An interventional study of SUMMIT intervention and Enhanced usual care in Health Services, Comorbidity and Primary Health Care, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Health services research
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.
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.
Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
And/OR:
And/OR
Exclusion Criteria:
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
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 experimental arm.
Also known as: intensive primary care team, complex care team
See description in active comparator arm.
Also known as: usual care
Medical Hospitalizations
Administrative data will be used to determine hospital admissions
Time frame: 6 months
Emergency Care visits
Administrative data will be used to determine Emergency Department (ED) visits over study period
Time frame: 6 months
Primary care utilization
Clinic administrative data will be used to determine primary care visits over study period
Time frame: 6 months
Patient Activation Measure (PAM)
Study survey of the PAM measure is a validated instrument to assess patient self-efficacy
Time frame: 6 months
Patient Experience (ambulatory CAHPS)
Study survey of patient reported assessment of patient experience
Time frame: 6 months
Life Chaos
Study survey of a validated instrument to assess self-reported life chaos
Time frame: 6 months
inpatient costs of care
claims data for patients will be used to determine costs of inpatient care
Time frame: 6 months
inpatient average length of stay
Administrative data will be used to determine average length of stay each hospitalization
Time frame: 6 months
Functional status using Short Form (SF)-12 survey
patient reported survey of functional status
Time frame: 6 months
number of falls
Study survey with question asking how many falls over the last 6 months
Time frame: 6 months
Edmonton Symptom Assessment Scale (ESAS) palliative measure
Study survey with one question from the ESAS questionaire
Time frame: 6 months
Medical Hospitalizations
Administrative data will be used to determine hospital admissions
Time frame: 12 months
Emergency Care visits
Administrative data will be used to determine ED visits
Time frame: 12 months
Patient Activation Measure (PAM)
Study survey of the PAM measure is a validated instrument to assess patient self-efficacy
Time frame: 12 months
Primary care utilization
Clinic administrative data will be used to determine primary care visits over study period
Time frame: 12 months
Plan to share: Yes — upon request, the investigators can share de-identified, cleaned IPD for other researchers.
Supporting information: Study protocol, Icf
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University