Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03224858
Other study ID # 15285
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2016
Est. completion date December 30, 2021

Study information

Verified date February 2023
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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 information / eligibility

Status Completed
Enrollment 200
Est. completion date December 30, 2021
Est. primary completion date August 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
SUMMIT intervention
See description in experimental arm.
Enhanced usual care
See description in active comparator arm.

Locations

Country Name City State
United States Central City Concern Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Chan 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Medical Hospitalizations Administrative data will be used to determine hospital admissions 6 months
Primary Emergency Care visits Administrative data will be used to determine Emergency Department (ED) visits over study period 6 months
Primary Primary care utilization Clinic administrative data will be used to determine primary care visits over study period 6 months
Primary Patient Activation Measure (PAM) Study survey of the PAM measure is a validated instrument to assess patient self-efficacy 6 months
Primary Patient Experience (ambulatory CAHPS) Study survey of patient reported assessment of patient experience 6 months
Secondary Life Chaos Study survey of a validated instrument to assess self-reported life chaos 6 months
Secondary inpatient costs of care claims data for patients will be used to determine costs of inpatient care 6 months
Secondary inpatient average length of stay Administrative data will be used to determine average length of stay each hospitalization 6 months
Secondary Functional status using Short Form (SF)-12 survey patient reported survey of functional status 6 months
Secondary number of falls Study survey with question asking how many falls over the last 6 months 6 months
Secondary Edmonton Symptom Assessment Scale (ESAS) palliative measure Study survey with one question from the ESAS questionaire 6 months
Secondary Medical Hospitalizations Administrative data will be used to determine hospital admissions 12 months
Secondary Emergency Care visits Administrative data will be used to determine ED visits 12 months
Secondary Patient Activation Measure (PAM) Study survey of the PAM measure is a validated instrument to assess patient self-efficacy 12 months
Secondary Primary care utilization Clinic administrative data will be used to determine primary care visits over study period 12 months
See also
  Status Clinical Trial Phase
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Recruiting NCT04151056 - Impact of the Social Determinants of Health in the Central Catalan Region
Recruiting NCT05715151 - Continuous Quality Improvement Cohorts on Advanced Access N/A
Completed NCT01242319 - Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice N/A
Recruiting NCT06155292 - Report Cards and Feedback for PCCE N/A
Completed NCT02955433 - The Impact of Rideshare Transportation Services on Appointment Adherence N/A
Completed NCT02266069 - PROject - Supportive and Palliative Care and INnOvation - Antwerp (Pro-Spinoza) N/A
Recruiting NCT04702711 - Experiences of Anger in Patients in Primary Health Care With Symptoms of Generalized Anxiety
Completed NCT04521816 - PIM 2.0: Patient Aligned Care Team (PACT) Intensive Management (PIM) Project N/A
Recruiting NCT05709860 - An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy N/A
Completed NCT05121688 - Effectiveness of a Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care. N/A
Completed NCT05329246 - Validation of PMcardio AI-assisted Clinical Assistant in Primary Care N/A
Completed NCT02953925 - National-wide Survey on Primary Health Care in China N/A
Completed NCT03100526 - Patient Aligned Care Team (PACT) Intensive Management (PIM) Project N/A
Active, not recruiting NCT04585191 - Reducing Treatment Risk in Older Adults With Diabetes N/A
Recruiting NCT05609981 - Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug Dispensing Systems N/A
Completed NCT04688359 - Effectiveness of Nurse-coordinated Follow-up Program in Primary Care for People at Risk for T2DM N/A
Completed NCT04237883 - Primary Care Clinical Excellence Incentive Study N/A
Withdrawn NCT04010136 - Identification of Elderly Patients in Need of Palliative Care by Family Physicians N/A
Completed NCT04183504 - Screening for Therapy and Empowering Parents: A Pilot Study N/A