Primary Care Quality MetricsNCT03327896
The Impact of Patient Complexity on Healthcare Utilization
An observational study of Primary Care Quality Metrics and Well Child Visits in First 15 Months of Life NQF 1392, run by OCHIN, Inc..
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Care Quality Metrics, Well Child Visits in First 15 Months of Life NQF 1392, Diabetes Mellitus NQF 0059
- What is being tested?
- Charlson score and Community Social Deprivation
- How many people
- 200,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2017to Aug 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stage 1 (Patient Level): Established patients of primary care providers with a visit in 2015 Stage 2 (Provider level): Primary Care providers with at least 20 patients from established patients in 2015 Stage 3 (Clinic level): Primary care Clinics
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Primary Care Quality Metrics, Well Child Visits in First 15 Months of Life NQF 1392, Diabetes Mellitus NQF 0059, Colorectal Cancer Screening NQF 0034, Emergency Department Utilization, Alcohol and Drug Screening
- Being tested
- Charlson score and Community Social Deprivation
- Keywords
- Quality Measures, Social Determinants of Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charlson score and Community Social DeprivationOther
This is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Charlson score and Community Social Deprivation | |
| 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. Receives: Other: Charlson score and Community Social Deprivation | |
| 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. Receives: Other: Charlson score and Community Social Deprivation | |
| 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. Receives: Other: Charlson score and Community Social Deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year (2015)
Secondary outcomes (6)
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
Measured: 15 months
Screening for alcohol and drug misuse (patient level)
Documented screening for alcohol or drug misuse in patients aged 12 and over
Measured: 1 year (2015)
Emergency Department Visits (Patient level)
Age stratified Emergency department visit rates in patients in Medicaid cohorts
Measured: 1 year (2015)
Avoidable Emergency Department Visits (Patient level)
Age stratified Avoidable Emergency department visit rates in patients in Medicaid cohorts
Measured: 1 year (2015)
Uncontrolled Hemoglobin A1c in Diabetics (patient level)
Last recorded HbA1c greater than 9 in patients with recorded diagnosis of Diabetes (EHR cohorts only)
Measured: 1 year
Colorectal Cancer Screening (Patient level)
Documented colorectal cancer screening in 2015 (Oregon Medicaid cohort only)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start15 Jan 2017
- Primary completionAug 2017
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Care Quality MetricsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OCHIN, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Abigail Sears, MBA, Principal investigator, OCHIN, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327896
- Sponsor's protocol ID
- HSD-1603-34987
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27170802
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patient Complexity on Healthcare Utilization
- ClinicalTrials.gov ID
- NCT03327896
- Acronym / sponsor ID
- HSD-1603-34987
- Conditions
- Primary Care Quality Metrics, Well Child Visits in First 15 Months of Life NQF 1392, Diabetes Mellitus NQF 0059, Colorectal Cancer Screening NQF 0034, Emergency Department Utilization, Alcohol and Drug Screening
- Keywords
- Quality Measures, Social Determinants of Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- OCHIN, Inc.University, hospital or other
- Collaborators
- University of Florida
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2018 (estimated)
- First posted
- 1 Nov 2017 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OCHIN EHR | – | Other: Charlson score and Community Social DeprivationPatients 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. |
| OneFlorida EHR | – | Other: Charlson score and Community Social DeprivationPatients 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. |
| Oregon Medicaid | – | Other: Charlson score and Community Social DeprivationClients 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. |
| Florida Medicaid | – | Other: Charlson score and Community Social DeprivationClients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stage 1 (Patient Level): Established patients of primary care providers with a visit in 2015 Stage 2 (Provider level): Primary Care providers with at least 20 patients from established patients in 2015 Stage 3 (Clinic level): Primary care Clinics
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Charlson score and Community Social DeprivationThis is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment. | Other | Florida Medicaid, OCHIN EHR, OneFlorida EHR, Oregon Medicaid |
Primary outcome
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
6 secondary outcomes
Well Child Visits in first 15 Months of life (patient level)
Time frame: 15 months
Screening for alcohol and drug misuse (patient level)
Time frame: 1 year (2015)
Emergency Department Visits (Patient level)
Time frame: 1 year (2015)
Avoidable Emergency Department Visits (Patient level)
Time frame: 1 year (2015)
Uncontrolled Hemoglobin A1c in Diabetics (patient level)
Time frame: 1 year
Colorectal Cancer Screening (Patient level)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Background: PubMed 27170802Hughes 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.
- Article abstractLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Abigail Sears, MBA principal investigator
OCHIN, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Care Quality Metrics and Well Child Visits in First 15 Months of Life NQF 1392, run by OCHIN, Inc..
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 0 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: status not confirmed, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Provider Ranking as Assessed by Health Care Quality Metrics (time frame: 1 year (2015)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03327896, which also lists 1 linked publication.
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 1 Nov 2017.