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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
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
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
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
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?
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?
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
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
Treatment for Uncomplicated Chlamydia
Infections of the Cervix, Urethra, and Rectum
Recommended
Azithromycin
1g
Orally
Once
Orally
Twice a day for
7 days
OR
Doxycycline
100 mg
http://www.cdc.gov/std/treatment/2010/chlamydial-infections.htm
Treatment for Uncomplicated Gonococcal
Infections of the Cervix, Urethra, and Rectum
Recommended
Ceftriaxone
250 mg
IM
Once
Orally
Once
Orally
Twice a day for
7 days
PLUS
Azithromycin
1g
OR
Doxycycline
100 mg
Quinolones are no longer recommended in the United States for the treatment of gonorrhea and
associated conditions, such as PID
www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w
Treatment for Uncomplicated Gonococcal
Infections of the Cervix, Urethra, and Rectum
Alternative 1: If Ceftriaxone is not available
Cefixime
400 mg
Orally
Once
Orally
Once
Orally
Twice a day for
7 days
PLUS
Azithromycin
1g
OR
Doxycycline
100 mg
PLUS
Test of cure in 1 week
www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w
Treatment for Uncomplicated Gonococcal Infections
of the Pharynx
Ceftriaxone
250 mg
IM
Once
PLUS
Azithromycin
1g
Orally
Once
Doxycycline
100 mg
Orally
Twice a day for
7 days
www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w
OR
Treatment for Uncomplicated Gonococcal Infections of
Cervix, Urethra, Rectum, and Pharynx
Alternative 2: If patient is cephalosporin-allergic
Azithromycin
2g
Orally
Once
PLUS
Test of cure in 1 week
www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm?s_cid=mm6131a3_w
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
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
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
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
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
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
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
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)
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
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
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
Phase 1: CQI found low TOR rates
Ideal Timeframe ≈ 90 days*
Phase 1
Period 5/7/2009-7/12/2010
Patients + CT and/or GC
107 (about 15 months)
Percent Retested
Percent Retested for TOR
61% (65/107)*
28% (30/107)
Percent who asked for TOR
46% (30/65)
Percent + at TOR
13.3% ( 4/30) ALL CT
Missed Opportunity (not tested but
seen)
13.1% (14/107)
tested in Ideal timeframe
17% (18/107)
TIME TO RETEST
number patients tested in time frame
<42 days
17
42-90 days
18
91-180 days
15
180-365 days
10
>365 days
5
Average time
* CDC guidelines : 42 to 90 days is
closest to time frame
125.7 days (range 10-490 days)
*35 came back only due to s/s of STD
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
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
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
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.
Phase 2: CQI – Goal: Increase TOR rates
Phase 2
Period 8/2/2010 -5/3/2011
Number cases CT/GC/both
57 (8 months)
Percent Retested
Percent retested for TOR
56% (32/57)*
40% (23/57)
Percent who asked for TOR
72% (23/32)
Percent Positive at TOR
13.3% (3/23) all CT ↔
Missed opportunity
8% (2/57) ↓
Percent tested within Ideal
Timeframe
16% (9/57) ↓
Time to Retest
# patients tested
<42 days
5
42-90 days
9
91-180 days
16
180-365 days
1
>365 days
1
Average time to retest
104 days (7-490 days)
* 9 came in with s/s of an STD
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?
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
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.
c.
Not aware that any partner, who he/she had had sex with in
last 6 months, needed to be notified and treated/ tested.
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?
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
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!
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????
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
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
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?
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.
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!).
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+
Patient education: Gonorrhea Positive letter
Patient Education: Chlamydia positive Letter
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.
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:
Outcome of Phase 3 - who returned?
Phase 3 8/13/11 to 4/4/12
Ideal time frame 25-55 days
Number + CT/GC or both
45
% retested
91.1 % (41/45)
% CT cases
88.8 % (40/45)
% GC cases
9.8 %
% GC+CT
(5/45)
0%
median age
Age range for both males /females
% who asked for TOR?
% positive at TOR
20.9
17 to 39
100 % (41/41)
4.87 % (2/41 CT)
% tested in Ideal time frame
95.4% (39/41)
# tested 855
5.4% positive
Outcome Phase 3: positive CT/GC by Ethnicity
Ethnicity
Males
Females
White
18
9
Black
7
5
Asian
1
3
Hispanic
0
1
Multiracial
0
1
26
19
23 * (1 missed opportunity CT +
1 not qualified GC )
18 * (1 CT missed
opportunity)
Total +
Returned for testing?
average age both sexes
Age range both sexes
20.9
17-39
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 frame
# tested in ideal time frame
median in days
Range in days
25-55 days
39/41 (95.1%)
39.1 days
23-59 days
23 days* due to international sports travel
days to retest
<24 days
1*
25-55 days (ideal time)
39
56-75 days
2
76-90 days
0
> 90 days
0
University Of New York
○ Acknowledged in JAMA
4/11/2012
• Phase 3 CQI is successful so
process has continued….
○ Presented at IPP 1
Annual meeting 2012
○ Poster at CDC STD
meeting 2012
○ Telephone In-service for
Lincoln Nebraska DOH
3/11/13
no changes made as of
12/2012
JAMA
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”.
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.
Protocol has continued for Fall and Spring
semester 2012-2013
New data for Fall semester 2012!
Data from continuation of Phase 3 - 8/2/12 to 12/17/12
Phase 3 8/2/12 - 12/17/12
Ideal time frame 25-55 days
Number + CT/GC or both
41
% retested
95.12% (39/41)
# CT cases
85.36% (35/41)
# GC cases
9.75% (4/41)
# GC+CT
4.87% (2/41)
median age
Age range for both males /females
% who asked for TOR?
% positive at TOR
% tested in Ideal time frame
# tested 507
NO ONE RETURNED DUE TO STD s/s
20.9
18 to 28
100 % (39/39)
4.87 % (2/39 CT) females/ one had been GC+CT +
95.1% (39/41)
8.08% positive (Ct/GC or GC+CT)
Continuation of Phase 3: positive CT/GC by Ethnicity
8/2/12 to 12/17/12
Ethnicity
Males
Females
White
9
9
Black
4
5
Asian
4
4
Hispanic
3
2
Multiracial
0
1
20
21
18
21
Total +
Returned for testing?
average age both sexes
Age range both sexes
20.9
18-28
Breakdown of ideal time frame for Continuation of Phase 3
8/2/12 to 12/17/12
ideal time frame
# tested in ideal time frame
median in days
Range in days
25-55 days
37/39 (94.8%) who followed up for retesting
38.9 days
17*-153 days*
17 days by off campus GYN
153 days routine f/u Appointment
days to retest
<24 days
1
25-55 days (ideal time)
37
56-75 days
0
76-90 days
0
> 90 days
1
Brief Outline of Phase 3 TOR protocol
• + STD case
Step 1
Step 2
Step 3
• RN or Provider contacts patient
• 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
• 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
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.
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”.
As for Clinic CQI!
•
•
•
•
Found a need
Developed a plan(s)
Analyzed results
• This is a perfect
Continued to improve plan
example of a process of
until the goal was reached
creating an
Outcome is multifaceted:
environment in which
For the patient: Improved
management and
quality of care for patientsworkers strive to create
hopefully, decreased PID etc.
constantly improving
For the staff:
quality!
Improved morale & better use of EMR
Team work
Continuous review
Questions/ Concerns/ Explanations?