High Risk Outpatient Intern-led Care (HeROIC) Clinic Initiative
Primary Purpose
Comorbidities and Coexisting Conditions, Risk Reduction, Emergencies
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Risk Clinic
Sponsored by
About this trial
This is an interventional other trial for Comorbidities and Coexisting Conditions focused on measuring High utilizer, High needs, Multimorbidity, Intensive outpatient care, Resident education
Eligibility Criteria
Inclusion Criteria:
- ≥ 6 medical comorbidities
- ≥ 2 admissions past 6 months or ≥ 4 past 1 year
- New or returning patient in resident primary care clinic
Exclusion Criteria:
- Primary mental health disease driving hospitalizations
Sites / Locations
- Johns Hopkins Outpatient Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
Complex Clinic Arm
Arm Description
Outcomes
Primary Outcome Measures
Number of Inpatient or ER visits
Presentations to the ER and hospitalizations
Secondary Outcome Measures
Total medical cost
Total medical costs (Outpatient, Inpatient, Imaging, Labs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04375189
Brief Title
High Risk Outpatient Intern-led Care (HeROIC) Clinic Initiative
Official Title
Impact of a Novel Complex Outpatient Clinic Setup on Patient Outcomes and Intern Education
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Covid-19, funding
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background: A small subset of the patient population is responsible for a significant proportion of healthcare expenditures. These patients are cared for in academic medical centers by internal medicine residents however there has been no research to date about the education or the management of patients with complex multimorbidity in the outpatient setting.
Objective: To evaluate the impact of the High Risk Outpatient Intern-led Care (HeROIC) Clinic on internal medicine interns' perceived ability to manage complex outpatients as well as pre and post intervention total patient healthcare cost.
Methods: The investigators created the HeROIC outpatient clinic environment to comprise longer visit time slots, "bedside" presentations, and team-based care (one intern primary care provider, one secondary intern, and one longitudinal attending). All non-preliminary interns based at one primary care site participated in the intervention while interns at a second site continued to practice in the usual outpatient clinic environment. The interns in the HeROIC clinic arm assumed the roles of primary care providers for 34 complex patients in total. The primary outcome was the perceived confidence in the management of complex outpatients as assessed by a survey. Secondary outcomes included perceptions about the ability to provide high-quality outpatient and evidence-based outpatient care, as well as statewide pre-post patient healthcare cost data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Comorbidities and Coexisting Conditions, Risk Reduction, Emergencies
Keywords
High utilizer, High needs, Multimorbidity, Intensive outpatient care, Resident education
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Title
Complex Clinic Arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High Risk Clinic
Intervention Description
Subgroup of primary care clinic where patients have longer time slots, supervision by one longitudinal attending, "bedside" presentations
Primary Outcome Measure Information:
Title
Number of Inpatient or ER visits
Description
Presentations to the ER and hospitalizations
Time Frame
Up to 2 years post enrollment
Secondary Outcome Measure Information:
Title
Total medical cost
Description
Total medical costs (Outpatient, Inpatient, Imaging, Labs)
Time Frame
Up to 2 years post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 6 medical comorbidities
≥ 2 admissions past 6 months or ≥ 4 past 1 year
New or returning patient in resident primary care clinic
Exclusion Criteria:
Primary mental health disease driving hospitalizations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Epstein
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High Risk Outpatient Intern-led Care (HeROIC) Clinic Initiative
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