Edm site visit slides sills

Patient-Reported Outcomes

Marion R. Sills, MD, MPHAssociate Professor of PediatricsUniversity of Colorado School of Medicine

SAFTINet

Patient-Reported Outcomes: Agenda

Agenda Research design considerations Selecting a PRO tool for asthma Implementation plans for the ACT



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


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


Data sources: Electronic health record (EHR) at each clinic Claims data Enhanced data collection (includes PROs)

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CONTROL



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)


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

PROs in Asthma


PROCESSES OF CARE +



CONTROL

PRO

Existing data


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

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


PEC: Of the 2 PROs, selected the ACT after discussions with

CER team members Provider groups



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

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

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?

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

SAFTINet Comparative Effectiveness Research (CER)

Marion R. Sills, MD, MPHAssociate Professor of PediatricsUniversity of Colorado School of Medicine

SAFTINet

SAFTINet CER

Agenda Methods and protocol development

Research questions and hypotheses Cohort development Measuring health care delivery systems

factors for CER [Analytic plans]

SAFTINet CER



factors for CER

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

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

http://www.strobe-statement.org/

http://www.ispor.org/workpaper/practices_index.asp

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

SAFTINet CER



factors for CER



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CONTROL

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

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

SAFTINet CER



factors for CER

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

Cohort development: A layered approach (asthma example)

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

SAFTINet CER



factors for CER

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)

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CONTROL

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

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.