TB Notes Newsletter

No. 3, 2012

HIGHLIGHTS FROM STATE AND LOCAL PROGRAMS

Reports from the 2012 National TB Workshop

The following articles are based on talks or abstracts that were presented at the 2012 National TB Workshop in Atlanta and that the authors agreed to share in TB Notes.

3HP Implementation – Mississippi

With the release of the study results for 3-month, once-weekly isoniazid and rifapentine (3HP) for treatment of latent TB infection (LTBI), the Mississippi State Department of Health TB program (MSDH) had to look at workloads and budgets to determine if the switch to shorter LTBI therapy could be done. Reviewed here are those initial considerations and questions raised about the benefit and cost of the new regimen, as well as early results of the implementation in Mississippi.

Initial Cost Justification
Cost of rifapentine was the first obstacle to implementation. The estimated drug cost of the new regimen was approximately $156–$165, compared to $19–$25 for 9 months of isoniazid (9INH), self-administered (SA). Funds had to be identified for purchase of the medication.  Second, it required 12 rather than 9 nursing visits when compared to 9INH SA treatment, with all doses of 3HP administered in a directly observed protocol. Third, it was noted that even though more patients completed 3HP, more patients stopped owing to adverse reactions, including hypersensitivity reactions. Finally, would the health providers be willing to accept a new regimen?

These factors had to be weighed against the benefit of a shorter medication time (12 weeks vs 9 months) with the potential for higher completion rates, and at least non-inferior (if not superior) long-term protection. With this information, we conducted an analysis to determine if the MSDH might use this new regimen in a cost effective manner.

To begin, justification for the direct and indirect costs needed to implement the 3HP regimen were reviewed in three standard patient scenarios comparing the 3HP to 9INH: 1) a nurse going to the patient’s home or workplace to administer 3HP (3HP-N) vs. twice-weekly INH by DOT by a nurse (9INH-N); 2) an outreach worker (ORW) going to the patient’s home or workplace three times a month, and a nurse traveling once a month, to administer 3HP (3HP-ON), compared to twice-weekly INH by DOT by ORW, except for the once-per-month nursing visit (9INH-ON); and finally, 3) the patient reporting to the clinic for each visit (3HP-C) compared to taking 9INH-SA.

The hypothetical standard patient was assumed to be fully compliant and non-complicated. We calculated minimal MSDH nursing/ORW time, mid-range salary, and minimal laboratory testing and drugs for periodic follow-up while on treatment. Travel was based on a 10-mile round trip taking 15 minutes to complete. Nursing and ORW visits were assumed to be 15 minutes each. Nursing costs were based on $26 per hour and ORW costs were based on $10 per hour. (Baseline testing costs for TB infection—chest x-ray, HIV test, and physician visit—were assumed to be the same for each regimen.)

Under these assumptions, $1,014.76 (including 32 hours of nursing time per patient) is saved by switching from 9INH-N to 3HP-N. The increased laboratory and drug costs (+$5.56 and +$140.88, respectively) are offset by savings in travel/mileage costs (-$328.70) and in nursing costs (-$832.50).

By switching from 9INH-ON to 3HP-ON, $566.26 is saved (including 3 hours of nursing time and 30.5 hours of outreach worker time per patient). The increased lab and drug costs (+$5.56 and +$140.88 respectively) are offset by savings in travel/mileage costs (-$328.70), nursing costs (-$79) and outreach worker costs (-$305).

By changing from 9INH-SA to 3HP-C, $159.56 is added (including 45 minutes of nursing time per patient).

The cost/time savings of the first two scenarios indicated 3HP would be a viable option. The third scenario demonstrates the up-front cost most clearly; this scenario needs justification apart from convenience for use. By this estimate, switching to 3HP-C from 9INH-SA would increase up-front costs $15,956 per 100 patient completions. The justification is found in the long-term public health benefit of the higher completion rates. The initial study demonstrated an increase in completion with 3HP vs 9INH (82% vs 69%). If we assume an increase in completion of 20%, the higher completion rates should translate into decreased morbidity and reduction in future transmission. If 3HP allows us to gain 20 additional completions per 100 patients, that should prevent two additional cases from occurring, 28 additional contacts (based on MSDH average of 14 contacts per TB case), and 5.9 new infections (based on MSDH average contact reactor rate of 21%). We estimate that an average MSDH contact investigation costs $6,927, and the national average cost of treating a routine TB case is estimated to be between $20,000 and $25,000. By these estimates, increasing completions from 60 per 100 to 80 per 100 would save at least $53,854 in future costs (costs of treating two unprevented cases and resulting contact investigations). Subtracting the costs of the new 3HP regimen from the future savings gives “bottom line” savings of at least $37,989. The question becomes, Are you willing to spend $15,956 to potentially save $37,989 in the future through reduced morbidity follow-up?

Implementation
In June 2011, MSDH piloted 3HP and also switched from the tuberculin skin test (TST) to QuantiFERON Gold in two areas of the state: Hinds County Health Department, which has a high-volume clinic dealing with TB in a large homeless population, and District VIII (9 county health departments) because of the active involvement of the local health officer and the rural patient volume. In November 2011, it was expanded to District II in northeast MS (11 counties) and District IX (6 counties) on the Gulf Coast. In March 2012 we moved from pilot to statewide implementation (82 counties).

Results
Through July 20, 2012, a total of 251 patients started medication; 145 have completed and 61 remain open. This is a completion rate of 75% among those that should have completed treatment. Forty-five have been closed without completion of 12 doses, with 27 due to adverse reactions and 9 by patient choice; 5 were lost to follow up; 3 moved out of state; 3 homeless persons were lost to follow-up (2 after 9 doses), and 1 was closed administratively after QFT testing was negative.

Lessons Learned
3HP treatment was initially harder than we thought to complete. Incentives used mainly in the homeless population have provided little benefit, but enablers, mainly bus tokens, have been helpful. More mature patients often prefer fewer pills at one time and a longer regimen over 3HP. It is challenging in high-risk / mobile populations. Some patients are apprehensive about the “new” regimen. The more intense monitoring (asking about specific side-effects) has increased emphasis on potential side effects. Health care providers were quicker to react to potential side effects of 3HP vs. INH, especially in the earliest implementation phase. Of 27 medical advice closures, only three have occurred in the past 3 months. Ten homeless patients have completed therapy.

Drug costs have to be paid up front. Nursing time is hard to measure, making actual savings more difficult to clarify. The question remains, will completion rates justify direct costs? Our completions have been less than desired so far, but are improving. MSDH already had high completion rates of LTBI with INH. The comfort level of health care providers is increasing and adverse reactions seem to be decreasing. Nurses like the shorter treatment. Combined with IGRA testing, we have seen a significant decrease in the number of LTBI patients statewide. While early, this is likely to be a popular regimen with patients and health care providers.

—Reported by Risa M. Webb, M.D.
State TB Consultant, and
J. M. Holcombe, MPPA, CPM
Director, Office of Tuberculosis and Refugee Health
Mississippi State Department of Health

Internet Directly Observed Therapy (I-DOT), the Future of DOT

Background: The Barren River District Health Department (BRDHD) serves an eight-county area in South Central Kentucky, including urban and rural communities. The district serves 253,276 people spread across 3246.2 square miles. Population density ranges from 29.8 persons/square mile to 210.1 persons/square mile, depending on the county. The 10-year average TB case rate in the district is 4.6/100,000 (ranging from 0.8 to 9.8/100,000). With a shrinking budget and limited staff, providing directly observed therapy (DOT) has been a huge challenge.

Objective: To demonstrate that using the Internet to observe patients taking TB medications is an effective alternative to face-to-face DOT.

Methods: Since early 2011, BRDHD’s Communicable Disease (CD) team has piloted the use of a webcam (video chat) with a microphone over the Internet to observe patients taking their TB medications. Patients had to meet the terms of the BRDHD’s I-DOT protocol for active TB in order to participate. Data were collected, reviewed, and compared for the following three categories: 1) mileage to and from the patient’s residence/work site, 2) cost of gasoline and car maintenance using Kentucky State travel reimbursement rate, and 3) amount of staff work time saved.

Results and findings: The data presented below are for two patients, both challenging in their own way. One patient traveled internationally for 2 weeks during the continuation phase. Eleven I-DOT encounters were completed while the patient was overseas.  The other patient’s residence was a 101-mile round trip from the health department. BRDHD saved an estimated $3,768 in transportation costs and 207 hours of staff time in less than a year just on these two patients. 

Conclusion: With increasing access to reliable high-speed Internet, even in rural communities, observing patients take their TB medication via the Internet is a cost-effective and reliable method of DOT. Patients are carefully selected using the exclusion criteria set by the BRDHD’s I-DOT protocol for active TB.

Barren River District Health Department Protocol for Internet DOT for Active TB

Providing DOT for treatment of active TB increases patient adherence to the medical regimen. Increased adherence reduces the risk of disease recurrence and prevents the development of resistant Mycobacterium tuberculosis strains.

Once the patient has completed 3 weeks of medication by standard DOT (face-to-face observation of administration of TB medicine), Internet DOT (I-DOT) may be considered an option. I-DOT can be a substitution for home/office DOT which the Barren River District Health Department (BRDHD) can offer to clients.  I-DOT will not be considered as an option if any of the following exclusion criteria are present.

Exclusion criteria:

• Patient is in isolation.
• Patient has side effects requiring graduated doses of medication.
• Illegal activity is or has occurred in the home.
• I-DOT cannot be accomplished within 15 minutes.
• There is a lack of stable environment.
• There is a lack of Internet access at patient’s location.
• Therapy compliance is less than 90% during the initial 3 weeks of standard DOT.
• Patient cannot effectively communicate via the Internet owing to disability
• Patient is unable to demonstrate effective use of the equipment.

To perform I-DOT, a weekly supply of prepackaged medication doses will be given to the patient at the weekly face-to-face DOT visit. A member of the BRDHD Communicable Disease Team (CDT) will arrange a set time for the I-DOT with the patient based on the signed DOT agreement. During the I-DOT, the patient will be expected to follow the BRDHD I-DOT procedure as outlined below. After successfully completing 4 weeks of I-DOT and attaining a compliance rate of 95% or higher, the patient will be allowed to increase I-DOT to 2-week intervals. This means they will be given a 2-week supply of prepackaged medicines and have a face-to-face DOT once every 2 weeks.

Procedure:

• BRDHD staff will set up the patient’s computer for I-DOT and will be at the patient’s home for no less than two I-DOT visits to ensure that the I-DOT access is properly functioning and the patient and/or family member is capable of accessing the Internet site independently.
• A telephone call will be placed to the client by a member of the BRDHD CDT at the agreed-upon designated time. The patient will have 15 minutes to access the Internet site for I-DOT.
• The patient understands that there is a 1-hour window period during which he/she must be available to BRDHD staff for the completion of the I-DOT.
• As with standard DOT, BRDHD staff will complete I-DOT Monday through Friday (based on the patient’s current medication regimen). The patient will self-administer medications on the weekends and holidays.
• The patient will have a weekly face-to-face DOT visit, at which time he/she will receive a 1-week supply of prepackaged medications. Once 4 weeks of I-DOT have been completed at a 95% compliance rate, consideration may be given to extending the time frame between face-to-face visits to 2 weeks.
• The patient will have a packet of medicines, a clear glass of clear liquid, and both hands in sight of the CDT member throughout the I-DOT.
• The patient will display the prepackaged packet of medicines for the CDT member to inspect.
• The I-DOT visit will not be counted towards treatment if the patient does not keep hands and medicine in full view of the CDT member during the entire I-DOT encounter (until all medicines are taken).
• After swallowing medications (whether it is one, two, or three pills at a time), the patient will display hands for viewing in an open, palm-up position.
• After taking the last pill, the patient will allow the CDT member to inspect the mouth to ensure patient has not “cheeked” medicines.
• The CDT member will chart the I-DOT at the BRDHD.
• Original copies of chart will be taken to the local health department (LHD) and placed on clinic chart when face-to-face DOTs are completed.
• At any time the client falls below 95% compliance, I-DOT will be discontinued and face-to-face DOT will be resumed.

—Reported by Srihari Seshadri, MBBS, MPH, Teresa Casey, RN, BSN,
Carolyn Lyons, RN, BSN, Sharon Ray, RN, Tina Loy, RN, and Beth Greene
Barren River District Health Department, Bowling Green, KY

 

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