Addressing Clinical Trial Recruitment and Patient Retention Issues Imposed by HIPAA Step by Step (third of a series)
Patient Retention
Recent reports have indicated that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct and patient retention by imposing significant time and cost burden and by impeding clinical trial recruiting and patient retention,1 which in turn has deterred patient search efforts–locating patients lost-to-follow-up. This commentary will serve as the third of a series that will discuss strategies to enhance patient retention and finding patients lost to follow-up based on evolving interpretations of the HIPAA regulations.
Challenges of Patient Retention
When conducting a clinical study on a treatment or intervention, it is imperative to retain patients throughout the entire study duration and for a follow-up period, which can be months or even a decade for longitudinal studies. Patient retention for study duration and follow-up represents a major challenge and we must address this issue to avoid potentially devastating consequences to the clinical trial industry.2
In fact, estimates reported in 2003, before HIPAA- impact, indicate that 85% of trials do not finish on schedule, 60% to 80% of clinical trials do not meet their chronological endpoints because of challenges in recruitment, and 30% of trial sites fail to recruit even a single participant.2
Additionally, disappointing statistics show that 26% of patients drop out after providing consent and greater than 94% of studies are delayed due to failed enrollment / patient retention (including patients lost to follow-up). The situation is worsening in large part due to HIPAA regulations. In fact from 1997 to 2003, the percentage of studies completed on time decreased from 18% to 6%.3,4 The costly consequences of trial delay are so staggering that each day of delay can equate to $220K, and a 2 month delay can equate to $70 million potential product sales due to postponed launch.
Strategies to Enhance Patient Retention
We can enhance retention of participants by utilizing appointment reminders with the caveat that this process must be cognizant of participant privacy. Under HIPAA, postcard reminders are discouraged due to the possibility of a patient’s medical diagnosis being inferred by anyone seeing the postcard (by virtue of a study logo or clinic’s name). Therefore, if utilizing mail reminders, enclose in an envelope without a return address that includes the affiliated study group (e.g., the Diabetes Research Group).2 Additionally, a mail reminder should not resemble a medical bill as patients may delay opening.
Utilizing a mail reminder several days in advance, followed by a telephone reminder 24 to 48 hours prior to a follow-up appointment is an effective strategy for patient retention. Utilizing this method, ensures that the patient’s protected health information (PHI) is not revealed. For example, if an appointment reminder is recorded on a patient’s answering machine the message should only provide the date and time for the pending appointment, and a contact number if needed by the patient for questions or re-rescheduling. While, e-mail has become another option for appointment reminders, we must recognize that older adults may not be computer savvy and some minorities may not have e-mail access.2
Reimbursement of patients is also a well-known strategy for effective patient retention. However, the processes of reimbursement must be consistent with participant privacy. The standard patient reimbursement process involves the research facility’s accounting department forwarding a check to the patient’s home. Patients can also be reimbursed with gift cards, books of stamps, and other monetary equivalents.
Lastly, a critical element of patient retention strategies are plans that include patient search initiatives to locate those lost to follow-up quickly and efficiently so they return to the study in a timely manner. It has been shown that if patients lost to follow-up are contacted expeditiously they will return to the study, either during the ongoing phase or for follow-up evaluations. This is critical because loss of patients equates to loss of data; loss of data causes trial delay; trial delay negatively affects regulatory submission and subsequent product launch; and together this debacle of events leads to an extremely high cost burden.
References:
1. Blanton, B. et al. Lessons learned in participant recruitment and retention: The EXCITE Trial. Physical Therapy. 2006; 86: 1520-1533.
2. Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act on participant recruiting and retention. Western Journal of Nursing. 2008;30: 399-53.
3. 5th annual patient recruitment and retention conference September 24-25, 2007; Washington DC; Data presented by John Benbrook and Malcolm Bohm of MMG & trialytics, Inc.
4. 101 facts about clinical research (2005) Accessed at www.ciscrp.org
5. Nature Reviews Drug Discovery 2, 851 (November 2003)
6. DataMonitor (2004), patient recruitment online
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