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, CHESResearch Associate/ORISE Fellow

TB Education and Training Network ConferenceSeptember 20, 2012

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB PreventionDivision of Tuberculosis Elimination

Reason for TreatmentRecommendationsTips for Adherence Problems to Watch For & Symptoms of Possible AEswith check boxes Expected Medication Side EffectsRegimen & ScheduleMissed 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 patient-specific resources for LTBI adverse events

Systematic Approach to Health Education

Development

Pilot-testing(Formative Evaluation)

Implementation(Process Evaluation)

Assess Effectivene

ss(Outcome and

Impact) Evaluation

(Formative Research)

NeedsAssessment

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

MethodsPhase I & Phase II

Phase I Fact sheet development

Phase II Pilot test with patients and providers

MethodsPhase 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

ResultsPhase I: Fact Sheet Development

Identified need to create three regimen-specific sheets

MethodsPhase 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

ResultsPhase II: Pilot Test- Demographics

Patients (n=8)

Diagnosed w/in last 30 days

6

Female 6

Black, non-Hispanic 6

Median Age 41 years (Range 16-61)

Providers (n=9)

Nurses 3

Physicians 4

Clinic Administrators 2

ResultsPhase II: Pilot Test- Patient Comprehension

Correct

Not Scored

Questions Related To:n %

Name of Medication 7/7 100% 1

Duration of Therapy 8/8 100% 0

Avoid Alcohol 8/8 100% 0

Questions 27/34 79%

Stop Medication due to:

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

Forgot Medication Scenario

Remembered later but same day 6/6 100% 2

Remembered the next day 5/6 83% 2

Impressions/ThemesPatients

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/ThemesProviders

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.

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

Impressions & Themes

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?

AcknowledgementsGloria Oramasionwu*

Joan Mangan*Andrew VernonStefan Goldberg

Elsa VillarinoAmera Khan

Wanda WaltonEric Pevzner

Sapna Bamrah Morris

Rose SalesBen Yarn

Ruby HardyOmar MohamedSusan Cookson

Alawode OladeleTitilola “Lola” Rush

Aliya YamenKiren Mitruka

*Co-Investigators

Patients & Providers at the TB Clinics

Thank you!

For more information please contact Centers for Disease Control and Prevention

1600 Clifton Road NE, Atlanta, GA 30333Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: cdcinfo@cdc.gov 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 PreventionDivision of Tuberculosis Elimination

EXTRA SLIDES

Fact Sheet Development: Sources

What You Need to Know About TB Infectionhttp://www.cdc.gov/tb/publications/pamphlets/TB_infection.pdf

Treatment Options for Latent Tuberculosis Infectionhttp://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 Providershttp://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.

Reason for TreatmentRecommendationsTips for Adherence Problems to Watch For Symptoms of AEs & Action Steps

Expected Medication Side EffectsRegimen & ScheduleMissed Dose InstructionsClinic Contact Information

Fact Sheet: Prior to Pilot Test

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. Stomach pain b. Sweating c. Nausea (upset stomach) or vomiting

6 The next few questions are about your medicine. a. First, what is the name of the medicine(s) will you take?b. What day(s) of the week are you scheduled to take this medicine?c. How many pills will you take, for each dose of medicine?d. How long will you have to take the medication for LTBI? (regimen dependent)

7 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