Skip to content

Ambulatory ICU Study for Medically and Socially Complex Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03224858
Acronym
SUMMIT
Enrollment
200
Registered
2017-07-21
Start date
2016-09-27
Completion date
2021-12-30
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comorbidity, Health Services, Primary Health Care

Keywords

Patient-Centered Care, Comorbidity

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.

Interventions

OTHERSUMMIT intervention

See description in experimental arm.

OTHEREnhanced usual care

See description in active comparator arm.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Medical Hospitalizations6 monthsAdministrative data will be used to determine hospital admissions
Emergency Care visits6 monthsAdministrative data will be used to determine Emergency Department (ED) visits over study period
Primary care utilization6 monthsClinic administrative data will be used to determine primary care visits over study period
Patient Activation Measure (PAM)6 monthsStudy survey of the PAM measure is a validated instrument to assess patient self-efficacy
Patient Experience (ambulatory CAHPS)6 monthsStudy survey of patient reported assessment of patient experience

Secondary

MeasureTime frameDescription
Life Chaos6 monthsStudy survey of a validated instrument to assess self-reported life chaos
inpatient costs of care6 monthsclaims data for patients will be used to determine costs of inpatient care
inpatient average length of stay6 monthsAdministrative data will be used to determine average length of stay each hospitalization
Functional status using Short Form (SF)-12 survey6 monthspatient reported survey of functional status
number of falls6 monthsStudy survey with question asking how many falls over the last 6 months
Edmonton Symptom Assessment Scale (ESAS) palliative measure6 monthsStudy survey with one question from the ESAS questionaire
Medical Hospitalizations12 monthsAdministrative data will be used to determine hospital admissions
Emergency Care visits12 monthsAdministrative data will be used to determine ED visits
Patient Activation Measure (PAM)12 monthsStudy survey of the PAM measure is a validated instrument to assess patient self-efficacy
Primary care utilization12 monthsClinic administrative data will be used to determine primary care visits over study period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026