Clinical Trial Recruitment

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 by imposing significant time and cost burdens, and by impeding clinical trial recruitment and retention,¹ which in turn has deterred finding patients lost-to-follow-up (LTFU).  This post will serve as the second of several that will discuss strategies to enhance recruitment, retention, and finding patients lost-to-follow-up based on evolving interpretations of the HIPAA regulations and will focus on initial patient contact.

Contacting eligible participants for clinical trial recruitment is a challenge and HIPAA regulations have made this process more complicated.  Pre-HIPAA, patient lists and their contact information were accessible for review, and clinical study personnel were able to identify and subsequently contact eligible participants. 

Conversely, post-HIPAA, the contact information of potential participants cannot be accessed without the participants’ explicit authorization, a clear hindrance to the contact and clinical trial recruitment process.  In this regard, the burden shifted to the health care provider (who now becomes the recruiter), already inundated with patient care responsibilities and time constraints, to introduce the study to the patient and obtain their consent for subsequent contact.² 

As a result, there have been substantial decreases in participant accrual, as well as increases in recruitment costs.  For example:  studies have reported that clinical trial recruitment has decreased from an average of 12.4 participants per week pre-HIPAA to 1.9 participants per week post-HIPAA.^3,4 Additionally, recruitment costs have increased from $49 per participant to $169 per participant post- HIPAA, a situation particularly problematic for studies already in progress at the time of the HIPAA implementation.⁴

Despite the burden the HIPAA privacy rule has placed on contacting patients for clinical trial recruitment, deliberation of the seemingly logical intent of these regulations, along with prior planning can facilitate these efforts.  In response to the HIPAA privacy rule, routine clinic visits by study personnel such as medical directors, nurses, etc., now speak directly to patients about their eligibility and study participant interest vs. identifying their names from lists.  Clinical collaborators and staff liaisons now obtain patient authorizations with their contact information and provide this data to the appropriate persons for study recruitment.  Additionally, clinical collaborators write letters on the clinicians’ letterhead including clinicians’ signature to potential eligible patients of interest, informing them of the study.⁵

Further, a number of other innovative-HIPAA compliant strategies have been implemented to make initial contact with participants, subsequent to local IRB approval.  These include:  flyers, advertisements, and electronic media.  Flyers are posted at health care institutions such as hospitals and clinics, as well as in community locations including pharmacies, public libraries, and senior and community centers.  

Most academic health sciences centers have a web page advertising current clinical trials that are designed to include contact information of the study coordinator, or to include a study sign-up form embedded on the page to be completed by those interested.  An example of this form is located at https://apps.muhealth.org/clinical_research/.²  

Subsequent to receipt of participant information, the study site calls respectively to gain additional eligibility criteria, or PHI per HIPAA.  It’s important to note that no specific HIPAA guidance is available on this last contact approach, therefore logic should prevail and many institutes interpret this contact NOT to require additional HIPAA or alternative authorization because the person is freely volunteering to provide his or her health information.

Because the challenges imposed by HIPAA for clinical trial recruitment, retention, and finding patients lost to follow-up are ambiguous, logical interpretation and processes must guide the clinical trial conduct process until further clarification and guidance are made available.

A future post will focus on processes compliant to patient retention and long-term follow-up.
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. Ness, R. B. (2005). A year is a terrible thing to waste: Early experience with HIPAA [Editorial]. Annals of Epidemiology, 15, 85-86.

4. Wolf, M. S., & Bennett, C. L. (2006). Local perspective of the impact of the HIPAA privacy rule on research. Cancer, 106, 474-479.

5. Olsen, D. P. (2003). HIPAA privacy regulations and nursing research. Nursing Research, 52, 344-348.

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Please share your thoughts regarding our post on Addressing Clinical Trial Recruitment and Retention Issues Imposed by HIPAA.  And, please do email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.