Programs taking a look at electronic monitors

Expert: Good results when used ‘very judiciously’

For a select group of tuberculosis patients, electronic monitoring devices — long the subject for skepticism, if not outright derision in many TB control circles — seem to be slowly earning a legitimate place for themselves.

In some cases, electronic monitors are being used as a substitute for directly observed therapy (DOT); in other instances, they serve as an alternative to incarceration.

In New York City, the TB control program has been using electronic monitoring devices — pill-bottle caps embedded with a computer chip that records the date and time of every "opening event" — to keep an eye on adherence among a handful of trustworthy patients, says Paula Fujiwara, MD, the city’s head of TB control. That handful includes about 60 patients who’ve already demonstrated good compliance but who — perhaps because they work two jobs and are rarely home — are very difficult to supervise with DOT, she says.

So far, the devices have proven useful "for most of the patients," says Fujiwara, who plans to continue using the monitors.

An alternative to incarceration

In San Diego, electronic ankle bracelets of the type used to keep watch over ex-prisoners on parole are being deployed to keep track of patients just the opposite of those being monitored in New York — that is, smear-positive patients who’ve shown repeated noncompliance and who would otherwise need to be incarcerated, says Eric Adler, MPH, supervising investigator for the electronic monitoring program for TB control in San Diego.

At $6 a day, the ankle bracelets are a bargain, compared with the $1,800 per diem price attached to incarcerating an infectious patient, says Adler. In addition, the bracelets meet state legal requirements that "the least restrictive means possible" be employed to restrain recalcitrant TB patients.

Among monitors that aim to track adherence among trustworthy patients, one system now on the market has several features designed to boost compliance as well as to track it. APREX, a division of Apria, a Menlo Park, CA, company, makes a cap that comes equipped with a beeper that goes off when it’s time for a dose. The cap also features two digital readouts; one shows how long it’s been since the last dose and the other says how many doses remain for the given time period.

The computer chip in the cap downloads its data automatically every night via a modem, using an 800 number; and if the next day’s read-out shows a slip-up, a nurse contacts the patient by phone.

"We simply don’t have enough resources to put everyone on DOT, whether you’re talking about a busy city or a rural area where people are many miles apart," says Bruce Davidson, MD, president of the National Tuberculosis Controllers Association and TB consultant for Montgomery County, PA. More research into the use of the monitors makes sense, Davidson says, especially when it comes to tracking adherence in patients who claim to be taking their meds but who aren’t improving as fast as they should be.

"Provided these things actually work the way they’re supposed to, I think they could certainly serve as a useful adjunct to a TB control program," Davidson says. "We need all the useful tools we can get."

Used purely as a way to monitor adherence, the devices are useful only for a small proportion of TB patients, says Fujiwara.

"These are cases where we’ve tried to supervise therapy at the clinic and then tried supervising them at home, but it still didn’t work — maybe because the patient was at work from 7 a.m. until 11 p.m.," she says. "Under those circumstances, I still want the ability to monitor."

Simply equipping someone with a beeping bottle cap to track pill-taking behavior doesn’t appear to improve adherence, Fujiwara adds. "Even when patients on DOT had been 100% compliant, nobody on the monitoring devices was 100% compliant," she says.

The technology has grown more sophisticated and is much easier to use than the predecessor generation of monitoring devices, says Janice Wohltmann, vice president and general manager of APREX, which has been supplying a simplified version of its caps to New York City.

At a cost of between 50 cents and $2 a day, electronic monitors are cheaper to use than DOT, and managed care organizations have begun to embrace them, Wohltmann says. Clinicians who treat diseases other than TB, where long-term compliance is critical — as it is, for example, with diabetics, or transplant recipients suffering end-stage renal disease — have welcomed the monitors as well.

Now, the advent of new combination therapies for people with HIV has spurred a wave of interest in another field, as clinicians try to decide whether beeping bottle caps and blister-pack pills equipped with computer chips might help AIDS patients remember when it’s time for the next dose.

In the New York City pilot, patients were given caps only after having successfully completed the initial phase of therapy. For the continuation phase, they took isoniazid and rifampin in the form of a single combination tablet, says Fujiwara. In other pilot projects around the country, TB controllers use the caps in just the opposite order, notes Wohltmann. "Sometimes, they use our products for a month to see if patients need DOT," she says. "Other times, they give DOT for two months to see if patients can be switched to our technology."

In New York, caps got lost or forgotten

New York City patients were told to bring the caps to the TB clinic every month so data could be collected, Fujiwara says. The results indicated that nobody tried to cheat (by, for example, opening the bottle right before a scheduled clinic visit and dumping remaining pills), says Fujiwara.

But some patients forgot to bring the caps, forcing TB control personnel to go to patients’ houses to retrieve them. Other patients lost their caps altogether, and the city had to buy new ones, says Fujiwara.

Even though she plans to keep using them, Fujiwara emphasizes that she regards the electronic monitors as purely a last resort — and then, only for carefully selected patients. "We chose only those who’d already proven to be very reliable," Fujiwara says. "These people were the cream of the crop. I would never present this as an option to someone who didn’t want to take their meds."

In San Diego, smear-positive patients on house arrest are outfitted with electronic ankle bracelets. The bracelets send out an electronic signal warning a TB control staffer if a patient strays more than 100 feet from a monitoring box placed in the house, says Adler.

Such devices traditionally have been used to monitor the actions of prisoners on parole, adds Adler; but as crime-prevention measures, they often fall short. "They can’t show whether someone’s committing a crime inside the house, only whether or not they’ve left the house," says Adler. Luckily, he adds, with smear-positive TB patients, "that’s really all we need to know."

[For more information on monitoring systems, see Anderson Clinical Technology’s Web site at www.andersonclinical.com, or contact the firm by phone at (847) 392-9190. See APREX’S Web site at Aprex.com, or contact the firm by phone at (650) 614-4100.]