A Pilot Study On the Informed Consent Process Among Spanish Speaking and English Speaking Latinos With Schizophrenia

Background/Purpose: There has been a dearth of research focused on decisional capacity and the informed consent process among Latinos. This pilot study was aimed at identifying the degree to which language, acculturation, education, health, and research literacy affect participants’ initial comprehension and 1-month retention of information. Based on a conceptual model highlighting the role of a research schema in the consent process, we tested the effects of a pre-consent educational intervention on initial comprehension and 1-month retention. The overall aim was to establish feasibility of an enhanced consent approach for a larger randomized controlled trial (RCT) focused on Latinos with schizophrenia.

Methods: We enrolled 24 Latinos with schizophrenia (12 English- and 12 Spanish-speaking) receiving mental health care. Participants were randomly assigned to the (1) routine condition or (2) “enhanced consent” condition utilizing scripted content focused on clinical research concepts and methods, as well as an overview of informed consent itself. Participants in each condition were presented with a consent form describing an RCT of antipsychotic medications. The participant was told to imagine he or she was being asked to enroll in this trial. After reviewing the clinical trial consent information, participants’ comprehension of the disclosed information was assessed with English or Spanish language versions of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and a Scale for Assessing Participant Satisfaction with Consent Procedure. Retention of information was reassessed 1-month later.

Results: Differences in baseline comprehension indicated that among those receiving routine consent procedures, Spanish-speaking participants had worse comprehension than English-speaking participants. The mean MacCAT-CR Understanding subscale total for English versus Spanish-speaking participants in the routine condition were 14.8 (SD=4.5) and 9.2 (SD=5.3) of 26 possible points, respectively. Education (yrs) and health literacy were both positively correlated with the MacCAT-CR Understanding subscale total, rs = .423 and .658, respectively. For the enhanced consent condition several trends reflect that this condition appears to have had a positive effect on comprehension, particularly among Spanish-speaking participants. In the latter group the mean MacCAT-CR Understanding subscale total for the routine vs. enhanced consent groups were 9.2 (SD=5.3) vs. 15.5 (SD=6.3), respectively. A similar pattern was seen at the 1-month follow-up. However, there was a wide range of scores within each language-by-consent type group, and variability among participants in level of satisfaction with the procedures.  

Conclusions/Implications: The overall aim was met in that feasibility of procedures and the enhanced consent approach was demonstrated. The baseline differences and the diversity of opinion among the groups underscore the need and importance for a larger RCT to examine the effects and interactions among participant characteristics and consent method on comprehension and retention.  It will be important to include a qualitative component to better identify common themes in the dimensions of such preferences and to shed light on underlying cultural influences. Such work is essential to ensuring that social work and other clinical researchers are able to enroll a diverse range of Latinos with schizophrenia using linguistically, culturally appropriate, and effective procedures for obtaining informed consent for participation.