Funded by North American Menopause Society & Pfizer Independent Grant for Learning & Change # , KAISER PERMANENTE CENTER FOR HEALTH RESEARCH

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1 Design & Implementation of a Clinician- Focused Intervention to Improve Diagnosis & Management of Symptomatic Vulvovaginal Atrophy: Clinician-reported barriers Kimberly K. Vesco, MD, MPH Kaiser Permanente Northwest (KPNW) Department of Obstetrics & Gynecology Center for Health Research Funded by North American Menopause Society & Pfizer Independent Grant for Learning & Change #10319

2 Study Team Kimberly K. Vesco, MD, MPH Amanda Clark, MD, MCR Kate Beadle, NP, NCMP Joanna Bulkley, PhD Ashley Stoneburner, MPH Michael Leo, PhD

3 Disclosures The investigators have no financial conflicts of interest to disclose.

4 Background Nearly 50% of postmenopausal women experience symptoms related to vulvovaginal atrophy (VVA), including: Vulvovaginal dryness and irritation Painful intercourse Dysuria, urinary urgency, urge incontinence, and recurrent urinary tract infection Despite the availability of effective treatment options, few women seek treatment for these symptoms and few providers ask women about VVA-related symptoms.

5 Say Yes to Vulvovaginal Health (Yes VVH) Yes VVH is a cluster randomized trial of a health system-based intervention to improve diagnosis and management of symptomatic vulvovaginal atrophy

6 Study Design

7 Assessing Clinician Knowledge, Attitudes, and Barriers to Diagnosis &Treatment of VVA

8 Survey development Knowledge assessment 8 multiple choice questions about VVA prevalence, diagnosis, and treatment Attitude/Confidence assessment 3 questions, 5 point Likert scale response Likelihood to assess for VVA at a routine visit and confidence in ability to counsel patients about VVA and its treatment Barriers 12 barriers presented in a list We asked clinicians to check all those that apply

9 Survey development Barrier categories/themes Lack of time Clinician and patient discomfort discussing VVA Cost, side effects, and HEDIS & FDA warnings for estrogen treatment Lack of patient education materials Lack of provider knowledge of VVA diagnosis and treatment and/or clinician support tools

10 Administering the on-line survey Survey Monkey format CME department involvement for sending the survey request and tracking responses invitation sent to all KPNW Primary Care and Ob/Gyn providers with an address (n=363) 4 weeks time allowed for responses 2 reminder s sent Response rate was 33% (120/363)

11 Demographics of Respondents Primary Specialty Family Medicine 41% Internal Medicine 34% Ob/Gyn 25% Gender Female 71% Clinician type Physician (MD/DO) 77% Clinician (NP, CNM, PA) 23% Age range (years) <35 15% % % >55 28%

12 Clinician Knowledge of VVA Diagnosis and Treatment OB/GYN 78% of responses were correct (Range 37%-97% across all questions) Primary Care 64% of responses were correct (Range of 18%-97%) Primary discrepancies in knowledge were related to treatment

13 Clinician Treatment/Practice Attitudes 90% Percent answering 4-5 on the Likert Scale 80% 70% 60% 50% 40% 30% 20% 73% 73% 28% 33% 77% 30% OB/GYN Primary Care 10% 0% Likely to assess during routine visit Confidence to advise Pts on VVA symptoms Confidence to advise Pts on estrogen treatment 82% of routine visits for women 55 years are conducted by Primary Care providers

14 Most and least commonly reported barriers OB/GYN Primary Care Lack of time to discuss VVA with patient during visit 66% 79% Lack of educational materials for patients 59% 41% Patients discomfort raising/discussing vulvovaginal concerns with you 31% 45% HEDIS warning for estrogen as a high risk med in elderly women 38% 36% Lack of your knowledge of diagnosis and treatment of VVA 21% 36% FDA black box warning in vaginal estrogen product labeling 38% 29% Pt dissatisfaction with current options for local estrogen, e.g. messiness of creams, challenge of using Estring, etc. 45% 25% High cost of vaginal estrogen therapy 58% 19% Concern about increasing the risk of Br Ca by prescribing local estrogen therapy 14% 28% Lack of support tools for diagnosis and management 17% 19% Discomfort discussing sexual concerns w your patients 3% 2% Discomfort discussing urinary concerns w your patients 0% 2%

15 Concerns about the safety of vaginal estrogen HEDIS warning for estrogen as a high risk medication in elderly women FDA black box warning in vaginal estrogen product labeling Concern about increasing the risk of Breast Cancer by prescribing local estrogen therapy OB/GYN Primary Care 38% 36% 38% 29% 14% 28%

16 Greatest difference in barrier identification between Primary Care and Ob/Gyn clinicians OB/GYN Primary Care Lack of time to discuss VVA with patient during visit 66% 79% Lack of educational materials for patients 59% 41% Patients discomfort raising/discussing vulvovaginal concerns w you 31% 45% HEDIS warning for estrogen as a high risk med in elderly women 38% 36% Lack of your knowledge of diagnosis and treatment of VVA 21% 36% FDA black box warning in vaginal estrogen product labeling 38% 29% Pt dissatisfaction with options for local estrogen, e.g. messiness of creams, challenge of using Estring, etc. 45% 25% High cost of vaginal estrogen treatment 58% 19% Concern about increasing the risk of Br Ca by prescribing local estrogen therapy 14% 28% Lack of support tools for dx and management 17% 19% Discomfort discussing sexual concerns w your patients 3% 2% Discomfort discussing urinary concerns w your patients 0% 2%

17 Summary Provider knowledge about VVA symptoms and diagnosis is good Knowledge about treatment is lower among primary care providers Barriers to patient care may explain underdiagnosis and undertreatment of VVA-related symptoms Lack of time Lack of patient educational materials Lack of knowledge or concerns about safety of treatment Perceived patient discomfort with discussion of symptoms

18 Implications for Health System Change Health system interventions need to focus on addressing barriers to health care delivery and providing tools to overcome those barriers.

19 Questions? Say Yes to Vulvovaginal Health!

20 Yes VVH Intervention In person and online clinician educational training to improve knowledge, diagnosis, and management of vulvovaginal atrophy and related disorders Implementation of EMR-based tools to assist with patient care and education

21 VVA Smart Set (Epic EMR patient care tool)

22 VVA Smart Set (Epic EMR patient care tool)

23 Primary Outcome Measures To determine if Primary Care and Ob/Gyn clinicians randomized to the intervention clinics are more likely than those in control clinics to: Diagnose VVA Prescribe vaginal estrogen for VVA and other genitourinary disorders Use VVA-related computer tools (Smart Sets) and referrals for patient care

24 Secondary Outcome Measures To determine if patients in the intervention clinics compared to control clinics are more likely to: Report discussing VVA-related symptoms with their Primary Care or Ob/Gyn provider Receive information about VVA-related conditions from their provider Report using treatment for VVA-related conditions

25 KPNW OB/GYN and Primary Care Clinician Population Characteristics Department N = 368 Family Practice 45% Internal Medicine 35% OB/GYN 20% Clinician type Overall OB/GYN PC Physician (MD/DO) 79% 65% 82% Allied Clinician (NP, CNM, PA) 21% 35% 18% Gender Female 61% 80% 57%

26 Proportion Getting Knowledge Questions Correct Overall OB/GYN PC % of postmenopausal women affected by VVA 35% 43% 33% Facts about vulvovaginal atrophy 90% 93% 89% How to confirm diagnosis of atrophic vaginitis 96% 93% 97% Estrogen treatment of vulvovaginal atrophy 70% 90% 63% Vaginal estrogen and local estrogen therapy 76% 97% 69% Low-dose local estrogen therapy 93% 93% 93% VA treatment and history of estrogen-receptor positive breast cancer 23% 37% 18% Local estrogen therapy and urinary issues 55% 77% 48% Average for all 8 questions 67% 78% 64%

27 Clinician Population There are 18 unique clinics in KPNW that house Primary Care and OB/GYN. 368 KPNW Primary Care and OB/GYN clinicians (MD, NP, CNM, PA) were randomized Intervention: N = 189 (144-PC, 45-OB/GYN) Control: N = 179 (149-PC, 30-OB/GYN) Most well-care visits of women 55 years are conducted in Primary Care (82%)

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