1. Medical Management of Contacts to Infectious Pulmonary Tuberculosis Alfred Lardizabal, MD New Jersey Medical School Global Tuberculosis Institute

2. Continuing Education Statement The University of Medicine and Dentistry of New Jersey –Center for Continuing and Outreach Education (UMDNJ-CCOE) designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits. Physicians should only claim credit commensurate with the extent of their participation in the activity. UMDNJ-CCOE certifies that this continuing education offering meets the criteria for up to.15 Continuing Education Units, as defined by the National Task Force on the Continuing Education Unit (CEU), provided the activity is completed as designed. One CEU is awarded for 10 contact hours of instruction.

3. Faculty Disclosure Alfred Lardizabal has expressed that his presentation does not include discussion of commercial products or services, or an unapproved or uninvestigated use of a commercial product. He has no significant financial relationships to disclose. Lillian Pirog has expressed that her presentation does not include discussion of commercial products or services, or an unapproved or uninvestigated use of a commercial product. She has no significant financial relationships to disclose.

4. Background (1) 1962: Isoniazid (INH) demonstrated to be effective in preventing tuberculosis (TB) among household contacts of persons with TB disease –Investigation and treatment of contacts with latent TB infection (LTBI) quickly becomes strategy in TB control and elimination in the U.S. 1976: American Thoracic Society (ATS) published guidelines for investigation, diagnostic evaluation, and medical treatment of TB contacts

5. Background (2) 2005: National TB Controllers Association (NTCA) and CDC release guidelines on the investigation of contacts of persons with infectious TB –Expanded guidelines on investigation of TB exposure and transmission, and prevention of future TB cases through contact investigations –Standard framework for assembling information and using findings to inform decisions

6. Contact Investigations – A Crucial Prevention Strategy On average, 10 contacts are identified for each person with infectious TB in the U.S. 20%–30% of all contacts have LTBI 1% of contacts have TB disease Of contacts who will ultimately have TB disease, approximately one-half develop disease in the first year after exposure

7. Decisions to Initiate a Contact Investigation Public health officials must decide which –Contact investigations should be assigned a higher priority –Contacts to evaluate first Decision to investigate an index patient depends on presence of factors used to predict likelihood of transmission –Site of disease –Positive sputum bacteriology –Radiographic findings

9. Determining the Infectious Period Focuses investigation on contacts most likely to be at risk for infection Sets time frame for testing contacts Information to assist with determining infectious period –Approximate dates TB symptoms were noticed –Bacteriologic results –Extent of disease

10. Start of Infectious Period Cannot be determined with precision; estimation is necessary Start is 3 months before TB diagnosis (recommended) Earlier start should be used in certain circumstances (e.g., patient aware of illness for longer period of time)

11. Closing the Infectious Period Effective treatment for ≥ 2 weeks, Diminished symptoms, and Bacteriologic response Infectious period closed when all the following criteria are met

12. Assigning Priorities to Contacts

13. Prioritization of Contacts (1) Patient has pulmonary, laryngeal, or pleural TB with cavitary lesion on chest radiograph or is AFB sputum smear positive Household contactHigh Contact <5 years of ageHigh Contact with medical risk factor (HIV or other medical risk factor) High Contact with exposure during medical procedure (bronchoscopy, sputum induction, or autopsy) High Contact in a congregate settingHigh Contact exceeds duration/environment limits (limits per unit time established by the health department for high-priority contacts) High Contact is ≥ 5 years and ≤ 15 years of ageMedium Contact exceeds duration/environment limits (limits per unit time established by the health department for medium-priority contacts) Medium Any contact not classified as high or medium priority is assigned a low priority.

14. Prioritization of Contacts (2) Patient is a suspect or has confirmed pulmonary/pleural TB – AFB smear negative, abnormal chest radiograph consistent with TB disease, may be NAA and/or culture positive Contact <5 years of ageHigh Contact with medical risk factor (e.g., HIV)High Contact with exposure during medical procedure (bronchoscopy, sputum induction, or autopsy) High Household contactMedium Contact exposed in congregate settingMedium Contact exceeds duration/environment limits (limits per unit time established by the local TB control program) Medium Any contact not classified as high or medium priority is assigned a low priority.

15. Diagnostic Evaluation of Contacts

16. Information to Collect During Initial Assessment (1) Previous M. tuberculosis infection or disease and related treatment Contact’s verbal report and documentation of previous TST results Current symptoms of TB illness

17. Information to Collect During Initial Assessment (2) Medical conditions making TB disease more likely Mental health disorders Type, duration, and intensity of TB exposure Sociodemographic factors

18. Information to Collect During Initial Assessment (3) HIV status; contacts should be offered HIV counseling and testing if status unknown Information regarding social, emotional, and practical matters that might hinder participation

19. Reassess Strategy After Initial Information Collected After initial information collected –Priority assignments should be reassessed –Medical plan for diagnostic tests and possible treatment can be formulated for high- and medium-priority contacts

20. Tuberculin Skin Testing All high or medium priority contacts who do not have a documented previous positive tuberculin skin test (TST) or previous TB disease should receive a TST at the initial encounter. If not possible, TST should be administered –≤7 working days of listing high-priority contacts –≤14 days of listing medium-priority contacts

21. Interpreting Skin Test Reaction ≥ 5 mm induration is positive for any contact Two-step procedure should not be used for testing contacts A contact whose second TST is positive after initial negative result should be classified as recently infected

22. Postexposure Tuberculin Skin Testing Window period is 8–10 weeks after exposure ends Contacts who have a positive result after a previous negative result are said to have had a change in tuberculin status from negative to positive

24. Evaluation and Follow-up of Children <5 Years of Age Always assigned a high priority as contacts Should receive full diagnostic medical evaluation, including a chest radiograph If TST ≤5 mm of induration and last exposure <8 weeks, LTBI treatment recommended (after TB disease excluded) Second TST 8–10 weeks after exposure; decision to treat is reconsidered –Negative TST – treatment discontinued –Positive TST – treatment continued

25. Evaluation and Follow-up of Immunosuppressed Contacts Should receive full diagnostic medical evaluation, including a chest radiograph If TST negative ≥ 8 weeks after end of exposure, full course of treatment for LTBI recommended (after TB disease is excluded)

26. Window-Period Prophylaxis The frequency, duration, and intensity of exposure Corroborative evidence of transmission from the index patient Decision to treat contacts with a negative skin test result should take the following factors into consideration

27. Prophylactic Treatment With HIV infection Taking immunosuppressive therapy for organ transplant Taking anti-tumor necrosis factor alpha (TNF- α) agents Prophylactic treatment (after TB disease is excluded) of presumed M. tuberculosis infection recommended for persons

28. Treatment After Exposure to Drug-Resistant TB Consultation with physician with MDR expertise recommended for selecting a LTBI regimen Contacts should be monitored for 2 years after exposure

29. Selecting Contacts for Directly Observed Therapy Contacts aged <5 years Contacts who are HIV infected or otherwise substantially immunocompromised Contacts with a change in their tuberculin skin test status from negative to positive Contacts who might not complete treatment because of social or behavior impediments

30. Source-Case Investigations

31. Seeks the source of recent M.tuberculosis infection In the absence of cavitary disease, young children usually do not transmit M.tuberculosis to others Recommended only when TB control program is achieving its objectives when investigating infectious cases

33. Child with LTBI Search for source of infection for child is unlikely to be productive Recommended only with infected children <2 years of age, and only if data are monitored to determine the value of the investigation

34. Procedures for Source-Case Investigation Same procedure as standard contact investigation Patient or guardians best informants (associates) Focus on associates who have symptoms of TB disease Should begin with closest associates

35. Contact Investigations

36. Background – 1 6/14/04 39 year-old female admitted to the hospital with complaints for approximately one month of cough, fever, decreased appetite, night sweats and 23 lb weight loss 6/17 Chest x-ray cavitary disease consistent with TB 6/17 Bronchial wash AFB smear positive (3+)

38. Background - 2 6/19 Treatment (RIPE) initiated 6/21 Suspected case of tuberculosis verbally reported by hospital infection control to the local health department

39. Background – 3 6/21 LHD informed TB Control of suspected case adding the following information –Presenting patient was a volunteer at a daycare center –Director of center is the sister of patient –Name, address and telephone of daycare center provided

40. Background – 4 6/21 Telephone call to director of daycare center from TB controller –Purpose to set up a meeting to discuss potential exposure to children and staff Conduct on-site exposure assessment of center Provide TB education to the director Identify high-priority contacts during infectious period established at 2/14–6/14/04

41. Background - 5 During telephone conversation, the following was indicated by the director: –Index patient was a part-time volunteer a “couple of hours” (2-5) per week –Secretary with little or no exposure to children

42. Background - 6 Near the conclusion of telephone call the following exchange occurred –Director: So, should my daughter be tested? –TB Control: Tell me about your daughter and how much exposure she had to your sister –Director: Not too much. She doesn’t attend the daycare but we do spend some time socially (maybe 5 hours) together on the weekends going to the mall

43. Background - 7 –TB Control: How old is your daughter? –Director: 6 months –TB Control: I’ll make arrangements for your daughter to be tested tomorrow morning –TB Control: By the way, how is your daughter feeling? –Director: Well, she was diagnosed with bronchitis a few weeks ago and is still coughing

44. Final culture result MTB

45. Contact Investigation 6/22: First of 4 TB interviews with the patient conducted by HCW in hospital revealed –Infectious period confirmed at 2/14-6/14/04 –Patient may have spent more time in daycare than originally described –Patient indicates not much contact with children at daycare –8 high priority contacts identified 2 household 6 social 6/23 Initiation of on-site assessment of daycare center

47. Contact Investigation As a result of on-site assessment 35 high priority contacts identified –30 children ages 3-4 years –5 staff members Notification process begins for testing Education sessions provided to parents of daycare children During these sessions it is learned that the 6 month old infant, director’s daughter, was at daycare center on regular basis

48. Contact Investigation 6/23 6 month old infant (director’s daughter) evaluated at clinic –TST 15 mm –CXR hilar adenopathy with suspected miliary TB –Admitted to hospital with diagnosis of suspected miliary TB

50. Contact Investigation 6/25 Field visit to social contact residence by HCW identifies a second 6 mo. old infant not named on initial interview –70 hours exposure per week during infectious period –Diagnosed with pneumonia 3 weeks ago HCW & TB Controller consult with pediatric nurse practitioner at Lattimore and infant is referred to ED and is admitted with a diagnosis of suspected pulmonary TB

52. Medical Evaluation 6/29 - 6/30 Tuberculin skin tests administered on all 35 daycare contacts and chest x-rays taken on all 30 children from daycare Extra clinic sessions scheduled in addition to 3 evening clinics at local health department where most contacts reside to accommodate the medical evaluations of the 30 children

53. Contact Investigation Initial Infection & Disease Results: Household and Social Contacts Total 9 high priority contacts identified –4 children/5 adults  TST (+) 5/9 (56%) TB disease 2/9 (22%) –2 infants  TST (-)4/9 (44%)

54. Contact Investigation Infection & Disease Results: Daycare Children30 (3-4 years of age) TST (+) TST (+) w/ disease 11/30 (37%) 5/11 (45%) TST (-) TST (-) w/ disease 19/30 (63%) 2/19 (11%) Staff5 TST (+) TST (-) 3/5 (60%) - 2 adolescents 2/5 (40%) No disease

55. Contact Investigation Results: Totals After Initial Testing Investigation Totals4432 ≤ 4 yrs old TST (+)19/44 (43%) TST (-)25/44 (57%) TB disease 9/44 (20%)All ≤ 4 yrs old

56. Prevention of Tuberculosis in Children: Missed Opportunities Failure to find and appropriately manage adult source cases (Case finding) Delay in reporting the initial diagnosis of TB Contact investigation interview failure Delay in evaluation of exposed children Failure to completely evaluate exposed children Failure to maintain a contact under surveillance LTBI diagnosed; treatment not prescribed Failure to complete treatment for LTBI (Adherence)

57. Contact Investigations: Lessons Learned Importance of on-site assessment Re-interviews of presenting patients strongly recommended to allow a complete and accurate assessment of exposure –Different interviewers if no contacts, rapport issue Despite the rapidity of the CI process 9 cases of disease occurred –Children develop disease soon after infection so it is imperative to move quickly Local pediatricians are generally not familiar with the evaluation recommended for and the prophylactic treatment of children exposed to tuberculosis

59. Medical Management of TB Contacts from a Nursing Perspective Lillian Pirog, RN, PNP Nurse Manager-Lattimore Practice NJMS Global Tuberculosis Institute

60. The Role of the Nurse Case Manager with Respect to TB Contacts Interview the index case for contacts Administer and read the TST Educate the contacts Monitor contacts at monthly interval Ensure treatment adherence Note: Not all duties discussed today will apply to all nurses, and some duties performed by TB nurse case managers may not be discussed

61. Interviewing the Index Case Interviewing the index case for contacts should be done on more than one occasion –On the initial visit –On subsequent visits until you are satisfied all the contacts have been identified –A visit to the site of exposure will help provide important information regarding possible transmission and contacts

62. Past Medical History Obtain contact’s past medical history –Ask the contact Have you ever been diagnosed with tuberculosis? Have you ever had a TB skin test? –If yes why, when, where, and what was the result Ask about medical conditions that may elevate the contact’s status to high risk Ask about behaviors that may elevate the contact’s status to high risk Ask about TB symptoms Ask about previous HIV testing

63. Contact Education Explain the following: –Transmission and Pathogenesis –TST (how it is performed) –TST results and what they mean –Retesting (if necessary) Always give the contact an opportunity to ask questions And ask them to tell you in their own words what they’ve learned

64. Contact Education cont. The evaluation process –TST If you are tested you must be available for the reading in 48-72 hours X-ray –Medical examination –Treatment if necessary Importance of adherence with treatment –Provide literature

65. TST Administer the TST –Explain the procedure –Explain that PPD is not a live bacteria. It can not give you TB –Explain how to care for the site Do not place a bandage on the site Do not scratch –Pat it with cold cloth –Can rub it with ice It’s okay to bathe and wash the site

66. TST cont. Results –Explain a positive result It only tell us that the germ is in your body nothing more. Further medical evaluation is needed –Explain a negative result –Explain the need for retesting (if necessary) –Explain window prophylaxis (if necessary)

67. Monthly Follow up Visits First visit –Review test results Blood Sputum –Explain how medications are taken –Explain possible adverse reactions to medication –Provide clinic telephone number and an emergency telephone numbers for after clinic hours and weekends.

68. Monthly Follow up Visits First visit cont. –Reiterate the importance of medication adherence and follow up appointments –Offer HIV test (if HIV status is unknown) HIV testing should be offered to all contacts

69. Subsequent Follow up Visits Ask about medication side effects Observe for possible adverse reactions Reiterate importance of compliance with treatment and follow up visits Review medication regimen Give follow up appointment (in a month)

70. High Risk Contacts HIV + Children <5 years old Those with Other medical conditions

71. Window Period The window period is the eight to ten week period after last exposure Window Prophylaxis Treatment doing the window period has been recommended for susceptible and vulnerable contacts to prevent rapidly emerging of TB disease

72. Signs of Adherence Problems Missed follow up appointments Not picking up medication refill from pharmacy Finding too many pills when conducting a pill count Unaddressed adverse reactions

73. Addressing Adherence Problems Identify adherence problems and try to resolve them Reeducate Free medication (Gratis Medication Program) DOT for contacts (If funding permits)

74. Don’t Underestimate the Power of a Smile Build a rapport Show you care

75. Any Questions?