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Evaluation of Latent Tuberculosis Infection (LTBI)
Adverse Event Fact Sheets:
“What You Need to Know about your Medicine for
Latent Tuberculosis Infection”
Kimberley Chapman, MPH, CHES
Research Associate/ORISE Fellow
TB Education and Training Network Conference
September 20, 2012
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination
Reason for Treatment
Recommendations
Tips for Adherence
Problems to Watch For &
Symptoms of Possible AEs
with check boxes
Expected Medication
Side Effects
Regimen & Schedule
Missed Dose
Instructions
Clinic Contact Information
Background & Motivation

Adverse events (AEs) during treatment for latent
tuberculosis infection (LTBI) are rare but could be
harmful if they do occur

Education could minimize the severity of the event

Fact sheets can improve patient and provider
knowledge of treatment regimens and their response
to symptoms

Review of available materials revealed a lack of patientspecific resources for LTBI adverse events
Systematic Approach to Health Education
Needs
Assessment
(Formative Research)
Assess
Effectiveness
(Outcome and
Impact)
Development
Evaluation
Implementation
(Process Evaluation)
Pilot-testing
(Formative Evaluation)
Goal of Fact Sheet


Develop an evidence-based, well-designed, patient fact
sheet on LTBI adverse events
Publish on the CDC website so it will be available for
distribution to:
 State and local health departments
 Private clinicians
Objectives

Inform patients about
 LTBI regimen schedule
 Expected side effects
 Symptoms indicative of a possible adverse event
 Actions to take in the event of symptoms

Develop a fact sheet for providers to
 Tailor regimen information to the patient
 Use while counseling patient about treatment regimen
Methods
Phase I & Phase II


Phase I
 Fact sheet development
Phase II
 Pilot test with patients and providers
Methods
Phase I: Fact Sheet Development

Content sourced from CDC Guidelines

Phase I: Consulted with key stakeholders and subject
matter experts
• Internal CDC staff
• TB staff in public health departments
Results
Phase I: Fact Sheet Development

Identified need to create three regimen-specific sheets
Methods
Phase II: Pilot Test of Fact Sheet

Aim: Assess effectiveness in communicating AEs with
patients & providers

Conducted at two Atlanta area TB clinics

Recruited convenience sample of patients newly or
recently diagnosed with LTBI

Providers were asked to use the fact sheet

Patients and providers were asked questions using a
structured interview guide
Results
Phase II: Pilot Test- Demographics
Patients
Diagnosed w/in last 30 days
Female
Black, non-Hispanic
Median Age
Providers
Nurses
Physicians
Clinic Administrators
(n=8)
6
6
6
41 years (Range 16-61)
(n=9)
3
4
2
Results
Phase II: Pilot Test- Patient Comprehension
Correct
Questions Related To:
n
%
Not
Scored
Name of Medication
7/7
100%
1
Duration of Therapy
8/8
100%
0
Avoid Alcohol
8/8
100%
0
27/34
79%
Stomach Pain (correct answer YES)
6/7
86%
1
Sweating (correct answer NO)
3/7
43%
1
Nausea/Vomiting (correct answer YES)
7/8
88%
0
Remembered later but same day
6/6
100%
2
Remembered the next day
5/6
83%
2
Questions
Stop Medication due to:
Forgot Medication Scenario
Impressions/Themes
Patients

Happy with overall appearance

Recommended highlighting text about missed doses

Nullified concerns over too much information on one
page

Understood when to call a provider
Impressions/Themes
Providers

Suggested changes:





Simplify language/ substitute phrases
More “white space”
Explain LTBI
Change “call” instructions for missed doses
Clarify the importance of not “doubling-up” on medication
following a missed dose.
 Regimen specific fact sheet - Side effects should be
“regimen-specific”

Fact sheets may have to be altered for cultural
appropriateness.
Impressions & Themes
Patients
Providers
Preferred the regimen specific sheet
over the fact sheet that included all
regimens
67%
56%
Indicated the fact sheets would
enhance patient education sessions


Limitations

A number of the patients that we encountered at one of
the clinics could not be interviewed because they were
non-English speaking

During pilot test, materials only available in English

Did not assess reading skills of patients
Conclusions

Using the Systematic Process for Health Education
 Provides insight for optimizing educational resources
for LTBI treatment.
 In response to participants’ comments and answers to
investigator questions, ensures that target audience
comments are incorporated

Next Steps
 Work to finalize graphic to post on CDC website
 Evaluate how they are using the fact sheet at the clinic
• Are clinics downloading or ordering the form?
• How are the fact sheets being used?
Acknowledgements
Rose Sales
Gloria Oramasionwu*
Joan Mangan*
Ben Yarn
Andrew Vernon
Ruby Hardy
Stefan Goldberg
Omar Mohamed
Elsa Villarino
Susan Cookson
Amera Khan
Alawode Oladele
Wanda Walton
Titilola “Lola” Rush
Eric Pevzner
Aliya Yamen
Sapna Bamrah Morris
Kiren Mitruka
Patients & Providers at the TB Clinics
*Co-Investigators
Thank you!
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333
Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348
E-mail: [email protected] Web: http://www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the
Centers for Disease Control and Prevention.
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination
EXTRA SLIDES
Fact Sheet Development: Sources

What You Need to Know About TB Infection
http://www.cdc.gov/tb/publications/pamphlets/TB_infection.pdf

Treatment Options for Latent Tuberculosis Infection
http://www.cdc.gov/tb/publications/factsheets/treatment/LTBItreatmentoptions.htm

Aggregate Reports for Tuberculosis Program Evaluation: Training Manual and User’s
Guide
http://www.cdc.gov/tb/publications/PDF/ARPEs_manualsm1.pdf

Latent Tuberculosis Infection: A Guide for Primary Health Care Providers
http://www.cdc.gov/tb/publications/LTBI/default.htm

CDC. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection. MMWR
2000;49(No. RR:6):1–51.

CDC. Severe Isoniazid-Associated Liver Injuries Among Persons Being Treated for Latent
Tuberculosis Infection — United States, 2004—2008. MMWR 2010;59:224-9.

CDC. Recommendations for Use of an Isoniazid-Rifapentine Regimen with Direct
Observation to Treat Latent Mycobacterium tuberculosis Infection. MMWR 2011;60:1650-3.
Fact Sheet:
Prior to Pilot Test
Reason for Treatment
Recommendations
Tips for Adherence
Problems to Watch For
Symptoms of AEs & Action Steps
Expected Medication
Side Effects
Regimen & Schedule
Missed Dose Instructions
Clinic Contact Information
Patient Questions
#
Questions
3
Demographics
4
What language do you feel most comfortable reading?
5
According to the fact sheet you received, should you stop the medication right away
and then call your TB doctor or nurse if you have:
a.
b.
c.
6
The next few questions are about your medicine.
a.
b.
c.
d.
7
Stomach pain
Sweating
Nausea (upset stomach) or vomiting
First, what is the name of the medicine(s) will you take?
What day(s) of the week are you scheduled to take this medicine?
How many pills will you take, for each dose of medicine?
How long will you have to take the medication for LTBI? (regimen dependent)
Next I am going to describe 2 different situations and ask what you would do if this
happened to you.
a.
Scenario #1: If you are getting ready for bed and you realize you did not take your LTBI
medications earlier in the day- should you take the medication before you go to sleep?
Scenario #2: If you realize you forgot to take your dose of LTBI medication from the day
before- what should you do?
Patient Questions
#
Questions
8
Should you drink alcohol while undergoing treatment for LTBI?
9
What number should you call if you have questions?
10
What do you like about this fact sheet?
11
What do you dislike about this fact sheet?
12
Did you find any of the information confusing?
13
Is there too much information on the sheet?
14
Would you prefer a 1-page fact sheet that covers all the LTBI regimens or 3 separate
fact sheets, with 1 regimen type per sheet?
Provider Questions
# Questions
1 How likely are you and your colleagues to use this type of fact sheet in the
care and education of your patients?
2 Do you feel the sheet enhanced the education you provided patients about
their treatment regimen and potential adverse events today?
3 Is there any wording that you would change? If so, what?
4 In your opinion, have we included any information that might confuse a
patient? If so, what?
5 In your opinion, is the amount of information on the sheet:
6 Was the time spent reviewing the fact sheet with the patient a worthwhile
use of your time?
7 Is there any information you feel should be added to the sheet?
8 Is there any information you feel should be removed from the sheet?
9 Would you prefer a 1-page sheet that covers all the LTBI regimens or 3
separate sheets, with 1 regimen type per sheet?
Incentives



No funding available
Light snacks given to participants
Light breakfast provided to clinic site on first day