- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03327896
The Impact of Patient Complexity on Healthcare Utilization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The analysis will be conducted in 2 stages. In the first stage, indicators of social complexity (as assessed by characteristics of the patients' geocoded addresses) will be tested for significant association with patient level outcomes (meeting or not meeting a specific standard of care). These indicators will be assessed in 4 cohorts: 2 cohorts of patients identified in electronic health records of Clinical Research Networks of community health centers, and 2 cohorts of patients insured by Medicaid in 2015 (Oregon and Florida Medicaid cohorts). Due to limitations in the available data, some quality indicators can only be evaluated in a subset of the cohorts. The consistency of specific social complexity indicators, referred to as Community Vital Signs (CVS), will be evaluated across the cohorts and quality metrics.
In the second stage, CVS indicators that contributed consistently to models at the patient level will be evaluated for their effect on provider ranking on quality metrics if the metrics are adjusted for the social complexity of the providers' patient panel in addition to the panels' clinical complexity.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria for clinics: Clinics must be a clinic that offers Primary Care (Family Medicine Clinics, Pediatrics Clinics, General Practice Clinics, Internal Medicine clinics that are not limited to a subspecialty focus, and multi-specialty clinics that include primary care providers as part of a comprehensive care team.) Clinics must have implemented their EHR by 1/1/2014.
Inclusion criteria for patients: EHR Patients must be established patients within a health care system: at least one ambulatory visit to an included clinic in 2015 and at least 1 visit to a primary care clinic within the same health system prior to that visit.
Inclusion criteria for patients for Medicaid based Outcomes: Patient must have been continuously covered by Medicaid in 2015 and have had at least 1 visit billed as an office visit in 2015 with a provider identified as a primary care provider and at least 1 prior claim billed to the same provider. Patients must meet the age/condition criteria for the assessment of at least 1 secondary outcome.
Exclusion Criteria:
Exclusion criteria for patients: Patients with no geocoded address on file will be excluded from the analysis.
Exclusion criteria for patients for Medicaid based Outcomes: Patient with Medicaid coverage gaps of >45 days will be excluded from theses analyses. Exclusion criteria for providers: Providers with <20 patients in any Quality metric denominator.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
OCHIN EHR
Patients who were established patients at OCHIN Primary Care Clinics in 2015 and had a face to face visit at the clinic in 2015. Inclusion criteria for specific outcomes varies by criteria for demoninator specification for the metric. |
This is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment.
|
OneFlorida EHR
Patients who were established patients at OneFlorida Primary Care clinics in 2015 and had a face to fact visit at the clinic in 2015. Inclusion criteria for specific outcomes varies by criteria for demoninator specification for the metric. |
This is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment.
|
Oregon Medicaid
Clients who were continuously insured through Oregon Medicaid in 2015 and had a claim with an Evaluation and Management Current Procedure Terminology (CPT) code indicating an office visit listing a Primary Care provider as the performing provider. Inclusion criteria for specific outcomes varies by criteria for demoninator specification for the metric. |
This is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment.
|
Florida Medicaid
Clients who were continuously insured through Florida Medicaid in 2015 and had a claim with an Evaluation and Management Current Procedure Terminology (CPT) code indicating an office visit listing a Primary Care provider as the performing provider. Florida Medicaid data is limited to clients who were 22 years or younger. Inclusion criteria for specific outcomes varies by criteria for demoninator specification for the metric. |
This is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider Ranking as Assessed by Health Care Quality Metrics
Time Frame: 1 year (2015)
|
Comparison of adjusted provider quality rankings with metrics adjusted for Charlson Morbidity Scores and Patient Panel Neighborhood Deprivation Indicators
|
1 year (2015)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Well Child Visits in first 15 Months of life (patient level)
Time Frame: 15 months
|
Number of well child visits in first 15 months of life in children turning 15 months in 2015
|
15 months
|
Screening for alcohol and drug misuse (patient level)
Time Frame: 1 year (2015)
|
Documented screening for alcohol or drug misuse in patients aged 12 and over
|
1 year (2015)
|
Emergency Department Visits (Patient level)
Time Frame: 1 year (2015)
|
Age stratified Emergency department visit rates in patients in Medicaid cohorts
|
1 year (2015)
|
Avoidable Emergency Department Visits (Patient level)
Time Frame: 1 year (2015)
|
Age stratified Avoidable Emergency department visit rates in patients in Medicaid cohorts
|
1 year (2015)
|
Uncontrolled Hemoglobin A1c in Diabetics (patient level)
Time Frame: 1 year
|
Last recorded HbA1c greater than 9 in patients with recorded diagnosis of Diabetes (EHR cohorts only)
|
1 year
|
Colorectal Cancer Screening (Patient level)
Time Frame: 1 year
|
Documented colorectal cancer screening in 2015 (Oregon Medicaid cohort only)
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Abigail Sears, MBA, OCHIN, Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSD-1603-34987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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