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Ambulatory ICU Study for Medically and Socially Complex Patients (SUMMIT)

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ClinicalTrials.gov Identifier: NCT03224858
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Brian L Chan, 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.

Condition or disease Intervention/treatment Phase
Health Services Comorbidity Primary Health Care Other: SUMMIT intervention Other: Enhanced usual care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Health Services Research
Official 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
Actual Study Start Date : September 27, 2016
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : July 30, 2019

Arm Intervention/treatment
Experimental: SUMMIT intervention group
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
See description in experimental arm.
Other Name: intensive primary care team, complex care team

Active Comparator: enhanced usual care group
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 active comparator arm.
Other Name: usual care




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224858


Contacts
Contact: Brian Chan, MD 5034942010 chanbri@ohsu.edu

Locations
United States, Oregon
Central City Concern Recruiting
Portland, Oregon, United States, 97209
Contact: Rachel Solotaroff, MD    971-271-6084    Rachel.Solotaroff@ccconcern.org   
Principal Investigator: Brian Chan, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Brian Chan, MD Assistant Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian L Chan, assistant professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03224858     History of Changes
Other Study ID Numbers: 15285
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian L Chan, Oregon Health and Science University:
Patient-Centered Care
Comorbidity