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Kimberley Chapman, MPH, CHES

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.

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Kimberley Chapman, MPH, CHES

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  1. 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

  2. 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

  3. 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

  4. Systematic Approach to Health Education NeedsAssessment (Formative Research) Assess Effectiveness Development (Outcome and Impact) Evaluation Pilot-testing Implementation (Formative Evaluation) (Process Evaluation)

  5. 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

  6. 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

  7. MethodsPhase I & Phase II • Phase I • Fact sheet development • Phase II • Pilot test with patients and providers

  8. MethodsPhase I: Fact Sheet Development • Content sourced fromCDC Guidelines • Phase I: Consulted with key stakeholders and subject matter experts • Internal CDC staff • TB staff in public health departments

  9. ResultsPhase I: Fact Sheet Development • Identified need to create three regimen-specific sheets

  10. 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

  11. ResultsPhase II: Pilot Test- Demographics

  12. ResultsPhase II: Pilot Test- Patient Comprehension

  13. 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

  14. 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.

  15. Impressions & Themes

  16. 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

  17. 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?

  18. Acknowledgements Gloria Oramasionwu* Joan Mangan* Andrew Vernon Stefan Goldberg Elsa Villarino Amera Khan Wanda Walton Eric Pevzner SapnaBamrah Morris Rose Sales Ben Yarn Ruby Hardy Omar Mohamed Susan Cookson AlawodeOladele Titilola “Lola” Rush AliyaYamen KirenMitruka Patients & Providers at the TB Clinics *Co-Investigators

  19. 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: 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 Prevention Division of Tuberculosis Elimination

  20. Extra slides

  21. 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.

  22. Reason for Treatment Recommendations Tips for Adherence Problems to Watch For Symptoms of AEs & Action Steps Expected Medication Side Effects Fact Sheet: Prior to Pilot Test Regimen & Schedule Missed Dose Instructions Clinic Contact Information

  23. Patient Questions

  24. Patient Questions

  25. Provider Questions

  26. Incentives • No funding available • Light snacks given to participants • Light breakfast provided to clinic site on first day

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