Identification, Management, and Treatment of Persons with TB Disease
Effective treatment of persons requires both a tailored medical management plan and a patient-focused case management plan. After disease has been verified or is strongly suspected, both plans should be coordinated so that the most optimal care is provided to the patient, family, and community.
Available Services for TB Control
TB control programs should ensure that the services needed for evaluating, treating, and monitoring TB patients are readily available in each community. In certain areas, these services might be provided directly by the state TB program. In other areas, local TB programs or health care professionals, with supervision and consultation from the city or state TB program, provide patients’ treatment services. The policies, procedures, and laws specified at the beginning of this report (see Overall Planning and Policy Components) provide guidance for managing care for persons with TB disease. Although patients might undergo the majority of their evaluation and treatment in settings other than the health department, the major responsibility for monitoring and ensuring the quality of all TB-related activities in the community lies with the health department as part of its duties in protecting public health.
Protocols for TB Case Management and Treatment
The public health goals of TB patient management are to initiate treatment promptly and ensure completion of effective therapy to cure disease, reduce transmission, and prevent development of drug-resistant TB. These goals are achieved through case management. The TB program should have protocols in place for TB case management and treatment (46,47). The TB control program, in conjunction with the patient’s health care provider, is responsible for ensuring that the TB patient completes the recommended treatment for TB disease in a timely manner.
Identifying Persons with Clinically Active TB Disease: Diagnostic Methods
TB programs should be familiar with and have access to new diagnostic tools (e.g., blood-based IGRAs, nucleic acid amplification tests [NAATs], and other diagnostic tests as they become available). The laboratory appendix (Supplementary Appendix D; https://stacks.cdc.gov/view/cdc/90289) includes information regarding specific tests. Sputum and other specimens from suspected sites should be obtained as soon as possible for acid-fast bacillus smear and culture, rapid identification of M. tuberculosis complex by using NAATs, and initial molecular testing within the limits of the guidelines (48). Each patient should receive a medical evaluation and chest radiography, with additional imaging of the affected area, if not the lungs. Additional tests, including assessment for HIV infection status, should be performed, depending on the patient’s medical history and current condition. A medical regimen should be prescribed on the basis of patient clinical and epidemiologic characteristics (48).
Management and Treatment: Medical and Case Management Collaboration
Case Management Plan
Case management for TB disease includes patient-centered activities (e.g., DOT for medications, assessment of side effects, and patient monitoring) and other public health activities. The case management team should work closely with those providing medical management to ensure optimal care for each patient. Public health workers in TB programs play an integral role in helping patients complete TB treatment through the case management process. Case management provides patient-centered care for treatment completion and ensures that all public health activities related to stopping TB transmission are completed. This includes ensuring that each patient is educated about TB and its treatment, the importance of treatment adherence, and that contacts should be elicited and evaluated. This patient-centered approach can help ensure successful treatment and public health outcomes because it emphasizes a tailored approach that addresses both the patient’s clinical and social concerns.
Within 3 working days after the case is reported, a health department worker should visit the patient in the hospital or at home to conduct an interview, initiate patient education, identify contacts, make referrals for medical evaluation, and detect possible problems related to adherence to therapy. An initial treatment and monitoring plan should be developed and implemented within 1 week of diagnosis. This treatment plan should be reviewed regularly and modified as needed when additional relevant information becomes available (e.g., DST results) or when the patient’s care is transferred from one provider to another.
When developing and implementing a treatment plan, TB programs should work closely with health care providers from local hospitals, drug treatment centers, HIV clinics, correctional facilities, dialysis centers, health maintenance organizations, private physicians’ offices, and other facilities where TB patients receive medical care. TB programs should fulfill their mandated responsibilities and also respect the relationship between the patient and the primary health care provider. Other resources describe case management for persons with TB disease (46,47).
Case Management Team
In addition to the medical and case manager, team members might include clinic supervisors, outreach workers, health educators, nurses, nurse practitioners, physician assistants, pharmacists, physicians, and social workers. The patient is always a member of the team; family members might assist as available or interested. Specific responsibilities might be assigned to other team members; however, the case manager is ultimately responsible for ensuring that needed activities are performed. The specifics of this team, including size and number of members and function of each member, vary by jurisdiction and local needs.
Although certain patients might undergo their evaluation and treatment in settings other than the health department (e.g., hospitals or correctional facilities), the health department is legally obligated to monitor and ensure the quality of all TB-related activities within a health jurisdiction. Thus, all TB patients should be assigned case managers, whether they receive TB care in health department clinics or from private providers.
A specific clinician should be responsible for decisions regarding patient medications, testing, and assessment of progress throughout treatment. That clinician should provide medical oversight of all patient care and thus should have an excellent understanding of TB disease and its treatment, the effect of comorbidities on TB treatment, and drug-to-drug interactions (49).
A specific health care worker (i.e., a case manager) should be assigned primary responsibility for ensuring that all treatment and public health activities associated with the TB patient are completed. Although one person is assigned primary responsibility, case management can involve a team of persons who collaborate to provide continuity of care. The case manager is responsible for ensuring the following activities are completed for all TB patients to whom they are assigned:
Establishing a trusting relationship with the patient;
Educating the patient about TB and its treatment;
Ensuring that treatment and monitoring plans are in place;
Ensuring the patient adheres to and completes treatment;
Identifying contacts of a patient with infectious TB and providing testing and treatment as needed for all contacts;
Expanding the contact investigation as necessary when results from initial investigations become available; and
Conducting quality assurance through routine systematic review of patient progress.
Assessing and Promoting Adherence
Methods for promoting adherence to therapy should be tailored to the patient’s needs, lifestyle, social support system, and beliefs about health. An assessment of these factors should be included in developing a case management plan (46,47). TB programs should educate patients about the causes and effects of TB, dosing and possible adverse reactions of their medications, and the importance of taking their medications according to the care plan. To facilitate adherence, the plan should use short-course treatment regimens and fixed-dose combinations, if such regimens and combinations are recommended and available. A welcoming and respectful atmosphere within the clinic setting is fundamental to maintaining adherence.
The case manager should conduct an assessment of risk for nonadherence to treatment. TB programs should consider treating all patients with DOT, which is the standard of care in the United States (50). With DOT, a health care provider or other responsible person observes the patient swallowing each dose of anti-TB medication. DOT can be administered with daily or intermittent regimens and can be administered to patients in an office or a clinic setting or by an outreach worker in the patient’s home, place of employment, school, or other mutually agreed-upon place. In certain instances, DOT might be administered by the staff of correctional facilities or drug treatment programs, dialysis center staff, home health care personnel, staff of maternal and child health facilities, or responsible community members. New technologic methods (e.g., video DOT) might be used to promote adherence to treatment when in-person DOT is not feasible (51,52).
Incentives and enablers should be available for enhancing adherence to therapy. An incentive is an inducement or reward that serves as motivation for a desired action (e.g., a gift card for a local shop after completion of the first 2 weeks of treatment or a small toy for a child who takes the medication). An enabler is an item or action that removes barriers for achieving a desired outcome (e.g., transportation passes to get to the clinic or assistance with rent payments to prevent a person from becoming homeless).
Health care professionals, including private practitioners, who become aware of a TB patient who has demonstrated an inability or unwillingness to adhere to a prescribed treatment regimen should immediately consult the health department. The TB program can assist in evaluating the patient for the causes of nonadherence to therapy and provide assistance (e.g., outreach worker services) to enable the patient to complete the recommended therapy. If the patient still does not adhere to treatment, the health department should take action based on local and state laws and regulations. This entails issuing a health officer order for DOT or seeking court-ordered DOT or detention for patients who are unwilling or unable to complete treatment and who have infectious TB or for those who are at risk for becoming infectious or experiencing drug-resistant TB. A list of recommended legal resources for TB programs has been developed (19).
Additional services might be needed to facilitate continuity and completion of therapy. Social workers, interpreters, and referral sources should be available in the clinic or easily accessible to the patients. To ensure that patients receive treatment until they are cured, TB programs should make use of available legal authority and facilities available to isolate and treat patients who have infectious TB (see Overall Planning and Policy Components). When all less restrictive measures have failed, TB programs should be prepared to use any available legal authority to detain patients unwilling or unable to complete their treatment. This authority also might apply to nonadherent patients who no longer have infectious TB but whose disease might again become infectious or develop drug resistance. Procedures and plans should be established to ensure that patients in isolation or detention have safeguards for due process (e.g., how to request release from detention) and have their basic needs met (e.g., food, basic supplies, and other necessities).
Medical Management Plan
Although the majority of medical treatment plans for TB disease begin with the standard four-drug regimen (rifampin, isoniazid, pyrazinamide, and ethambutol [RIPE]), patient-specific drug regimens should be considered on the basis of the patient’s history. For example, a history of exposure to persons with multidrug-resistant TB (MDR TB) might change the initial medication recommendations. A history of bladder cancer treatment in a patient with disseminated disease might lead the clinician to consider that the cause of the TB disease is Mycobacterium bovis BCG rather than M. tuberculosis.
Clinicians should take a thorough medical history, conduct a complete physical examination to detect TB disease outside the lungs, and assess the patient’s history of exposure to TB disease and other factors in the patient’s history to select the best initial drug regimen. Subsequent decisions about the patient’s regimen depend on the results of drug susceptibilities, side effects experienced by the patient, disease progression, and any new information about the patient’s history and exposures that are discovered after the initial evaluation.
Initiation of the Treatment and Case Management Plans
As soon as patient specimens and bacteriology are obtained and TB disease is diagnosed or suspected, a clinician should start treatment and ensure the TB case is reported to the health department. TB programs should send smear-positive respiratory specimens for TB identification and molecular diagnostic testing to test for genetic mutations that are surrogates for drug-resistant TB (48). TB programs should start TB treatment either empirically or on the basis of laboratory findings such as molecular analysis or DST results. Because the majority of TB disease in the United States is pansusceptible, patients usually can be started empirically on the standard four-drug treatment regimen noted previously in the most recent version of the ATS/CDC/IDSA TB treatment guidelines (48).
Clinic services provided by TB programs, if available, should be accessible and acceptable to community members served by the clinic. Clinic hours should be convenient and ideally might include evening or weekend hours for persons who work or attend school. The clinic should be easily accessible by public transportation, or transportation should be provided, if possible. Intervals between the time of referral and the time of appointment and waiting times in the clinic should be kept to a minimum. In busy TB clinics or multipurpose clinics, priority should be given to persons with TB disease or being evaluated for TB disease and to persons receiving TB medications. Clinic services, including diagnostic evaluation, medications, and transportation, should be provided regardless of the patient’s ability to pay. The clinic should have staff who speak the same language and have similar cultural and socioeconomic backgrounds as the community served by the clinic, or the clinic should employ persons trained to work in cross-cultural settings. Language interpretation services should be available.
Clinical Consultative Services
Expert medical consultation should be available for management of all TB patients, including those who have drug-resistant TB. These consultative services should be available to the TB program and health care providers in the community. The consultation might be provided by a staff member of the TB program or by a local or regional consultant collaborating with the health department. Consultative services are also provided through CDC’s TB Centers of Excellence (53).
Drug-Resistant and MDR TB
MDR TB should be considered in patients with of a history of previous TB treatment or who are from a country with high MDR TB rates (37). Treatment initiation decisions can be guided by results of molecular testing. Molecular testing results might be obtained by sending specimens to the CDC Molecular Detection of Drug Resistance (MDDR) service (54) and public health laboratories. Specimens might also be sent to National Jewish Health in Denver, Colorado, or to other laboratories, for a fee. Certain instruments can test for isoniazid resistance, as recommended by WHO. Rifampin resistance can be tested by the GeneXpert or through MDDR testing.
Newer drugs (e.g., bedaquiline) have been approved for MDR TB treatment. Drugs that are approved for other bacterial infections (e.g., fluoroquinolones and linezolid) also are important drugs for treating MDR TB. Although shorter treatment regimens for MDR TB are being investigated, describing those trials is beyond the scope of this report. TB controllers should keep abreast of new developments related to drug-susceptible and drug-resistant TB. Medical consultation should be sought for any questions related to TB treatment and especially for decisions regarding MDR TB treatment regimens. Certain jurisdictions have specific MDR TB consultative services; consultation might also be obtained from the TB Centers of Excellence. A guide to testing and treatment for drug-resistant TB is available from the Curry International Tuberculosis Center’s website (55). On the basis of broad individual patient data meta-analyses, newer guidelines for treating drug-resistant TB have been developed by ATS, CDC, the European Respiratory Society, and IDSA (56).
Referral System for Other Medical Problems
A system should be in place to facilitate referral of TB patients for evaluation and treatment of other medical problems, including those conditions that can affect the course or outcome of TB treatment (e.g., HIV infection, underlying malignancy, diabetes mellitus, and substance abuse). Consultants should see referred patients in a timely fashion, and the consultant’s assessment and recommendations should be made available promptly to the referring health care provider. If patients receive care in more than one setting, treatment should be coordinated with the other health care providers to ensure continuity and completion of therapy, minimize drug interactions, and avoid duplication of efforts. The TB program takes primary responsibility for ensuring TB treatment and monitoring for adherence. TB programs should refer patients with infectious TB with recommended respiratory precautions and notify the receiving health care provider or transport personnel that the patient has an aerosol-transmissible disease.
TB Care in Inpatient and Other Clinical Settings
The TB program and all clinical settings should develop and implement protocols for ensuring rapid reporting of known or suspected TB cases to the health department having jurisdiction. Regardless of the patient’s ability to pay, TB programs should make accommodations available for any TB patient requiring inpatient hospital care for TB-related conditions. The facility should have effective infection control measures in place to prevent transmission of TB infection within the hospital (18). For example, the hospital should have provisions that allow patients with suspected or confirmed infectious TB disease to be separated from other patients. Although ideally such patients should be placed in an airborne infection isolation room, if such a room is unavailable, a room with effective general ventilation should be used, with use of air cleaning technologies (e.g., a portable high-efficiency particulate air [HEPA] filtration system). Medical staff knowledgeable about the management of TB patients should be available to assist in patient care while the patient is hospitalized. In addition, medications should be available in the facility so that the patient can start or continue therapy in the hospital. Diagnostic services (e.g., radiology and mycobacteriology) should be available for monitoring the patient for the response to treatment. The patient should also be monitored for adverse events and for other existing or new medical conditions.
Inpatient Care. Staff at inpatient settings might be unfamiliar with standards of TB treatment (e.g., DOT for all medications). Ingestion might not be documented, or the doses might not be counted in the overall dose count for treatment; therefore, the TB program and the patient are best served by the inpatient staff performing DOT and documenting actual ingestion of the medications. As soon as possible after admission, a representative from the TB program should visit the patient in the hospital to identify contacts, collect information for the initial treatment plan, and ensure that no obstacles to the patient’s follow-up care exist.
Discharge planning from the hospital begins as soon as the patient is admitted. TB programs should work with the hospital to facilitate TB patient discharge. Some jurisdictions allow the discharge of patients with infectious TB into the community, provided that DOT has been initiated and that the patient is tolerating medications, is being discharged to a setting that facilitates continued care and treatment while minimizing potential exposure of others, and has an appointment for follow-up. A contract between the patient and the health department to maintain noninstitutional home isolation might be required. A hospitalized patient should be reported to the health department; in many jurisdictions, approval from the health department must be obtained before discharge (57–59).
Other Settings: Coordinating Care with Other Health Care Providers and Facilities. TB patients often receive care in multiple settings, including HIV clinics, drug treatment centers, correctional facilities, hospitals, nursing homes, or primary care clinics. When patients move among these different settings, continuity and completion of treatment can be compromised, unless a system for coordinating care exists. To provide and coordinate continuous TB treatment and to facilitate transfers of care, TB programs should communicate regularly with providers and facilities involved in TB patient care, including hospitals, infection control practitioners, private practitioners, community clinics, correctional facilities, homeless shelters, and drug treatment centers.