A cost-effectiveness analysis of subject recruitment strategies in the HIPAA era: results from a colorectal cancer screening adherence trial.

Background: Changes in regulatory standards that restrict use of identifiable health information can reduce patient recruitment to clinical trials and increase recruitment costs.

Purpose: To compare subject accrual rates and costs of three recruitment strategies that comply with new regulatory standards within the context of a clinical trial evaluating the impact of shared decision-making on colorectal cancer screening adherence.

Methods: Sequential cohorts of English-speaking, average-risk patients due for colorectal cancer screening were allocated to one of three recruitment strategies: (1) a provider-initiated electronic 'opt-in' referral (Click) method; (2) a provider-mediated 'opt-in' referral letter (Letter) method; and (3) an investigator-initiated direct contact 'opt-out' (Call) method.

Results: During distinct 6-month recruitment periods between March 2005 and April 2006, 100 potential subjects were identified using the Click method, 847 by the Letter method, and 758 by the Call method. After excluding ineligible prescreened patients, accrual rates were higher for the Call method (188 of 531 [35.4%]) than either the Click (12 of 72 [16.7%]; p = 0.002) or Letter (17 of 816 [2.1%]; p < 0.001) methods. The average cost per patient enrolled for the Call ($156) method was competitive with the Click ($129) and substantially lower than the Letter ($1967) methods; the Call method was least expensive if combined with automated patient identification ($99). Data extrapolation suggest it would take 2.4 years at an overall cost of $138,518 to recruit a target sample of 900 patients by the Call method, 40.5 years at $62,419 for the Click method and 27.9 years at $1,737,757 for the Letter method.

Limitations: The study was nonrandomized and findings may not be generalizable to other research settings.

Conclusion: The investigator-initiated direct contact 'opt-out' strategy is significantly more cost-effective and feasible than provider-initiated and provider-mediated 'opt-in' strategies for patient recruitment to clinical trials.