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

Welcome

John Fontaine, MD, MBA, FACC, FHRS

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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.

The Patient Voice

Scott Johnson, Stakeholder Advisory Board

Patient-centered care vs. Patient- centered research

Eldrin Lewis, MD, MPH

Patient-centered care

• Patient’s specific health

needs and desired health

• utcomes drive the clinical

encounter

• Patients are “care partners”

with their health care providers

• Focus on quality of health

care and the patient experience

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Care vs. Research

Patient-centered research

• Patient’s health care questions

and desired health outcomes drive the research agenda

• Patients are “co-developers” of

research protocols with research team

• Focus on research that is

meaningful and health

• utcomes that matter to

patients

Patient Centered Outcomes Research Institute (PCORI)

Eldrin Lewis, MD, MPH

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’s Mission

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

PCORI considers funding research based on:

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

Building Capacity in PCOR

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

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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

• f 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

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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.

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

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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

• 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

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Comparative Effectiveness Research (CER)

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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

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

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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

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Cardiovascular Patient-Centered Outcomes Research (PCOR)

Catherine E. Cooke, PharmD, BCPS, MS (PHSR)

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10 10-ste steps ps in CV in CV PCOR PCOR

PLANNING the Study

Topic Solicitation Prioritization Framing the Question Selection of Comparators and Outcomes Creation of Conceptual Framework Analysis Plan Data Collection / Patient Recruitment Reviewing & Interpreting Results Translation Dissemination

CONDUCTING the Study DELIVERING Solutions

With patients and stakeholders as research team members:

Vandigo J, et al. Expert Rev Pharmacoecon Outcomes Res. 2016;16(2):193-8.

• 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.

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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

• f other factors that could impact this relationship.

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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

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PLANNING 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

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CONDUCTING the Study

• 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

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DELIVERING Solutions

1) Trust is the key overarching element for PCOR 2) Patient vs. person 3) “Outcome” is an unfamiliar term 4) Research is an abstract concept for many patients 5) Framing and phrasing of questions is critical for eliciting patients’ views 6) Patients come into research with their own agendas 7) Community-based PCOR requires flexibility, compromise and time 8) PCOR investigators should give something back to the community 9) Underserved patients do not like being asked repeated questions

27 RESULTS – LESSONS LEARNED

On-demand videos coming soon:

• Development of patient-centered research program in

my practice, and collaborating with others

• How to formulate patient-centered research questions
• Making the results of research meaningful for patients
• Handling PCOR data and understanding the findings
• Designing a plan for getting patient input for research

For your patients

• Upcoming Training Program for patients on PCOR

– Live webinar, and on-demand videos

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Engaging in PCOR

Research Questions for Cardiovascular Patient-Centered Outcomes Research (PCOR)

Angela Burroughs, MSPH

Tips for Writing a Practical & Useful Research Question

• Need to include the following to ensure practical

and usable research question:

– People…to be studied or involved – Options…of care to be studied or compared – Outcomes…potential good/bad things patient might expect from options

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https://www.pcori.org/get-involved/suggest-patient-centered-research-question/how-write- practical-useful-research-question

Tips for Writing a Practical & Useful Research Question

• People:

– People living with a specific condition, OR – People who are at risk for a specific condition, OR – Caregivers for people with a specific condition

• Options:

– One or more tests or treatments for a specific condition, OR – One or more ways to deliver the care for the specific condition, OR – Choosing among different ways to inform people about the benefits and harms of different choices

• Outcomes:

– Identifying which treatment or test option has the most benefits and the least harms for the population of interest, OR – ​Identifying which form of healthcare delivery is most likely to produce a specific benefit such as improved pain control

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https://www.pcori.org/get-involved/suggest-patient-centered-research-question/how-write- practical-useful-research-question

Examples of CV PCOR Research Questions

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Take-Away Points

• Patient-centered outcomes research (PCOR)

allows the patient’s voice to be heard

• Because PCOR provides more meaningful data,

patients and their health care providers

– Can make better treatment decisions – May be more adherent to evidence-based recommendations – May contribute to reductions in wasteful spending

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