How to ensure patient adherence in decentralized clinical trials

October 14, 2022
patient adherence

Patient adherence in clinical trials without technology

How can you assure patient adherence to the protocol, when you don’t see the patient?

Life science companies are increasingly  turning to decentralized clinical trial models. This means that patients are home alone.   They use ePRO to record side effects and outcomes from the treatment.

With 10X more data from patients and their connected devices, how can we assure patient adherence to the clinical protocol

In this post, award-winning author and international speaker, Dr. Jane Bluestein shows how to ensure patient adherence by understanding the difference between boundaries and rules.

The question is:  Can we inspire self-management in patients?

The relationship between clinician and patient is not symmetrical.  In recent years, the term patient compliance has been generally replaced by the term patient adherence.  The idea is that the paternalistic relationship between doctor and patient has evolved to become a relationship of mutual question, answer, care and respect.

Patients may be the biggest un-utilized resource in healthcare as  they are the experts on their personal experiences, but doctors are still the authorities on the clinical issues and treatment plans.

Rules and boundaries: win-win does not ensure patient compliance

After 40 years working with children, Dr. Jane Bluestein came to the conclusion that win-win environments are not the best way to inspire self-management by patients.

When I started practicing, I had some reservations about being completely in charge and responsible for the rules, so I tried involving the patients in this task. Part of my intention was an honest stab at building a positive, win-win environment, wanting to acknowledge their needs for input and control. I also believed, or at least hoped, that their input would magically inspire self-management and reinforce patient adherence.

I was wrong. My first foray out into the real of win-win practice  killed the entire morning and produced about 478 “don’ts,” nearly a quarter of which had to do with a range of things that patients that they should not be eating.

I quickly realized that the brunt of enforcing patient compliance would ultimately rest on my shoulders, and with nearly 500 rules, their list would have certainly kept me hopping, putting me more in the role of policing my children patients rather than educating them and helping them get better.

This was my first inkling that there were some serious problems with rules, at least as we know them best. I found this revelation extremely disconcerting:

It was obvious that no medical practice could succeed without some kind of structure and authority, but were rules the best tool for establishing them?

Rules certainly were familiar! But there were simply too many places where the methods and dynamics of rule-making and enforcing just didn’t fit in with my idea of win-win. What else was there? Was there a way for clinicians to truly get what they wanted from their patients without creating additional conflicts, resorting to power or somehow compromising entire patient-physician relationship?I started looking for techniques that worked, strategies that were not only effective in the office and behavior management, but also in creating the kind of climate that would support the goals and values of successful healthcare outcomes.

I had noticed that certain “if . . . then” statements were more positive, more effective and less power-oriented than rules for patient adherence. I discovered that the promise of positive outcomes was less destructive than the threat of negative consequences. And I found that the most successful physicians were teachers who asked what they wanted with clarity, assertiveness and great respect for the needs, preferences and dignity of their students. Additionally, research and experience in fields that included business management, child development, counseling and addiction (family systems as well as chemical dependency) gave me a few more critical ingredients to throw in this stew.

The result involved reframing rules as boundaries and suddenly the whole process fell into place.

Now I’m hardly the first person to write about boundary setting (although not all definitions include the characteristics I believe to be essential) and quite frankly, the idea is, in many ways, not all that different from more common terms like limits, contingencies or, in some ways, rules. But the interaction patterns involved in this technique are quite different from those used with rules, and they’re still pretty uncommon in most educational settings.

During the past two decades, I’ve had the good fortune of visiting hundreds of  institutions throughout the world. Among the features common to most of these vastly different environments were the inevitable lists of “Rules”,  In some settings the Rules were displayed in every doctors office, in others, in just a handful. Some healthcare organizations had imposing signs to greet patients, staff and families as they entered the building; others had more covert documents with friendly titles like “10 things you should do when you’re pregnant.

Are Rules a good way to reinforce patient adherence to the clinical protocol?    No.

Regardless of format or conveyance, these lists were often negative. Often the rule itself was stated negatively: “No smoking,” “Don’t drive when you can walk,” “Eating junk food is prohibited.”

However, even when the rule was stated positively (“Go to bed on time,” “Don’t get angry”, the result of an infraction was always negative. In some instances, the punishments—often called “consequences”—were listed right along with the rules. Frequently, to my amusement, the list included consequences for the first infraction, the fifth infraction, the thirtieth infraction . . .Talk about enforcing patient compliance with a stick.

OK, so maybe they didn’t go up quite that high, but think about it: If you’ve got plans (and expectations) for second, third, fourth or whatever occasions to catch patients, in particular older ones, doing something wrong, clearly something is not working. In many cases the consequences of the first several transgressions were so inconsequential that the message to the patients was clear:

“You can break this rule so-many times before anything serious happens to you. You don’t need to change your behavior until right before you really get in trouble!”

There are subtle differences, in process and focus, between building patient adherence with cooperative behavior and discouraging uncooperative behavior. Rules and penalties depend on the patients’ fear of the negative consequences. If patient  is afraid of dying, then she may do what you want, at a cost to her emotional safety.

But how many people aren’t fazed by even the most severe negative consequences? (Indifference is a great tool for creating safety in an otherwise unsafe environment.)

Either way, if you’re committed to 21st century win-win priorities, when you rely on rules, you lose.

Boundaries do not depend on fear or power, other than our power as clinicians to allow a positive consequence to occur when our patients have done their part in patient adherence.

This positivity represents an important characteristic of a boundary, as well as a significant difference between boundaries and rules. As a management tool in a win-win setting, boundaries are always stated positively, as promises rather than threats. Likewise, boundaries offer a refreshing change from punishment-oriented strategies to a reward-oriented approach to behavior management and consistent patient adherence to the clinical protocol.

Boundaries allow us to think of consequences as the good things patients get (or get to do) as a result of their cooperation, changing the prevailing connotation of the word “consequence” from negative to positive and reinforce patient adherence.

In addition to being positive, boundaries support win-win power dynamics because they are themselves win-win. Even the most reasonable rules are oriented to the power needs of the physician, providing information for the patients how not to “lose.” Rarely do rules communicate how patients can “win” in any other, more positive way.

Boundaries, on the other hand, take into consideration to the desires and needs of the patients we attempt to motivate in our medical practice.

Additionally, boundaries are proactive, attempting to prevent problems in positive ways.

Rules typically focus on the negative or punitive reaction of the physician (or a spouse or parent) when a patient gets caught breaking the rules (drinking, smoking, not taking medicine….). Both rules and boundaries can prevent misbehavior, but because with rules the payoff for patient compliance is simply avoiding a negative consequence, the process of enforcement becomes unavoidably reactive. (This is why simply posting a bunch of rules, penalties or punishments for patients is proactive only in forewarning of impending reactivity!) With a boundary, a positive outcome simply does not happen unless the desired behavior occurs. The absence of the positive outcome—pending the patient’s cooperation—is, in most cases, the only “physician reaction” necessary.

The subtlety of the differences between boundaries and rules makes it easy to discount the impact each can have on the relationship between clinicians and patients.

However, clinicians who endeavored to shift from the win-lose familiarity of rules to the win-win prospects of boundaries report a significant decrease in conflicts and power struggles in their problematic cases, and far greater success in reaching people previously deemed difficult, unmotivated or, in some instances, even dangerous, than with any strategy previously attempted.

And finally – when patient compliance improves, then treatment efficacy improves.

Which is what its all about – treating patients.

About Dr. Jane Bluestein

Dr. Bluestein specializes in programs and resources geared to provide practical and meaningful information, training and hope in areas related to relationship building, effective instruction and guidance, and personal development.

Much of her work focuses on interactions between adults and children, especially children at risk.

Her Web site is

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