Friday, September 27, 2002

This presentation is part of : Research with Older Adults: Overcoming the Challenges

Recruitment and Retention of Older Adults in Clinical Research

Marianne Shaughnessy, CRNP, PhD, assistant professor, Dept of Adult Health Nursing, Dept of Adult Health Nursing, University of Maryland School of Nursing, Baltimore, MD, USA

Introduction: The most critical step in implementation of a study is recruitment of an appropriate number of qualified subjects. Failure to achieve recruitment goals can compromise a study by providing too few subjects for analysis, and efforts at additional recruitment may result in uneven workloads, extension of the study and budget overruns. Relaxation of the inclusion criteria may further affect the results in an unpredictable way. Once recruited into a study, the next challenge for investigators is to retain enrollees. This is particularly important in studies with older adults who may be lost to follow up due to changes in living situation, acute illness, or death. Retention in longitudinal studies also may be affected by subject’s inadequate understanding of the study protocol, or unpleasant experiences as a result of early study participation. The importance of careful planning prior to initiation of a study with older adults to ensure sufficient participation cannot be overstated.

Common Problems in Recruitment and Retention: Inadequate planning and adaptation of recruitment strategies is a major problem for many clinical studies. Definition of the eligible population is often overestimated, and a specific type of population sought may introduce additional barriers to recruitment (e.g. outpatient vs. inpatient, disease-specific vs. prevention). The recruitment of older adults into clinical studies is further complicated by visual, hearing, literacy and cognitive issues, which can influence understanding of protocols and therefore informed consent. Older adults also have less functional reserve and may have a lower threshold for respondent burden than younger adults. Lack of transportation or time may also preclude study participation. Finally, mistrust of investigators by potential enrollees or their families may create reluctance to participate.

Commonly used strategies to recruit community-based study participants are: physician referrals, presentation to community/church groups or free screenings, media, mailings, fliers, or telephone solicitations. The literature suggests that multiple overlapping strategies are necessary to meet recruitment goals and that continual monitoring and adaptation of strategies as appropriate is imperative to successful, continued recruitment. Longitudinal studies require attention to patient as partner to ensure continued participation over time. Examples from several moderate and large clinical trials will be utilized to illustrate successful use of multiple methods.

Discussion/Recommendations: Successful recruitment and retention of older adults in clinical studies is based on incorporating six fundamental concepts: 1) historical cognizance; 2) sanctioning; 3) trust-building; 4) mutuality; 5) recognition of heterogeneity; and 6) researcher self-reflection a nd introspection (Dennis & Neese, 2000). Examples of how these concepts were used in the recruitment and retention of participants in the Baltimore VA Pepper/OAIC and Baltimore hip studies will be provided. Use of this framework is an effective way for novice and experienced nurse researchers to recruit and retain older adults and their families as partners in research.

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