Predictors of refusal during a multi-step recruitment process for a randomized controlled trial of arthritis education

Objective Randomized controlled trials in patient education often have difficulty enrolling vulnerable populations – specifically, older, poorer and less educated individuals. We undertook a randomized controlled trial (RCT) of an educational intervention for arthritis management, which included strategies to remove literacy-related barriers to participation. This paper reports on the multi-stage recruitment process and assesses whether refusal to participate was related to education, age, gender, working status or insurance status. Methods The recruitment protocol was designed to eliminate literacy-related barriers to participation. Patients were never asked to read or fill out forms. Interactions were oral, using everyday terms and short, clear sentences. Patients who declined during a screening call were considered Stage 1 Refusers. Patients who initially expressed interest but neither completed a baseline questionnaire nor provided consent were considered Stage 2 Refusers. Patients who consented were considered Enrollees. Age, gender, and insurance status were compared between Stage 1 Refusers and Enrollees. A second analysis compared these variables, plus educational attainment and working status, between Stage 2 Refusers and Enrollees. Results Of 408 eligible patients, there were 193 (47.3%) Stage 1 Refusers, 81 (19.9%) Stage 2 Refusers and 134 (32.8%) Enrollees. A higher proportion of Stage 1 Refusers than Enrollees were ≥65 years old (58% vs. 37%, p=.0003). Multivariate analysis, adjusting for gender and insurance status, confirmed the effect of older age on refusal (OR=2.3 (1.4, 3.6)). There were no significant differences between Stage 2 Refusers and Enrollees. Conclusion We found no evidence of refusal to participate due to educational attainment, working status, insurance status, or gender. Older patients were more likely to refuse participation at the first stage of recruitment. Practice Implications Researchers should continue efforts to increase participation among older patients, particularly when studies are designed to be generalized to an elderly population as is the case with arthritis research. Strategies used in this recruitment protocol designed to remove literacy-related barriers to recruitment may be responsible for the observation that subjects with lower education did not have lower refusal rates. Such strategies deserve further study.