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Ambulatory ICU Study for Medically and Socially Complex Patients

Not Applicable
Completed
Conditions
Primary Health Care
Health Services
Comorbidity
Interventions
Other: SUMMIT intervention
Other: Enhanced usual care
Registration Number
NCT03224858
Lead Sponsor
Oregon Health and Science University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SUMMIT intervention groupSUMMIT interventionThis 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.
enhanced usual care groupEnhanced usual careThis 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.
Primary Outcome Measures
NameTimeMethod
Emergency Care visits6 months

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

Primary care utilization6 months

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

Patient Activation Measure (PAM)6 months

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

Patient Experience (ambulatory CAHPS)6 months

Study survey of patient reported assessment of patient experience

Medical Hospitalizations6 months

Administrative data will be used to determine hospital admissions

Secondary Outcome Measures
NameTimeMethod
Life Chaos6 months

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

Medical Hospitalizations12 months

Administrative data will be used to determine hospital admissions

Functional status using Short Form (SF)-12 survey6 months

patient reported survey of functional status

Emergency Care visits12 months

Administrative data will be used to determine ED visits

inpatient costs of care6 months

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

inpatient average length of stay6 months

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

Edmonton Symptom Assessment Scale (ESAS) palliative measure6 months

Study survey with one question from the ESAS questionaire

Patient Activation Measure (PAM)12 months

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

number of falls6 months

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

Primary care utilization12 months

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

Trial Locations

Locations (1)

Central City Concern

🇺🇸

Portland, Oregon, United States

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