Making Sense of Patient Reported Outcomes (PROs)

Making Sense of Patient Reported Outcomes (PROs)

Making Sense of Patient Reported Outcomes (PROs)

A Common Sense Guide for Oncology Practices in the OCM

Getting the Right Information – Avoiding the Pitfalls

December 8, 2015

Wes Chapman

 

This is the first in a series of articles dealing with the information requirements that medical oncology practices will need to address as part of the new Oncology Care Model (OCM) program being initiated by CMS in 2016. The OCM offers the promise of better care and improved financial performance, but will require new operating and information systems and tools. The OCM moves the patient to the center of the reporting structure for 8 of the 34 Quality and Performance Measures for Quality, and at least one patient navigation activity. For many practices these information requirements are new, or have been of secondary importance in the past. Success in the OCM will require a successful execution of a PRO strategy – there is no way around it.

Banana Peel

PROs – A strategy to avoid mistakes

Patient-reported outcomes measures are a critical component of assessing whether clinicians are improving the health of cancer patients, and form a core requirement in effective execution of the OCM. PROs are any report of status that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. Unlike process measures, which capture provider productivity and adherence to the standards of recommended care, or patient experience measures, which focus on aspects of care delivery such as communication. PROs attempt to capture whether the services provided actually improved cancer patients’ health and sense of well-being.

PRO measures represent the effect of the disease as well as the positive and negative consequences of treatment on health and functioning from the patient’s perspective. For example, patients might be asked to assess their general health, ability to complete various activities, mood, level of fatigue, and pain. These are critically important elements in medical oncology, as the provision of care normally produces extreme patient symptoms, often leading to unnecessary hospitalization.

Until now, state and federal governments as well as private payers attempting to assess outcomes have mostly relied on measures of avoidable readmissions, hospital-acquired infections, and mortality. Oncology care is unique in that it requires PROs to deliver effective treatment as well as determine outcomes. The ultimate measure of health system performance is whether it helps people recover from cancer, live well with cancer in a chronic state, or face the end of life with dignity—and people’s reports are the only way to gauge success.

Background

Patient reported outcomes (PROs) are widely recognized as an important component in measuring healthcare outcomes. The National Institutes of Health (NIH), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS), in their various programs, have all specified the use of PROs in determining effectiveness, safety, or value of a particular clinical program, pathway, medical device, or drug. This makes good sense; the goal of healthcare is to improve the health of patients, and only the patients themselves can tell us how well they feel, before, during, and after the treatment.

As opposed to objective measures of health (blood pressure, bone density, lung capacity, etc.), which doctors or nurses can measure and report, PROs depend on answers patients provide to subjective questions about physical, mental, and emotional health: how much pain they’re feeling, how much energy, how much anxiety. In fact, there are some conditions – gastrointestinal distress, depression – where PROs are the only available measure without additional testing. PROs also examine the effects of these feelings on functional aspects of life.

Direct Applicability to the OCM and Value Based Cancer Care

There are three overarching areas in which PROs impact the OCM:

  • 24/7 effective triage of patient symptoms and care requirements. This is fundamental to all medical home models and the OCM – it is also the only way to really manage patient care requirements and control costs associated with unnecessary hospitalizations. If you want to be effective in delivery of value based care, triage needs to be a fundamental cornerstone of your clinical program, and to make triage work you need clear, concise and valid patient reports. It is fundamental to have an effective strategy for the use of PROs.
  • PROs are a fundamental component of accreditation and quality reporting metrics (see chart below). Without a clear and effective PRO system, it is simply impossible to meet the accreditation requirements for QOPI, medical homes or other required reporting requirements in the OCM.
  • Payment is tied directly and indirectly (through utilization based cost control) to patient reported outcomes. Some form of CAHPS (Cancer CAHPS) will be a key determinant of quality based payment adjustment under the OCM. Any practice that wants to get paid for the savings that they achieve will need to ensure a high level of patient satisfaction. Having an effective strategy for monitoring patient satisfaction will be fundamental to having a controlled and effective system.

Survey, questionnaire and computer mouse, business concept

Satisfied Patients will be Key for Future Payment Strategies

PRO Supporting/Promulgating Organizations

There are literally thousands of PRO tools in use, many of which are homegrown, and designed by the providers who use them. While many of these are effective in use and valuable to the organizations that use them, the data that they produce is idiosyncratic to the clinical organizations in which they are used, and is of no use in developing benchmarks or valid scientific conclusions. We are strongly in favor of the use of validated tools – they cost little more, and the ability to use the data for analytics depends on tool validity. Some prominent organizations in the design, use and evaluation of PRO tools include:

  • PROMIS Patient Reported Outcomes Measurement Information System is a government program, funded by NIH, but not yet officially endorsed by CMS, AHRQ, or NQF. It is not oncology-specific, but it is very flexible; the user can select from existing core PRO sets and individual questions, as well as add questions of their own creation. PROMIS measures can be used as primary or secondary endpoints in clinical studies of the effectiveness of treatment, and PROMIS®tools can be used across a wide variety of chronic diseases and conditions and in the general population.
  • Canadian Organizations – Alberta Health Services & Cancer Care Ontario Cancer Founded in 1947, Cancer Care Ontario (CCO) drives continuous improvement in disease prevention and screening, the delivery of care and the patient experience for chronic diseases and acts as advisor to the Government of Ontario in matters related to the delivery and organization of cancer care in the province. Alberta Health Services (AHS) is Canada’s first and largest province wide, fully-integrated health system, and has had a multi-year effort to develop and validate PROs to support its mission of patient-centric care delivery. Both of these organizations have developed first rate tools which are broadly adopted for PRO applications.
  • International Society for Quality of Life Research (ISOQOL) ISOQOL is a research society dedicated to the development and validation of PROs. Their design and validation focuses on: 1) Reliability, Internal Consistency, 3) Test-Retest Reliability, 4) Measurement Reliability, 5) Content Validity, 6) Criterion Reliability, 7) Responsiveness to change, 8) Interpretability of Scores, and Administrative Burden. While most of ISOQOL efforts are focused on research based tools, many find direct use in clinical practice. They have published an excellent user’s guide for PROs in clinical practice.
  • D. Anderson Symptom Inventory M.D. Anderson is one of the preeminent providers of cancer research and clinical care, and also sponsors a robust research effort in PROs and symptom management. M.D. Anderson maintains an excellent symptom inventory which is very useful in the design of PRO clinical strategies.
  • Consumer Assessment of Health Providers and Systems (CAHPS) Is a PRO system developed and sponsored by AHRQ, which is directly tied to payment through thePhysician Quality Reporting System (PQRS) and Value-Based Payment Modifier (VM).  A cancer specific CAHPS is expected in the next year, which has been developed in consultation AHRQ, NCI, California Health Care Foundation, American Institutes for Research and Mayo Clinic. This is a comprehensive survey across all types of cancer care, and will correspond directly to the new management responsibilities under the OCM, and will be a critical tool to measure how providers interact with patients, Shared decision making, medical communication, access to information (patient education), care coordination and providers who are up-to-date. Ultimately it will be central to the assessment of care quality from the payer’s perspective, and therefore payment.
  • FACT-G, CTAE, CIPN-20/TNS Were originally individual PRO tools, which have evolved over time into more of an ecosystem of reporting options around a common validated PRO tools. A similar tool is the NCCN Distress Thermometer, which is widely adopted in practice and supported by the National Comprehensive Cancer Network, NCCN, which is extremely influential in cancer care, but has a limited footprint in PROs.

 

Effective PRO Systems Design

In order to be effective in a clinical oncology setting, PRO systems must be flexible in administration between interactive telephony, provider based triage and direct patient input into electronic systems. Systems must offer flexibility in PRO tool selection, and direct links to the EMR and patient portal. Direct patient inputs should be tied to educational and triage systems to facilitate timely and responsive information flow. Similarly, it is essential to have analytics and work-listing tied to the PRO system. For clinics using CRM systems such as Salesforce, it is highly desirable to tie PROs to the CRM system, such that users can have access to the most recent and relevant patient data. A well designed PRO system will use screening questions plus drill downs to develop valid positive screens. Finally, cloud based PRO systems are vastly easier to support and utilize than enterprise based systems, and frequently offer “by-the-drink” pricing, which is strongly preferred to enterprise or seat license methods.

Of the thousands of validated PRO measures available, the ones described below offer wide utility, commercial tool availability and clinical acceptance:

 

PRO’s and Delivery of Value-based Cancer Care

Key PRO Measures

PRO Measures Chart

Summary and Conclusions
The OCM and related value based cancer care payment programs require a carefully designed and well executed strategy for the gathering, use and analytics of PROs. It will be impossible to execute a successful OCM program without careful use of PROs – and payment will ultimately depend on the results of CAHPS surveys – whose administration and use reside with regulatory entities. This is a brave new world for most oncology practices and providers, and will require program design, software integration, training and time to be successful. The best PRO systems available today offer cloud based access to multiple validated tools, where inputs and results are available through the EMR and patient portal, and where analytics are robust, flexible and available on a real-time basis.

Wes Chapman
Written by Wes Chapman

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