Problem statement: 

How might we motivate and engage Acne Trial participants to maintain 100% adherence to the trial protocol? 

The ask:

The client is looking for ideas to ensure 100% compliance. Full compliance in this context means that participants will apply medicine
as instructed for 12 weeks without missing
an application.

“For topical acne products, the typical instructions for use involves applying medicine (e.g. a lotion or cream) after washing the face area 1 or 2 times a day. One important reason for non-compliance is simply forgetfulness. There may be a distraction at the regular time and they forget to do it later. Compliance may sometimes be adequate in the short term but when extended time is involved (up to 12 weeks), compliance may significantly decrease." (innocentive.com) 

Background: 

The apparent failure of the usual prescriptive techniques and educational approaches to inform and guide human behavior highlights the complexity of such an objective.  To forge a solution space for this challenge, various theories of behavior modification and design have been taken under consideration. 

Learning from direct marketers and behavioral economics.

The solution outlined in this report is based in part, on a brief literature review of clinical trial design and behavioral economics as well as some anecdotal, ethnographic evidence.

The patients recruited and retained for trials will not only have very different mind sets and personalities but also different motivations for participation. They are a truly heterogeneous group that only have the study protocol criteria in common. With this in mind, the solution outlined can be easily customized to be effective for a diverse participant group.

How do you ensure 100% compliance to what appears to be a relatively effortless activity?

The application of a lotion to a freshly washed face once or twice daily is similar if not identical to behaviors for general personal hygiene and medication regimens, e.g. brushing teeth, swallowing pills, taking showers, etc. The reasons cited (in the brief) for lack of compliance as forgetfulness seem elemental, however, to achieve 100% compliance, it’s patently clear that merely forgetting or being distracted is a manifestation of some deeper issues that will be resistant to change based on “education” or prescriptive measures alone. 

To fill in the ethnographic research blanks, I used theory and practice from the way marketers create direct marketing campaigns in consumer environments that rely on specific behaviors from users. Although these marketers typically only need to trigger one or two behaviors just once, the bigger challenge is to sustain and repeat a behavior over a 12 week period.

A simple causal loop diagram (below) maps the reinforcing nature of behavior and demonstrates the “degrading” effect that distractions or forgetfulness has on achieving successful repetitive behavior over time. 

* “Habits perpetuate prior behaviors and limit the effectiveness of downstream interventions.”1

The clinical trial “habit” or adherence to protocol is a new “habit/behavior” that we need to firmly establish upstream, to ensure 100% compliance to the study.

The following section visualizes a solution that injects “nudge” points and factors to trigger and sustain the desired behaviors of our participants. We don’t give them an opportunity to forget!

Participating in clinical trials takes dedication, commitment and integrity. Despite this, motivation to sustain participation will also tend to wane in direct proportion to the complexity of the trial protocol, even if the participant is fully aware of the requirements from the outset. Why? Life happens and the option to discontinue the study is always on the table.

This solution puts the participant demonstrably in the centre of the study. Simply telling them that their involvement is critical to the success of a trial, pales in comparison to vividly demonstrating their value through interaction with tangible artifacts:

1. Personalize a study-kit with a high-quality yet economical, on-demand printing system.
2. Create a kit that is substantial in its physical qualities to assert its “value”
3. Instil a sense of community by inviting participants to an online space where they can“check in” and share thoughts in a private forum if desired, or just review other pages on the site that talks about the science behind the trial
4. Reinforce their behavior with random incentives and allow them to choose from a 
   set of different gifts

We’re not “buying” their 100% compliance to protocol, just nudging them, lest they forget why they agreed to participate in the first place!

END NOTES + SOURCES

 1.Verplanken, B., & Wood, W. (2006). Interventions to break and create consumer habits. Journal of Public
Policy & Marketing, 25(1), 90-103.

Alexander, W. (2013). The Uphill Path to Successful Clinical Trials: Keeping Patients Enrolled. Pharmacy and Therapeutics, 38(4), 225.

Bargh, J. A., & Chartrand, T. L. (1999). The unbearable automaticity of being. American psychologist, 54(7), 462.

Baumeister, R. F., Heatherton, T. F., & Tice, D. M. (1994). Losing control: How and why people fail at self-regulation. Academic press.

Ly, K., Mažar, N., Zhao, M., & Soman, D. (2013). Nudging.

Muraven, M., & Baumeister, R. F. (2000). Self-regulation and depletion of limited resources: Does self-control resemble a muscle?. Psychological bulletin, 126(2), 247.

Sheppard, B.H., Hartwick, J. & Warshaw, P.R. (1988). The theory of reasoned action: A meta-analysis of past research with recommendations for modifications and future research. Journal of Consumer Research, 15, 325–343.