Patient-Reported Outcomes Quality of Life (PROQOL)

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

2. Today’s 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

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

10. 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

11. 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@hhs.gov) and Dr. Jeff Sloan (jsloan@mayo.edu) that confirms your participation by 3/29/2012

13. 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

14. Biomaker Assay (BMA) Positive versus Negative23 Trials (3,704 patients) BMA+ BMA- Survival Time (Years)

15. 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

16. PROs in Clinic Can be Used to: • Find PRO-related problems • Uncover otherwise unknown problems • Modify treatment

17. 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

18. Case Study #1 • Psych referral • Anti-depressant • 1 month later QOL was 7

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

20. Item Bank of Diabetes PROs • Thousands of items • Research-orientated • Group comparison orientated • Not intended for individual patient management

21. 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

22. 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

23. 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

25. Clinical Flow Chart