utilization

    Time frame: 6 months

    Clinic administrative data will be used to determine primary care visits over study period

  4. Patient Activation Measure (PAM)

    Time frame: 6 months

    Study survey of the PAM measure is a validated instrument to assess patient self-efficacy

  5. Patient Experience (ambulatory CAHPS)

    Time frame: 6 months

    Study survey of patient reported assessment of patient experience

Secondary outcomes

  1. Life Chaos

    Time frame: 6 months

    Study survey of a validated instrument to assess self-reported life chaos

  2. inpatient costs of care

    Time frame: 6 months

    claims data for patients will be used to determine costs of inpatient care

  3. inpatient average length of stay

    Time frame: 6 months

    Administrative data will be used to determine average length of stay each hospitalization

  4. Functional status using Short Form (SF)-12 survey

    Time frame: 6 months

    patient reported survey of functional status

  5. number of falls

    Time frame: 6 months

    Study survey with question asking how many falls over the last 6 months

  6. Edmonton Symptom Assessment Scale (ESAS) palliative measure

    Time frame: 6 months

    Study survey with one question from the ESAS questionaire

  7. Medical Hospitalizations

    Time frame: 12 months

    Administrative data will be used to determine hospital admissions

  8. Emergency Care visits

    Time frame: 12 months

    Administrative data will be used to determine ED visits

  9. Patient Activation Measure (PAM)

    Time frame: 12 months

    Study survey of the PAM measure is a validated instrument to assess patient self-efficacy

  10. Primary care utilization

    Time frame: 12 months

    Clinic administrative data will be used to determine primary care visits over study period

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study 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

Acronym: SUMMIT

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jul 21, 2017
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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