Developing High Quality Medical Practices in Restorative Reproductive Medicine

Transcription

1 Developing High Quality Medical Practices in Restorative Reproductive Medicine Demonstrating and Improving the Quality of RRM Paul Carpentier, MD, CFCMC Joseph Stanford, MD, CFCMC October 13, 2018

2 Faculty Disclosure Paul Carpentier, MD, CFCMC I have no financial conflicts of interest Joseph Stanford, MD, CFCMC In 2017, I served as a scientific consultant for Swiss Precision Diagnostics, a company which makes fertility monitors and pregnancy tests.

3 Faculty Background Paul Carpentier, MD, CFCMC Family medicine, Creighton Model NaProTech Health care reform Started Gianna Clinic within Catholic health system Joseph Stanford, MD, CFCMC Family medicine, Creighton Model NaProTech Clinical and public health research Started NaPro clinic within academic health center

4 We are both members of the Board of the IIRRM (uncompensated)

5 Restorative Reproductive Medicine (RRM) Medical and surgical evaluation, techniques, and interventions that strive to restore, promote, or optimize the normal physiology and anatomy of the human reproductive system female and male Goal to optimize health of woman, man, and child Goal to maximize probability of natural conception when desired

6 Restorative Reproductive Medicine (RRM) Does not handle gametes outside the body Does not include superovulation Supports patients' right to understand and cooperatively manage their own fertility, with medical and surgical assistance

7 How can a Catholic health system ensure that the RRM services that it plans to offer are of the highest possible quality? Question

8 Response Focus of talk Quality assurance Evidence-base, quality improvement Clinical outcomes Not the focus Ethical boundaries Financial or legal structures Surgical component

9 Specific types of RRM NaProTechnology, based on the Creighton Model FertilityCare System Sensiplan with medical support Ovarian Monitor, with the Billings Ovulation Method

10 Assuring RRM Quality Training Mentoring and peers Certification Evidence-based CME Assess outcomes systematically (accountability) Features of a successful program

11 Training - clinicians Usually not part of standard medical training Few introductory CME courses Pope Paul VI Institute medical consultant course Some weekend courses One surgical fellowship (Pope Paul VI) A research fellowship (University of Utah)

12 Mentoring- clinicians Didactic training insufficient in of itself Must observe practice! Solo = sink Webinars by IIRRM Consulting colleagues or call a friend Gianna center group call

13 Training and mentoring Also applies to nurses, medical assistants, other personnel

14 Certification Currently available for NaProTechnology Through the American Academy of FertilityCare Professionals

15 Evidence-based CME American Academy of FertilityCare Professionals International Institute for Restorative Reproductive Medicine

16 Assess outcomes systematically Practice registry Continuous quality improvement Accountability to colleagues and the public inest STORRM

17 inest international NaProTechnology Evaulation and Surveillance of Treatment

18 inest enrollment Opened early 2006 Closed January 2016, ended follow-up Jan sites in USA; 1 each in Canada, UK, Poland 835 couples

19 inest participants 34.0 years mean woman s age 3.7 mean years trying to conceive 26% woman prior pregnancy 51% had at least one live birth during the study

20 Cumulative probability of conception to live birth by prior time trying

21 Impact of specific factors Higher success if Less previous time trying Had a prior pregnancy No significant impact Income Race Clinic site Woman s age

22 STORRM Surveillance of Treatment Outcomes in Restorative Reproductive Medicine

23 STORRM principles Accountability to the public and professionals annual outcomes for participating RRM clinics analogous to the annual reporting by most IVF clinics required by law in USA to SART-CDC Comprehensiveness include all patients treated (de-identified data)

24 STORRM principles Recognition of participating practices quality improvement and accountability in RRM Sustainability reasonable fees from participating practices maintain database without dependence on outside funders Inclusiveness any practice using principles of RRM willing to participate

25 STORRM core data Age of woman and man Preceding time attempting Prior treatments Prior live birth or pregnancy Surgery Evaluation and key diagnoses # of clinic visits Treatments since last update Pregnancy outcomes

26 STORRM current status On hold Time and money needed to start!

27 Summary: Ensuring Quality How to ensure highest possible quality of RRM services? Training Mentoring and peers Certification Evidence-based CME Assess outcomes systematically (accountability)

28 Value

29 Quality in Reproductive Healthcare RRM Compared to ART Live Birth Rate Multiple Gestation Maternal Complication Rate Perinatal Complication Rate Birth Defects and Pediatric Disabilities Miscarriage Rate Low Birth Weight

30 Cohort comparisons Twin Rates Time Crude Adj. Twins+ Birth wt Tx Location frame Birth Birth <2500 g NaPro Ireland 2 yrs 26% 53% 5% 5% NaPro Canada 2 yrs 38% 66% 0% 15% NaPro inest USA, Canada, UK, Poland 3 yrs 51% 60% 4% 7% IVF UK ~1.5 yr 42% 57% 25%??? IVF USA ~1.5 yr ~55% ~75% 47% 32% Cohort Explanations slide at end of the slide set

31 Restored Mom --> Healthier babies NPT IVF Low birth wt <5% 30% or more Prematurity <5% 30% or more Other issues Double perinatal mortality & birth defects J Am Board Fam Med 2008 Obstet Gynecol 2004 NEJM 2002

32 Cost: Episode of Care The entire cost of managing an illness varies by approach For example: A patient with a cough presents to the ER versus CXR, labs, prolonged stay, high utilization, no continuity A patient with a cough presents to their PCP Well known, minimal care needed Same outcome, less cost Quality Cost Value!!!

33 Episode of Care Infertility Treated by IVF vs NaProTECHNOLOGY

34 Infertility - IVF Price $12K $1000 IVF IVF IVF NICU 2 Babies IVF $100 S M Tr L Tw PB S PB E H 0 1 2~ Years Infertility - NPT $12K Price $1000 $100 S D S D Paul A. Carpentier, MD, CFCMC, In His Image Family Medicine, PC, 1/26/14

35 Restorative Reproductive Medicine Gaining Traction!

36 Obamacare Occurs (ACA) Fosters the development of accountable care This strives to: Integrate care Make physicians liable for the entire cost of their patients care Manage a population, as well as individuals Maintain quality while restraining costs

37 Infertility is due to Chronic disorders Acute treatments are expensive and do not serve chronic dis well Commissions, attorneys general and ACOs are poised to cut cost, dissipate power and foster chronic care management for the economic wellbeing of the country

38 The Stage is Set for an enlightened perspective toward infertility management and other gynecological disorders

39 It's fundamentally wrong to treat infertility as a sole diagnosis because the underlying cause of the infertility will vary... it could have "50, 60 or 70 different causes" Professor Lord Robert Winston, who has developed improvements in IVF techniques

40 ASRM Changes Their Opinion! Prioritizing fallopian tube repair over IVF In 2012, the American Society for Reproductive Medicine (ASRM) edited their opinion on tubal surgery This shift heralds a potential change in mainstream reproductive medicine This presentation compares the cost and effectiveness of IVF with currently available, ethically undisputed techniques of fallopian tube repair

41 HYST=hysteroscopic, LAP=laparoscopic, LEC=linear everting catheter, SS=selective salpingography Detailed Results

42 "One of the important issues is making a diagnosis and finding other more effective simpler remedies, but most clinics are now geared up to do IVF, so they don't actually treat the underlying issue." Professor Lord Robert Winston

43 Infertility is due to Chronic Disorders But so are many other Gyn problems If these are addressed Quality will improve Outcomes should improve Costs should be less This will catch the ear of insurers, IPAs and governmental programs

44 Atul Gwande Most expensive care is not necessarily the best care Best care often turns out to be the least expensive Decreased Complications Increased Efficiency TED talk 2015 Picture from Wikipedia

45 Atul Gwande For Best results: We need HEALTH SYSTEMS Components working in harmony toward goal One component might make revenue While another sets the stage Together improve value and quality e.g. PHO s

46 Research Accomplished to Evidence Based Guidelines Guide Decisions Taught to Providers and Incentivized Patient Choices

47 Cardinal Burke To achieve the best use of our goods in the service of those who have grown weak Catholic healthcare institutions should exemplify sound healthcare economy Picture from thecatholicthing.org

48 Demonstrating High Quality includes Measuring Outcomes Compare to other approaches Patient satisfaction Ethics could be considered Increased focus lately on Cultural Competence Reporting Meeting Thresholds Access, timeliness, meeting standards

49 Meeting the Needs If RRM is adopted, advocated CFCPs, CFCMCs/NPs Especially NaProSurgeons Could PPVI Institute Train More? Funding from insurers to train more per year New training sites elsewhere Increased funding per surgery might help

50 Who will set the standards? Factors involved: Price, price, price Power Health Policy Commissions Attorneys General Political agenda Access Professional Organizations Institute of Med, DPH, FDA

51 Barriers to Implementation Burdensome regulations Corporate struggles Lack of religious conscience protections Public not educated on approaches and costs Lack of formation Cultural attitudes and lobbies Medicaid covers fertility suppression but not improvement

52 Potential Gains Insurers less expenditures = lower premiums Compounding pharmacies more business Catholic Systems mission reminder Reimbursements for FCPs higher, covered Healthier women/families Fewer: Breast cancers Premature deliveries Hysterectomies

53 Authentic Feminism Life is a Gift Dignity of the Embryo Culture Benefits From Respect for Restorative Approach Personhood at earliest stages Increased respect Less embryo selection/eugenics Role of Husband/father appreciated again Societal value of Marriage

54 Discussion Insights to share/questions

55 Extra slides for questions or as needed

56 Cumulative probability of conception to live birth by prior live birth

57 Cohort comparisons Tx Location Reference NaPro Ireland Stanford JB, Parnell TA, Boyle PC. J Am Board Fam Med 2008, 21(5): NaPro Canada Tham E, Schliep K, Stanford J. Can Fam Physician 2012, 58(5):e267-e274 NaPro inest USA, Canada, UK, Poland Unpublished IVF UK McLernon DJ, Maheshwari A, Lee AJ, Bhattacharya S. Hum Reprod IVF USA Luke B, Brown MB, Wantman E, Lederman A, Gibbons W, Schattman GL, Lobo RA, Leach RE, Stern JE. N Engl J Med 2012, 366(26):

58 Cohort comparisons Tx Location N Year Mean age woman Time trying Prior pregnancy NaPro Ireland yrs 24% NaPro Canada yrs 44% NaPro inest USA, Canada, UK, Poland yrs 26% IVF UK 107, yrs??? IVF USA 246, ??????

59 Population-based premature birth in couples trying to conceive FL, MD, UT, Analysis; referent group ART IUI & OS OS Other Spont after tx All births, women trying to conceive All births, subfertile spontaneous Singletons, women trying to conceive Singletons, subfertile spontaneous 6.2 (4.2,9.2) 3.2 (1.7,6.0) 3.3 (1.7,6.2) 1.7 (0.8,3.7) 2.1 (1.2,3.6) 1.2 (0.6,2.5) 1.3 (0.6,2.5) 0.7 (0.3,1.8) 1.4 (1.0,1.9) 0.7 (0.4,1.3) 0.9 (0.7,1.4) 0.5 (0.2,1.0) 0.9 (0.5,1.6) 0.5 (0.2,1.0) 0.9 (0.5,1.6) 0.5 (0.2,1.1) 1.3 (0.8,2.0) ref 1.3 (0.8,2.0) ref TTC no tx ref ref Odds ratios adjusted for age, education, federal poverty level, BMI, parity, race, ethnicity, insurance, marital status, smoking Stanford JB et al. Brit J Obstet Gynecol 2015

60 Preterm birth and low birthweight by fertility treatment: FL, MD, UT, ART IUI and OS OS Other Spont after TX Preterm birth Low birthweight TTC, no tx Stanford JB et al. Brit J Obstet Gynecol 2015

61 Episode of Care - Key OCCURENCES S = Single Pregnancy Tr = Triplet Pregnancy L = Loss of one fetus Tw = Twin Pregnancy M = Miscarriage PB = Premature Birth E = Endometrial Ablation H = Hysterectomy D = Normal Delivery Height of Bubble = Cost Width of Bubble = Time Ave time to preg with NPT = 6.4 mos; almost always singleton = Doctor Evaluation = HSG = Semen analysis = Lab Tests = Ultrasound Pelvis = progesterone support = Monitoring Loss of One Fetus = 2 Premature NICU Stay > Month = Cost of Chronic Illness of Twins = Endometrial Ablation - DUB = Hysterectomy / BSO = FertilityCare Training Paul A. Carpentier, MD, CFCMC, In His Image Family Medicine, PC, 1/26/14

62 Another Key Example How to Approach Infertility after Endometriosis Surgery Better pregnancy rates for spontaneous attempts versus ovarian stimulation/iui (Summary by Dr. Kyle Beiter, personal communication) J Minim Invasive Gynecol Jan-Feb;21(1): doi: /j.jmig Epub 2013 Jul 31 SETTING: Cleveland Clinic Foundation, tertiary care center

63 "In many cases, in-vitro fertilisation is not the best [approach] but it's the most profit... Unexplained infertility is a nonsense; it's a failure to make a diagnosis." Professor Lord Robert Winston A leading IVF Specialist in the UK 8/1/18 ures/view/british-ivf-clinics-on-agravy-train-ivf-pioneer/21557

64 The National Gianna Center for Women s Health and Fertility New women's health center offers reproductive care, gynecology Catholic New York December 31, 2009 Anne Nolte, MD, CFCMC Ron Rak, CEO, St. Peters Univ Hospital Michele Giuiliano Kyle Beiter, MD, CFCMC There is an effective approach which is less expensive and morally acceptable, allowing couples to conceive through a natural act of intercourse. Accepts most major medical insurance plans including Medicaid.

65 Obamacare Occurs (ACA) National Affordable Care Act Actually a motivation and mechanism to change the macro-system Complicated by the fact that the administration planted their agenda within it Abortion Contraception Protecting pharmaceutical companies