Ambulatory ICU Study for Medically and Socially Complex Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Health Services, Comorbidity, Primary Health Care

Intervention / Treatment
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* Other: SUMMIT intervention
* Other: Enhanced usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUMMIT intervention group<br>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<br>* See description in experimental arm.<br>* Other names: intensive primary care team, complex care team;|
| Active Comparator: enhanced usual care group<br>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<br>* See description in active comparator arm.<br>* Other names: usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Chaos | Study survey of a validated instrument to assess self-reported life chaos | 6 months | 
| inpatient costs of care | claims data for patients will be used to determine costs of inpatient care | 6 months | 
| inpatient average length of stay | Administrative data will be used to determine average length of stay each hospitalization | 6 months | 
| Functional status using Short Form (SF)-12 survey | patient reported survey of functional status | 6 months | 
| number of falls | Study survey with question asking how many falls over the last 6 months | 6 months | 
| Edmonton Symptom Assessment Scale (ESAS) palliative measure | Study survey with one question from the ESAS questionaire | 6 months | 
| Medical Hospitalizations | Administrative data will be used to determine hospital admissions | 12 months | 
| Emergency Care visits | Administrative data will be used to determine ED visits | 12 months | 
| Patient Activation Measure (PAM) | Study survey of the PAM measure is a validated instrument to assess patient self-efficacy | 12 months | 
| Primary care utilization | Clinic administrative data will be used to determine primary care visits over study period | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-Centered Care, Comorbidity