High Risk Outpatient Intern-led Care (HeROIC) Clinic Initiative

Impact of a Novel Complex Outpatient Clinic Setup on Patient Outcomes and Intern Education

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.

Study Overview

• Status: Withdrawn
• Conditions: Emergencies; Risk Reduction; Comorbidities and Coexisting Conditions
• Intervention / Treatment: Other: High Risk Clinic

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care
Experimental: Complex Clinic Arm	Other: High Risk Clinic; Subgroup of primary care clinic where patients have longer time slots, supervision by one longitudinal attending, "bedside" presentations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Inpatient or ER visits	Presentations to the ER and hospitalizations	Up to 2 years post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total medical cost	Total medical costs (Outpatient, Inpatient, Imaging, Labs)	Up to 2 years post enrollment

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Jeremy Epstein, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Multimorbidity; High utilizer; High needs; Intensive outpatient care; Resident education
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: IRB00137125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No