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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03327896
Other study ID # HSD-1603-34987
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 27, 2017
Last updated October 27, 2017
Start date January 15, 2017
Est. completion date August 2018

Study information

Verified date October 2017
Source Ochin, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Healthcare providers are routinely being assessed for metrics designed to assess the quality of the care they deliver. There is growing consensus that these measurements, which typically assess the percentage of patients meeting a specific standard of care, should be adjusted for the clinical complexity of the providers. This study will assess whether adjusting for the social complexity of the patient panel adds significantly to adjustment for clinical complexity in explaining apparent differences in quality of care provided by Primary care providers and clinics.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200000
Est. completion date August 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Charlson score and Community Social Deprivation
This is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ochin, Inc. University of Florida

References & Publications (1)

Hughes LS, Phillips RL Jr, DeVoe JE, Bazemore AW. Community Vital Signs: Taking the Pulse of the Community While Caring for Patients. J Am Board Fam Med. 2016 May-Jun;29(3):419-22. doi: 10.3122/jabfm.2016.03.150172. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Provider Ranking as Assessed by Health Care Quality Metrics Comparison of adjusted provider quality rankings with metrics adjusted for Charlson Morbidity Scores and Patient Panel Neighborhood Deprivation Indicators 1 year (2015)
Secondary Well Child Visits in first 15 Months of life (patient level) Number of well child visits in first 15 months of life in children turning 15 months in 2015 15 months
Secondary Screening for alcohol and drug misuse (patient level) Documented screening for alcohol or drug misuse in patients aged 12 and over 1 year (2015)
Secondary Emergency Department Visits (Patient level) Age stratified Emergency department visit rates in patients in Medicaid cohorts 1 year (2015)
Secondary Avoidable Emergency Department Visits (Patient level) Age stratified Avoidable Emergency department visit rates in patients in Medicaid cohorts 1 year (2015)
Secondary Uncontrolled Hemoglobin A1c in Diabetics (patient level) Last recorded HbA1c greater than 9 in patients with recorded diagnosis of Diabetes (EHR cohorts only) 1 year
Secondary Colorectal Cancer Screening (Patient level) Documented colorectal cancer screening in 2015 (Oregon Medicaid cohort only) 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT01543438 - Using Point-of-Care Video Prescriptions to Improve Aftercare Following Discharge From a Pediatric Emergency Department N/A

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