Saturday, 15 January 2005 - 12:00 PM

This presentation is part of: Poster Session II

Efforts To Recruit Patients With Serious Mental Illness Into A Randomized Research Study

Purpose: Despite a NIH mandate for increased participation of minorities and women in health studies, these groups are often under-represented, partly as a result of difficulties in recruitment and enrollment. Recruitment of women and minority groups may be particularly difficult when research projects target patients with serious mental illness (SMI), a group of patients who often have unstable housing, no telephone service, and smaller social networks. Patient characteristics that can influence recruitment efforts include gender, age, comorbid substance abuse, illness severity, and social supports. Differential recruitment and dropout rates can introduce significant biases, less reliability, and low generalizability of study results. Within the Department of Veterans Affairs (VA), a veteran’s “period of military service” and level of service-related disability are important predictors for successful recruitment. The objective of this study is to examine reasons for differential contact and recruitment success during a randomized control trial (RCT) to improve medication adherence.

Methods: Research staff attempted to recruit all veterans with serious mental illness (schizophrenia, schizoaffective, or bipolar disorder) and poor antipsychotic adherence, meeting eligibility criteria for a multi-site RCT (N=241). Patients were in treatment at three VA medical centers (two urban, one suburban site). Patients were initially contacted by letter, followed by a telephone call or were approached during their next clinical appointment. Bivariate and multivariate logistic regression was used to analyze differences in staff’s “ability to contact” patients and refusal rates by location, diagnosis, patient demographics, medication adherence, and level of VA service-connection.

Results: Study personnel were able to contact 76 percent of the identified patients. In multivariate analyses, researchers were significantly more likely to successfully contact married patients (OR: 2.55), those living in the suburban site area (OR=1.71), and patients with service-related disability (OR: 1.80). However, there were no differences in contact rates by race, diagnosis, or substance abuse comorbidity. Of the 183 patients contacted, 71 (39 percent) agreed to participate in the study. Patients with a bipolar rather than a schizophrenia diagnosis, who lived in a suburban site area, who had a higher medication adherence rate, and who had a service-related condition were more likely to agree to participate (ORs: 3.07, 3.97, 2.17, and 2.32, respectively). There were no differences by race, marital status, substance abuse, or gender in the likelihood of participation. In this study, minority patients appeared just as likely to participate as non-minority patients, with adjustment for urban site location, service connection, and type of psychiatric diagnosis.

Implications for practice or policy: Challenges may arise during contact attempts and subsequent recruitment efforts, with differences by patient characteristics. However, once contacted, under-represented groups appear just as willing to participate in a health services study. Recruitment in urban areas may require special outreach efforts to locate patients.

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