The Challenge of Clinical Research Recruitment
The attrition numbers through the enrolment and retention funnel are clear. I for one have cited them countless times so it is nothing new to state that recruiting and retaining participants in clinical trials often proves challenging. Traditional approaches, focused on the benefits of participation or offering financial incentives, may not fully address the complex motivations driving individual choices. This is where Self-Determination Theory (SDT) offers valuable insights.
Understanding Self-Determination Theory (SDT)
SDT, a prominent theory in psychology, hypothesises that humans possess an innate drive towards growth and psychological well-being. This drive is fuelled by three basic psychological needs:
- Autonomy: The need to feel in control of one’s actions and choices.
- Competence: The need to feel effective and capable in one’s endeavours.
- Relatedness: The need to feel connected and experience a sense of belonging.
When these needs are satisfied, individuals are more likely to experience deep-rooted motivation, leading to greater engagement and persistence in their activities.
Applying SDT to Clinical Research Participation
By understanding and addressing the psychological needs of potential participants, we can create a more engaging and empowering research experience. Here’s how:
- Fostering Autonomy:
- Offer a Selection of Studies: Whenever possible, empower patients by presenting patients with a range of studies for which they may be eligible. This may seem counterintuitive to having the patient only be exposed to information about your trial with the intention of the patient participating in your trial, however the offer of choice promotes two key factors;
- by showing patients that you are happy for them to see that other studies are available, it demonstrates confidence in your study
- you end up with patients who choose to participate in your study and those patients are typically more likely to see their commitment through.
This allows patients to actively choose a study that aligns with their personal values, health priorities, and lifestyle preferences. This initial choice lays the foundation for a more autonomous and engaged participant experience.
- Provide Informed Choice: Go beyond standard consent forms. Offer information about each study, including potential risks and benefits, in a clear and accessible manner and through the use of multiple mediums and encourage questions and discussions.
- Offer Flexible Participation Options: Explore alternatives to rigid study protocols where the study objectives make this feasible. Allow for adjustments in schedules or procedures to accommodate individual needs and preferences yet be sure not to accommodate the few at the expense of the many. This is where relatedness becomes a key factor.
- Involve Patients in Decision-Making: Seek patient input on aspects of the study design or implementation. This could involve creating patient advisory boards or incorporating patient feedback mechanisms.
- Promoting Competence:
- The Knowledge Imperative: Equip participants with the knowledge and understanding necessary to feel confident in their role within the study. Offer clear explanations of procedures, expectations, and the overall research goals. Remember that most of your patients will be new to clinical research and are likely starting from a low knowledge base. Until the first contact they probably did not know what a clinical trial is let alone know about your company and the trial you are offering them. As such it is key that the education accounts for building base level understanding as well as study specific knowledge.
- Facilitate Skill Development: If the study involves specific tasks or activities, provide adequate training and support. Offer opportunities for refresher training and feedback to enhance participants’ sense of mastery.
- Recognise and Value Contributions: Acknowledge and appreciate the efforts and commitment of participants. Celebrate milestones and achievements throughout the study. If ever there was a place for gamification, this is it.
- Enhancing Relatedness:
- Create a Supportive Research Environment: Foster a sense of community among participants and research staff. Encourage open communication, empathy, and mutual respect.
- Facilitate Peer Interactions: Organise support groups, online forums, meet-ups etc where patients can connect with others involved in the study. Sharing experiences can foster a sense of belonging and reduce feelings of isolation.
- Build Strong Researcher-Participant Relationships: Invest time in developing a connection and trust with patients. Show genuine interest in their well-being and perspectives and you will have a committed and engaged patient.
Benefits of an SDT-Driven Approach
By integrating SDT principles into clinical research practices, we can:
- Increase Recruitment and Retention Rates: Motivated participants are more likely to enrol and remain committed to the study.
- Improve Data Quality: Engaged participants are more likely to adhere to study protocols and provide regular and accurate feedback on study related tasks and reporting requirements.
- Enhance the Overall Research Experience: A supportive and diverse research environment fosters positive experiences for both patients and researchers. Remember this is a partnership.
- Promote Ethical Research Practices: Respecting the autonomy and psychological needs of participants aligns with the core principles of the conduct of ethical research.
How to apply this practically:
- Supporting Autonomous Motivation in Recruitment Materials:
- Traditional Approach: Often, recruitment materials include background information about the medical condition the therapy targets, benefits of participation or offer financial incentives. While these can be motivating factors, they may not foster truly autonomous motivation.
- SDT Approach: Frame participation as an opportunity for patients to contribute to scientific advancement, make informed choices about their healthcare, and potentially access novel treatments. Highlight what matters to patients, such as
- risk and benefit
- how your therapy solves their problem – this does not always mean curing a disease it could be less frequent need to take medication
- the value of their individual contribution
- impact it can have on others including those closest to them
- Enhancing Competence through Clear Communication:
- Traditional Approach: In my role as a chair of an ethics committee I have seen my fair share of research protocols. What I seen too often is recruitment materials that are not only word dense but also many are full of technical jargon or complex language and they lack imagery and schematics to get their message across. This can be intimidating or confusing for potential patients.
- SDT Approach: Provide clear, concise, and accessible information about the study, including its purpose, procedures, and potential risks and benefits. Use plain language and make sure there is a logical flow to the information you share. You are telling a story, so do not start with the conclusion, i.e. “this therapy may reduce XXX”.
To promote equity and diversity in research, offer this information in multiple formats remembering everyone takes in information in different ways.
Always offer opportunities for patients to ask questions and receive personalised answers.
- Fostering Relatedness through Patient-Centred Interactions:
- Traditional Approach: Recruitment may be seen as a transactional process, focusing on filling enrolment quotas.
- SDT Approach: Create a welcoming and supportive environment for potential participants. Train research staff to engage in empathetic and patient-centred communication. Build rapport and trust by actively listening to patients’ concerns and addressing their individual needs.
Examples in practice
Theory is all good and well, however the use of SDT in healthcare and even clinical trial settings has moved beyond the theory. Here are a few examples of where SDT has had a positive impact in healthcare and clinical research.
Improving Dietary Adherence in a Weight Loss Trial:
Study: In a weight loss clinical trial, participants received an SDT-based intervention that focused on supporting their autonomy by involving patients in treatment decisions, promoting competence through nutrition education and cooking skills training, and fostering relatedness through group support sessions. [1]
Results: Participants in the intervention group showed greater adherence to the dietary recommendations and achieved greater weight loss compared to the control group. This highlights the importance of supporting the three basic needs to enhance motivation and adherence in clinical trials.
Enhancing Engagement in a Smoking Cessation Trial:
Study: Researchers integrated SDT principles into a smoking cessation intervention delivered within a clinical trial. The intervention included motivational interviewing techniques to enhance autonomy, personalised feedback to promote competence, and support groups to foster relatedness. [2]
Results: The SDT-based intervention led to higher quit rates and greater long-term abstinence compared to standard treatment. This demonstrates the potential of SDT to improve outcomes in clinical trials targeting addictive behaviours.
Supporting Autonomy in a Longitudinal Study on Aging:
Study: The Baltimore Longitudinal Study of Aging (BLSA), one of the longest-running studies on human aging, has maintained high retention rates over decades. While not explicitly stating the use of SDT, the BLSA incorporates elements that align with its principles. Participants are given a high degree of control over their involvement, including the flexibility to choose which assessments they participate in and how often they visit the research centre. This respects participant autonomy and may contribute to their continued engagement. [3]
Fostering Relatedness in a Mental Health Study:
Study: A study investigated the impact of a group-based intervention on depression and anxiety in patients with multiple sclerosis. The intervention involved group therapy sessions that provided a supportive environment for participants to share their experiences, connect with others, and learn coping strategies. This focus on group interaction and peer support aligns with the concept of relatedness in SDT, which could have contributed to the positive mental health outcomes observed. [4]
Outdo today, pave tomorrow
Although direct evidence of SDT’s impact on clinical trial enrolment is still emerging, the existing literature strongly suggests its potential. By applying SDT principles to create a more autonomy-supportive, competence-enhancing, and relatedness-fostering recruitment process, we will enhance patient engagement and improve enrolment and retention rates.
SDT offers a valuable framework for understanding and improving patient participation in clinical research. By fostering autonomy, competence, and relatedness, we can create a more engaging and empowering research experience, leading to improved outcomes for both individuals and the advancement of medical science.
We must be more open minded in adopting approaches from other sectors and innovating through understanding. SDT is not the one stop fix all for better patient engagement and retention in clinical trials, yet if studied and applied scientifically it can be a very powerful tool in our collective journey to improve our current pathway to patient empowerment and centricity in clinical research.
References:
[1] Teixeira, P. J., Silva, M. N., Mata, J., Palmeira, A. L., & Carvalho, J. (2012). Motivation, self-determination, and long-term weight control. International Journal of Behavioral Nutrition and Physical Activity, 9 (1), 1-10.
[2] Williams, G. C., Deci, E. L., Ryan, R. M., Niemiec, C. P., Patrick, H., & Ryan, A. M. (2006). Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. American Psychologist, 61(1), 76.
[3] Shock, N. W., Greulich, R. C., Andres, R., Arenberg, D., Costa Jr, P. T., Lakatta, E. G., & Tobin, J. D. (1984). Normal human aging: the Baltimore Longitudinal Study of Aging.
[4] González-Jaimes, E. I., Bateman, J. C., Rivera, M. I., Pérez-Olvera, N., García-Lázaro, J., & Feinstein, A. (2012). A pilot study of group cognitive behavioral therapy for depression and anxiety in multiple sclerosis patients. Multiple Sclerosis International, 2012.
Keith Berelowitz | Founder & CEO
Keith Berelowitz is the Founder of pRxEngage, a company redefining patient engagement and retention in clinical trials using living experience, proven methods, and AI.
