UPDATE: I recently did a interview on this topic with Natalie Morrison of Outsourcing Pharma. Listen to the podcast here: Improve Patent Compliance By Designing Trials Around Real Life.
I try to provide my newsletter readers with something extra that is not available publicly on the Rebar Interactive website. This post was originally published as the “something extra” in a recent newsletter. But after an extremely positive response and several requests to make it more easily shared, I’ve decided to publish it here (with some modifications/additions). Hope you enjoy! -Rahlyn
“Re-educate the patient.” This phrase is very familiar to site staff and CRAs. The reality of working with patients is that sometimes, for one reason or another, they do not follow instructions. And so they need to be “re-educated.”
But what does it mean to re-educate a patient?
In the context that I’ve heard this phrase, it seems to mean, “tell the patient what you already told him.” In some cases, this sort of reminder might be enough. In other cases, it won’t be.
Ruled By Habits
I couldn’t help but think about patient compliance (and other challenges in clinical research) as I recently read a book called The Power of Habit by Charles Duhigg.
This book is about transforming habits. The writer uses new scientific research and engaging anecdotes to illustrate how changes in habit occur in individuals, organizations, and societies. At the start of the book, the author emphasizes a fact of life that can prove frustrating at times.
We are ruled by habit.
And we need to be. Otherwise we would be completely paralyzed by simple decisions. Our brains use habit to ensure that we don’t spend the entire day deciding what to have for breakfast. Habits are critical to our functioning as humans.
Unfortunately, habits are extremely difficult to change. People who have tried to quit smoking, lose weight, or promote innovation within their company understand this fact well. And so do clinical research professionals tasked with getting subjects to take an investigational drug or complete a diary.
Using The “Habit Loop” to Change Habits
In The Power of Habit, Duhigg describes what he calls the “habit loop.” Each habit has three components, occurring in this sequence.
- A cue triggers your brain to use a particular habit and go into automatic mode.
- Your brain uses a routine, which is the automatic process.
- A reward helps your brain determine if this particular habit is worth remembering for future use.
Over time this process of cue, routine, and reward becomes more and more automatic. And a habit is born.
Visually, the habit loop looks like this:
The secret to changing habits is to leverage the habit loop to your advantage. Rather than attempt to create or destroy a habit, use an existing habit loop to spur the change you desire. Keep the cue and the reward of the existing loop, and substitute a new (more desirable) routine.
When Clinical Trials Conflict With Existing Patient Habits
In the context of patient compliance, we often attempt to create new habits. Unfortunately, we don’t always consider how these new habits relate to existing habits, which can prove problematic.
For instance, consider PRO devices that have become common in clinical trials. These devices often have an alarm, which is intended to serve as a completion reminder for clinical trial subjects. I once had a subject whose device alarm coincided with the time his young child was asleep. The alarm’s loud volume could not be adjusted, and the device repeatedly woke his child.
The PRO device conflicted with a very important habit for this subject. And I was not given the ability, as a study coordinator, to adjust the time on the alarm to better coincide with this subject’s habits. Not surprisingly, the habit won and the PRO device lost. The subject withdrew from the study. And this was a subject who had previously participated in other trials without a problem.
Using Habits to Improve Patient Compliance
Consider another scenario that regularly occurs at sites. A patient is repeatedly missing doses. The study coordinator has “re-educated” the patient, but the patient reports that he “forgets.” What sometimes occurs is this cycle of re-education and forgetting continues, and the subject is dropped from the trial.
Rather than continuing this cycle, it would be beneficial for the study coordinator to sit down with the patient to discuss his habits. Maybe the study coordinator notices that most missed doses are occurring in the afternoon. So the study coordinator asks the subject to describe his afternoon habits. The subject begins describing his typical afternoon, and at one point, he describes a habit of interest to the study coordinator.
After further questioning, the study coordinator notes the following:
- The habit occurs at 3:30pm (cue) every work day.
- At this time, the subject rises from his desk to stretch and get a snack (routine).
- He returns to his desk about 15 minutes later feeling refreshed (reward).
As noted in our discussion of the habit loop, habits are best created (and destroyed) by keeping the cue and reward of an existing habit and substituting the routine. So the coordinator tells the patient that when he rises from his desk at 3:30 to stretch and get a snack, he should also take his dose. The cue and reward remain the same but the routine is altered.
This seems like a simple exercise, but it’s something subjects rarely do on their own. The thing about habits is that we aren’t conscious of them unless we make it a point to be. Sites can help subjects consciously identify existing habits (cue, routine, reward), which will serve as the foundation for new clinical research participation habits.
A Caveat About Desire
This example is one of many possibilities for how habits can be used to improve patient compliance, not to mention other aspects of clinical research. And of course habits can be used to create change in other areas as well. In the book, Charles Duhigg described how he used the habit loop to overcome his stubborn afternoon cookie eating habit.
But this technique requires careful application to be successful. Before using it, attempt to determine the root of your subject’s non-compliance. If the root relates to a lack of desire, habits are not your problem. The subject must actually want to be compliant for habits to be a solution.
In some cases, the subject is just not that into it. And if lack of enthusiasm is the problem, the issues making participation undesirable need to be addressed. Of course, in some cases, those issues may not be addressable. For example, AEs sometimes fall into the “unaddressable” category if the protocol does not allow dose adjustments.
But in instances where subjects want to be compliant, you can use the habit loop technique to help patients create new research participation habits.
I can’t possibly do this subject justice in the context this post, but I think the habit loop is a useful concept and wanted to at least introduce it. If you are interested in further reading, I highly recommend The Power of Habit. Charles Duhigg is an engaging writer, and the information he presents is very interesting. He has also done several interviews, which you can find online.
What do you think? Is this useful information for clinical research professionals? Are there other ways we can use habit to improve clinical research? Please share your thoughts below.
Image Credit: The Habit Loop