1. Test of Reinfection for Chlamydia trachomatis and Neisseria gonorroheae University Student Health Center Protocol to Increase Rescreening Rates Through a Clinic-Based Quality Improvement Plan

2. Test of Reinfection for Chlamydia trachomatis and Neisseria gonorroheae: a University Student Health Center Protocol to Increase Rescreening Rates Through a Clinic-Based Quality Improvement Plan A clinic based quality improvement plan Susan Mancuso FNP, MSN University at Buffalo Health Services Gale R Burstein MD, MPH Erie County Health Department (ECDOH) Buffalo, New York

3. Acknowledgements for valued assistance Katherine Hsu MD MPH, Sylvie Ratelle STD/HIV PTC of New England Scott Zimmerman DrPH, former director Erie County Public Health Laboratory and staff, Buffalo, New York Heather Lindstrom PhD, former Director Disease Surveillance, ECDOH, Buffalo, New York Kelly Morrison Opdyke MPH, CAI Global Region 2 IPP Health Services Staff, University at Buffalo

4. Objectives List the 2010 CDC recommended STD treatment guidelines for Chlamydia trachomatis (CT ) and Neisseria gonorrhoeae (GC) Explain importance of CT and GC Test of Reinfection (TOR) List 3 strategies to improve CT and GC TOR patient compliance - Treatment plan - Patient brochure - Electronic medical records - Health department collaboration

5. Questions…. How many work in a o University? o College? o Community college? o Other? How many work in clinics that offer o Routine STI services? o Routine contraception services?

6. Questions…. How many routinely advise patients treated for chlamydia to return for a test of reinfection? How many routinely provide expedited partner therapy? How many work in clinics that conduct QI?

7. University at Buffalo Health Services and Erie County Department of Health Collaboration SUNY at Buffalo and ECDOH collaboration CQI implementation to “routinize” annual GC and CT testing and test of reinfection (TOR) rates

8. Annual CT/GC Screening Recommendations All sexually active ♀ aged ≤25 years o Vaginal swab NAAT preferred ♂ aged <30 years with multiple partners in ↑ CT prevalence clinics o Urine NAAT preferred MSM o Urine GC/CT NAAT if insertive intercourse o Rectal GC/CT NAAT if receptive anal sex o Pharyngeal GC NAAT if receptive oral sex o ↑ frequent STD screening (3–6 mo) if multiple or anonymous partners or sex with illicit drug use

9. Treatment for Uncomplicated Chlamydia Infections of the Cervix, Urethra, and Rectum http://www.cdc.gov/std/treatment/2010/chlamydial-infections.htm Azithromycin1 gOrallyOnce OR Doxycycline100 mgOrally Twice a day for 7 days Recommended

10. Treatment for Uncomplicated Gonococcal Infections of the Cervix, Urethra, and Rectum Ceftriaxone250 mgIMOnce www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w Azithromycin1 gOrallyOnce OR Doxycycline100 mgOrally Twice a day for 7 days PLUS Quinolones are no longer recommended in the United States for the treatment of gonorrhea and associated conditions, such as PID Recommended

11. Treatment for Uncomplicated Gonococcal Infections of the Cervix, Urethra, and Rectum Cefixime400 mgOrallyOnce Azithromycin1 gOrallyOnce OR Doxycycline100 mgOrally Twice a day for 7 days PLUS Alternative 1: If Ceftriaxone is not available PLUS Test of cure in 1 week www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w

12. Treatment for Uncomplicated Gonococcal Infections of the Pharynx Ceftriaxone250 mgIMOnce Azithromycin1 gOrallyOnce OR Doxycycline100 mgOrally Twice a day for 7 days PLUS www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w

13. Treatment for Uncomplicated Gonococcal Infections of Cervix, Urethra, Rectum, and Pharynx Azithromycin2 gOrallyOnce Alternative 2: If patient is cephalosporin-allergic PLUS Test of cure in 1 week www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w

14. GC Follow up testing Test of cure is not recommended if recommended regimen is administered Test of cure is recommended if o alternative regimen is administered o Sx persist after Tx and not from reinfection (Rx failure) Test of cure by N. gonorrhoeae culture o Test isolated GC for antimicrobial susceptibility o If no Cx access, use NAAT most GC NAATs negative within a week of GC Rx Repeat testing in 3 months regardless of Rx www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w

15. Test of reinfection Retest ~ 3 months after CT or GC treatment o regardless if believe sex partners treated o ↑ CT & GC prevalence among those treated for CT or GC during preceding several months o if retesting at 3 months not possible, retest whenever persons next present for medical care o Earliest can retest: CT: 3 weeks GC: 1 week

16. University at Buffalo, Buffalo New York Largest University in the State system: approximately 29,000 students enrolled yearly both USA and international a.19,000 undergraduates/ 9,000 Graduates/ ~ 2000 in other campuses Health Services is located on South Campus (city) a.Funded through student fees/no charge to get seen b. > 9 credit hours must be insured (as of 2010) c.Most common ICD code in our clinic: STD or STD related

17. Challenges Students not able to obtain confidential sexual health services from health plan o Out of network o EOBs o Hi copayments Students not accessing care or accessing at ECDOH STD clinic

18. Solution: UB TESTED ECDOH collaboration provided Student Health o Free STD tests o STD test data for program evaluation o ↑ provider STD/HIV knowledge with annual ECDOH in-service training UB charges $10 for administrative fees o no $ needed at appointment o Cost billed to student accounts as “medical treatment charge” Eliminated EOB s and ↑↑ confidentiality

19. Process Began very slowly…..changes did not happen over 1 or 2 semesters! Started CQI protocols to improve STD screening on campus…. and eventually reach our goal to improve CT & GC TOR rates

20. First Collaboration CQI Study: number tested and incidence of communicable disease Data from 6/2007 to 5/31/2009 compiled by the ECDOH division of STD surveillance. 1366 were tested……. Self reported ethnicities: 58% white, 18% Black, 12% Asian, 6% Hispanic, and 6% other or not declared. 6.5% + Chlamydia: 1. the highest + rate Black males <25 years of age. 2. 6.5% of + CT were international student 3. 4.1% of + CT were asymptomatic screens a.No + HIV, Hepatitis A or B b.< 0.5% + for GC, Syphilis or Hepatitis C

21. What analysis of first CQI study revealed? A. Error in reporting and treatment a. 4 females, + CT, were not treated or notified of + status 1. 3 found & treated > 6 months to 1 yr after + CT report 2. 1, age 23, had graduated and been treated for PID B. Low incidence of Syphilis, Hepatitis A, B, C and HIV 1/2 and over testing of low risk students…providers just checked boxes on ECPHL form! C. Leads to first CQI improvement → Phase 1….tracking of + results and improved ordering by providers (risk ordering)

22. Start of Yearly Quality Improvement for STD Testing and Treatment at the Student Health Center - 5/7/2009 Annual ECDOH in-service for providers a.Reviewed CDC / STD guidelines b.Emphasized importance of TOR testing c.Emphasized importance of tailoring lab testing to risk

23. After in-service →started Phase 1 CQI Goals: a. improve receipt of STD results (rec’d many ways)? b. track our TOR rates for CT and GC (not done previously) c. tailor tests ordered to risk Steps instituted: 1.RN intervention: every +CT/+GC report, fax or phone call is given to one specific RN or her replacement 2.RN or provider contacts + pt: treatment 3. Complete Excel: id#, sex/race, DOB, DOV, + test, txmt date, TOR date/ result 4. RN completes/faxes ECDOH CRF for Reportable diseases after she makes sure pt was seen/tx’d/referred

24. Phase 1 CQI Results: 5/7/09 to 7/12/10 – RN Excel tracking Coordinator reviewed all 107 +CT/GC EMR progress notes: 2 Goals were achieved for Phase 1 - no missed +CT/+GC cases -ordering STD lab tests was correlated to risk/decreased cost! -BUT Very low TOR rates → only 30 returned for TOR in CDC ideal timeframe of 90 days → 4 were still + for CT/ no + GC at TOR → WIDE RANGE for retesting with NAAT→ 10 DAYS TO >15 MONTHS

25. Phase 1: CQI found low TOR rates Ideal Timeframe ≈ 90 days* Phase 1Period 5/7/2009-7/12/2010 Patients + CT and/or GC107 (about 15 months) Percent Retested Percent Retested for TOR 61% (65/107)* 28% (30/107) Percent who asked for TOR46% (30/65) Percent + at TOR13.3% ( 4/30) ALL CT Missed Opportunity (not tested but seen) 13.1% (14/107) tested in Ideal timeframe17% (18/107) TIME TO RETESTnumber patients tested in time frame <42 days17 42-90 days18 91-180 days15 180-365 days10 >365 days 5 Average time125.7 days (range 10-490 days) * CDC guidelines : 42 to 90 days is closest to time frame *35 came back only due to s/s of STD

26. Phase 1: Who was retested (TOR) within 42-90 days? Female gender: 47 of 59 (80%) were retested with only 15 of 59 (25%) tested within 90 days* Male gender: 18 of 48 (38%) retested with only 6% retested within 90 days* Males represented 71% of students (30 of 42) who were not retested. Although, 65 were retested ONLY 30 came in for TOR…..35 came in only due to STD s/s! CDC RECOMMENDS 90 DAYS as ideal timeframe

27. Results of Phase 1 CQI presented to provider staff in Annual ECDOH In-Service for Providers Low TOR rates: encourages Phase 2 Other important points found in analysis of Phase 1: -Retesting too early with NAAT method -Better ordering by medical providers -not one positive STD was missed

28. PHASE 2: Goal to increase TOR rates for + CT/+ GC at University Student Health Center RN: UB Email reminders added RN continued to receive all + reports Continued Excel Continued completion of CRF

29. Phase 2 plan outline RN will now send a UB Email reminder to all +CT/ +GC …post cards eliminated as reminder option! Collect data from first day of Fall semester 2010 to last day of Spring semester 2011 – coordinator review Medical staff will emphasize to each + case the importance of TOR Medical staff will still continue to order labs based on risk.

30. Phase 2: CQI – Goal: Increase TOR rates Phase 2Period 8/2/2010 -5/3/2011 Number cases CT/GC/both57 (8 months) Percent Retested Percent retested for TOR 56% (32/57)* 40% (23/57) Percent who asked for TOR72% (23/32) Percent Positive at TOR13.3% (3/23) all CT ↔ Missed opportunity8% (2/57) ↓ Percent tested within Ideal Timeframe 16% 16% (9/57) ↓ Time to Retest# patients tested <42 days5 42-90 days9 91-180 days16 180-365 days1 >365 days1 Average time to retest104 days (7-490 days) * 9 came in with s/s of an STD

31. Phase 2 - Who was tested within Ideal Timeframe (3 months) Female gender: 17 of 30 (57%) retested 4 tested in ideal timeframe (13% ) Male gender: 15 of 27 (56%) retested 5 tested in ideal timeframe (19%) significant increase in number of males retested in Phase 2 – leads to Phase 3 CQI….what was different? Is this important in increasing our TOR rates for both males and females? ↓ ? Is there a difference between female and male care at the clinic?

32. Overview of what record review revealed for Phase 2: 8/2/10 to 5/3/11 Still tested too early (1) < 21 days Decreased TOR in ideal time frame (17% to 16%) 3 patients were still + CT at TOR follow-up: why? Frustration of RN: In some cases, especially “minors and patients with multiple episodes of +Ct/+GC”, she sent 3-5 Emails and 1-2 phone calls and they did not follow-up Variability in how + cases were handled by 11 providers

33. Why were 3 patients still positive for Chlamydia trachomatis after treatment? All 3 were interviewed privately by Coordinator a.Not aware that if they vomited within 2 hours or got profuse diarrhea that they needed to get retreated. b.Not aware to abstain from sex for 8 days after treatment. c.Not aware that any partner, who he/she had had sex with in last 6 months, needed to be notified and treated/ tested. c.Not aware that you can get an STD prior placement of condom! “Not aware”: Students had not been PROPERLY INFORMED ON KEY POINTS RELATED TO STD EDUCATION – WHY?

34. Other patients who did not come in were contacted by coordinator (10) Very difficult task to contact patients – months later: no cell, cell number changed, cell no longer in service and not at UB anymore etc. Had received UB E Mail but they did not know who RN was so did not open the Email (spam/virus/worm issue). Had not been made aware by provider that TOR was VERY important – only suggested by provider 5 had s/s again - testing and treated off campus

35. Comparison Phase 1 versus 2 Phase 1: Excel Tracking Number retested 1. % females 15 or 25% 2. % males 18 or 6% For both genders, only 17% (18/107) retested in 42-90 days Phase 2: Excel, in-service staff/ UB E mail Number retested 1. % females 4 or 13%↓ 2. % males 27 or 56%↑ For both genders, 16% (9/57) retested in 42-90 days Significant improvement in male retesting!

36. What was different between female and male treatment of +CT/GC in Phase 2? All EMR Records of + cases were reviewed by coordinator Some very different treatment plans found between the 11 providers→ a.Male providers: patient returned for “in person” treatment/education/ discussion/ and educational pamphlets given b. Female providers discussed + result by phone contact and left script at reception or called script into local pharmacy: no “personal contact”. 1. only one provider gave any patient education booklets. 2. no available open appointment time so phone call used????

37. Phase 3 CQI : Improve Test of Reinfection rates for Chlamydia trachomatis and Neisseria gonorrhea Yearly in-service by ECDOH with providers → a. Coordinator advised ECDOH STD Medical director of Phase 2 TOR results b. Coordinator asked ECPHD for assistance in formulating an improvement plan, after identifying a need (data analysis). c. ECDOH STD Medical director contacted Region 2 IPP (Cicatelli) for assistance

38. Phase 3 begins: to develop an improved Protocol to increase Test of Reinfection rates for CT and GC at our University Health Services Collaborators: Cicatelli Associates (IPP2), ECDOH STD surveillance division & University Health Services

39. Main concerns that were discussed by team Focus groups? Incentives? EPT? Can we provide this at SUNY? Educate so “not aware is not an issue” but in 15 minute appointment? How can we do this? Is 55-90 days an ideal time frame for this age population? How to remind + patients to f/u? texting, University assigned Email again, private Email contact, phone, or postcard??? Follow-up appointment: should it be made at end of treatment appointment? EMR records this ……”no show” recorded Should improved success with male follow-up in Phase 2 be an important factor?

40. Phase 3 CQI plans: To improve Test of reinfection rates for CT and GC Using telephone conference calls, many ideas were discussed and investigated over the 2011 summer sessions, and statistical re-analysis of phase 1 and 2 was done by Cicatelli associates→ outcome allowed everyone to input “some one point that they thought was very important” to improve rates.

41. Breakdown of Phase 3: changes implemented 8/2011 RN – will still get all + reports/complete CRF etc from Phase 1 Appointment - All patients MUST return to clinic if + report and no phone treatment or scripts called in from Phase 2! Any exceptions? - Make f/u appt – triggers “free parking pass and UB E mail reminder” Treatment – “free oral or IM medication”…incentive? Education – EMR available patient education letter written – “not aware-answer?” * TOR return appointment : now 25-55 days - (? better time frame for this transient population!).

42. Phase 3 protocol continued: Coordinator takes over → reviews + STD/ CRF and EMR note 1. Completes variables on Excel spreadsheet (Phase 1) 2. Places ID/test result in Outlook calendar – 25 days to 30 days after txmt (my automatic reminder) 3. Send UB Email, private Email or call phone (student given choice)…….(Phase 2 improvement) 4. If no appointment is made in 5-7 days, one phone reminder! 5. Patient returns: TOR template in EMR (saves time) 6. TOR lab result tracked/recorded on Excel..process starts again if TOR+

43. Patient education: Gonorrhea Positive letter

44. Patient Education: Chlamydia positive Letter

45. Template for Email Reminder Date: Dear UB student: On 00/00/0000, you tested POSITIVE for a test done at the University at Buffalo Student Health Center and you were treated with medication by medical provider: Name of Provider This is an important reminder to make a follow-up appointment with a provider for retesting. The infection that you were treated for can cause medical complications to your body, if the infection has stayed in your body. Please call 716-xxx-xxxx and reschedule a follow-up appointment with a provider for TEST OF REINFECTION TESTING. You need to make this appointment no later than 2 weeks from the date of this e mail.

46. TOR Template – example of some questions asked Were you diagnosed at UB/elsewhere? Were you diagnosed with CT/GC/Both? What medication(s) were you given? a. Zithromycin b. Doxycycline c. Rocephin and a or b d. Other? Did you have any problems with the medications? Yes, what? Did you notify all your sexual partners from the last 6 month? Did you get the secure E mail reminder to come in for TOR Any concerns:

47. Outcome of Phase 3 - who returned? Phase 3 8/13/11 to 4/4/12Ideal time frame 25-55 days Number + CT/GC or both45 % retested91.1 % (41/45) % CT cases88.8 % (40/45) % GC cases 9.8 % (5/45) % GC+CT0 % median age 20.9 Age range for both males /females17 to 39 % who asked for TOR?100 % (41/41) % positive at TOR 4.87 % (2/41 CT) % tested in Ideal time frame # tested 855 95.4% (39/41) 5.4% positive

48. Outcome Phase 3: positive CT/GC by Ethnicity EthnicityMalesFemales White189 Black75 Asian13 Hispanic01 Multiracial01 Total +2619 Returned for testing?23 * (1 missed opportunity CT + 1 not qualified GC ) 18 * (1 CT missed opportunity) average age both sexes 20.9 Age range both sexes 17-39

49. Breakdown of ideal time frame for Phase 3 Ideal time frame 25-55 days NOTE: all TOR were done within 90 day ideal time frame per CDC ideal time frame25-55 days # tested in ideal time frame39/41 (95.1%) median in days39.1 days Range in days23-59 days 23 days* due to international sports travel days to retest <24 days1* 25-55 days (ideal time)39 56-75 days2 76-90 days0 > 90 days0

50. University Of New York Phase 3 CQI is successful so process has continued…. no changes made as of 12/2012 ○ Acknowledged in JAMA 4/11/2012 ○ Presented at IPP 1 Annual meeting 2012 ○ Poster at CDC STD meeting 2012 ○ Telephone In-service for Lincoln Nebraska DOH 3/11/13

51. JAMA

52. Comments: more Positive outcomes Increased staff morale Patients seem to be better informed – in Phase 1/ 2 patients returned for testing only because they had s/s of STI again..(0/41) + Patients (5/41) actually “took charge of their health” and made f/up appointments for TOR without E mail or phone reminder..this is what we strive for! + Patients brought their contacts in for testing and treatment (7/41). Patients actually must have read educational letter and called or Emailed me if they had medication problems (4/41) or other concerns (2/41). Decreased missed opportunity – but could improve with “EMR pop up prompts”.

53. Some Negative outcomes Still 2/41 were positive for CT - issues with long distance relationships? Making follow-up appointment for 4-6 weeks later at end of treatment appointment did not seem to work. Patients advised to do this but > 85% did not! If follow-up appointment is made, Medicat sends out automatic appointment reminder (only to UB Email) and free parking pass only 8 hours before appointment! Most patients didn’t even see it.

54. Protocol has continued for Fall and Spring semester 2012-2013 New data for Fall semester 2012!

55. Data from continuation of Phase 3 - 8/2/12 to 12/17/12 Phase 3 8/2/12 - 12/17/12Ideal time frame 25-55 days Number + CT/GC or both41 % retested95.12% (39/41) # CT cases 85.36% (35/41) # GC cases 9.75% (4/41) # GC+CT4.87% (2/41) median age 20.9 Age range for both males /females18 to 28 % who asked for TOR?100 % (39/39) % positive at TOR 4.87 % (2/39 CT) females/ one had been GC+CT + % tested in Ideal time frame # tested 507 NO ONE RETURNED DUE TO STD s/s 95.1% (39/41) 8.08% positive (Ct/GC or GC+CT)

56. Continuation of Phase 3: positive CT/GC by Ethnicity 8/2/12 to 12/17/12 EthnicityMalesFemales White99 Black45 Asian44 Hispanic32 Multiracial01 Total +2021 Returned for testing?1821 average age both sexes 20.9 Age range both sexes 18-28

57. Breakdown of ideal time frame for Continuation of Phase 3 8/2/12 to 12/17/12 ideal time frame25-55 days # tested in ideal time frame37/39 (94.8%) who followed up for retesting median in days38.9 days Range in days17*-153 days* 17 days by off campus GYN 153 days routine f/u Appointment days to retest <24 days1 25-55 days (ideal time)37 56-75 days0 76-90 days0 > 90 days1

58. Brief Outline of Phase 3 TOR protocol Step 1 + STD case RN or Provider contacts patient Step 2 Appointment – “in person appointment advised” Free Treatment/educate/make follow-up/ pt aware of TOR and staff contact name etc! Given EMR educational letter/ pamphlets RN completes/faxes STD/CRF ECDOH Step 3 Coordinator: reviews CRF/ review EMR progress note Completes Excel / Outlook- 4-5 weeks Send reminder to f/u in 2 weeks..pt has choice of reminder Follow lab report of TOR – complete Excel

59. Can this be duplicated elsewhere? Yes - but you must have team effort! Team must understand disease $ burden to health care system, the importance of TOR There definitely must be a central way that all + CT/GC are managed → coordinator or dept “Champion”? ○ most established protocols can be “retooled” easily EMR system makes it easier for analysis of data EMR templates and prompts help staff Coordinator needs confidential Excel and/or electronic calendar for reminders.

60. Other points regarding duplication of our success! Some important points we learned through our “slow but steady improvements”: The name and contact information of the Coordinator, who will be contacting the + patient, must be known by the patient. How the patient wants to receive a reminder must be known by Coordinator. What would be the ideal timeframe for your population? Feedback from team needs to be evaluated frequently and protocol “tweaked”.

61. As for Clinic CQI! This is a perfect example of a process of creating an environment in which management and workers strive to create constantly improving quality! Found a need Developed a plan(s) Analyzed results Continued to improve plan until the goal was reached Outcome is multifaceted: For the patient: Improved quality of care for patients- hopefully, decreased PID etc. For the staff: Improved morale & better use of EMR Team work Continuous review

62. Questions/ Concerns/ Explanations?