Welcome John Fontaine, MD, MBA, FACC, FHRS Disclaimer - PowerPoint PPT Presentation

Welcome John Fontaine, MD, MBA, FACC, FHRS

Disclaimer Acknowledgment: This presentation was based on work completed under contract number 8275-UMB funded by the Patient-Centered Outcomes Research Institute (PCORI). • The views expressed in this presentation are solely those of the speakers and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee. 2

The Patient Voice Scott Johnson, Stakeholder Advisory Board

Patient-centered care vs. Patient- centered research Eldrin Lewis, MD, MPH

Care vs. Research Patient-centered care Patient-centered research • Patient’s specific health • Patient’s health care questions needs and desired health and desired health outcomes outcomes drive the clinical drive the research agenda encounter • Patients are “co - developers” of • Patients are “care partners” research protocols with with their health care research team providers • Focus on research that is • Focus on quality of health meaningful and health care and the patient outcomes that matter to experience patients 5

Patient Centered Outcomes Research Institute (PCORI) Eldrin Lewis, MD, MPH

PCORI’s Mission PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high- integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community. PCORI’s Strategic Goals Increase quantity, quality, and timeliness of useful, trustworthy research information available to support health decisions Speed the implementation and use of patient-centered outcomes research evidence Influence research funded by others to be more patient-centered

PCORI considers funding research based on: 1: Impact of the condition on health of individuals and populations Is associated with a significant burden in the US population (prevalence, mortality, morbidity, individual suffering, or loss of productivity) 2: Potential for the study to improve health care and outcomes Has the potential to lead to meaningful improvement in the quality and efficiency of care and to improvements in outcomes important to patients 3: Technical merit Has a research design of sufficient technical merit to ensure that the study goals will be met 4: Patient-centeredness Focuses on questions relevant to outcomes of interest to patients and caregivers 5: Patient and stakeholder engagement Includes patients and other healthcare stakeholders as partners in every stage of the research

Building Capacity in PCOR Funding from: PCORI’s Eugene Washington Engagement Award for Training & Development Project Title: PCOR Training for ABC Practitioners and their Patients

Project Background • This project focuses on diseases related to heart health and seeks to train ABC healthcare providers and their patients to improve patient engagement in heart health research • We will train ABC members and their patients on PCOR to increase capacity and efficiency for more involvement from underrepresented patients in the research process • The result of increased diversity is expected to improve clinical care by answering research questions that are meaningful to underrepresented patients and applying the results in real-world settings 10

Project Aims 1. Form an Advisory Committee to guide all project aspects 2. Develop a PCOR training program for ABC members and their patients to educate participants on the key principles and methods of PCOR based on practices suggested in the PCORI Stakeholder Engagement Rubric 3. Deliver training to 80-100 ABC members and their patients to effectively collaborate on PCOR 4. Evaluate the training to identify areas of improvement for future training programs geared toward cardiovascular disease PCOR in underrepresented populations 5. Develop recommendations for future PCOR training and engagement of underrepresented populations in cardiovascular disease PCOR studies 11

Anticipated Project Outcomes • A curriculum and training materials for PCOR training among ABC clinicians and patients • ABC clinicians and patients will have increased capacity to participate in PCOR Patients who have or are at higher-risk of cardiovascular disease will be able to help shape the direction of research most important to their concerns, needs and goals. 12

Stakeholder Advisory Board Members Clinician Advisors Patient Advisors Philip Duncan Clarence Ancar Daphne Ferdinand Sharon Bond Rosevelt Gilliam Florence Goodwyn Eldrin Lewis (Chair) Scott Johnson Jeanne Regnante Rhonda Monroe 13

From Randomized Controlled Trials (RCTs) to Patient-Centered Outcomes Research (PCOR) C. Daniel Mullins, PhD

Comparative Effectiveness Research (CER) “What differentiates CER from conventional medical research is that it is demand-driven rather than investigator-driven. Demand is defined by the needs of decision makers, including public and private payers, clinicians, patients, and professionals.” Chalkidou K, Anderson G. CER: International Experiences and Implications for the USA, 2009; www.academyhealth.org 15

Comparative Effectiveness Research (CER) • Active comparators (i.e., not a placebo comparator) • Broad patient population • Outcomes that are meaningful to patients • Innovative Methods - Clinical trials - Electronic health records - Registries - Insurance claims datasets 16

From CER to PCOR • Active comparators (i.e., not a placebo comparator) • Broad patient population • Outcomes that are meaningful to patients • Innovative Methods - Clinical trials - Electronic health records - Registries - Insurance claims datasets Combination of the above + Patient Engagement = PCOR 17 Mullins CD et al. JAMA 2012; 307(15): 1587-8.

Take-Away Points • Patient engagement at every step transforms CER into PCOR • Patient engagement is a continuous process • Patient engagement requires trust & respect • Pre-engagement is a critical component • Patient engagement should involve diverse patients including underserved patients 18

Patient Engagement: Why? • Public health could be improved – Patients have unique insights – Priority setting is important – Pragmatic considerations • It shows an honest commitment to PCOR 19

Cardiovascular Patient-Centered Outcomes Research (PCOR) Catherine E. Cooke, PharmD, BCPS, MS (PHSR)

10 10-ste steps ps in CV in CV PCOR PCOR With patients and stakeholders as research team members: Topic Solicitation Prioritization Framing the Question PLANNING the Study Selection of Comparators and Outcomes Creation of Conceptual Framework Analysis Plan Data Collection / Patient Recruitment CONDUCTING the Study Reviewing & Interpreting Results Translation DELIVERING Solutions Dissemination 21 Vandigo J, et al. Expert Rev Pharmacoecon Outcomes Res. 2016;16(2):193-8.

PLANNING the Study • Step 1: Discuss cardiovascular topics of interest – Comments from patients in your practice, “giving me more pills” – Identify Patient Partner(s) from your practice • Step 2 : Prioritize topics to find most relevant and urgent – Conduct citizen jury, discrete choice experiment, survey • Step 3: Frame the real world interests into research questions – Conduct focus group discussions led by Patient Partner(s) – E.g., “How do different antihypertensive titration strategies compare?” – Form Stakeholder Advisory Board to guide remaining steps. 22

PLANNING the Study • Step 4: Select appropriate comparators and outcomes – Use Delphi process to determine comparators and outcomes: • E.g., Comparators: Maximize initial antihypertensive dose before adding another vs. Add another antihypertensive before maximizing dose of first • E.g., Outcomes: Blood pressure goals, tolerability, number of changes, pill burden, medication adherence • Step 5: Develop conceptual framework – Hold teleconference to define the framework that links the relationship between the comparators and outcomes of the study within the context of other factors that could impact this relationship. 23

PLANNING the Study • Step 6: Develop the study protocol and analysis plan – Ask the advisory board questions to guide the study protocol and analysis – Invest time to follow-up with advisors and utilizing teach-back methods to assure comprehension to develop cohort of advisors 24

CONDUCTING the Study • Step 7: Recruiting patients/Collecting data – Engage stakeholders on how best to recruit patients – Wording and process for informed consent – How best to obtain data from patients • Step 8: Review and interpret results – Stakeholders enlighten researchers regarding potential alternative explanations 25

DELIVERING Solutions • Step 9: Translate results to make understandable and meaningful to patients/advocates – E.g., There are several different ways that doctors can change your blood pressure medicines to get your blood pressure under good control. This study looked at two different ways to change your blood pressure medicines and found that one of the ways worked better than the other. • Step 10: Disseminate results – Social media, videos, on-line interactive brochures, infographics in a community newsletter, poster on a community billboard, text messaging system – Virtual poster session 26