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Newhouse arkansas 4-7-14(v2)


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Robin Newhouse 4/7/14 PCORI Seminar series

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Newhouse arkansas 4-7-14(v2)

  1. 1. Healthcare Decisions and Methods that Matter: The Link to Patient Centered Outcomes Research Methodological Standards Robin Newhouse, PhD, RN, NEA-BC, FAAN University of Arkansas for Medical Sciences Translational Research Institute April 7, 2014
  2. 2. Key Points PCOR methods matter…they 1. affect design, methods and outcomes. 2. produces evidence for practice that can be used to make decisions by patients, providers, caregivers and policy makers. 3. use outcomes that people care about. 2
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  4. 4. The Patient Centered Outcomes Research Institute Robin Newhouse is Chair of the Methodology Committee of the Patient Centered Outcomes Research Institute (PCORI).The views expressed in this presentation are those of the authors and not necessarily those of PCORI.
  5. 5. 5 • Research has not answered many questions patients face. • People want to know which treatment is right for them. • Patients need information they can understand and use. Why PCORI?
  6. 6. “The purpose of the Institute is to assist patients, clinicians, purchasers, and policy- makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis...and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services...” PCORI Has a Broad and Complex Mandate -- from Patient Protection and Affordable Care Act 4
  7. 7. PCORI Is Accountable for Changing Practice -- from Patient Protection and Affordable Care Act “(g) FINANCIAL AND GOVERNMENTAL OVERSIGHT. … (2) REVIEW AND ANNUAL REPORTS. … (iv) Not less frequently than every 5 years … the overall effectiveness of activities conducted under this section … such review shall include an analysis of the extent to which research findings are used by health care decision-makers, the effect of the dissemination of such findings on reducing practice variation and disparities in health care…” 5
  8. 8. Mission PCORI helps people make informed health care decisions, and improves health care delivery and outcomes, by producing and promoting high integrity, evidence- based information that comes from research guided by patients, caregivers and the broader health care community. 6
  9. 9. Strategic Goals Influence Research Funded by Others Speed the Implementation and Use of Evidence Increase Quantity, Quality and Timeliness of Research Information 7
  10. 10. Engagement Goals Promote Dissemination and Implementation Engage the PCOR Community in Research Build a Patient-Centered Outcomes Research Community 8
  11. 11. National Priorities for Research Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication & Dissemination Research Addressing Disparities Accelerating PCOR and Methodological Research 9
  12. 12. 6 Patients Are Our “True North”
  13. 13. Study Design/ Implementation Evaluation Topic Selection and Research Prioritization Merit Review 10 We engage stakeholders at every step Key Features of PCORI Research
  14. 14. Key Features of PCORI Research Our work answers patient’s questions. “Given my personal characteristics, conditions and preferences… …what should I expect will happen to me?” …what are my options and what are the potential benefits and harms of those options?” .. what can I do to improve the outcomes that are most important to me?” …how can clinicians and the care delivery systems they work in help me make the best decisions about my health and healthcare?” 11
  15. 15. Key Features of PCORI Research Study the benefits and harms of interventions and strategies delivered in real-world settings Compare at least two alternative approaches Research Should: Special Topics of Interest: Be based on health outcomes that are meaningful to the patient population Be likely to improve current clinical practices Conditions that heavily burden patients, families and/or the health care system. Chronic or multiple chronic conditions Rare and understudied conditions Conditions for which outcomes vary across subpopulations 12
  16. 16. 13 Formulating Research Questions Patient-Centeredness Data Integrity and Rigorous Analyses Preventing/Handling Missing Data Heterogeneity of Treatment Effects Key Features of PCORI Research Research should adhere to PCORI’s Methodology Standards. Data Networks Data Registries Adaptive and Bayesian Trial Designs Causal Inference Studies of Diagnostic Tests Systematic Reviews Methodology Standards: 11 Broad Categories
  17. 17. Patient Engagement vs. Patient-Centeredness  Patient engagement is about having patients as partners in research as opposed to merely subjects  Active engagement between scientists, patients, and stakeholders  Community, patient, and caregiver involvement already in existence or a well-thought out plan  Patient- Centeredness is a component of what PCOR is looking for in research applications  Does the project aim to answer questions or examine outcomes that matter to patients within the context of patient preferences?  Research questions and outcomes should reflect what is important to patients and caregivers 17
  18. 18. Engage Patients and Stakeholders in the Research Process  Patients and Caregivers  Patient Organizations  Practice-Based Research Networks  Medical Groups  Health Plans  Integrated Delivery Systems  Disease Registries  Centers for Medicaid and Medicare Services  State and Local Health Agencies 18
  19. 19. Engagement Principles Trust Transparency Co-learning Reciprocal Relationships Partnerships Honesty Incorporates the Engagement Principles* and conceptual framework of patient engagement in research developed by PCORI’s scientific team (Source: Curtis, P, Slaughter-Mason, S, Thielke, A, Gordon, C, Pettinari, C, Ryan, K, Church, B, King, V(2012). PCORI Expert Interviews Project) 19
  20. 20. Examples of Promising Practices from First 150 Awards Patients participate in: Determining what needs to be researched The creation of the intervention to be studied Defining outcomes important to patients Leading the project as Co-PI, consultant or advisory committee member Determining methods and processes of research study Recruiting and retaining participants Collecting data and, co creating privacy and confidentiality policies Creation of patient friendly informed consent forms Evaluating the patient engagement throughout the life of the project Disseminating research results to advocacy organizations and research participant community 20
  21. 21. Methodology Committee of the Patient Centered Outcomes Research Institute. (2013). Hickam, D., Totten, T., Berg, A., Rader, K., Goodman, S., Newhouse, R. (Eds). Section II, Prioritizing Research Questions and Development of the Translation Table, pages 11-20. PCORI Translation Table
  22. 22. Our Growing Research Portfolio
  23. 23. Funded Projects to Date Total number of research projects awarded : 279 Total funds awarded: $464.2 million Number of states where we are funding research: 38 states (plus the District of Columbia and Quebec, Canada) 15
  24. 24. 24 Snapshot of Funded Projects
  25. 25. Assessment of Prevention, Diagnosis, and Treatment Options Seeks to fund investigator- initiated research that: • Compares the effectiveness of two or more options that are known to be effective but have not been adequately compared in previous studies. • Among compared population groups, investigates factors that account for variation in treatment outcomes that may influence those outcomes in the context of comparing at least two treatment approaches. Portfolio Snapshot By primary health topic • 65 Projects • $117 Million Awarded 18
  26. 26. Selection of Peritoneal Dialysis or Hemodialysis for Kidney Failure: Gaining Meaningful Information for Patients and Caregivers Francesca Tentori, MD, MS, Arbor Research Collaborative for Health Engagement • Interviews over 130 patients with kidney disease to determine how to address personal preferences in choosing type of dialysis: hemodialysis or peritoneal dialysis. Potential Impact • Over 100,000 patients start dialysis in the United States each year. • This research could provide practical information regarding the consequences (outcomes) of each choice for patients with kidney disease and their families. Methods • Research is completed through qualitative methods. Aims to identify factors that matter to most to patients with kidney disease and study how they are impacted by different types of dialysis, focusing on hemodialysis and peritoneal dialysis. Today, patients often choose a dialysis type without fully understanding how it will impact their lives Assessment of Prevention, Diagnosis and Treatment Options, awarded December 2012 19
  27. 27. Improving Healthcare Systems Seeks to fund investigator-initiated research on effects of system changes on : • Patients’ access to high quality, support for self-care, and coordination across healthcare settings. • Decision making based on patients’ values. • Experiences that are important to patients and their caregivers, such as overall health, functional ability, quality of life, stress, and survival. • The efficiency of healthcare delivery, as measured by the amount of ineffective, duplicative, or wasteful care provided to patients. Portfolio Snapshot By primary health topic • 41 Projects • $76.5 Million Awarded 20
  28. 28. Evaluating the Impact of Patient-Centered Oncology Care Sarah Scholle, MPH, DPH National Committee for Quality Assurance Engagement • A broad multi-stakeholder advisory group will help define the Patient- Centered Oncology Care model. Potential Impact • Could change practice by addressing current gaps in cancer care and providing patients and clinicians with important information about what kind of care is possible. Methods • Research is completed through qualitative and quantitative analysis. Tests and evaluates using the patient-centered medical home (PCMH) model of care for treating oncology patients. The goal is to examine whether the model improves patient experiences and quality of care, reduces events such as ED visits and hospital stays, and whether its adoption varies across practices. Improving Healthcare Systems, awarded May 2013 21
  29. 29. Communication and Dissemination Research Portfolio Snapshot • 25 Projects • $43.2 Million Awarded Seeks to fund investigator- initiated research in: • Clinician engagement with CER. • Translating research, decision support interventions, and risk communication. • For this funding announcement, studies of decision support aids are not encouraged. • Distribution of CER to patients, caregivers, and providers. By population; some projects address multiple populations. 22
  30. 30. Patient-Identified Personal Strengths (PIPS) vs. Deficit-Focused Models of Care Kurt Stange, MD, PhD, Case Western Reserve University Engagement • Engages patients, caregivers, and primary care clinicians in identifying mechanisms by which leveraging focusing on patient-identified strengths might affect processes and patient-centered outcomes of care. Potential Impact • Could change practice by demonstrating a method for motivating positive change and engaging patients in ways that the usual deficit-based model of chronic care cannot. Methods • Uses a mixed methods approach. Compares a model of chronic care focused on patient-identified personal strengths vs. deficit-focused models of care to leverage strengths that can help patients to live a fulfilling life with multiple chronic illnesses. Aims to build simulation models for how focusing on patient-identified strengths can change outcomes. Communication and Dissemination, awarded December 2012 23
  31. 31. Addressing Disparities Portfolio Snapshot • 31 Projects • $53 Million Awarded By primary health topic Seeks to fund investigator-initiated research that: • Compares interventions to reduce or eliminate disparities in patient- centered outcomes. • Identifies/compares promising practices that address contextual factors and their impact on outcomes. • Compares health care options across different patient populations. • Compares and identifies best practices within various patient populations for information sharing about outcomes and research. 24
  32. 32. Long-Term Outcomes of Community Engagement to Address Depression Outcomes Disparities Kenneth Brooks Wells, MD, MPH University of California, Los Angeles Engagement • Community agencies collaborate to tailor depression toolkits to needs and strengths of community. Potential Impact • Could change practice by providing information about how depressed patients prioritize outcomes and make decisions. Also, could impact practice by showing how clinicians respond to patients’ preferences. Methods • Research is completed both a mixed methods approach and a randomized controlled trial. Project looks at whether a community engagement intervention or technical assistance model will improve clients’ mental health and physical functioning and reduced risk factors for homelessness. It will also identify patient preferences and priorities and assess community capacity to respond to these priorities. Addressing Disparities Research Project, awarded December 2012 25
  33. 33. Portfolio Snapshot • 30 Projects • $28.1 Million Awarded Seeks to fund investigator-initiated research that: Improving Methods for Conducting Patient- Centered Outcomes Research • Addresses gaps in methodological research relevant to conducting patient-centered outcomes research (PCOR). Results of these projects will inform future iterations of PCORI’s Methodology Report. • Focuses on Patient-Reported Outcome Measurement Information System (PROMIS)- related research. 26
  34. 34. The National Patient-Centered Clinical Research Network (PCORnet) System-based networks, such as hospital systems Patient-Powered Research Networks Coordinating Center Provides technical and logistical assistance under the direction of the Steering Committee and PCORI Staff. 35 • 11 Networks • $76.8 Million Awarded • 18 Networks • $16.8 Million Awarded Patients with a single condition form a research network Clinical Data Research Networks
  35. 35. Pragmatic Clinical Studies and Large Simple Trials Opportunity Snapshot Number of Anticipated Awards: Six to Nine Funds Available: $90 Million Maximum Project Duration: 5 Years Maximum Direct Costs Per Project: $10 Million Seeks to fund investigator-initiated research that compares two or more alternatives for: • Addressing prevention, diagnosis, treatment, or management of a disease or symptom • Improving health care system–level approaches to managing care; or • Eliminating health or healthcare disparities. • Research topics of particular interest identified by stakeholders, or questions included in IOM’s Top 100 Topics for CER or AHRQ’s Future Research Needs. 36
  36. 36. Eugene Washington PCORI Engagement Awards Smaller awards, up to $250,000 total, to provide “wrap-around” support and enhance impact of PCORI’s scientific research. Objectives  Engage new groups who have not previously been involved with PCORI  Develop new mechanisms for disseminating research findings  Promote research done differently by supporting the engagement and partnering Three Types of Awards  Knowledge: Support knowledge of PCORI’s work, and inform about our program efforts  Training and Development: Training and development of “non-usual suspects” and non-traditional researchers  Dissemination and Implementation: Disseminate the results of our research to promote implementation into practice 37
  37. 37. Application and Review Process
  38. 38. How to Submit an Application Visit Key Dates Funding Announcements Application Guidelines and Templates Guidance on the PCORI Methodology Standards Sample Engagement Plans Frequently Asked Questions 40
  39. 39. PCORI’s Merit Review Process 39 1. Impact of the condition on the health of individuals and populations 2. Potential for the study to improve healthcare and outcomes 3. Technical merit 4. Patient-centeredness 5. Patient and stakeholder engagement Applications are reviewed against five criteria: Applications are reviewed by a committee of two scientists, one patient, and one other stakeholder PCORI’s Board of Governors makes funding decisions based on merit review and staff recommendations 41
  40. 40. Have a Question? General Inquiries | (202) 827-7200 Research/Programmatic Questions | (202) 627-1884 Administrative/Financial/Technical Questions 43
  41. 41. Connect with PCORI Bryan Luce, PhD, MBA Chief Science Officer Regina L. Yan, MA Chief Operating Officer Joe V. Selby, MD, MPH Executive Director 44
  42. 42. Find Us Online 45
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  44. 44. Straus, S.E., Tetroe, J. & Grahm, I.D. (2009). Knowledge to action: What it is and what it isn’t. In Knowledge Translation in Health Care: Moving from Evidence to Practice. Hoboken, N.J.:Wiley-Blackwell, pp. 3-9. Johantgen, M., Newhouse, R. P. (2013). Participating in a Multi-Hospital Study to Promote Adoption of Heart Failure Guidelines: Lessons Learned for Nurse Leaders. Journal of Nursing Administration, 43(12), 660-666. 44
  45. 45.  2 hospitals  HF patients (N=40, 20 each hospital)  Nurses who care for HF patients on study units This study is funded by AHRQ as a subproject (Newhouse, PI) in PATient-centered Involvement in Evaluating the effectiveNess of TreatmentS (PATIENTS) Program. ( PATIENTS PI, Mullins, 1R24 HS22135-01) 45
  46. 46. 46 Expanding PCOR through Advancements in Implementation & Dissemination Science • Develop infrastructure for dissemination and implementation of research products and findings to patients, patient advocates, clinicians, and healthcare systems • Build sustainable digital infrastructure for data mining, data set integration, and virtual collaborations for training and research • Provide mentorship for faculty research development • Offer tools and methods for implementation and dissemination PATient-centered Involvement in Evaluating the effectiveNess of TreatmentS (PATIENTS) Program. AHRQ (PI, Mullins). (1R24 HS22135-01)
  47. 47. 47 PCOR is a Win for Everyone PATIENT RESEARCHER Informed decision making Meaningful research Not a “one- size-fits-all” result Interaction Continuous Topics and research questions Translate/disseminate results Comparators and outcomes
  48. 48. Implementation Science: Best Practices 48 • Mixed methods • Engagement of target audience and stakeholders • Conceptual models and implementation frameworks (RE-AIM) • Tailoring interventions to context • Fidelity • Measurement (context and outcomes) • Evidence-based interventions Required to build the science: 1) Core set of implementation concepts and metrics 2) Standards for implementation methods 3) Reporting standards for implementation studies Newhouse, R.P., Bobay, K, Dykes, P.C., Stevens, K.R., Titler, M. (2013). Methodology Issues in Implementation Science. Medical Care, 51,S32-S40. doi: 101097/MLR.0b013e31827feeca
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  50. 50. Committed to advance research to improve health care………… Robin Newhouse, PhD, RN, NEA-BC, FAAN