Comprehensive Strategies to Improve Clinical Outcomes in Heart Failure. Live and Enduring Interim Outcomes Report. Novartis Grant ID: NGC29501

Transcription

1 Comprehensive Strategies to Improve Clinical Outcomes in Heart Failure Live and Enduring Interim Outcomes Report Novartis Grant ID: NGC29501

2 Program Information Overview This symposium and enduring material featured an expert panel of three faculty members who participated in an interactive discussion integrating problem based learning with evidence based medicine in an effort to incorporate newly issued guideline updates into clinical practice. A case study that was woven throughout the program, helped highlight clinical trial data and how new therapies may be optimized to delay device use in patients with heart failure (HF). This also highlighted how post hospital discharge strategies can be augmented in order to improve patient outcomes and reduce hospital readmission rates in HF. Intended Audience This activity was intended for interventional cardiologists, cardiologists, vascular surgeons, cardiothoracic surgeons, technologists, and nurses involved in the care and treatment of patients with heart failure. Live Symposium Date Sunday, February 19, 12:30 1:30 PM, during the CRT Conference mycme Launch/Expiration April 21, 2017 through April 21, 2018 Credit 1.0 AMA PRA Category 1 Credit for physicians Sponsored By The Academy for Continued Healthcare Learning (ACHL) Funding Supported by an educational grant from Novartis Pharmaceuticals Corporation

3 Executive Summary Activity Reach 135 Live Participants during the CRT Conference 701 Enduring Participants as of July 31, 2017 (2,000 Guaranteed by 4/21/18) 289 Certificates (combined) as of July 31, 2017 (350 Guaranteed by 4/21/18) As of August 31, enduring metrics show an additional 200 participants and 64 certificates. (Totals of 901 participants and 353 certificates respectively) This shows a 29% and 24% increase in participation and certificates in one month. Professions Reached 45% Physicians/Physician Assistants 27% NP/Nurses 28% Fellows/Other 52% of attendees have a Cardiology or Interventional Cardiology Specialty Activity Satisfaction All faculty were highly rated with an average rating of 3.55/4.0. Appropriateness and effectiveness of the active learning strategies were evaluated as excellent with a rating of 3.47/4.0 96% of learners would recommend this activity to a colleague Learning Objectives Learners strongly agree or agree that they are better able to meet the learning objectives after completing the activity; average rating of 3.49/4.0 Impact Changes made from this activity will impact up to 6320 heart failure patients with HFrEF each month 33% of learners, respectively, indicated patient outcomes and performance would be positively impacted

4 Executive Summary (cont) Level 3 4 Outcomes: Impact and Barriers 6 of learners will change their practice based on this activity 39% will change the management and/or treatment of their HF patients by ensuring optimal medication therapy upon discharge to minimize rehospitalizations 3 will create/revise protocols, policies and/or procedures to reflect treatment guidelines (including care coordination/transition of care strategies). 53% and 5 of learners, respectively, indicated patient outcomes and performance would be positively impacted Changes made from this activity will impact up to 6,222 patients each month Participants indicated cost as the most common barrier to implementing changes, followed by lack of experience and patient compliance issues Another barrier to using newer medical therapies in HF was the long time needed to obtain prior authorizations. However, healthcare providers are open to working with insurance coordinators to improve patient outcomes. Learners also cite higher confidence when using older medical therapies to help manage HF (ie, ARBs, ACEi, beta blockers, diuretics, etc)

5 Executive Summary (cont) Level 3 4 Outcomes: Practice based Changes and Future Education Following the activity, learners demonstrated increased knowledge and competence on questions related to: Care coordination, guideline directed care, transitions of care, the safety profile of sacubitril/valsartan, and ventricular remodeling Clinicians are well versed with respect to individualization of therapy and demonstrate knowledge of the types of patients that would benefit from sacubitril/valsartan therapy Clinicians are more open to additional patient education either via dialogue or handouts such that patients are more competent when managing their disease. Furthermore, clinicians recognize the importance of communitybased patient follow up (ie, nurse navigators) Interventional cardiologists are also open to working more closely with general cardiologists, in order to optimize medical therapy. Learners would benefit from further education on appropriate treatment protocols for patients initially diagnosed with, and admitted for heart failure as well as comprehensive heart failure programs.

6 Faculty Peter Carson, MD Professor of Medicine Georgetown University Chief, Coronary Care Unit Washington VA Medical Center Washington, DC Navin K. Kapur, MD Associate Professor of Medicine Executive Director of Research and Innovation The Cardiovascular Center at Tufts Medical Center Boston, MA Ileana L. Piña, MD, MPH Professor of Medicine Professor of Epidemiology and Population Health Director of Cardiology Montefiore Medical Center Bronx, NY

7 Level 1: Participation Participation by Clinician Type Participants Certificates 14% 5% 32% Physician Physician Assistant Fellow Nurse/Nurse Practitioner 27% Other Clinical Other Non clinical Participation by Specialty 13% 9% 28% 4 Cardiology Interventional Cardiology Critical Care 13% General Practice 7% 12% Other

8 Level 2: Learning Objectives Please rate the following objectives to indicate if you are better able to: Explore current evidence based guideline recommendations for pharmacological management of heart failure Analysis of Respondents Rating Scale: 4 = Strongly Agree 1 = Strongly Disagree 3.54 Interpret recent clinical trial findings with new therapies for heart failure 3.48 Formulate appropriate heart failure therapeutic strategies based on the patient s disease status and other related diagnostic factors, comorbidities, and individual needs Discuss the importance of care coordination and transition for improving clinical outcomes in patients with heart failure of learners strongly agree or agree that all learning objectives were met, with an average rating of % of learners would recommend this activity to a colleague! N=284 (live and enduring combined)

9 Level 2: Faculty Evaluation Faculty Evaluation Rating scale: 4 = Excellent, 1 = Poor Peter Carson, MD Navin Kapur, MD Ileana Piña, MD, MPH Ability to effectively convey the subject matter Ability to deliver an objective and balanced presentation Ability to present scientifically rigorous information Expertise on the subject matter All faculty were highly rated across all five areas, with an average rating of N=284 (live and enduring combined)

10 Level 2: Satisfaction Overall Evaluation Analysis of Respondents 4 = Excellent, 1 = Poor Quality of educational content 3.53 Appropriateness and effectiveness of active learning strategies (questions, cases, discussion) 3.47 Usefulness of course handouts/educational material 3.50* Time allotted for presentation of information 3.36* Time allotted for question and answer session(s) 3.36* All aspects of the activity were highly rated with an average of Please rate the importance of your reasons for participating in this educational activity: Analysis of Respondents 4 = Extremely, 1 = Not at all Topics 3.25 CME credit 3.19 N=278 (live and enduring combined) N*=22 (3 questions asked only during live)

11 Level 2: Objectivity & Bias Did you Perceive Any Bias? This activity was perceived as objective, balanced, and largely non biased. As guideline updates focused on ivabradine and sacubitril/valsartan, there was the perception that the symposium was focused on newer agents. 2 1 Yes No N=284 (live and enduring combined)

12 Level 3 4: Pre test vs. Post test (Live vs. Enduring) Correct responses: Pre Post 10 75% 5 25% 2 8 Q1 Q2 Q3 Q4 88% 88% 96% 86% 85% 87% % 46% 5 27% 22% 77% Q Topic Live % Change Enduring % Change 1 Care Coordination % 2 Patients who would benefit from ARNI therapy 85% 3 Safety profile of sacubitril/valsartan 2 53% 4 Ventricular remodeling 6 25 Participants improved knowledge and competence on three of the four pre /post test questions (live activity), and all four questions on the enduring activity, demonstrating that participants are well versed on the advantages of sacubitril/valsartan. It should be noted that at the time of activity completion, participants are well versed across all content areas for the activity, regardless of baseline/pre test performance.

13 Level 3 4: Pre test vs. Post test Kristine is a 72 year old woman, living independently. She suffers from stage C heart failure. She was recently admitted to the hospital for her heart failure as she was noncompliant with her therapy (beta blockers) because they make her feel tired all the time. Which strategy below best represents coordinated care to help improve patient outcomes? 10 75% Pre (N=20) 8 6 Live Post (N=25) A. Switch Kristine s medication to ivabradine or sacubitril/valsartan B. Switch Kristine s medication and enlist the help of a nurse navigator so that she can be followed while outside of a clinical setting C. While Kristine is in the hospital, provide disease state education and stress the importance of her medication D. Provide a multidisciplinary team of clinicians to coordinate her care while she is either in the hospital or doctor s office Four times as many participants answered this question correctly on the post test as compared with the pre test indicating that learner competence regarding care coordination, increased. It is recommended that patients receive follow up care once they have left the clinical setting. One method of care coordination is via outreach from a nurse navigator or case manager who can provide follow up with the patient to ensure they are compliant with medication and lifestyle changes. These clinical adjuncts can provide a bridge between providers, help reinforce and deliver guideline directed care, minimize the occurrence of adverse events, as well as serve as a clinical resource for patients. 5 25% 10 75% 5 25% % 1 4% A B C D 23% 27% 3% Pre (N=357) 86% Enduring Post (N=267) 34% 16% 3% 8% A B C D

14 Level 3 4: Pre test vs. Post test Under which of the following conditions can sacubitril/valsartan be substituted for an ACE inhibitor or an ARB? Pre (N=16) Live Post (N=25) A. Patients who were hospitalized in the last 12 months and who can tolerate enalapril 10 mg, twice daily B. Patients who are intolerant to ACE inhibitors and who were not hospitalized in the last 12 months C. Patients with HFpEF and who were hospitalized in the last 12 months D. Patients who are intolerant to ARB and who have been hospitalized within the last 12 months Post test knowledge was high, demonstrating that clinicians, by the end of these activities, are aware of the efficacy associated with sacubitril/valsartan. Differences in pre test performance between live and enduring is likely due to audience composition/specialty, wherein CRT had a greater concentration of physicians (76%) who were interventional cardiologists while the participant mix for the enduring was more diverse (ie, only 41% MDs [both percentages inclusive of fellows]) and also included PAs, NPs, RNs. Interventional cardiologists, thus, demonstrate a strong baseline knowledge of how to use sacubitril/valsartan. In the clinical trials for sacubitril/ valsartan, investigators transitioned patients who were receiving enalapril, a standard therapy for BP control, to sacubitril/ valsartan. If taking sacubitril/valsartan, patients should discontinue use of ACEi to protect themselves from a risk of hypotension % 5 25% 10 75% 5 25% 88% 46% 88% 8% 4% 12% A B C D 85% Pre (N=357) Enduring Post (N=267) 25% 18% 11% 6% 5% 4% A B C D

15 Level 3 4: Pre test vs. Post test Which of the following adverse events have been found to be associated with sacubitril/valsartan use in clinical trials? 10 75% Pre (N=20) Live Post (N=25) 8 96% A. Dementia, hyperkalemia B. Increased water retention C. Angioedema, dementia D. Hypotension, hyperkalemia 5 25% 2 4% A B C D About half of the participants, prior to participation in the activity, were familiar with the adverse event profile of sacubitril/valsartan. Further, after having participated in either the live or enduring activity, clinician knowledge with regard to the safety profile of this drug increased by 2 53%, respectively. Other adverse events which clinicians should monitor for include cough, renal dysfunction, and increases in serum creatinine and/or potassium. It should be noted that the safety profile in clinical trials, rarely deterred patients from taking their medication % 5 25% Pre (N=356) 14% 14% 15% 2% 3% 8% Enduring Post (N=267) 57% A B C D 87%

16 Level 3 4: Confidence Which of the following conditions are detrimental when looking to reduce blood volume? A. Release of natriuretic peptides to reduce preload and afterload in normal and failing hearts B. Ventricular remodeling that results in decreases in end diastolic or systolic volume C. Structural remodeling of the heart resulting in impaired bioavailability of nitric oxide D. Reduced congestion and maintenance or improvement of renal function 10 75% 5 25% 8% Pre (N=8) 12% 12% 5 Live Post (N=25) 8 38% A B C D Pre (N=356) Enduring Post (N=267) The number of correct responses on the post test increased by a minimum of 6 relative to the pre test, indicating that participants were more aware of the roles in which nitric oxide (ie, one pathophysiological molecule in HF) may play in ventricular remodeling in patients with heart failure % 5 25% 77% 31% 32% 22% 15% 1 1 3% A B C D

17 Level 3 4: Post test Sacubitril/valsartan reduced readmission rates for heart failure in patients discharged from the hospital, 30 days prior. As a clinician, what keeps you from utilizing sacubitril/valsartan in your patients with heart failure? A. Cost B. Formulary availability C. Unfamiliar with clinical trial data D. More comfortable with ACEi, ARBs, beta blockers despite side effects associated with these medications E. Other Cost and formulary availability account for 76% of clinicians at the live activity not utilizing sacubitril/valsartan. These same reasons, as well as the confidence associated with prescribing older therapies, account for prescribing barriers cited during the enduring activity. Future education addressing these barriers may improve clinician willingness to appropriately utilize this therapy % 5 25% 10 75% 5 25% 48% 28% 2 Live Post (N=25) 4% A B C D E 32% 24% 14% Enduring Post (N = 247) 21% 9% A B C D E

18 Level 3 4: Patient Case (Live) A 63 year old man with a history of Non ST elevation myocardial infarction and low LV ejection fraction required protected PCI of the left circumflex and right coronary arteries six months ago. He now presents with worsening dyspnea over the past one week, palpitations, and bilateral ankle swelling. What is your next step with this patient? A. Increase torsemide and discharge home B. Admit and diurese with IV loop diuretics C. Admit, initiate inotropes and IV diuretics D. Urgent right and left heart catheterization E. Admit for right heart catheterization first 10 75% 5 25% Pre (N=22) 41% 27% 18% 9% 5% A B C D E As only 41% of participants correctly answered this question, data demonstrate that further education is needed on the differences between inotropic therapy and diuretics. Ironically, as heart failure results from impaired contractions and inotropes can modify the strength of the heart s contraction, these therapies do not work as effectively in patients with HF as diuretics. In the symposium closing, faculty discussed how to optimize and transition care for the patient upon leaving the hospital. Discussions centered on follow up from paraclinical staff, optimizing treatment regimens, and ensuring medication compliance.

19 Level 4: Impact of Activity Please rate the projected impact of this activity on your performance and patients outcomes: This activity increased my performance. Yes: 53% No: 14% Validated Practice: 33% Utilize new treatment options Learning benefits of treatment outcome will enhance my communication with the team In management of CCF To be more cognizant of available effective therapies for management of heart failure This activity increased my patient outcomes. Yes: 5 No: 17% Validated Practice: 33% Studies suggest that implementation of these newer, effective therapies should result in better outcomes for my patients The more knowledge I have of a patient s condition the more helpful I can be talking to the person This activity was moderately effective, with 5 indicating that their patient outcomes would be enhanced as a result of having participated in this activity. N=284 (live and enduring combined)

20 Level 4: How Will You Change Your Practice? Select all that apply: Change management and/or treatment of my HF patients by ensuring optimal medication therapy upon discharge to minimize rehospitalizations. 39% Create/revise protocols, policies, and/or procedures to reflect treatment guidelines (including care coordination/transition of care strategies). 3 Other Change 7% This activity validated my current practice; no changes will be made of learners will change their practice by either engaging in strategies to optimize medications or plans to improve transitions of care and/or care coordination! N=284 (live and enduring combined)

21 Level 4: How Will You Change Your Practice? (cont) Change management and/or treatment of my HF patients by ensuring optimal medication therapy upon discharge to minimize rehospitalizations. Please specify: Increase use of ACE/ARB in patients with abnormal renal function Be more aggressive in treatment Treatment of HF patients will be improved More confidence in increasing medications Closer review of clinical trials Use of latest effective therapies Improve the use of medicine like sacubitril/ valsartan Use Entresto Put more thought into medication choices/class of medications Monitor subtle changes in progress Create/revise protocols, policies, and/or procedures to reflect treatment guidelines (including care coordination/transition of care strategies). Please specify: Create clearer protocols for better care Closer follow up after discharge Implement patience education and teamwork More aggressive in HF management in outpatient clinic N=284 (live and enduring combined)

22 Level 4: Key Takeaways What is one pearl you took away as a result of your participation? Very pleased with the team concept in treatment and how important it is to the patient and staff Maximize medication dosage for maximum benefit Research/utilize new medication options Provide effective treatment of heart failure Sacubitril may be useful in HFpEF Cost should not be a determining factor in all areas of care Provide a logical approach to HF management Learnings on care coordination We have to consistently work to reduce readmission rates Valsartan reduces hospital readmission Validation of the importance of nurse navigator for outpatient follow up between appointments Understanding of better diagnostics methods and approaches Benefits were consistent across different age ranges and risk profiles Optimizing medical treatment for HF patient using new agents Knowledge of newer medications It is not about the dose of the B blocker but the lower heart rate target Effectiveness of ARNIs Enjoyed the lectures and the new mix of medication recommended for CHF Rehospitalization of CHF patients can be reduced thru many factors, involving changes in pharmacologic management, enhanced patient education, etc.

23 Level 4: Key Takeaways (cont) What is one pearl you took away as a result of your participation? Using ACE inhibitors against renal disease Details on PARADIGM study Use more frequently the newer pharmacological therapies Don't be timid in using new medications but be fully informed about their use You can be more aggressive with lowering HR, even with borderline BP Lower heart rates are a predictor of good outcomes Multimodal therapy is valuable Need for multidisciplinary approach to compliance Titrate beta blockers more aggressively Review hospitalization mortality data The need for more comprehensive/collaborative HF programs Exciting that there is new technology coming besides mechanical support Proper education and home health assistance is necessary to avoid readmittance and death Pharmacology outcomes Directed treatment based on wet/dry warm/cold Alternative drugs can assist in varying symptoms of different patients which may yield good results Updated care guidelines for patients with CHF Better heart failure management skills More details regarding sacubutril/valsartan The incredible cost of health care in HF patients

24 Level 4: Perceived Barriers Please indicate any barriers you perceive in implementing these changes: Select all that apply: Other No barriers Lack of consensus or professional guidelines Patient compliance issues Reimbursement/insurance issues Lack of time to assess/counsel patients Lack of administrative support Lack of resources (equipment) Lack of opportunity (patients) Lack of experience Cost 3% 4% 8% 11% 12% 15% 19% 18% 25% 25% 26% 25% 5 N=282 (live and enduring combined) Participants indicated cost (26%) as the most common barrier to implementing changes, followed by lack of experience or patient compliance issues (25%).

25 Level 4: Perceived Barriers Please list one barrier you have encountered with utilizing one of the newer pharmacological therapies (ie, ivabradine or sacubutril/valsartan): Cost Financials/affordability Complex approval process Side effects Tolerability Nurse and physician awareness Non formulary drug No time to pre certify Hypotension Health systems Physician and hospitalist willingness Insurance approval/lack of coverage Lack of education Complexity of decision making Will you attempt to address these barriers in order to implement changes in your competence, performance, and/or patients outcomes? Yes How? Utilize new treatment options Better treatment of patients Reinforced education Encourage compliance Proactively demand coverage No Why not? Time restraints No resources Through a therapeutic committee Discuss with pharmacy team Work with insurance coordinators Create patient education handout/checklist Work with cardiologist Not able to control cost Insurance restrictions N=280 (live and enduring combined)

26 Level 4: Impact of Changes on Patient Care Number of patients with heart failure with reduced ejection fraction (HFrEF) seen per month who take either ivabradine or sacubitril/valsartan? 5% 4% 27% % >50 47% Changes will impact up to 6,320 heart failure patients with HFrEF (who take ivabradine or sacubitril/valsartain) each month. This assumes data in chart above represents all healthcare professionals in attendance (823), who indicated they would change their practice as a result of this activity (6). N=284 (live and enduring combined)

27 Level 4: An Opportunity to Optimize Medical Therapy Percent of patients with heart failure who receive both medical therapy (ACE inhibitor, beta blocker, newer agents) AND have a device: <1 48% 1 25% 31% >25% 21% More than a quarter of heart failure patients utilize both a device and medical therapy. Devices are typically a last alternative before consideration of a heart transplant. If medical therapy was optimized, a potentially greater time to (an invasive and life altering) surgery could be realized. N=282 (live and enduring combined)

28 Topics of Interest What topic areas would you like to see in future activities? Select all that apply: Left Atrial Access 23% Transseptal Puncture 17% Post procedure Anti coagulation Guidelines 56% Revascularization Strategies to Avoid Recurrent HF 46% Other 6% 25% 5 75% Post procedure anti coagulation guidelines was rated with highest interest for future education (56%), followed by revascularization strategies to avoid recurrent HF (46%). Other options for future education were strongly team and patient focused: collaboration in a team environment, comprehensive heart failure programs, the importance of managing the patient. N=242 (live and enduring combined)

29 Next Steps Enduring webcast launched April 21, 2017 on mycme and is available for one year Final outcomes to be provided in June 2018 For questions, please contact: Richard Keenan VP, Education Development Academy for Continued Healthcare Learning (ACHL) E: P: ext. 215 C:

30 Appendix

31 Symposium Marketing

32 Symposium Marketing

33 Enduring Landing Page mycme