An untapped opportunity

How to motivate patients who aren't ready, by Kirk Nielson

“Early implementation of the Transtheoretical Model should be considered for recruitment of almost any phase II or III trial where enrolment rates are expected to be low”

Let's say for the sake of making my point clear, that you have completed your early enrolment strategic planning, finalized your protocol, conducted all of your site initiation visits, and you are wrapping up the coordinator training session on the last day of your investigator meeting. Oh, and let's not forget that your primary investigators are perfectly comfortable with the somewhat aggressive, eight-patients-per-month enrolment goal you just presented. Do you feel you have things pretty well covered?

Now, imagine how it might feel if at that very moment, I tapped you on the shoulder and informed you that only 50 percent of the patients your investigators (or CROs) have earmarked for this trial are actually 'ready' to participate in your study. Does that feeling intensify when you realise that the actual percentage could be as low as 20 percent?

Imagine the potential cost savings you could amass if you were able to drive that percentage up 10 or even 20 percentage points across your entire pipeline. Better yet, think of the possible savings a 10 percent increase in 'ready' patients would amount to if applied to the nearly 50,000 phase II and III clinical trials currently registered on clinicaltrials.gov. Feeling better?

The good news is that there is a proven approach to motivating patients locked in this 'non-ready' state to change. The bad news is that it is not exactly just-in-time behavioural change.

The approach used for driving this change in behaviour is called the Transtheoretical Model of Change (TTM). This model, commonly referred to as Stages of Change, involves a set of health psychology strategies for addressing patient ambivalence or resistance to change. TTM assesses an individual's readiness to act on a new behaviour, and provides strategies to direct an individual through the various stages to adoption and sustained behavioural change (maintenance).

There are five stages of change that make up the core constructs. These integrated stages form a continuum of motivation centred around 'readiness to change'. Movement along this continuum occurs by successfully completing (outcome measures), the process of change within each specific stage. The stage construct is important because it represents a temporal dimension. Change implies phenomena that have occurred over time. This is very different from other theories of change, often considered a point in time or an event. It is important to point out that the TTM model focuses on the individual's decision-making process.

The five stages of change include: precontemplation - there is no action expected in the foreseeable future, usually measured as the next six months; contemplation - there is an intention to change in the next six months; preparation - there is an intention to take action in the immediate future, typically within the next month; action - there has been an overt modification to the existing behaviour within the past six months; and maintenance - there is a planned effort to prevent relapse, estimated to last from six months to about five years.

In addition, the model includes a relapse pathway, which is not a stage, but signifies a return from action or maintenance to an earlier stage.

The model includes a series of intermediate/outcome measures, which allow for greater monitoring of change over the five stage transitions, and therefore, better optimisation of the process of change. While a more detailed description of the model is required to gain a sound understanding of how it produces the motivation necessary to change behaviour and maintain that change, early implementation of the Transtheoretical Model should be considered for recruitment of any phase II or III trial where enrolment rates are expected to be low or study recruitment difficult. The model's success stems from its recognition that different individuals will be in different stages and that appropriate intervention must be developed for everyone.

Finally, due to its patient-focused design and more intrinsic, motivational approach, the Transtheoretical Model can also help drive greater participant retention rates, another area of challenge in many of today's complex clinical trials.

Kirk Nielson is Senior Vice President and Managing Director of Iris Global Clinical Trial Solutions. Nielson leads the Intelligent Trials Practice, uniquely motivating sites, subjects and sponsors to drive enrollment success in challenging clinical trials, including early strategic consulting with sponsors to more effectively optimize their site enrollment activities.