CDC Presentation

Evaluation of Latent Tuberculosis Infection (LTBI) Adverse Event Fact Sheets:What You Need to Know about your Medicine for Latent Tuberculosis InfectionKimberley Chapman, MPH, CHESResearch Associate/ORISE FellowTB Education and Training Network ConferenceSeptember 20, 2012National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Division of Tuberculosis Elimination Good morning.

My name is Kimberley Chapman and I work for CDCs Division of TB Elimination.I worked on this evaluation with Joan Mangan and Gloria Oramasionwu.1

Reason for TreatmentRecommendationsTips for Adherence Problems to Watch For & Symptoms of Possible AEswith check boxes Expected Medication Side EffectsRegimen & ScheduleMissed Dose InstructionsClinic Contact Information I would like to tell you about our experience of developing and pilot testing a recently created fact sheet about possible adverse events that patients might experience while undergoing treatment for latent TB infection. [PAUSE]This is the fact that sheet that we created.As you can see here, the fact sheet is divided into different sections, which include [CLICK]:Reason for Treatment [CLICK]Recommendations for the patient while they are undergoing treatment for LTBITips for Adherence [CLICK]Problems to Watch For & Symptoms of Possible Adverse events and action steps [CLICK]Expected Medication Side Effects [CLICK]AND instructions for when a patient misses a dose

2Background & MotivationAdverse events (AEs) during treatment for latent tuberculosis infection (LTBI) are rare but could be harmful if they do occurEducation could minimize the severity of the eventFact sheets can improve patient and provider knowledge of treatment regimens and their response to symptomsReview of available materials revealed a lack of patient-specific resources for LTBI adverse events

To give you some backgroundAdverse events while taking treatment for latent tuberculosis infection are rare; however these adverse events could have harmful results if they do occur. Appropriate education about the discontinuation of therapy at the onset of an adverse event could minimize the severity of the event. Fact sheets to educate patients, providers and their families about what to expect and what to monitor for while taking LTBI treatment, can improve patient and provider knowledge of the treatment regimens, and response to symptoms of an adverse event.After reviewing available materials, we found a lack of patient-specific resources about possible adverse events while undergoing treatment for LTBI.

3Systematic Approach to Health Education

DevelopmentPilot-testing(Formative Evaluation)Implementation(Process Evaluation)Assess Effectiveness(Outcome and Impact) Evaluation(Formative Research)NeedsAssessmentWe used the systematic process for health education to ensure that the target audiences needs would be met.

4Goal of Fact SheetDevelop 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 departmentsPrivate clinicians

Our Primary Goal wasTo develop an evidence-based, well-designed, patient fact sheet of possible adverse events while undergoing LTBI treatment, to be distributed to patients beginning LTBI therapy, complementing the counseling conducted by the provider and serving as a written reminder for the patient.The goal is to publish the fact sheet on the CDC website so it will be available to state and local health departments as well as private clinicians.5ObjectivesInform patients about LTBI regimen scheduleExpected side effects Symptoms indicative of a possible adverse event Actions to take in the event of symptoms Develop a fact sheet for providers toTailor regimen information to the patient Use while counseling patient about treatment regimenOBJECTIVESOur Objective in creating the fact sheet was toto inform patients aboutLTBI regimen schedulesThe expected side effects Symptoms indicative of a possible adverse events ANDActions to take in the event of symptoms We also wanted to create a fact sheet for providersTo tailor the regimen information to the patientAnd to use while counseling the patient about their treatment regimen

6MethodsPhase I & Phase IIPhase IFact sheet developmentPhase IIPilot test with patients and providers

To get the fact sheet to where it is today, there were two phases

Phase I consisted of developing the fact sheet and obtaining informal feedback.

AND

During phase II, we pilot tested the fact sheet with patients and providers.7MethodsPhase I: Fact Sheet DevelopmentContent sourced from CDC GuidelinesPhase I: Consulted with key stakeholders and subject matter expertsInternal CDC staffTB staff in public health departmentsMETHODSTo Develop the Fact Sheet, During Phase I, information on adverse events was gathered from several sources and the fact sheets were modeled after pre-existing piloted tuberculosis patient education materials from the CDCWe worked with multiple stakeholders and subject matter experts in CDCs Division of TB Elimination and TB staff in public health departments around the country. 8ResultsPhase I: Fact Sheet DevelopmentIdentified need to create three regimen-specific sheets

During Phase I, we received feedback from the subject matter experts that providers may want to have regimen-specific fact sheets rather than an all-inclusive sheet.We decided to then create three other sheets that were regimen specific but looked almost exactly the same, to be pilot tested in PHASE II with providers and patients at TB clinics and determine their preference for either one all-inclusive sheet or three regimen-specific sheets.9MethodsPhase II: Pilot Test of Fact SheetAim: Assess effectiveness in communicating AEs with patients & providersConducted at two Atlanta area TB clinics Recruited convenience sample of patients newly or recently diagnosed with LTBIProviders were asked to use the fact sheetPatients and providers were asked questions using a structured interview guide Pilot TestThe goal of the pilot was to assess the effectiveness of the fact sheet in communicating adverse events and what to if one does occur.To achieve this, we asked specific questions to:Assess patient comprehension ANDGather suggestions for improving the sheetsEvaluations included brief structured interviews that were conducted at two Atlanta area County Health Departments TB clinics.We approached all patients that were newly diagnosed with LTBI or diagnosed approximately within the last 30 days, to participate and complete a structured interview. We asked providers to use the fact sheet during their consultation with the patient and to alternate between using the All Regimen sheet, and the regimen-specific fact sheets for LTBI therapy.We asked providers and patients if we could sit-in and observe while providers used the fact sheets to discuss LTBI therapy and its possible adverse events with patients.We asked them to focus specifically on the section "What problems should you watch for? Following the provider-patient interaction, we asked patients to answer 14 questions regarding their impressions and their understanding of fact sheet. Providers were also asked 9 questions from a different structured interview guide or they were given the opportunity to complete the questions independently.The structured interview guide was used with additional probing questions as needed. 10ResultsPhase II: Pilot Test- DemographicsPatients(n=8)Diagnosed w/in last 30 days6Female6Black, non-Hispanic6Median Age41 years (Range 16-61)Providers(n=9)Nurses3Physicians4Clinic Administrators2During the pilot test, a total of 8 patients were interviewed: 6 were diagnosed with LTBI during the clinical visit and 2 had begun LTBI treatment within the last month. The age of the patients ranged from 16-61 years old.The median age was 41 yearswith the majority being female (75%), and black, non-Hispanic (75%)The 9 providers that responded were nurses, physicians, and clinic administrators

ONLY IF QUESTIONSOne patient was 16 years old. She gave assent and her father provided consent and sat with her in the room while we asked questions. 11ResultsPhase II: Pilot Test- Patient ComprehensionCorrectNot ScoredQuestions Related To:n%Name of Medication7/7100%1Duration of Therapy8/8100%0Avoid Alcohol8/8100%0Questions27/3479%Stop Medication due to:Stomach Pain (correct answer YES)6/786%1Sweating (correct answer NO)3/743%1Nausea/Vomiting (correct answer YES)7/8 88%0Forgot Medication ScenarioRemembered later but same day6/6100%2Remembered the next day5/683%2Patient ComprehensionFor the scored questions assessing patient comprehension, all patients correctly reported the name of their medication, duration of therapy, and the need to avoid alcohol during treatment.A total of 27 (79%) correct answers were obtained in response to 5 questions about: missed medication dosesstopping the medicationand calling a provider in the event of side effects. A patients response was not scored if the concept was not reviewed with the provider.12Impressions/ThemesPatientsHappy with overall appearance Recommended highlighting text about missed doses Nullified concerns over too much information on one pageUnderstood when to call a provider During the pilot test, we found that patients wereHappy with the overall appearance of the fact sheet.They recommended highlighting the section about missed doses. A few of the patients mentioned that section of the fact sheet did not stand out enough.We originally had some concerns that there was too much information on the fact sheet but patients did not report this, when asked specifically.Also, patients understood when to call a provider, though it seemed that some patients based their answers on prior knowledge.

13Impressions/ThemesProvidersSuggested changes: Simplify language/ substitute phrasesMore white space Explain LTBIChange call instructions for missed dosesClarify the importance of not doubling-up on medication following a missed dose.Regimen specific fact sheet - Side effects should be regimen-specificFact sheets may have to be altered for cultural appropriateness.Providers offered suggestions for several specific changes including:Simplify the language and wording AND adding more white space.Providers suggested adding an explanation of LTBI AND revising the When to call the clinic instructions.They also recommended that we clarify the importance of not doubling-up on medication following a missed dose.Providers suggested that for the all-inclusive fact sheet, side effects should be regimen-specific, for example with check-boxesA few providers mentioned that fact sheets will have to be translated into additional languages, which we thought would be the caseThey also mentioned that the fact sheet may have to be altered for cultural appropriateness as far as the use of some terms or phrases.For example, one provider reported that the use of an alarm clock, as listed under TIPS FOR ADHERENCE, may confuse some foreign-born patientsOther wording changes were recommended including one provider suggesting that we use the phrase Coca-Cola in place of dark-colored urine.14PatientsProviders Preferred the regimen specific sheet over the fact sheet that included all regimens67%56%Indicated the fact sheets would enhance patient education sessionsImpressions & ThemesOne of our over arching questions was whether patients and providers preferred a regimen-specific or an all-inclusive sheet: Nearly two-thirds of patients and slightly over half of providers preferred the regimen specific sheet over the fact sheet that included all regimens.

One provider summarized it saying that logistically, for the clinic, it would be better to have oneall-inclusive sheet. However, to avoid confusing the patient, a regimen specific sheet would be better.

Overall, patients and providers indicated the fact sheets would enhance the patient education sessions.15LimitationsA number of the patients that we encountered at one of the clinics could not be interviewed because they were non-English speakingDuring pilot test, materials only available in EnglishDid not assess reading skills of patientsLimitations We had three primary limitationsA number of the patients that we encountered at one of the clinics could not be interviewed because they were non-English speaking Also, because this was a pilot evaluation, fact sheets were only available in English and therefore could not be used with non-English speakers. Did not assess the reading skills of patients

16ConclusionsUsing the Systematic Process for Health EducationProvides insight for optimizing educational resources for LTBI treatment. In response to participants comments and answers to investigator questions, ensures that target audience comments are incorporatedNext StepsWork to finalize graphic to post on CDC websiteEvaluate how they are using the fact sheet at the clinicAre clinics downloading or ordering the form?How are the fact sheets being used?In ConclusionThese results provide an opportunity to optimize educational resources for LTBI treatment. The fact sheet has been revised to include the suggestions from patients and providers.

Next steps includeFormatting the fact sheet through the Graphics Services division.Future steps include evaluating how the fact sheet is being used at the clinics and whether it is being used as part of the providers consultation with the patient, answering the questions:Are clinics download or ordering the form?How are the fact sheets actually being used?

17AcknowledgementsGloria Oramasionwu*Joan Mangan*Andrew VernonStefan GoldbergElsa VillarinoAmera KhanWanda WaltonEric PevznerSapna Bamrah MorrisRose SalesBen YarnRuby HardyOmar MohamedSusan CooksonAlawode OladeleTitilola Lola RushAliya YamenKiren Mitruka*Co-InvestigatorsPatients & Providers at the TB ClinicsI would like to thank my co-investigators, Gloria and Joan. We would like to thank the managers in our respective branches,Andy VernonStefan GoldbergElsa VillarinoAmera KhanWanda WaltonEric PevznerMy co-investigators and I would like to offer a special thanks to the clinic staff and providers and patients for all of their invaluable feedback.18Thank 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 Thank you!19Extra slides20Fact Sheet Development: SourcesWhat You Need to Know About TB Infectionhttp://www.cdc.gov/tb/publications/pamphlets/TB_infection.pdfTreatment Options for Latent Tuberculosis Infectionhttp://www.cdc.gov/tb/publications/factsheets/treatment/LTBItreatmentoptions.htmAggregate Reports for Tuberculosis Program Evaluation: Training Manual and Users Guide http://www.cdc.gov/tb/publications/PDF/ARPEs_manualsm1.pdfLatent Tuberculosis Infection: A Guide for Primary Health Care Providershttp://www.cdc.gov/tb/publications/LTBI/default.htmCDC. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection. MMWR 2000;49(No. RR:6):151.CDC. Severe Isoniazid-Associated Liver Injuries Among Persons Being Treated for Latent Tuberculosis Infection United States, 20042008. 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;60:1650-3.21

Reason for TreatmentRecommendationsTips for Adherence Problems to Watch For Symptoms of AEs & Action StepsExpected Medication Side EffectsRegimen & ScheduleMissed Dose InstructionsClinic Contact Information Fact Sheet: Prior to Pilot TestThis is the fact that sheet that we created for PHASE I and used for the pilot test.As you can see here, the fact sheet was divided into different sections, which include:Reason for TreatmentRecommendations for the patient while they are undergoing treatment for LTBITips for AdherenceProblems to Watch For & Symptoms of Possible Adverse events and action stepsExpected Medication Side EffectsAND instructions for when a patient misses a dose

22Patient Questions#Questions3Demographics4What language do you feel most comfortable reading? 5According to the fact sheet you received, should you stop the medication right away and then call your TB doctor or nurse if you have:Stomach pain Sweating Nausea (upset stomach) or vomiting 6The next few questions are about your medicine. 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)7Next I am going to describe 2 different situations and ask what you would do if this happened to you. 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?23Patient Questions#Questions8Should you drink alcohol while undergoing treatment for LTBI? 9What number should you call if you have questions? 10What do you like about this fact sheet? 11What do you dislike about this fact sheet? 12Did you find any of the information confusing? 13Is there too much information on the sheet? 14Would you prefer a 1-page fact sheet that covers all the LTBI regimens or 3 separate fact sheets, with 1 regimen type per sheet? 24Provider Questions#Questions1How likely are you and your colleagues to use this type of fact sheet in the care and education of your patients? 2Do you feel the sheet enhanced the education you provided patients about their treatment regimen and potential adverse events today? 3Is there any wording that you would change? If so, what? 4In your opinion, have we included any information that might confuse a patient? If so, what? 5In your opinion, is the amount of information on the sheet: 6Was the time spent reviewing the fact sheet with the patient a worthwhile use of your time? 7Is there any information you feel should be added to the sheet? 8Is there any information you feel should be removed from the sheet? 9Would you prefer a 1-page sheet that covers all the LTBI regimens or 3 separate sheets, with 1 regimen type per sheet? 25IncentivesNo funding availableLight snacks given to participantsLight breakfast provided to clinic site on first dayIncentivesThere was no available funding for incentives; however, we purchased bottles of water, granola bars and trail mix as a small token given to patients thanking them for their participation. Coffee, donuts and bagels were also provided to clinic staff on the first day at each respective clinic.

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