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The Statistical Power of Patient Retention

Why is patient retention critical for study success? With busy workloads and pressures from sponsors regarding patient recruitment, patient retention often gets overlooked. However, from the Sponsor’s perspective, retaining as many patients as possible is a priority since it directly affects the statistical power of the study. There‘s an economic factor as well. Delays in recruiting patients, coupled with retention loss can contribute significantly to an increase in overall study and per patient costs. The more patients retained, the lower the overall cost of each viable subject. Furthermore, it is our opinion that the cost to recruit a patient is significantly greater, perhaps as much as five times greater, than to retain an existing patient in a clinical trial.

Currently, few sponsors take time to adequately prepare study coordinators for the patient retention task. In turn, few study coordinators take time to strategically develop a retention plan; in part because their time is already constrained and also because retention requires an understanding of the patient-study dynamics. For example, each retention plan must specifically answer the basic questions that drive patient motivation— “So what is so important about this study?” “Why should I (the patient) care about continuing to return for study visits?” “What‘s in it for me to continue to participate?” Regardless of therapeutic area, these retention questions are universal, but the answers are study dependent.

Drivers of patient motivation: So what? Who cares? What‘s in it for me?

A retention plan should expand on these three core questions— So what? Who cares? What‘s in it for me? A retention plan should include answers to these fundamental questions that drive the retention process. Additionally, the development of a retention plan prepares study coordinators in advance to proactively step into the shoes of their patients and anticipate the various retention issues and how to deal with them. Consider for example that some patients will be concerned about the time required for study participation. The recruitment plan should include an answer to the basic “What‘s in it for me” question, yet tailored to address the question of time commitments; “What’s in it for me to give up so much time for this study?—what will I get out of this?” Answers to these core questions must include the balance of benefits rather than just the features of a study. All too often patients are only told about the study’s features such as study length, number of visits or types of procedures without ever hearing about corresponding benefits such as: frequent visits that translate into close medical attention and the opportunity to develop a close and comforting relationship enabling patients to ask questions about their health and their study participation.

What motivates one patient to join a clinical study may be quite different for another. Understanding the various underlying motivators for each patient is a first step for study coordinators to ensure that a patient‘s study expectations are met, or as is sometimes the case, whether they are unrealistic. For example, if a patient acknowledges that one of the primary reasons for joining the study was to see the doctor more frequently, but this does not occur, then it is clear that expectations did not match experiences and as such this patient may withdraw from the study.

Retention begins at the very first study visit

First impressions count and study staff, primarily the study coordinator, is key to setting the right tone at this first encounter. Recognizing and addressing a patient‘s fear at the first meeting and throughout the study is important to retaining the patient to study completion. At the first meeting if a patient has a fear, it has to be addressed by a study coordinator or principal investigator who listens to and answers their questions, thereby demonstrating care and concern for their wellbeing. Often patients do not articulate their level of fear about the clinical trial. An approach used by study coordinators to explore this issue more deeply is to ask patients if they would hypothetically enroll a family member in the study, and if not, why not. It may also be suggested that patients bring a family member to subsequent visits.

Additionally, the principal investigator should be alerted and possibly intervene to increase the patient‘s comfort level in continuing to remain in the study. Principal investigator involvement on a continual basis demonstrates the physician‘s interest in a patient’s well being and builds their trust in the research process. As part of the retention plan, it is important that study coordinators follow a structured process of noting information about a patient’s fear and readdressing it at subsequent study visits. Another approach to reassuring patients on an ongoing basis is to provide study patients with a contact phone number to call for questions at anytime during the study. That contact phone number should also be provided to the patient‘s primary care physician to call with questions and for updates.

External influences

There are multiple reasons why patients drop from study participation. Some reasons are within the control of study staff-the study coordinator and the PI—such as clinical trial fatigue, logistical issues, and expectations of participation versus experience; while other reasons are beyond the control of the study team, such as adverse advents. Additionally, external influences such as family related issues or concerns of the patient‘s primary care provider can significantly impact patient participation. Talk to your patient about these external issues. If calling the patient’s family member or medical provider to discuss the patient‘s study participation will help, consider doing so. Naturally, there may be issues beyond your scope, but remember, it is important to continually talk to your patient about their concerns, whatever the source.

For long term studies and studies involving a primarily elderly population, the stability of study staff is important. There is no doubt that study coordinator turnover can affect patient retention. Continuous turnover impedes the ability of site staff to build lasting relationships with study patients. It can compromise patients‘ commitment to the study when they have established a strong connection to the study coordinator who is suddenly replaced.

Red Flags of Discontent

Study staff armed with tools for effective patient retention can be trained to look for “the red flags of patient discontent”. These red flags are signals identified through patient behavior. An astute study coordinator prepared in patient retention techniques can look for these behaviors and know which solutions to apply to address them. Missed visits, negative or unfavorable comments about the study, loss of communication between the principal investigator/study coordinator and the patient are examples of these behaviors that can lead to patient withdrawal.

Valuing patients individually

Most people are unaware of the clinical trials process and its role in the development of future drugs, devices and biologics. While the first study visit is a time to establish the tenure of the relationship, it is also the opportunity to explain the clinical trials process and build a comfort level about study participation. By using examples of approved medicines such as ibuprofen and others, patients can see how they can make a difference in people’s lives. It is yet another answer to the question “what’s in it for me to participate?”

Consider again the three questions that drive patient motivation— So what? Who cares? What’s in it for me?—and the behavioral strategies that also answer them. For example, when study coordinators non-verbally answer these questions —“So what? Who cares?”—they are doing so by ensuring that the patient feels that their time is valued by not keeping them waiting at study visits, making eye contact when a patient is speaking to demonstrate interest and providing a warm and friendly manner. If a patient asks a question to which study staff does not know the answer, assuring patients that someone will get back to them promptly is another demonstration that they are valued. Such attention to detail contributes to making the patient feel that they are important. Each behavior exhibited by study coordinators is a step toward answering the “What’s in it for me to participate?” question from patients. Good vibes from this first encounter and subsequent visits will encourage the patient to remain committed to the study until completion.

Conflicting terminology

In this industry medical terminology can often undermine study success. Often a potential patient is labeled as a “subject” as soon as they sign the informed consent. This terminology, while consistent with regulatory standards, is disconcerting to many patients and study staff alike. Referring to a patient as a “subject” can negatively impact patient retention. Many study patients believe this term connotes the abdication of all rights and that they are subject to testing in the same way as lab rats and guinea pigs. Study coordinators successful in sustaining patient retention avoid using this term. Instead the relationship is based on a first name basis. Some study coordinators will ascertain by which name a patient prefers being called; Mrs. Kim Smith, Mrs. Smith, Kim or Kimberly for instance.

Patient retention involves great customer relations

Names are important to people, and ensuring that a person’s name is spelled and spoken correctly is part of this. But establishing the patient-study staff relationship also requires going beyond name affirmation and showing a personal interest in their family, friends, career, pets and hobbies. Demonstrating an interest in who they are as individuals contributes to helping the patient feel comfortable with the study team, and this transcends to the study. As a retention tool, successful study coordinators will write down points of interest and keep them on a separate piece of paper in the patient’s chart. In this way, study coordinators demonstrate their continued personal interest.

Keeping patients motivated in a clinical trial is a continuous process. Part of this process includes reinforcing the study purpose and the value of their participation at each study visit. Research has shown that few patients can explain the purpose of the study in which they have enrolled. And, reaffirming the study’s importance and purpose equips them with information to help explain this to others.

Patient retention involves great customer relations. Patients are people too and treating them in the same way as you would want to be treated will build the trust and confidence required to retain a patient in a clinical trial.

Authors: Karen Williams and Nanci Hook-Seid