Health ServicesSUMMITNCT03224858
Ambulatory ICU Study for Medically and Socially Complex Patients
A study testing SUMMIT intervention in people with Health Services and Comorbidity, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Services, Comorbidity, Primary Health Care
- What is being tested?
- SUMMIT intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2016to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Health Services, Comorbidity, Primary Health Care
- Being tested
- SUMMIT intervention, Enhanced usual care
- Keywords
- Patient-Centered Care, Comorbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUMMIT interventionOther
Also called intensive primary care team, complex care team
See description in experimental arm.
Enhanced usual careOther
Also called usual care
See description in active comparator arm.
| Study group | Role | What they receive |
|---|---|---|
| SUMMIT intervention group | Experimental | 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. Receives: Other: SUMMIT intervention |
| enhanced usual care group | Active comparator | 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. Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Hospitalizations
Administrative data will be used to determine hospital admissions
Measured: 6 months
Emergency Care visits
Administrative data will be used to determine Emergency Department (ED) visits over study period
Measured: 6 months
Primary care utilization
Clinic administrative data will be used to determine primary care visits over study period
Measured: 6 months
Patient Activation Measure (PAM)
Study survey of the PAM measure is a validated instrument to assess patient self-efficacy
Measured: 6 months
Patient Experience (ambulatory CAHPS)
Study survey of patient reported assessment of patient experience
Measured: 6 months
Secondary outcomes (10)
Life Chaos
Study survey of a validated instrument to assess self-reported life chaos
Measured: 6 months
inpatient costs of care
claims data for patients will be used to determine costs of inpatient care
Measured: 6 months
inpatient average length of stay
Administrative data will be used to determine average length of stay each hospitalization
Measured: 6 months
Functional status using Short Form (SF)-12 survey
patient reported survey of functional status
Measured: 6 months
number of falls
Study survey with question asking how many falls over the last 6 months
Measured: 6 months
Edmonton Symptom Assessment Scale (ESAS) palliative measure
Study survey with one question from the ESAS questionaire
Measured: 6 months
Medical Hospitalizations
Administrative data will be used to determine hospital admissions
Measured: 12 months
Emergency Care visits
Administrative data will be used to determine ED visits
Measured: 12 months
Patient Activation Measure (PAM)
Study survey of the PAM measure is a validated instrument to assess patient self-efficacy
Measured: 12 months
Primary care utilization
Clinic administrative data will be used to determine primary care visits over study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start27 Sep 2016
- Primary completion28 Aug 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian L Chan, Oregon Health and Science University
- Investigators
- Brian Chan, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224858
- Sponsor's protocol ID
- 15285
- Acronym
- SUMMIT
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2017
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request, the investigators can share de-identified, cleaned IPD for other researchers.
Publications
Chan B, Edwards ST, Devoe M, Gil R, Mitchell M, Englander H, Nicolaidis C, Kansagara D, Saha S, Korthuis PT. The SUMMIT ambulatory-ICU primary care model for medically and socially complex patients in an urban federally qualified health center: study design and rationale. Addict Sci Clin Pract. 2018 Dec 14;13(1):27. doi: 10.1186/s13722-018-0128-y.
PubMed 30547847Chan B, Hulen E, Edwards S, Mitchell M, Nicolaidis C, Saha S. "It's Like Riding Out the Chaos": Caring for Socially Complex Patients in an Ambulatory Intensive Care Unit (A-ICU). Ann Fam Med. 2019 Nov;17(6):495-501. doi: 10.1370/afm.2464.
PubMed 31712287Chan B, Cook R, Levander X, Wiest K, Hoffman K, Pertl K, Petluri R, McCarty D, Korthuis PT, Martin SA. Buprenorphine discontinuation in telehealth-only treatment for opioid use disorder: A longitudinal cohort analysis. J Subst Use Addict Treat. 2024 Dec;167:209511. doi: 10.1016/j.josat.2024.209511. Epub 2024 Sep 5.
PubMed 39243979Chan B, Edwards ST, Srikanth P, Mitchell M, Devoe M, Nicolaidis C, Kansagara D, Korthuis PT, Solotaroff R, Saha S. Ambulatory Intensive Care for Medically Complex Patients at a Health Care Clinic for Individuals Experiencing Homelessness: The SUMMIT Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342012. doi: 10.1001/jamanetworkopen.2023.42012.
PubMed 37948081
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03224858
- Acronym / sponsor ID
- SUMMIT / 15285
- Conditions
- Health Services, Comorbidity, Primary Health Care
- Keywords
- Patient-Centered Care, Comorbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SUMMIT intervention group | Experimental | Other: SUMMIT 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 group | Active comparator | Other: Enhanced 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- One or more of the following medical diagnoses:
- congestive heart failure
- uncontrolled diabetes
- end stage liver disease
- chronic kidney disease (stage III or higher)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUMMIT interventionAlso: intensive primary care team, complex care teamSee description in experimental arm. | Other | SUMMIT intervention group |
| Enhanced usual careAlso: usual careSee description in active comparator arm. | Other | enhanced usual care group |
Primary outcome
Medical Hospitalizations
Time frame: 6 months
Administrative data will be used to determine hospital admissions
Emergency Care visits
Time frame: 6 months
Administrative data will be used to determine Emergency Department (ED) visits over study period
Primary care utilization
Time frame: 6 months
Clinic administrative data will be used to determine primary care visits over study period
Patient Activation Measure (PAM)
Time frame: 6 months
Study survey of the PAM measure is a validated instrument to assess patient self-efficacy
Patient Experience (ambulatory CAHPS)
Time frame: 6 months
Study survey of patient reported assessment of patient experience
10 secondary outcomes
Life Chaos
Time frame: 6 months
inpatient costs of care
Time frame: 6 months
inpatient average length of stay
Time frame: 6 months
Functional status using Short Form (SF)-12 survey
Time frame: 6 months
number of falls
Time frame: 6 months
Edmonton Symptom Assessment Scale (ESAS) palliative measure
Time frame: 6 months
Medical Hospitalizations
Time frame: 12 months
Emergency Care visits
Time frame: 12 months
Patient Activation Measure (PAM)
Time frame: 12 months
Primary care utilization
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 30547847Chan B, Edwards ST, Devoe M, Gil R, Mitchell M, Englander H, Nicolaidis C, Kansagara D, Saha S, Korthuis PT. The SUMMIT ambulatory-ICU primary care model for medically and socially complex patients in an urban federally qualified health center: study design and rationale. Addict Sci Clin Pract. 2018 Dec 14;13(1):27. doi: 10.1186/s13722-018-0128-y.
- Background: PubMed 31712287Chan B, Hulen E, Edwards S, Mitchell M, Nicolaidis C, Saha S. "It's Like Riding Out the Chaos": Caring for Socially Complex Patients in an Ambulatory Intensive Care Unit (A-ICU). Ann Fam Med. 2019 Nov;17(6):495-501. doi: 10.1370/afm.2464.
- Derived from this study: PubMed 39243979Chan B, Cook R, Levander X, Wiest K, Hoffman K, Pertl K, Petluri R, McCarty D, Korthuis PT, Martin SA. Buprenorphine discontinuation in telehealth-only treatment for opioid use disorder: A longitudinal cohort analysis. J Subst Use Addict Treat. 2024 Dec;167:209511. doi: 10.1016/j.josat.2024.209511. Epub 2024 Sep 5.
- Derived from this study: PubMed 37948081Chan B, Edwards ST, Srikanth P, Mitchell M, Devoe M, Nicolaidis C, Kansagara D, Korthuis PT, Solotaroff R, Saha S. Ambulatory Intensive Care for Medically Complex Patients at a Health Care Clinic for Individuals Experiencing Homelessness: The SUMMIT Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342012. doi: 10.1001/jamanetworkopen.2023.42012.
- Individual participant dataSharing planned: Yes. upon request, the investigators can share de-identified, cleaned IPD for other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Chan, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUMMIT intervention in people with Health Services and Comorbidity, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Hospitalizations (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224858, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.