NATIONAL ASSOCIATION FOR CONTINUING EDUCATION. Experts on Call: Current Issues in the Management of Hypogonadism:

Transcription

1 NATIONAL ASSOCIATION FOR CONTINUING EDUCATION Experts on Call: Current Issues in the Management of Hypogonadism: Final Outcome Report for Three Live Online Webinars Report Date: 03/10/2014

2 Copyright 2014 National Association for Continuing Education All rights reserved. No part of this document may be reproduced without written permission of the copyright holder. Requests for permission or further information should be addressed to: National Association for Continuing Education 300 NW 70 th Avenue, Suite 102 Plantation, FL (954)

3 Course Director Gregg Sherman, MD Family Practice Northwest Heart and Health Margate, FL Activity Planning Committee Gregg Sherman, MD Harvey C. Parker, Ph.D., CCMEP Michelle Frisch, MPH, CCMEP Alan Goodstat, LCSW Cheryl C. Kay

4 Course Accreditation The National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The National Association for Continuing Education designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity. National Association for Continuing Education is approved as a provider of nurse practitioner continuing education by the American Association of Nurse Practitioners. AANP Provider Number This program has been approved for 1.0 contact hour of continuing education (which includes 0.50 hours of pharmacology).

5 Commercial Support Experts on Call: Current Issues in the Management of Hypogonadism CME activity was supported by an independent medical education grant from AbbVie.

6 Dates and Times Experts on Call: Current Issues in the Management of Hypogonadism Live Webinar Schedule December 10, :00pm 8:00pm EST January 13, :00pm 9:00pm EST January 21, :30pm 9:30pm EST

7 Levels of Evaluation Consistent with the policies of the ACCME, NACE evaluates the effectiveness of all CME activities using a systematic process based on Moore s model. This outcome study reaches Level 5. Level 1: Participation Level 2: Satisfaction Level 3: Declarative and Procedural Knowledge Level 4: Competence Level 5: Performance Level 6: Patient Health Level 7: Community Health Moore DE Jr, Green JS, Gallis HA. Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities.j Contin Educ Health Prof Winter;29(1):1-15

8 52 attendees Level 1: Participation 49% Physicians; 49% NPs or PAs; 0% RNs; 0% Other 62% PCP, 9% Endocrinology; 29% Other or did not respond Did we reach the right audience? Yes!

9 Level 2: Satisfaction 93% rated the activity as very good to excellent 100% indicated the activity improved their knowledge 89% stated that they learned new strategies for patient care 84% said they would implement new strategies that they learned in their practice 100% said the program was fair-balanced and unbiased Sample Size: N = 43 Were our learners satisfied? Yes! Data was collected during all three webinars for Experts on Call: Current Issues in the Management of Hypogonadism.

10 Did Learners Say They Achieved Learning Objective? Upon completion of this activity, I can now Identify the prevalence, risk factors and co-morbid conditions associated with low testosterone; Recognize the importance of testing testosterone levels before prescribing PDE-5 inhibitors; Assess the safety, efficacy, benefits, and risks associated with the utilization of treatment options for low testosterone; Outline the challenges to short- and long-term management and monitoring of testosterone therapy: 90% 80% 70% 60% 50% 40% 79% 30% 20% 10% 0% Sample Size: N = 43 21% 0% Yes Somewhat Not at all Yes! 100% believed they did.

11 Outcome Study Methodology Goal To determine the effect this CME activity had on learners with respect to competence to apply critical knowledge, confidence in treating patients with diseases or conditions discussed, and change in practice behavior. Dependent Variables 1. Level 3-5: Knowledge, Competence, and Performance Case-based vignettes and pre- and post-test knowledge questions were asked with each session in the CME activity. Identical questions were also asked to a sample of attendees 4 weeks after the program to assess retention of knowledge. Responses can demonstrate learning and competence in applying critical knowledge. The use of case vignettes for this purpose has considerable predictive value. Vignettes, or written case simulations, have been widely used as indicators of actual practice behavior Practitioner Confidence Confidence with the information relates directly to the likeliness of actively using knowledge. Practitioner confidence in his/her ability to diagnose and treat a disease or condition can affect practice behavior patterns. 3. Level 5: Self-Reported Change in Practice Behavior Four weeks after CME activity, practitioners are asked if they changed practice behavior. 1. Peabody, J.W., J. Luck, P. Glassman, S. Jain, J. Hansen, M. Spell and M. Lee (2004). Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med14(10):

12 Outcome Study Methodology (Cont.) 4. Readiness to Change Behavior (Prochaska and DeClemente Model) CME activities can motivate providers to move through different stages of change which can ultimately lead them to take action and modify their practice behavior in accordance with the objectives of the education. Movement through these stages of change is an important dependent variable to consider in evaluating the impact of CME. Participants were asked to evaluate their stage of change with respect to specific topics being presented. Pre-contemplation stage: I do not manage (XXX illness), nor do I plan to this year. Contemplation stage: I did not manage (XXX illness) before this course, but as a result of attending this course I'm thinking of managing it now. Pre-contemplation/confirmation stage: I do manage patients with (XXX Illness) and this course confirmed that I do not need to change my treatment methods. Preparation for action stage: I do manage patients with (XXX illness) and this course helped me change my treatment methods. Prochaska, et al (1988). Journal of Consulting and Clinical Psyhcology., 56,

13 Learning Objectives Experts on Call: Current Issues in the Management of Hypogonadism Faculty Mohit Khera, MD, MPH 1. Identify the prevalence, risk factors and co-morbid conditions associated with low testosterone 2. Recognize the importance of testing testosterone levels before prescribing PDE-5 inhibitors 3. Assess the safety, efficacy, benefits, and risks associated with the utilization of treatment options for low testosterone 4. Outline the challenges to short- and long-term management and monitoring of testosterone therapy

14 Key Findings Experts on Call: Current Issues in the Management of Hypogonadism Knowledge/Competence Learners demonstrated significant improvement from pre to post-testing in their answers to three out of four of the case-based questions regarding male hypogonadism. Confidence Due to technical difficulties with data collection, a pretest confidence level could not be obtained. Post program though, moderate to very confident levels reached 86%. Intent to Perform Change of Practice Behavior *N= 16 As a result of this program, 21% of learners who did not manage male hypogonadism before are considering doing so, while 58% indicated that they will change their treatment methods. 93% of learners who responded to our four week survey indicated that they had changed their practice behavior to implement the learning objectives of this program within four weeks after they attended the activity. * Completed four week case question survey

15 Case Vignette Knowledge and Competence Assessment Questions Presented before and after lecture. Boxed answer is correct Arthur is a 67 yr old obese male with type 2 DM Presents to PCP for routine follow-up States he has recently retired and his stress level is improved but he doesn t feel any better I ve gained 10 pounds, I just don t have the energy or motivation to do much and Now that I have the time, I just don t have the interest in sex and I am not sure that things are working so well Based on Arthur s age (67 yrs) alone his risk of having androgen deficiency is: (Learning Objective 1) 45% 40% P Value: >0.221 Not Significant 35% 30% 25% Pre % 20% 15% 39% 37% 37% 33% Post % 10% 5% N= 43 0% 19% 14% 7% 9% 2% 2% < 20% 20% to 40% 40-50% 50-60% > 60% Red highlight indicates no significant difference between pre and post testing.

16 Case Vignette Knowledge and Competence Assessment Questions Presented before and after lecture. Boxed answer is correct Charles is a 67 yr old male who complains of erectile dysfunction. He states - It is difficult to get a fully rigid erection and when he does it doesn t last long enough. Can I try one of those pills for ED doc? PMHX: Hypertension and Gout PSH: cholecystectomy Meds: amlodipine, losartan, allopurinol. ROS: denies LUTs, negative stress test, notes decreased libido and fatigue PE: prostate small without nodules/ tenderness. For this patient, checking a serum testosterone prior to starting a PDE-5 inhibitor is recommended based on all of the following except: (Learning Objective 2) 60% P Value: < Significant 50% 40% 30% 56% Pre % 20% Post % 10% 27% 26% 21% 21% 31% N =43 0% Low testosterone predicts a poor response to PDE-5 inhibitors 9% Prevalence of testosterone deficiency is as high as 35% in ED patients The addition of testosterone to PDE-5 inhibitors has been demonstrated to improve ED in men with testosterone level between ng/dl Green highlight indicates significant difference between pre and post testing. 9% Low testosterone increases smooth muscle apoptosis, reducing erectile tissue relaxation and reducing nitric oxide production

17 Case Vignette Knowledge and Competence Assessment Questions Presented before and after lecture. Boxed answer is correct Ralph is a 65 yr old morbidly obese male with diabetes 2, hypertension, dyslipidemia and hx of MI s/p angioplasty and stents. He smokes 1 pack of cigarettes per day and drinks one glass of wine in the evening. He has the following concerns: - Trouble sleeping, fatigue, and has been gaining weight - States I am just not interested in sex anymore doc - Its hard doc, my wife sleeps in the guest bedroom because of my snoring He wants testosterone therapy as he thinks it may help his energy level and libido but my wife is worried about my heart. Meds: Simvastatin, Metformin, HCTZ, Metoprolol Family History: Father diagnosed with prostate cancer at 76 yrs, +CVD; PE: BP - 150/80 Labs: Serum testosterone of 300; Normal: FSH, LH, Prolactin, PSA, CBC, TFTs and Liver profile. Total cholesterol 189. Which of the following would be a concern for starting Ralph on testosterone replacement therapy? (Learning Objective 3) 90% P Value: < Significant 80% 70% 60% 50% 40% 30% 20% 45% 41% 84% Pre % Post % 10% 0% N = 43 12% 7% 2% 7% 2% Cardiovascular risk Concomitant medications Sleep apnea Smoking and drug-drug interactions Green highlight indicates significant difference between pre and post testing.

18 90% Case Vignette Knowledge and Competence Assessment Questions Presented before and after lecture. Boxed answer is correct Steve is a 56 year old African American male. He started on testosterone gel therapy for hypogonadism. His initial labs prior to starting testosterone therapy include: Serum testosterone 280 ng/dl CBC normal Cholesterol 180, HDL 80, LDL 100 PSA 1.6 Normal LFTs, Chem 7 What potential changes in his labs, related to the testosterone gel, require long term monitoring include all of the following except: (Learning Objective 4) 80% 70% 60% 50% 40% 71% 79% Pre % Post % 30% P Value: < Significant 20% 10% 0% N = 43 12% 2% 5% 2% Increase in PSA Increase in Hematocrit Decrease in total cholesterol 12% 16% Increase in LFT s Green highlight indicates significant difference between pre and post testing.

19 Change in Practice Behavior Question Presented after lecture. Which of the statements below describes your approach to diagnosing and treating male hypogonadism? Pre-Contemplation Stage Contemplation Stage Preparation for Action Stage Pre-Contemplation/ Confirmation Stage 70% 60% 50% 40% 30% 58% 20% 10% 0% N= 43 14% I do not manage male hypogonadism, nor do I plan to this year. 21% I did not manage male hypogonadism before this course, but as a result of attending this course I'm thinking of managing it now. I do manage male hypogonadism and this course helped me change my treatment methods. 7% I do manage male hypogonadism and this course confirmed that I don't need to change my treatment methods.

20 50% Four Week Case Study Questions Key Findings Boxed answer is correct Arthur is a 67 yr old obese male with type 2 DM Presents to PCP for routine follow-up States he has recently retired and his stress level is improved but he doesn t feel any better I ve gained 10 pounds, I just don t have the energy or motivation to do much and Now that I have the time, I just don t have the interest in sex and I am not sure that things are working so well Based on Arthur s age (67 yrs) alone his risk of having androgen deficiency is: (Learning Objective 1) 45% 40% 35% 30% 25% 20% 15% 43% 39% 37% 37% 36% 33% Pre % Post % 4 Weeks Post 10% 19% 5% 14% 12% 9% 7% 6% 2% 3% 2% 0% *N= 16 < 20% 20% to 40% 40-50% 50-60% > 60% * Completed four week case question survey Red highlight indicates no significant difference between pre and post testing.

21 Four Week Case Study Questions Key Findings Boxed answer is correct Charles is a 67 yr old male who complains of erectile dysfunction. He states - It is difficult to get a fully rigid erection and when he does it doesn t last long enough. Can I try one of those pills for ED doc? PMHX: Hypertension and Gout PSH: cholecystectomy Meds: amlodipine, losartan, allopurinol. ROS: denies LUTs, negative stress test, notes decreased libido and fatigue. PE: prostate small without nodules/ tenderness For this patient, checking a serum testosterone prior to starting a PDE-5 inhibitor is recommended based on all of the following except: (Learning Objective 2) 60% 50% 40% 30% 20% 10% 0% *N= 16 27% 26% 14% Low testosterone predicts a poor response to PDE-5 inhibitors * Completed four week case question survey 26% 21% 21% 9% 56% 56% Prevalence of testosterone The addition of testosterone to deficiency is as high as 35% in PDE-5 inhibitors has been ED patients demonstrated to improve ED in men with testosterone level between ng/dl 31% Green highlight indicates significant difference between pre and post testing. 9% 4% Low testosterone increases smooth muscle apoptosis, reducing erectile tissue relaxation and reducing nitric oxide production Pre % Post % 4 Weeks Post

22 90% Four Week Case Study Questions Key Findings Boxed answer is correct Ralph is a 65 yr old morbidly obese male with diabetes 2, hypertension, dyslipidemia and hx of MI s/p angioplasty and stents. He smokes 1 pack of cigarettes per day and drinks one glass of wine in the evening. He has the following concerns: - Trouble sleeping, fatigue, and has been gaining weight - States I am just not interested in sex anymore doc - Its hard doc, my wife sleeps in the guest bedroom because of my snoring. He wants testosterone therapy as he thinks it may help his energy level and libido but my wife is worried about my heart. Meds: Simvastatin, Metformin, HCTZ, Metoprolol Family History: Father diagnosed with prostate cancer at 76 yrs, +CVD; PE: BP - 150/80 Labs: Serum testosterone of 300; Normal: FSH, LH, Prolactin, PSA, CBC, TFTs and Liver profile. Total cholesterol 189. Which of the following would be a concern for starting Ralph on testosterone replacement therapy? (Learning Objective 3) 80% 70% 60% 50% 40% 30% 84% 74% Pre % Post % 4 Weeks Post 20% 45% 41% 10% 12% 14% 7% 2% 6% 0% *N= 16 Cardiovascular risk Concomitant medications and drug-drug interactions * Completed four week case question survey 7% 2% 6% Sleep apnea Smoking Green highlight indicates significant difference between pre and post testing.

23 Four Week Case Study Questions Key Findings Boxed answer is correct Steve is a 56 year old African American male. He started on testosterone gel therapy for hypogonadism. His initial labs prior to starting testosterone therapy include: Serum testosterone 280 ng/dl CBC normal Cholesterol 180, HDL 80, LDL 100 PSA 1.6 Normal LFTs, Chem 7 What potential changes in his labs, related to the testosterone gel, require long term monitoring include all of the following except: (Learning Objective 4) 90% 80% 70% 60% 50% Pre % 40% 30% 71% 79% 80% Post % 4 Weeks Post 20% 10% 0% *N= 16 12% 2% 6% 5% 2% 0% Increase in PSA Increase in Hematocrit Decrease in total cholesterol * Completed four week case question survey 12% 16% 14% Increase in LFT s Green highlight indicates significant difference between pre and post testing.

24 50% Experts on Call: Current Issues in the Management of Hypogonadism On a scale of 1 to 5, please rate how confident you are with diagnosing and treating male hypogonadism after this program? (Pre-test confidence levels unavailable due to technical issues) 45% 40% 35% 30% 25% 47% 20% 15% 30% 10% 5% 0% 14% 9% 0% Not all confident Slightly confident Moderately confident Pretty much confident Very confident N= 43

25 Intention to Change Practice Behavior and Implement Learning Experts on Call: Current Issues in the Management of Hypogonadism How likely are you to implement strategies learned from this presentation in your practice? 70% 60% 50% 40% 30% 65% 20% 10% 19% 14% N= 43 0% Very Likely Somewhat likely Unlikely Not applicable 2%

26 Experts on Call: Current Issues in the Management of Hypogonadism What specific skills or practice behaviors have you implemented for patients with male hypogonadism since this CME activity? (Comments received from attendees at 4 week follow up) Increased screening for hypogonadism OSA screening with sleep study prior to repletion of testosterone Monitoring of testosterone levels in men on chronic opiates Measuring testosterone levels before prescribing PDE-5 inhibitors Check T level in AM, in mid cycle Encouraging weight loss Ordering more labs Monitor labs more regularly On the lookout for patients with obstructive sleep apnea Administering testosterone topically Testing for low testosterone in ED patients

27 Experts on Call: Current Issues in the Management of Hypogonadism Describe/list any other educational activities that you attended in the last month concerning the treatment of male hypogonadism. (N=16) 94% 0% 6% 0% None Live Program* Enduring** Journal*** 1 respondent attended enduring program: ** NACE Spaced Education enduring course on hypogonadism

28 Experts on Call: Current Issues in the Management of Hypogonadism What specific barriers have you encountered that may have prevented you from successfully implementing strategies for patients with male hypogonadism since this CME activity? (Comments received from attendees at 4 week follow up) I work in geriatric palliative care setting Practice setting Cost of Testosterone therapy Pts wanting higher dose of testosterone despite erythrocytosis

29 Discussion and Implications Experts on Call: Current Issues in the Management of Hypogonadism The need for continued education in the early diagnosis and management of Hypogonadism was demonstrated based on literature reviews and surveys completed prior to the conference series. Attendee knowledge was assessed at 3 points for this program: prior to the lecture, immediately following the lecture and again at 4 weeks after the conference using the case vignettes listed above. The results indicated a statistically significant improvement in knowledge in three out of the four areas tested. Specifically, as a result of this lecture, participants: recognize that the addition of testosterone therapy to PDE5 inhibitors in men with ED has limited impact when testosterone levels are between ng/dl, realize the importance of diagnosing and treating Sleep Apnea prior to instituting testosterone replacement therapy; and understand that long term monitoring of liver functions is not indicated for men receiving testosterone therapy. Participants remained unclear on the specific age related risk of Hypogonadism as only 1/3 of attendees knew the correct answer before and after the program. Data obtained from participants 4 weeks after the program demonstrated consistent improvement from pre-test scores in 3 of the 4 questions. These results suggest that nearly all of the learning objectives for this activity were effectively addressed with attendees. Persistent gaps in knowledge were evident with the following findings: 57% of learners are still not clear on the actual prevalence of androgen deficiency in a 67 y/o male; 44% of participants still do not realize that adding testosterone therapy to PDE-5 inhibitors is unlikely to improve ED with Testosterone levels of ng/dl; 26% are still unaware that sleep apnea must be ruled out before adding Testosterone replacement therapy; 80% of clinicians incorrectly believe that total cholesterol levels will go up with testosterone and 86% believe they need to monitor for increasing LFT s.

30 Discussion and Implications Experts on Call: Current Issues in the Management of Hypogonadism Due to technical difficulties with data collection, a pre-test confidence level could not be obtained. Post program though, moderate to very confident levels reached 86%. In addition, 21% of learners who did not participate in the management of patients with Hypogonadism before the program are considering doing so, while 58% who are involved with managing Hypogonadism indicated that they will change their treatment methods as a result of this program. At 4 weeks, 93% of respondents indicated that they had already changed their practice behavior in the management of Hypogonadism. Attendees indicated multiple new, specific, practice behaviors they implemented as a result of this program that included: more detailed history taking to uncover hypogonadism; more regular lab monitoring of testosterone therapy; screening for obstructive sleep apnea in patients with hypogonadism; and increased comfort in prescribing topical testosterone therapy. 94% of participants had no other educational exposures concerning Hypogonadism, indicating their behavioral changes were most likely related to this program. Barriers to care included medication costs, formulary coverage, communication and patient acceptance. The notable changes in posttest scores signify a clear gap in knowledge and an unmet need among primary care clinicians. It continues to be an important area for future educational programs. Additional programming should continue to educate clinicians on: the risk and prevalence of hypogonadism in men, the role of testosterone therapy in men with Erectile Dysfunction, the importance of screening and treating Sleep Apnea prior to initiating testosterone therapy, and long term monitoring strategies.