Chronic IllnessNCT01797068
Patient Navigation for Medicaid Frequent ED Users
A study testing Patient Navigator in people with Chronic Illness, run by Yale University at 1 site in United States.
Trial summary
A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED) visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported health status, quality of life… Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Chronic Illness
- What is being tested?
- Patient Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2015
- 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 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 4-18 ED visits per year
- Frequent ED users
- age 18 to 62
- Medicaid insurance only
- Those living in the greater New Haven area (i.e. having a zip code that matches that)
Who cannot join
- the current visit for primary psychiatric or substance abuse
- more than 50% of all ED visits in the past year for primary psychiatric or substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Navigation to Improve Care and Reduce Costs for High Utilizers of the Emergency Department
A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED) visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported health status, quality of life, access/barriers to care) among Medicaid patients who are high utilizers of the ED, as well as to identify best practices for engaging and providing healthcare services to underserved patients using patient navigation. This study will address needs that have been identified within the New Haven community and the local healthcare system, contribute to knowledge and literature surrounding the use of patient navigation to improve care for underserved patients and improve health system efficiency, and inform the design and development of programs that address these needs both locally and in other communities.
- Conditions
- Chronic Illness
- Being tested
- Patient Navigator, Standard of Care
- Keywords
- HEALTHCARE UTILIZATION, ED UTILIZATION, PRIMARY CARE UTILIZATION, PATIENT NAVIGATION, UNDERSERVED POPULATIONS, HEALTH DISPARITIES
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigatorBehavioural
Patients in the intervention group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH), a local non-profit organization that coordinates the provision of donated medical care and services to underserved patients through a network of participating hospitals and volunteer physicians.
Standard of CareOther
Patients in the standard of care group will experience the usual intake process in the ED setting.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigator | Experimental | Patients in the experimental group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH). Receives: Behavioral: Patient Navigator |
| Standard of Care | Active comparator | Patients in the active comparator group will experience the usual intake process in the ED setting. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ED visits
Additional outcomes include number of hospitalizations, number of outpatient visits, and outpatient imaging utilization.
Measured: One Year
Secondary outcomes (3)
Number of hospitalizations
Measured: One Year
Number of outpatient visits
Measured: One Year
Costs by analyzing global use with Medicaid claims data
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by Yale 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797068
- Sponsor's protocol ID
- 1007007154
- Status last verified
- Nov 2016
- First submitted
- 20 Feb 2013
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation to Improve Care and Reduce Costs for High Utilizers of the Emergency Department
- ClinicalTrials.gov ID
- NCT01797068
- Acronym / sponsor ID
- 1007007154
- Conditions
- Chronic Illness
- Keywords
- HEALTHCARE UTILIZATION, ED UTILIZATION, PRIMARY CARE UTILIZATION, PATIENT NAVIGATION, UNDERSERVED POPULATIONS, HEALTH DISPARITIES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- First posted
- 22 Feb 2013 (estimated)
- 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.
A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED) visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported health status, quality of life, access/barriers to care) among Medicaid patients who are high utilizers of the ED, as well as to identify best practices for engaging and providing healthcare services to underserved patients using patient navigation. This study will address needs that have been identified within the New Haven community and the local healthcare system, contribute to knowledge and literature surrounding the use of patient navigation to improve care for underserved patients and improve health system efficiency, and inform the design and development of programs that address these needs both locally and in other communities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigator | Experimental | Behavioral: Patient NavigatorPatients in the experimental group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH). |
| Standard of Care | Active comparator | Other: Standard of CarePatients in the active comparator group will experience the usual intake process in the ED setting. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 4-18 ED visits per year
- Frequent ED users
- age 18 to 62
- Medicaid insurance only
- Those living in the greater New Haven area (i.e. having a zip code that matches that)
Key exclusion criteria (2 listed)
- the current visit for primary psychiatric or substance abuse
- more than 50% of all ED visits in the past year for primary psychiatric or substance abuse.
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 |
|---|---|---|
| Patient NavigatorPatients in the intervention group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH), a local non-profit organization that coordinates the provision of donated medical care and services to underserved patients through a network of participating hospitals and volunteer physicians. | Behavioural | Patient Navigator |
| Standard of CarePatients in the standard of care group will experience the usual intake process in the ED setting. | Other | Standard of Care |
Primary outcome
Number of ED visits
Time frame: One Year
Additional outcomes include number of hospitalizations, number of outpatient visits, and outpatient imaging utilization.
3 secondary outcomes
Number of hospitalizations
Time frame: One Year
Number of outpatient visits
Time frame: One Year
Costs by analyzing global use with Medicaid claims data
Time frame: One year
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 30 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator in people with Chronic Illness, run by Yale 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 5 inclusion and 2 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 30 Mar 2020. 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?
Number of ED visits (time frame: One Year). 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 30 Mar 2020.