edm site visit slides sills
TRANSCRIPT
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Patient-Reported Outcomes
Marion R. Sills, MD, MPHAssociate Professor of PediatricsUniversity of Colorado School of Medicine
SAFTINet
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Patient-Reported Outcomes: Agenda
Agenda Research design considerations Selecting a PRO tool for asthma Implementation plans for the ACT
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Patient-Reported Outcomes: Agenda
Agenda Research design considerations Selecting a PRO tool for asthma Implementation plans for the ACT
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Research design considerations: Context for PROs in SAFTINet
Specific Aim 3: Develop and enhance four sentinel cohort pairs of patients with asthma (pediatric and adult), hypertension, and hypercholesterolemia distinguished by their care delivery characteristics which can support comparative effectiveness research Specific Aim 3.3 Enhance the data set by
implementing point-of-care data collection tools
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Research design considerations: Context for PROs in SAFTINet
HEALTH CARE DELIVERY SYSTEM FACTORS, such as the patient-centered medical home are important to the CONTROL of asthma (children, adults)high blood pressure hypercholesterolemia
PROCESSES OF CARE +
HEALTH CARE DELIVERY SYSTEM
FACTORS+ PATIENT FACTORS → CHRONIC DISEASE
CONTROL
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Research design considerations: Context for PROs in SAFTINet
Data sources: Electronic health record (EHR) at each clinic Claims data Enhanced data collection (includes PROs)
PROCESSES OF CARE +
HEALTH CARE DELIVERY SYSTEM
FACTORS+ PATIENT FACTORS → CHRONIC DISEASE
CONTROL
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Patient-Reported Outcomes: Agenda
Agenda Research design considerations Selecting a PRO tool for asthma Implementation plans for the ACT
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Selecting PROs: Stakeholders and Process
Researchers: Comparative Effectiveness Research
(CER) Team (many in this group are also providers) Administrators/Providers/Patients: Partner
Engagement Community (PEC)
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Selecting PROs: Stakeholders and Process
CER Team: based on the paucity of asthma “disease control”
measures captured in EHR and claims data, chose to
work on asthma PRO first Asthma cohort experts recommended 2 PRO options
for PEC consideration: the Asthma Control Test (ACT)
and the Asthma APGAR
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PROs in Asthma
HEALTH CARE DELIVERY SYSTEM FACTORS, such as the patient-centered medical home are important to the CONTROL of asthma (children, adults)high blood pressure hypercholesterolemia
PROCESSES OF CARE +
HEALTH CARE DELIVERY SYSTEM
FACTORS+ PATIENT FACTORS → CHRONIC DISEASE
CONTROL
PRO
Existing data
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Selecting PROs: Stakeholders and Process
CER Team: based on the paucity of asthma “disease control”
measures captured in EHR and claims data, chose to
work on asthma PRO first Asthma cohort experts recommended 2 PRO options
for PEC consideration: the Asthma Control Test (ACT)
and the Asthma APGAR
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Comparing ACT and APGAR to EPR-3EPR-3 recommendation ACT APGAR
Precipitating factors N Y
Patient’s self-mgt knowledge/skills N Y
Nighttime awakenings Y Y
Daytime symptoms Y Y
Need for rescue SABA Y (adult) Y
Work/school days missed N N
Engage in normal daily activities Y Y
Quality-of-life Y Y
4 weeks of symptomsAdult and child4-5 options/question5-7 questions<20 = poor control
2 weeks of symptomsNo child version3 options/question8 questionsAlgorithm for mgt
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Selecting PROs: Stakeholders and Process
PEC: Of the 2 PROs, selected the ACT after discussions with
CER team members Provider groups
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Patient-Reported Outcomes: Agenda
Agenda Research design considerations Selecting a PRO tool for asthma Implementation plans for the ACT
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Implementation plans for the ACT
Organization worksheet completed by partner
organizations consulting with their provider groups CER Team review and feedback
Structured interview with PEC and CER team
leaders
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Implementation plans for the ACT: Organization Worksheet
Walks through implementation issues and processes
To be completed by each organization, with assistance from PEC liaison
Weekly phone calls with PEC liaison
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Implementation plans for the ACT: Worksheet Overview
• What are the research and clinical goals for collecting a PRO?• What resources are available? • Which key barriers require attention?• Which groups of patients will you assess?• How do you select which questionnaire to use? • How often should patients complete questionnaires? Should it be tied to
visits or a way to follow patients between visits?• How will the PRO be administered and scored? • What tools are available to aid in interpretation and how will scores requiring
follow-up be determined?• When, where, how, and to whom will results be presented?• What will be done to respond to issues identified through the PROs? • How will the value of using PROs be evaluated?
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Implementation plans for the ACT: Timeline
Explore options for asthma PROs
Discuss PRO with provider
groups
Select asthma PRO tool
Make implementation plan for asthma
PRO tool
Create infrastructure for PRO tool deployment
(e.g., EHR template, iPad
purchase & configuration)
PRO tool training
Begin using asthma PRO tool
March
April May June July Sept Oct
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SAFTINet Comparative Effectiveness Research (CER)
Marion R. Sills, MD, MPHAssociate Professor of PediatricsUniversity of Colorado School of Medicine
SAFTINet
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SAFTINet CER
Agenda Methods and protocol development
Research questions and hypotheses Cohort development Measuring health care delivery systems
factors for CER [Analytic plans]
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SAFTINet CER
Agenda Methods and protocol development
Research questions and hypotheses Cohort development Measuring health care delivery systems
factors for CER
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Methods and protocol development: CER Team
Marion SillsCo-investigator
SAFTINet Comparative Effectiveness Research Team
Health care delivery systems experts
Cohort experts
Brian Sauer
Diane Fairclough
Rob Valuck
Elaine Morrato
PCMH: Lisa Schilling
IMHC: Ben Miller
Child asthma: Monica Federico
Adult asthma: Barbara Yawn
Hypertension, Hypercholesterolemia: Karl Hammermeister
CER methods experts
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Methods and protocol development: Protocol template
Protocol and Manuscript Template—developed from: STROBE (STrengthening the Reporting of
OBservational studies in Epidemiology) statement ISPOR good research practices for CER
(nonrandomized studies using secondary data sources)
flow diagrams such as the CONSORT diagram
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Methods and protocol development: Protocol template
Protocol and Manuscript Template Discussed in weekly meetings of the CER Team One template per cohort
Cohort-specific items: cohort leaders Delivery-systems items: content experts Analytic plan: analytic team
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SAFTINet CER
Agenda Methods and protocol development
Research questions and hypotheses Cohort development Measuring health care delivery systems
factors for CER
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Research design considerations: Context for PROs in SAFTINet
HEALTH CARE DELIVERY SYSTEM FACTORS, such as the patient-centered medical home are important to the CONTROL of asthma (children, adults)high blood pressure hypercholesterolemia
PROCESSES OF CARE +
HEALTH CARE DELIVERY SYSTEM
FACTORS+ PATIENT FACTORS → CHRONIC DISEASE
CONTROL
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PCMH Hypothesis
Practices exhibiting characteristics of a Patient Centered Medical Home will demonstrate better outcomes for patients with a diagnosis of asthma, hypertension or hypercholesterolemia. Disease control
Patient-reported control of asthma Adherence to medication Health care utilization Major adverse cardiac events
Cost
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Integrated Mental Health Hypotheses
In patients with comorbid mental and physical illness, integrated mental health care features will lead to better outcomes Chronic disease management:
Adherence to antihypertensive medication Hypertension control
Mental health management: Mental health screening and assessment Plans for mental health treatment/referral Medication adherence
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SAFTINet CER
Agenda Methods and protocol development
Research questions and hypotheses Cohort development Measuring health care delivery systems
factors for CER
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Cohort development: A layered approach
Clinical definition
Incident or Prevalent Disease
Utilization
Surveillability
•Diagnosis code•Clinical indicators•Medication•Procedure code•Clinical exclusion criteria
•New diagnosis (not meeting criteria in [time frame]
•Existing diagnosis
•Any claim in [time frame]•Any encounter in [time frame]•Additional criteria (e.g., #'s of claims/encounters)
• Insurance eligibility•Continuous eligibility in [time frame]•Person-months
•"e_string": covariate in time-adjusted Poisson regression
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Cohort development: A layered approach (asthma example)
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Cohort development: A layered approach (asthma example)
More inclusive: all adults (ages 18 and over) who have had either: at least 2 primary care visits separated by at least 30 days coded as 493.xx in
the 18 months prior to enrollment AND/OR a single diagnosis of 493.xx and two filled prescriptions for an
asthma maintenance medication separate by at least 30 days in the past 12 months
Sicker subgroup: those meeting one or both of the above definitions, AND who have had one or more asthma exacerbations in in the past 12 months, defined as one of the following: a visit resulting an oral steroid burst, an ED or urgent care visit with code of
493.xx (any position in list of diagnoses) three or more outpatient visits within a 14 day period with codes of 493.xx
(any position in list of diagnoses) one or more hospitalizations related to asthma in the past 12 months
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SAFTINet CER
Agenda Methods and protocol development
Research questions and hypotheses Cohort development Measuring health care delivery systems
factors for CER
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Measuring health care delivery systems factors for CER
Two measures of healthcare delivery system factors in SAFTINet hypotheses Patient centered medical home (PCMH) Integrated mental healthcare (IMHC)
PROCESSES OF CARE +
HEALTH CARE DELIVERY SYSTEM
FACTORS+ PATIENT FACTORS → CHRONIC DISEASE
CONTROL
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Patient Centered Medical Home
NCQA PCMH 2011 Standards and Elements1. PCMH1: Enhance Access and Continuity2. PCMH 2: Identify and Manage Patient Populations
a) Patient informationb) Clinical data (e.g., up-to-date problem list, list of Rx, BP, height,
weight, calculation of BMI) in structured fieldsc) Comprehensive health assessmentd) Use data for population management
3. PCMH 3: Plan and Manage Care4. PCMH 4: Provide Self-Care Support and Community Resources5. PCMH 5: Track and Coordinate Care6. PMCH 6: Measure and Improve Performance
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Integrated Mental Health Care
Butler M, Kane RL, McAlpine D, Kathol, RG, Fu SS, Hagedorn H, Wilt TJ. Integration ofMental Health/Substance Abuse and Primary Care No. 173. AHRQ Publication No. 09-E003. Rockville, MD. Agency for Healthcare Research and Quality. October 2008.