Innovative practices in patient and stakeholder organization engagement in PCORI’s pragmatic clinical studies program Academy Health Research Meeting, June 27, 2016 Jaye Bea Smalley, MPA Melissa Delbello, MD MS Engagement Officer, PCORI Professor of Psychiatry, Pediatrics & Psychology, University of Cincinnati Anne Trontell, MD, MPH Angie Day Associate Director, Science, PCORI Chapter and Volunteer Services Manger, Depression Bipolar Support Alliance Jean R. Slutsky, PA, MSPH Chief Engagement and Dissemination Officer, PCORI
Agenda • Introduction to PCORI and the Pragmatic Clinical Trial Program • Introduction to PCORI engagement and early engagement learnings from Pragmatic Clinical Trials Program • MOBILITY* Trial and Impact of Engagement • Patient organization perspective * M ETFORMIN FOR OVERWEIGHT & OB ESE CH IL DREN AND ADOLESCENTS WITH B I POLAR SPECTRUM DISORDERS T REATED WITH SECOND-GENERATION ANTIPS Y CHOTICS
PCORI • An independent research institute authorized by Congress in 2010 and governed by a 21-member Board representing the entire healthcare community • Funds comparative clinical effectiveness research (CER) that engages patients and other stakeholders throughout the research process in order to compare alternative options in • Prevention, diagnosis, treatment, or management of a disease or symptom • Healthcare system – level approaches to managing care • Elimination of disparities in health or healthcare • Seeks answers to real-world questions about what works best for patients based on their circumstances and concerns 3
What is a Pragmatic Clinical Study? • Addresses compelling choices or “decisional dilemmas” facing patients and clinicians today • Compares the effectiveness of 2 or more options as they are used in “real - world” (non -research) settings • Maximizes the diversity of patients, care providers, and health care settings where the study is done • Limits the research burden on participating patients and clinicians • The goal: To be relevant, applicable, and readily implemented in care 4
What Does PCORI Seek in Funding Pragmatic Clinical Studies? • The potential to fill a defined, critical knowledge gap that is important to patients, clinicians, and others in health care Based on clinical burden, a gap identified from a synthesis of available data or guideline efforts, or from well-established research priorities Suggested by variations in practice that suggest clinical uncertainty • The potential for the study’s findings to be adopted into clinical practice to improve health and health care • The ability to assess if outcomes vary amongst different types or subpopulations of patients
PCORI’s Pragmatic Clinical Trials Initiative • Launched in 2014 to support large scale but simplified studies that meet requirements previously described • Current awards: 20 studies with total funding of $242.2 million • Individually and collectively a significant investment • Targeted studies similar but with a specified research focus • Engagement is critical – To define the problem, design the study that can address it, assure the study is realistic and feasible, and help its findings be adopted into practice
We Fund Research That… What we mean by… “Patient - centeredness” • The project aims 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 “ P atient and stakeholder engagement” • Patients are partners in research, not just “subjects” • Active and meaningful engagement between scientists, patients, and other stakeholders • Community, patient, and caregiver involvement already in existence or a well-thought-out plan
The PCORI Approach to Engagement-Our Engagement Rubric
Who Are Our Stakeholders? Caregivers/Family Members Clinicians Payers Purchasers Policy Makers Patients/Consumers Industry Hospitals/Health Systems Training Institutions Patient/Caregiver Advocacy Organizations
Patient-Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PESRAMHIP) Engagement • Patients, patient advocacy groups, providers (including pharmacists), professional societies, healthcare policy Examines whether symptom- experts, and content experts have been based use of inhaled engaged in formulating the research corticosteroids (ICS) reduces question, selecting the intervention, and asthma exacerbations compared to outcomes, and will continue to guide the daily use of ICS in African-American and conduct of the study. Hispanic/Latino patients with asthma. Potential Impact • Intervention could address knowledge gap and reduce asthma exacerbations in a manner concordant with patient Elliot Israel, MD treatment preferences. Brigham and Women’s Hospital • Findings could be included in the National Asthma Education Prevention Program Pragmatic Clinical Studies, (NAEPP) guidelines and influence clinical Awarded January 2016 practice.
Comparison of Operative versus Medical Endocrine Therapy for Low-Risk DCIS: The COMET Trial Engagement • Study team includes a Patient Leadership Team comprised of cancer survivors who will coordinate with the ALLIANCE Cooperative Group Patient Advocate Examines whether active Committee surveillance is non-inferior to guideline-based care for women Potential Impact diagnosed with low-risk ductal • Inform treatment decision making and carcinoma in situ (DCIS) potentially help to mitigate overtreatment and treatment-related morbidity of DCIS therapies Shelley Hwang, MS, MPH Methods Duke University • PCT Pragmatic Clinical Studies, Awarded January 2016
Thank you! www.pcori.org info@pcori.org
Recommend
More recommend
