Comorbidities and Coexisting ConditionsNCT04375189
High Risk Outpatient Intern-led Care (HeROIC) Clinic Initiative
A study testing High Risk Clinic in people with Comorbidities and Coexisting Conditions and Risk Reduction, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidities and Coexisting Conditions, Risk Reduction, Emergencies
- What is being tested?
- High Risk Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 20 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 6 medical comorbidities
- ≥ 2 admissions past 6 months or ≥ 4 past 1 year
- New or returning patient in resident primary care clinic
Who cannot join
- Primary mental health disease driving hospitalizations
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: 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.
- Being tested
- High Risk Clinic
- Keywords
- High utilizer, High needs, Multimorbidity, Intensive outpatient care, Resident education
- Medical subject headings
- Risk Reduction Behavior, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Risk ClinicOther
Subgroup of primary care clinic where patients have longer time slots, supervision by one longitudinal attending, "bedside" presentations
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Not described |
| Complex Clinic Arm | Experimental | Not described Receives: Other: High Risk Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Inpatient or ER visits
Presentations to the ER and hospitalizations
Measured: Up to 2 years post enrollment
Secondary outcomes (1)
Total medical cost
Total medical costs (Outpatient, Inpatient, Imaging, Labs)
Measured: Up to 2 years post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jul 2016
- Primary completion1 Jul 2022 (estimated)
- Study completion20 Jul 2022
Why it stopped: Covid-19, funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comorbidities and Coexisting ConditionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Epstein, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375189
- Sponsor's protocol ID
- IRB00137125
- Status last verified
- Jul 2022
- First submitted
- 1 May 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Novel Complex Outpatient Clinic Setup on Patient Outcomes and Intern Education
- ClinicalTrials.gov ID
- NCT04375189
- Acronym / sponsor ID
- IRB00137125
- Keywords
- High utilizer, High needs, Multimorbidity, Intensive outpatient care, Resident education
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19, funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 5 May 2020 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | – |
| Complex Clinic Arm | Experimental | Other: High Risk Clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 6 medical comorbidities
- ≥ 2 admissions past 6 months or ≥ 4 past 1 year
- New or returning patient in resident primary care clinic
Key exclusion criteria (1 listed)
- Primary mental health disease driving hospitalizations
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 |
|---|---|---|
| High Risk ClinicSubgroup of primary care clinic where patients have longer time slots, supervision by one longitudinal attending, "bedside" presentations | Other | Complex Clinic Arm |
Primary outcome
Number of Inpatient or ER visits
Time frame: Up to 2 years post enrollment
Presentations to the ER and hospitalizations
1 secondary outcome
Total medical cost
Time frame: Up to 2 years post enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Comorbidities and Coexisting Conditions
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2/3
Evaluating Smoking Cessation Interventions for PWH in South Africa
Smoking Cessation, HIV
RecruitingObservational study
Frailty in Outpatient Digestive Endoscopy
Frailty, Comorbidities and Coexisting Conditions
Recruiting
eCardiacRehab - a Hybrid Patient-Centered eHealth Programme
Comorbidities and Coexisting Conditions, Ethics
Active, not recruiting
Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity
Asthma Bronchiale, Breast Neoplasms
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.
Jeremy Epstein principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Risk Clinic in people with Comorbidities and Coexisting Conditions and Risk Reduction, run by Johns Hopkins 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Jul 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Inpatient or ER visits (time frame: Up to 2 years post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2022.