Patient-Reported Outcomes

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Patient-Reported Outcomes Quality of Life
(PROQOL)
How can the patients individual perspective of
well-being augment the real-time clinical
monitoring enabled by BEACON? March 22,
2012 Dr. Jeff Sloan, Mayo Clinic
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Todays Goals

• Describe Beacon PROQOL pilot
• Present training video
• Answer logistics questions
• Discuss site-specific information needed
• Identify champion(s)
• List of users
• Site-specific clinical pathways

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Beacon Pilot Project

• Overall Goal Integrate patient-reported outcomes
  consistently and efficiently into the BEACON
  network with minimum burden to the patient,
  clinicians, and affiliated systems to improve
  clinical outcomes.

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Background
Beacon Patient-Reported Outcomes (PRO) Pilot
Validation Pilot Project
Background The SE Minnesota Beacon has produced
a brief patient-reported outcome (PRO) assessment
for patients with diabetes. The assessment is
available in both paper and computer-driven
formats and we are presently in beta-testing of
the measure at sites in SE Minnesota. We would
like to work with other Beacon sites on a
national basis to test the PRO measures. Goal
We are seeking further sites across the national
Beacon network to gain further feedback and
validation data in different settings and with
diverse populations.

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General Request

• Request We are asking that you would consider
• Working with our group to customize the
  information and logistics to implement the PRO
  assessment at one or more sites within your
  Beacon network. It would be optimal to have just
  one physician champion at each site within your
  network so as to reduce practice variability and
  the associated effort of rolling this out in your
  network.
• Test the system for one month to gather
  validation data on 30 or more patients by June
  30, 2012.

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System
System Description The system is intended to be
self-administered via paper or computer before an
office visit, either in-clinic or at home. We
have prepared a 4-minute training video for staff
and patients. Each site will decide whether to
implement the paper and/or computer version of
the Patient-Reported Outcomes Quality of Life
(PROQOL) tool based on local logistics.
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System

• The PRO system asks the patients three things
• To identify their single biggest concern at the
  moment.
• To check their concerns.
• To answer six general QOL questions and three
  diabetes-specific QOL questions.
• The PRO data collection system takes no more than
  5 minutes whether it is administered by paper or
  computer. It produces a summary of present and
  longitudinal patient data in a report for the
  provider and patient.

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Benefits to Pilot Participants

• The goal of the project is to facilitate
  communication between the patient and the
  clinical team as well as identify resources
  within the community beyond the care team.
• Customizing the clinical pathways in the program
  for a given site, a comprehensive list of
  community resources, clinical team members, and
  contact information is constructed and available
  across the institution.
• Bringing this information together as to whom to
  contact for financial help, what state programs
  are available, how to get in touch with a support
  group, which local firms supply meal services and
  so on, represent a potential savings in staff
  time as well as improving the communication flow
  among the key stakeholders.

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Benefits to Pilot Participants

• Connecting the patient to the appropriate
  clinical personnel beyond the physician will
  alleviate time pressure to deliver aspects of
  care that physicians may feel ill-equipped to
  address or beyond their purview.
• Specific benefits to the pilot participants will
  include
• Co-authorship on a manuscript detailing the
  experience that will be targeted to Diabetes
  Care.
• Upon completion of the pilot to gather the
  community representatives together in a series of
  telecommunications to plan for future
  collaborations. We hence think of this as a
  continuing opportunity to learn and support each
  other as we try to facilitate diabetes care.
• Participate in a planned national webinar on the
  PROQOL pilot

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Pilot Expectations

• Agree to roll pilot out to a minimum of one
  physician
• Select a paper or electronic format
• Willingness to collaborate with SE MN Beacon on
  customizing the tool for your community
• Collect validation data on a minimum of thirty
  diabetic patients
• Comply with data feedback requirements
• Participate in check-in calls with SE MN PROQOL
  lead throughout pilot period

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Next Steps

• Confirm community, Beacon staff and provider
  interest/bandwidth to participate in the pilot
• Submit letter of intent from your program
  director to Amanda Misiti (amanda.misiti_at_hhs.gov)
  and Dr. Jeff Sloan (jsloan_at_mayo.edu) that
  confirms your participation by 3/29/2012

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The Vision QOL PROs as an Integrated Vital Sign
Patient Clinical profile
Patient-reported QOL-related assessment
intake
Prophylactic interventions for PRO QOL-related
domains
Treatment
Real-time Monitoring of PRO QOL-related domains
Triggered supportive care or treatment
modification
Reduced emergent care
Improved survival
Improved quality of life
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Biomaker Assay (BMA) Positive versus Negative23
Trials (3,704 patients)
Median Survival (Months)Median (95 CI) Log-rankP-value
BMA 16.8 (16.1, 17.4) 0.0001
BMA- 9.2 (8.1, 10.6) 0.0001
BMA
BMA-
Survival Time (Years)
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BMA- A Score of 5 or Lessin Patient-Reported
QOL on a 0-10 Scale
This is a reliable and valid measure for cancer
patient populations (Sloan, MCP, 2002 Huschka,
Cancer, 2005 Locke, JPSM,2007) cut-off
validation Butt, JPSM,2008 Sloan, Value in
Health, 2007 Temel, J Thorac Oncol, 2006
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PROs in Clinic Can be Used to

• Find PRO-related problems
• Uncover otherwise unknown problems
• Modify treatment

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Case Study 1

• 8 year cancer survivor annual clinic visit
• Rated QOL as a 2 out of 10
• Initiated conversation
• Insomnia
• Stupid thoughts
• Suicidal ideation

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Case Study 1

• Psych referral
• Anti-depressant
• 1 month later QOL was 7

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Beacon PROQOL Genesis

• Item bank of diabetes PROs
• Discussion Groups with stakeholders
• Logistics realities
• Beta testing of PROQOL system

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Item Bank of Diabetes PROs

• Thousands of items
• Research-orientated
• Group comparison orientated
• Not intended for individual patient management

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Discussion Groups

• To get initial feedback and validation on the key
  issues facing patients with diabetes and identify
  key domains for data collection
• Constrain the number of items

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PROQOL System Parameters

• Identify the most pressing/urgent/first mentioned
  needs of the patient and produce a clinical
  pathway system to
• clarify the issue with further probative items
  (minimalist)
• identify the actions that the clinician and
  patient could take
• engage appropriate referral/supportive services
  both clinical and community
• track and feedback this information for future
  visits and further needs assessment
• combine with other BEACON data

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Update

• Paper version available
• Computer version revised (March 1)
• Testing at Winona, OMC, Olmsted Public Health,
  Mayo
• Other Beacon sites interested in testing
• Meeting with sites for implementation

Submit
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Clinical Flow Chart