AlignMap

Source:
MIT Spectrum (Helping TB patients. Spring 2008)

CellCentives Compliance Program

This article in Spectrum, a MIT in-house newsletter, celebrates the CellCentives progam, originally discussed in an AlignMap post, Yunus Challenge Award Focuses On Patient Compliance in May 2007.

To recap, CellCentives was one of the winners of the Yunus Challenge, the topic of which was “Increasing Adherence to Tuberculosis Drugs in Rural Developing Country Contexts”

Excerpts:

Commentary

I didn’t get it when I first wrote about this program almost a year ago, but now … well, I still don’t get it now.

Oh, I get the incentive part. What I don’t get is the implication that CellCentives is the equivalent of DOTS. A patient punching in a number from the packaging for a capsule is not the same as a nurse “actually go[ing] to the homes of TB patients to watch them take their medication.” Until there is research demonstrating that CellCentives is as effective as DOTS, the fact that CellCentives is cheaper is an empty boast. A plastic pill dispenser would be cheaper than CellCentives – but so what? Doing nothing is cheaper still.

Perhaps I’m missing something. But until someone can enlighten me, I feel compelled to suggest that despite visit[ing] five cities in India [to survey] tuberculosis patients and their doctors to learn why patients don’t take their medication,” perhaps these students didn’t get the entire story on compliance.

To repeat two of my shibboleths,

1. Being correctly educated to the need for medication and being reminded to take the medication are not the only factors with an impact on medication compliance
2. Removing a pill from its packaging is not as effective a treatment as actually taking the pill

Where’s my prize?

The Research

A study published this week in The Journal of the American Medical Association indicated that expensive placebos were more effective than cheaper placebos.

An article from the March 5, 2008 New York Times, More Expensive Placebos Bring More Relief, summarizes the study:

Inevitably, some readers felt obliged to make comments along the lines of “I’m going to sell a pill for a gazillion dollars that will cure everyone.”

Sigh.

Ron Winslow, at the Wall Street Journal was more on point with his headline, Placebos Might Work Even Better With a Brand Name. He went on to observe

Still, this is the more of the same sort of thinking that has led to the current crisis in American healthcare. The brand names Mr. Winslow references are, after all, those of the same old pharmaceutical manufacturers.
Pharmaceutical manufacturers manufacture pharmaceuticals. The cognitive dissonance of “pharmaceutical manufacturers manufacture placebos” alone would wash out any potential benefit. Besides, if you’re selling Buicks, you can’t just double or triple the price of Buicks and hope that the customers will accept that increase without demanding an explanation.

One must give the customer/patient extra value for the extra price – which brings us to the new AlignMap business enterprise:

the placeboutique

Placeboutique - The Home Of High Priced & Highly Effective Placebos

The Clinical Retail Strategy

First, The AlignMap research staff carefully leeches out any potential chemically-mediated physiological effect from the products while retaining and, in some cases, expanding the expense of producing these placebos.

The key to the placeboutique business plan, however, is offering really prestige name brands. Check out these samples:

Now, those are names that are worth the extra dollars that will make these pseudo-pills expensive enough to be effective.

While the initial iteration of the placebotique tactics limited inventory exclusively to designer brands, we soon realized our humanitarian responsibilities obligated us to carry more affordable generics.

Consequently, we have developed an in-house category of drugs that lack the designer flare and logo but make their own distinctive, low-key statement by virtue of each pill and capsule bearing an embedded blue star diamond.

Remember: At Placeboutique, the diamonds are real; only the drugs are fake

These are quite presentable and, because they do not incur the cost of a designer, can be offered at a substantial savings. While some placebo categories, such as fake immunosuppressive drugs, may remain beyond the reach of a small percentage of the impoverished, more common remedies, such as the fake antibiotics in this line, are widely available at less than $1,000 per dose.

Several other affiliate deals are in the works. While royalties are still being negotiated, a Grey Goose branded bowel prep, for example, could be on the shelves by the end of the year.

Finally, all placebos sold at the placeboutique carry our unique clinical-fiscal guarantee: if the first course of a placeboutique pill does not result in a cure, we will provide a second course of even more prestigious pills at at least twice the price and effectiveness.

A recent AlignMap post, Individualized Dose Packets Simplify Medication Adherence, described onePac, a service of Parata, a company specializing in automated pharmacy services. OnePac is a system allowing local pharmacies to provide all of a specific patient’s oral and topical medications packaged by dose; the press release describes it as ” … a 30- to 90-day onePAC supply comes to patients as a perforated strip of individual onePAC packages, one for each dose, prepared in a convenient dispensing box that displays the next dose to be taken.”

I emailed Parata with questions I had that were not addressed in the release and received a prompt reply from Nanette Kirsch, Parata’s Senior Director of Marketing Communication.

I’ve pasted the questions I asked and the answers I received below:

Q: What, for example, is the incremental cost and is it anticipated that the local pharmacy will absorb it or will it be passed along to consumers? Will third party payers cover this benefit?
A: 1. Most pharmacies charge $10 – $20 for a 30-day supply.
2. We do have a new partner with which we’ll be exploring reimbursement through third-party payors. It is not presently available.

Q: On the technical side, can the onePAC system handle prescriptions calling for non-daily dosing, such as risedronate (Actonel) which is taken once a week?
A: Yes. In whatever manner the prescription is filled by the host system, it is sent to the PACMED system, which prepares onePACs. It will then package for example, a 14-day cycle with Actonel on each Monday in that week’s cycle.

I had other questions that required input from the product manager who was out today. Ms Kirsch hoped to obtain the responses tomorrow. I’ll post those when they arrive, at which time I’ll also have further commentary.

One Packet Manages Multiple Medications Per Dose

Graphic adapted from myonePAC web site

In a press release issued yesterday, Pharmacists Customize Prescriptions By Patient, Day and Dose with onePAC(TM) Packaging, Parata, which offers automated pharmacy services, announced the availability of onePac, a system allowing local pharmacies to provide all of a specific patient’s oral and topical medications packaged by dose.

According to the release,

One of the potential benefits of the pharmacy generated single dose packs is the elimination of many of the errors some patients make in distributing their medications in simple SMTWTFS pillboxes, reducing unintentional noncompliance.

Similar systems have been in place for some time at inpatient facilities and have been offered by some pharmacies to some patients. To my knowledge, this is the first widely available packaging system of this sort.

Unknown Issues Re onePAC

Because my information at this time is limited to a press release and whatever I could glean online, several important questions are unanswered.

What, for example, is the incremental cost and is it anticipated that the local pharmacy will absorb it or will it be passed along to consumers? Will third party payers cover this benefit?

On the technical side, can the onePAC system handle prescriptions calling for non-daily dosing, such as risedronate (Actonel) which is taken once a week?

If all of a patient’s prescriptions are processed and sold in 30-90 day bundles, how are changes in that patient’s medication regimen handled, both logistically and financially?

Is there research demonstrating that this type of packaging increases compliance?

I have emailed Parata with these questions and will share their responses here.

Update: Two of these questions are answer at Answers To Questions About onePAC. The remaining questions should have responses, I’m told, in the new day or two.

The Potential Utility of Individualized Dose Packets

If the system is practical (e.g., affordable, simple to use), this would be a potentially signficant compliance enhancement for anyone taking more than a single medication daily. Of course, my evaluation may be skewed by the fact that I have previously recommended such a program.

There is a significant gulf between good ideas and research-proven methodologies. And, as software manufacturers have repeatedly discovered, some flaws in any system are not apparent until that system is subjected to widespread implementation by actual end-users.

Nonetheless, onePAK does strike as a dandy idea and one that could benefit folks like my mother – and me.

Mission Accomplished: Noncompliance Bites Dust

Little did I suspect when I began my routine daily scan of scientific, news, and commercial reports pertinent to patient compliance that I would be reading about the imminent demise of healthcare noncompliance, my central professional interest for the past several years.¹

The opening sentence of Science sinks its teeth into 2500 year-old drug problem, a story in the 15 January 2008 online edition of Science Centric, provides the basic information, albeit a tad obliquely. ²

The introduction’s subjunctive voice (“may achieve”) and generic quality (“help patients follow treatment”), which finesse the issue of claims being made for this device and preclude accusations of overstatement, dissipate by the final lines of the article, giving way to a more positive and, eventually, a fully triumphant timbre.³

Well, that’s that. Clinicians no longer have to worry about nonadherent clients. The patient compliance research projects can start winding down, the pharmaceutical companies can end their medication reminder programs, and all those electronic gadgets that track compliance and set off bells, whistles, lights, sirens, email messages, or fireworks to signal that it’s time for a medication dose can be consigned to eBay.

Perhaps I can reorient AlignMap.com as as a nostalgia site with a spiel along the lines of this:

You kids may not know this, but once upon a time, some patients didn’t automatically take their medication as instructed – back in the old days, we called that “noncompliance.” That’s a funny word, isn’t it? But all that was before everyone had a prosthetic tooth that releases a controlled dose of medication at regular intervals.

And, after the wizards responsible for the prosthetic tooth that will end 2500 years of patient noncompliance have that issue under control, maybe they can take a crack at perpetual motion or world hunger or existential angst or …

But before that, let’s take a look at that tooth, or as I like to think of him -

Marshall Molar, Medication Modulator

The article first establishes its credentials by quoting both Hippocrates and Koop on compliance,⁴ noting that standard but misleading statistic that “studies indicate that up to 50% do not take their medicine,” and listing a number of negative consequences of noncompliance.

Information about the medication-packing tooth itself follows the introduction:

That device looks something like this model.

Heck, I’m impressed already – and I’m curious about the technique they use to remove two molars from the patient’s jaw and install that prosthesis with its ersatz tooth cover without resorting to an invasive procedure.

The article also discusses the increased bioavailability of the drug caused by passing it through the buccal tissue.

IntelliDrug’s Operative Mechanism

Excerpted from Science sinks its teeth into 2500 year-old drug problem:

A more complete rendition of the process is provided by Gizmag:

According to the piece, IntelliDrug, which could be applied to any drug, could be on the market in three years. On the other hand, a poster I downloaded just now from the IntelliDrug Project Site confidently asserts that “The prototype will be ready and tested by the end of 2006. It is expected that in 2007 the device will be available on the market.”

Just A Few Questions

For the sake of this post, let’s assume the tooth works perfectly. After all, it’s just “a reservoir and release mechanism; a programmable circuit, micro-sensors, an infrared sensor, micro-actuators and batteries. All housed in a tiny package.” What could go wrong?

Even so, questions arise. A representative but not exhaustive list follows:

• How much will the IntelliDrug appliance, its installation, and its ongoing operation cost?
• Who will pay that bill?
• Really? Which insurance company?
• If the candidate for the IntelliDrug doesn’t happen to have a handy two molar sized space in his or her jaw, is the plan to remove two healthy teeth – noninvasively – to make room for the device?
• What percentage of patients, according to the studies those folks on IntelliDrug must have done, will agree to have their medication compliance enhanced through installation of the bionic molar medicator, let alone endure the removal of two teeth if that is necessary?
• If we all think real hard, is it possible that we might come up with an alternative or two that might cost less, be less traumatic, and give the patient control of his or her own body?

Another Solution

IntelliDrug seems a legitimate, scientific project that could have an impact in some cases in which medication noncompliance is too dangerous or too costly to risk and the patient is cooperative.

Transforming an expensive potential tactic to improve adherence among a relatively small group of individuals into “an end to the 2500 year-old patient compliance conundrum” makes the project seem a joke and leads to mistrust of any future claims of effectiveness, however reasonable they might otherwise be.

My recommended solution to this problem follows:

Update

Some time after completing this post, I discovered that the Science Centric article, dated 15 January 2008, I first read this morning is actually a virtually unchanged copy of a report released 18 Oct 2007 by ICT Reports, which describes itself thusly, “The ICT Results service was developed in 2003 for the European Commission’s Directorate-General Information Society and Media. It changed names in 2007 and is now operated by a consortium with experience in research, editing, communication and marketing services, led by ESN and partners Assystem. ICT Results features online news and analysis on the emerging results from information and communications technology research. It reports on prototype products and services ready for commercialisation, as well as work in progress and interim results with significant potential for exploitation.”

So much for the “breaking news” angle. It seems the solution to medication adherence was announced three months ago, but I didn’t notice the change.

I must have been distracted.

1. I first read about IntelliDrug in February 2007, when similar reports surfaced. At that point, I had neither the time nor energy to address it. When a report of this technology reappeared this morning, however, I felt compelled to respond.↩
2. For the proper “late breaking news” effect, viewers may wish to click on the arrowhead below to trigger the clacking teletype sound for background and read the rest of this aloud with that Walter Winchell staccato phrasing. [audio:http://1heckofaguy.com/audio/teletype.mp3] ↩
3. To achieve the best effect in this instance, viewrs may wish to hum either “We Are The Champions” or “The Theme From Rocky” while reading this portion of the report.↩
4. These quotes have become almost obligatory for articles on patient compliance:
   Hippocrates: “Keep a watch also on the faults of the patients, which often make them lie about the taking of things prescribed.”
   Dr C Everett Koop: “Drugs don’t work in patients who don’t take them.”↩

Source: Effects of a Behavioral Intervention on Antiretroviral Medication Adherence Among People Living With HIV: The Healthy Living Project Randomized Controlled Study
Johnson, Mallory O, PhD; Charlebois, Edwin PhD; Morin, Stephen F PhD; Remien, Robert H PhD; Chesney, Margaret A PhD. JAIDS Journal of Acquired Immune Deficiency Syndromes. 46(5):574-580, December 15, 2007.

The Study

The study examined the effect of a 15-session individually delivered cognitive behavioral intervention on the self-reported antiretroviral (ART) medication adherence of 204 HIV-infected patients. 3800 HIV-positive participants were randomly assigned to participate in the counseling program or not to participate in the program. Investigators focused on changes in adherence patterns among “low adherers,” that is, the 204 participants who reported at baseline taking fewer than 85% of their doses. The mean adherence of this group was between 60 to 65% and did not differ between the counseled and non-counseled group.

The Compliance Enhancement Program

The program consisted of 15 structured, individual counseling sessions, each of which explored environmental, emotional and behavioral aspects of risk-taking behavior.

According to Effects Of Adherence Support Programmes May Be Short Lived by David McLay, AidsMap, January 02, 2008, the intervention program included three Modules:

Module One (Stress, Coping and Adjustment) addressed issues surrounding quality of life, coping and building supportive social networks and was delivered during the first five months of the study.

Module Two (Safer Behaviors) addressed avoiding sexual and drug-related risk of transmission of HIV and other infections and disclosure of HIV status. Module Two was delivered during months five and ten.

Module Three (Health Behaviors) addressed access to medical care, adherence to anti-HIV treatments and participation in health care decisions. The final module was presented from months ten to 15. Participants were then followed up to month 25.

Results

[Excerpted from abstract]

Commentary

The study is not optimal. Because the population studied was the low adherence group, part of their improvement in compliance may have been simply a regression toward the mean. Further, the compliance rate was calculated from patients’ self-reporting, a methodology repeatedly shown to overreport actual adherence.

Nonetheless, the trend toward improvement in compliance while the enhancement program is ongoing and deterioration of that improvement after completion of the program does support the concept that patient compliance is a behavior requiring constant nurturing rather than a deficit requiring a one-time educational intervention.

Almost certainly the most commonly used and typically recommended patient compliance enhancement device is the pillbox.

And pillboxes have frequently made appearances on the AlignMap site. Letterman, Pills, & Compliance Enhancement reported on Dave Letterman’s use of a common seven-day pill dispenser with flip lids on his show:

A spiffier Bang & Olufsen pill dispenser, capable of producing a visual or acoustic signal to the patient when a dosage is due and providing feedback to the patient via a red, yellow or green lights that indicate how well that individual has been taking the medication. was featured in Dispensing Pills In Style.

Electronic pillboxes are, it seems, quite the thing. This one was featured in The Latest Electronic Pillbox.

And the manufacturer of the model shown below claimed compliance rates of 98.6%, a statistical accomplishment which was explained in the conveniently named AlignMap post, 98.6% Medication Compliance.

Best of all, a pillbox success story was the focus of Pillbox Organizers May Improve Adherence To HIV Treatment.

How To Use Pillboxes and Medication Organizers

As it turns out, recent research shows that pill organizers have a great potential for enhancing medication adherence but also have their own set of recurrent problems. That is hardly unique: most tools that are useful also carry risks. The odd part is that physicians, pharmacists, nurses, health insurance companies, and the rest of the usual suspects rarely do more than recommend that patients use pill organizers. After that, folks are on their own.

That’s probably a mistake.

In upcoming posts, I’ll be reviewing the sparse literature on the use of simple, non-electronic medication organizers, adding my own observations to the findings and recommendations. If I do my job correctly, this should be immediately useful to may patients.

Today’s post, however, is limited to this introduction and the following set of graphics that illustrate, just for grins, the wide world of pillboxes and medication organizers that are practical, decorative, emblematic, clever, cheap, costly, round, square, huge, tiny, and much, much more. Also included are various medication-associated accoutrements, such as pill splitters, reminders, medication logs, etc.) that are often marketed as part of a set, the centerpiece of which is a medication organizer.

And just in time for Christmas.

Credit Due Department: The bejeweled pillboxes shown above are from and shown here courtesy of Kristi Lyn Glass.

The How To Use Medication Organizers series of posts
is scheduled to begin within the next week.

Two Wall Street Journal articles that are especially pertinent to patient compliance were published on 20 November 2006 during the AlignMap blog’s holiday hiatus.

Cell Phones Provide Medication Information and Reminders

don’t 4get ur pills: Text Messaging for Health¹ by Rachel Zimmerman explores the use of text messaging on nearly ubiquitous mobile phones as a real time means of conveying information about medical treatment, responding to healthcare queries, and, most significantly for patient compliance, sending reminders about medication doses to patients.

While I have been critical of marketing that promotes reminders of various sorts² to be the complete solution to medication noncompliance or suggests that reminders always result in downright miraculous improvements in adherence rates, I am taken with the notion of cell phone text messaging as a useful tool for patients who have difficulty taking the right medications at the right time (a category in which I frequently find myself when a new medication, such as an antibiotic, is added to my ongoing medication schedule for a one or two week period) and for exchanging information precisely because it requires, for most of us, no new or specialized equipment and fits into our daily routines.

Because I already use an analogous service to text messages to myself about everything from taking out the trash early Monday mornings for the weekly pickup and buying specific items currently on sale at my local grocery to adapting a business presentation in time for a meeting next week, I can see how medication reminders could also integrate into rather than impinge upon ones behavioral patterns. I can also imagine younger individuals, such as my 18 and 21 year old sons who would promptly toss a reminder device that attracted attention to themselves under a passing truck, being comfortable with this type of reminder.

Readers may recognize one service provider mentioned in the article, Intelecare Compliance Solutions, as the group represented by Knight, the author of the Medication Noncompliance Blog:

Patients, Doctors, Dollars, and Communication

Your Doctor’s Business Is Your Business by David Armstrong discusses how patients might best deal with the possibility that their doctor has a potential conflict of interest (e.g., a physician with a financial interest in an orthopedic device he developed might be tempted to prescribe it unnecessarily or a doctor might advise patients to undergo a CT scan at a given facility which he owned). While I certainly see the value of open disclosure on the part of clinicians re special financial considerations they might receive from prescribing a specific treatment, I’m less convinced of the practicality of the course of action promoted by this article. In a framed box entitled “WHAT EXPERTS RECOMMEND,” the recommendations are

Even though I’m a physician myself, I would find it awkward to ask each of my doctors every time they prescribe a medication, operation, physical therapy, etc, if they will personally benefit from that transaction. Using as an example, the treatment I received for my recent hip fracture as an example, I should, according to a straightforward reading of the article, have asked about conflicts of interest when

• My personal physician ordered a diagnostic x-ray from a facility located in a different office of the same medical building as his office
• My personal physician had his nurse obtain blood samples for the hospital admission work-up
• My personal physician referred me to a specific hospital for reparative surgery
• My personal physician referred me to a specific orthopedic group for further diagnosis and treatment
• The orthopedic surgeon recommended a hip pinning rather than other options
• The orthopedic surgeon referred me to a inpatient physical therapist for purchase of an assistive walking device and training in its use as a condition of discharge
• The orthopedic surgeon ordered pain medication for my post-operative use as needed
• The orthopedic surgeon ordered follow-up x-rays of the hip to be done in his office before every follow-up appointment
• The orthopedic surgeon recommended outpatient physical therapy at a specific facility

It seems to me that the real question readers are being prompted to consider is “Is my doctor ripping me off?” And, I think that is a legitimate enough concern; the problem is that if such fiscal treachery is afoot, one would hardly expect the perpetrator to automatically fess up when confronted with a simple question. How useful would it be to ask a car salesman, “By the way, my good man, are you charging me an excessive amount for this automobile and pushing the special undercoating only to build up your own commission?”³

The author of the article, perhaps recognizing this issue, advocates a second opinion if any potential conflict of interest is found. I’ve always pushed my own patients to obtain second opinions to pacify any qualms about my diagnoses or treatment recommendations, but second opinions are themselves often expensive (especially if not covered by insurance) and take time to arrange. Moreover, an expert in the appropriate field whose reputation is blemish-free and who is absolutely independent of potential conflicts may be hard to find on short notice. And, if the course of action recommended in the second opinion differs from the first treatment suggested, does the patient get a third opinion to break the tie? What if it turns out that the doctor providing the second opinion has his or her own financial arrangements that compete with those of the first doctor?

Finally, how significant and how specific to a given treatment does that financial involvement have to be to warrant notifying patients? Should the doctor who sells and dispenses mediations within the office list his profit margins for those medications? Does the prescriber who owns stock in a pharmaceutical company have a different obligation to inform clients than the prescriber who helped developed a medication and receives a royalty for every pill sold? Do doctors working for an HMO who receive an incentive for prescribing generic rather than brand drugs disclose that to every patient? Does a doctor who sends patients to a facility that uses a certain type of CT machine on which holds a patent have a different responsibility to disclose his financial arrangement than a doctor who orders CT scans on his patients done in the office with the CT machine his group practice owns and operates?

If the following statements were true, should I have told patients, “I’m prescribing Prozac for your depression, but you should be aware that Eli Lily, the company that manufactures Prozac, …

… pays me a royalty for every Prozac capsule sold because I helped get FDA approval”
… sells these capsules to our pharmacy wholesale and our pharmacy, which our practice owns, charges you a 200% markup when we sell you your medicine I’m prescribing”
… sends a salesman here every month who takes me to lunch where he tells me why I should prescribe Prozac instead of another medication”
… may be in the portfolio of some of the stock funds in which I’ve invested so their profit would benefit me”
… offered second year medical students at many medical schools in 1973 a free, medium quality stethoscope that I accepted”

I suspect few would think that admitting that I accepted a stethoscope from Lily is either necessary or useful, but defining how much financial involvement by a physician merits or requires disclosure is not a trivial task.

My discomfort with this piece, in fact, is not that the problem of a physician’s conflict of interest doesn’t exist but that the simple fixes the article described belies that complexity of the problem.

Additionally, such questions put to doctors are not always benign and may yield negative results, a concern noted in this excerpt:

Readers may also recognize Trisha Torrey as the author of Every Patient’s Advocate, a blog which occasionally appears here at AlignMap.

Disclosure Statement

Ahem, I have not accepted any financial remuneration from The Wall Street Journal, Every Patient’s Advocate, Medication Noncompliance, their authors, or their associated companies for mentioning them in this post.

One possible reason, in addition to my stalwart Midwestern upbringing, my seven years of perfect attendance at Sunday School, the two semesters I spent at Oklahoma Christian College, and my preternaturally staunch moral fiber, for my incredibly righteous stance in this regard is that none of those entities has (yet) offered me any such remuneration. I mean, if someone were to go to the trouble of, say, placing a manila envelope filled with a significant chunk of cash in small, unmarked bills in a locker at the bus station and sending me the locker key, it would be rude not to at least consider taking the money. Or if Mr Murdoch, who could certainly afford it, saw fit to comp me a daily copy of the WSJ, to which I subscribe at the exorbitant, full-price online subscription rate, I would feel obligated to live up to the standards of politeness instilled in me by my mother and to accept that offer as a no-strings goodwill gesture from a fellow publisher.

I freely admit that both of the individual blog authors mentioned do occasionally email me, typically to tell me or ask me about something going on in the wide world of patient compliance or exchange a tidbit or two about our personal lives. Trisha, for example, moved recently, and we briefly discussed the stresses such endeavors may inflict on households. I am only a teen-tiny bit jealous that their businesses were mentioned in WSJ articles and mine wasn’t. Both bloggers have written positive comments about AlignMap or me in previous posts, which is always nice.

Footnotes

1. If this article falls in the “subscriber-only” section of the WSJ, readers without such a subscription may be able to access this article by first going to the Digg Connection to this piece and then clicking on that link↩
2. “Reminders” include wrist watches that signal the time for medication, dispensers with flashing lights, recorded messages, and overtly noxious sounds, telephone calls, orbs that glow at the appropriate time, and a variety of Rube Goldberg contraptions↩
3. While a villainous doctor might be more forthcoming and the questioning process more amusing and gratifying if one employed more vigorous interrogation methodology such as that used on TV police procedurals or in the Spanish Inquisition, those techniques could prove off-putting to some healthcare professionals and could tend to taint the relationship between physician and patient.↩

The Hospital Compliance Improvement Project

There is a much to be learned about patient compliance from a recent New York Times article.¹ Some excerpts and paraphrases from the piece follow:

• “There also seem to be psychological reasons for noncompliance.”
  
• “Their incentives, in other words, were not quite aligned with the hospital’s.”
• “… incentive scheme” of “$10 Starbucks card as reward.”
  
• The staff  was “cajoled” to comply.
  
• “… surreptitiously [monitor and] report” on noncompliance.
  
• A “disgusting image” was used to dramatize consequences of noncompliance.
• “Compliance shot up to nearly 100 percent.”
  
• “But it also highlights how much effort can be required to solve a simple problem.”

Sounds pretty routine (with the exception of the near-100% compliance), doesn’t it?

Compliance Is Compliance Is Compliance

Well, as it turns out, Selling Soap By Stephen J. Dubner And Steven D. Levitt (New York Times, September 24, 2006) is not about improving adherence to an antibiotic regimen, a diabetic diet, a prenatal care program, or, indeed, any treatment program but is rather about enhancing doctors’ compliance with hand washing protocols.

The congruence of this hospital’s experience in attempting to improve their doctors’ adherence to hand hygiene regulations with efforts to enhance patients’ cooperation with prescribed healthcare is impressive, offering a new and potentially useful perspective on the management of patient compliance.

This worthwhile , which also presents a brief, interesting history of the sometimes awkward relationship between hospitals, germ theory, hand washing, and doctors, is available at Selling Soap

1. While I refer to this piece from the New York Times as an “article,” it is technically a column from that paper’s Freakonomics series.↩

Party Hearty For Healthcare Adherence

I cannot – apparently – resist the notion of patient compliance as a festive event. Ongoing readers may recall my enthusiasm about a campaign to increase the participation of African gold miners in a tuberculosis treatment program by “organiz[ing] a rally to promote adherence to the program, featuring songs, dancing and testimonials.”¹.

This is offered as an explanation of why, when I had indicated that the posts for the next few days would be dedicated to practical tips for decreasing unintentional medication noncompliance, I have inserted this report on a campaign by an Orlando radiology center to enhance compliance with mammogram screening for breast cancer.

The concept and its origin are explained in this excerpt from the Orlando Sentinel:

The most impressive portion of the newspaper story, however, concerns the woman who arranged the first of the parties, a 38 year old mother of two who “had been putting off getting her first mammogram. The chance to throw a party with her friends — and get a mammogram at the same time — convinced her to take the plunge.”

And, how long had she been putting off that first mammogram? Well, she tells us, I’ve had a prescription for three years, and it’s been sitting in my car visor since December of last year.

She – and ten of her friends – met at the clinic, chatted, laughed, drank glasses of wine, ate tiny desserts, had their nails painted and their feet massaged.

And had their mammograms.²

Originally, the parties, which can accommodate up to 14 women and last from 7 PM to midnight, were a promotion for Breast Cancer Awareness Month that were originally limited to 10 evenings in October. Because of demand, however, parties are now scheduled through the end of November.

But Is It Compliance If It’s Fun?

For the record, I am fully cynical enough to recognize several points about this idea that are vulnerable to criticism.

For example,
Associating parties with mammograms trivializes an important responsibility women have to themselves, this is a for-profit medical center so this looks like just another marketing program to make money, the dollars spent on pedicures and wine should have been be used to provide free mammograms to those who can’t afford them, non-profit clinics can’t use this kind of promotion, this creates false expectations, this is just another compliance bribery scheme, …

Nonetheless, the benefits of a promotion that successfully enhances compliance with breast cancer screening at a time when mammography rates nationwide are falling seems to me a laudable effort even if it is an imperfect one. That this goal is accomplished by making the screening more pleasant rather than using the horrors of cancer as motivation is a wonderful bonus.

For More Information
The imaging clinic has a web site devoted to the promotion at Midnight Mammogram. A video of a CBS News story about the Midnight Mammogram parties is available at CBS Midnight Mammogram Video.

Credit Due Department: The graphics are adapted from the Midnight Mammogram web site

1. See Celebrating Compliance↩
2. The cost of the mammograms was paid by insurance or out of pocket by the women. All other party costs, including the food, drink, and pedicure team, were paid by the clinic.↩

Study Shows Coaching Effective For Presymptomatic Disorder

Primary Source: Type 2 Diabetes Prevention in the “Real World” – One-year results of the GOAL Implementation Trial Pilvikki Absetz, PHD1, Raisa Valve, PHD2, Brian Oldenburg, PHD3, Heikki Heinonen, PHD1, Aulikki Nissinen, MD, PHD1, Mikael Fogelholm, SCD4, Vesa Ilvesmäki, MD, PHD5, Martti Talja, MD, PHD5 and Antti Uutela, PHD. Diabetes Care 30:2465-2470, 2007

Secondary Source & CME: Lifestyle Counseling Program May Help Reduce Risk of Developing Type 2 Diabetes¹

The Study

This article reports on 352 middle-aged participants with elevated type 2 diabetes risk enrolled in The Good Ageing in Lahti Region (GOAL) Lifestyle Implementation Trial² with lifestyle and risk reduction objectives derived from the major diabetes prevention efficacy trials. The intervention included six group counseling sessions, delivered by trained public health nurses. Measurement was conducted at baseline and 12 months. Clinical risk factors were measured by study nurses, and lifestyle outcomes were analyzed from self-reports. Lifestyle outcomes were compared with the outcomes achieved in relevant efficacy trials, and within-subject changes were tested for risk reduction.

Results, excerpted from the abstract, follow:

Commentary

While methodological problems, such as lack of randomization, use of unmasked study nurses, and recruitment among healthcare patients, limit the extension of the findings, the demonstration that patients who are at risk but asymptomatic for diabetes will comply with coaching interventions that can be economically delivered and scaled up as needed to change lifestyle habits is both impressive and heartening.

Footnotes

1. Lifestyle Counseling Program May Help Reduce Risk of Developing Type 2 Diabetes. News Author: Laurie Barclay, MD, CME Author: Désirée Lie, MD, MSEd. Release Date: October 2, 2007; Valid for credit through October 2, 2008. Credits Available: Physicians – maximum of 0.25 AMA PRA Category 1 Credit(s)™ for physicians; Family Physicians – up to 0.25 AAFP Prescribed credit(s) for physicians↩
2. This is a description of a real-world integrated program offered at 16 health centers in Finland in the GOAL project during a 1-year period. The program is a lifestyle implementation trial designed for primary care to assess the impact on behaviors and risk for diabetes during 12 months.
   Study Highlights

   * The GOAL program is a community health promotion program in an area in Finland covering 14 municipalities and a total of 208,000 inhabitants.
   * The education program was guided by 5 objectives: less than 30% intake from fat calories, less than 10% of total energy from saturated fat, at least 15 g of fiber per 1000 kcal, at least 4 hours per week of moderate-level physical activity, and more than 5% reduction in body weight.
   * The DPS had shown that attainment of at least 4 objectives led to a reduced risk for diabetes, and this was used as an outcome goal.
   * The educational model was group based and task oriented with use of counseling based on the Health Action Process Approach, a social-cognitive health behavior model.
   * Program sessions lasted 2 hours and were structured with information provision, group discussion, and self-monitoring of behavior.
   * Public health nurses delivered education, facilitating groups with support from dieticians.
   * The first 5 sessions occurred for 8 weeks with 2-week intervals, and the last session took place at 8 months.
   * Patients aged 50 to 65 years who had identified risk factors (obesity, hypertension, and elevated lipid or blood glucose levels) were recruited and were screened with a questionnaire.
   * A risk score of 12 or more (17%, 10-year risk for diabetes) based on the questionnaire was used to select 405 patients.
   * Excluded were patients with mental health problems and those who were diagnosed with type 2 diabetes, myocardial infarction in the past 6 months, or acute cancer.
   * 352 participants from 16 health centers were assigned to 36 groups for the intervention.
   * At 12 months, participants were mailed a questionnaire, had anthropometric measurements and laboratory blood tests, and completed a 3-day food diary.
   * Key lifestyle measures assessed at 12 months were total intakes of fat, saturated fat, and fiber; physical activity; and relative change in weight.
   * Secondary outcomes were change in risk from baseline to 12 months, waist circumference, blood pressure, and lipid and glucose levels.
   * Mean age was 58 years, two thirds had at least an elementary school education, 47% were retired, 70% were married or cohabiting, 70% were obese, 65% had normal glucose tolerance levels, and 30% of men and 21% of women had impaired glucose tolerance levels at baseline.
   * Mean waist circumference was more than 100 cm in women and 110 cm in men, and mean lipid and blood pressure levels were slightly elevated at baseline.
   * 57% of participants attended all 6 sessions, and attendance dropped from 90% by 5 sessions to 81% at the sixth session.
   * At 12 months, those who already met the 5 objectives at baseline were most likely to meet them.
   * 281 failed to meet 1 or more objectives.
   * 20% achieved at least 4 of 5 objectives.
   * Physical activity and weight loss were achieved significantly less frequently (65% vs 86% and 12% vs 43%, respectively).
   * Weight reduction was 1.5 kg in men and 0.5 kg in women, much lower than the 4.2 kg achieved in the DPS.
   * Program effects were stronger for men than for women.
   * Risk factors that decreased significantly in men were diastolic blood pressure, weight, and BMI.
   * Waist circumference decreased in both sexes.
   * There was an increase in impaired glucose tolerance levels for those with normal glucose tolerance levels at baseline but a decrease in those with baseline impaired glucose tolerance levels.
   * Among participants able to reach at least 4 objectives, 83% had normal glucose tolerance levels, 11% had impaired glucose tolerance levels, and 6% developed diabetes.
   * For those reaching 3 or fewer objectives, the respective rates were 73%, 25%, and 3%.↩

It Must Be The Free Samples

The pursuit of persistence
By James Chase Medical Marketing & Media October 01, 2007

This essay, written from the perspective of pharmaceutical marketing, is interesting for a number of reasons.

First, it’s refreshing to see a blatant lamentation about the difficulty of improving persistence arising from this industrial sector which is usually the source of copy that, at a minimum, implicitly describes pharma-sponsored compliance programs as successful.

Second, I’m impressed that a single sentence from the article accurately summarizes the experience of marketers and clinical researchers alike, Marketers believe there is an answer [to the problem of poor compliance and impaired persistence], but have yet to execute anything on a scale big enough to move the needle.

And I like the trend analysis:

Finally, the author demonstrates that, while there may be nothing new under the sun, there is apparently a thing or two that, if they are under the sun, have avoided my notice – in this case, it’s the possibility that free samples of meds may have a negative effect on persistence.

Not too shabby for less than a page of prose.

I would add only my usual refrain – that perhaps, to use the author’s words, the reason marketers and researchers “have yet to execute anything on a scale big enough to move the needle” is because they are looking for a solution that doesn’t exist. Again appropriating the language of the article, just because “marketers believe there is an answer” (and one could add researchers and clinicians to that wishful list) doesn’t mean one exists any more than the conviction held by explorers like Columbus that there was a navigational short cut from Europe to the Far East didn’t mean one existed. If our current concept of compliance is flawed, searches for the forces that influence compliance are unlikely to prove pragmatically successful.