Rationale. Successful recruitment and retention of ethnically diverse research participants in clinical studies depends heavily on the comprehension, needs, and preferences of potential participants.  A critical influence on these outcomes is health literacy, the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions.[i]  Since 30% of US adults have only basic health literacy,[ii] and Hispanic and African Americans are disproportionately concentrated among those of low health literacy,[iii] representation of these populations on clinical studies depends in part on the extent to which clinic and research staff can recognize patients of low or moderate literacy and communicate complex concepts to them in accessible and relevant terms. Tools that measure health literacy (commonly written questions that assess reading ability) have been criticized when used in clinical settings as alienating and stigmatizing to low literacy patients.[iv]  A recent review of health literacy research by the US Agency for Healthcare Research and Quality concluded that development of measures for spoken health literacy is a high priority.[v]

The proposed pilot study builds on a recently completed NCI RO1, Increasing Participation in Cancer Clinical Trials (2007-2012), that was a collaboration between the Kaiser Permanente (KP) Division of Research (DOR, C. Somkin, PI) and UCSF (R. Pasick, Co-I).  From in-depth analyses of 38 recorded nurse-patient clinical trial conversations, we elucidated 6 dimensions of patient utterances that we call “clinical trial health literacy” (CTHL), conversational indicators of a patient’s ability to understand basic concepts of trial participation: grammar, use of medical terms, knowledge of diagnosis and treatment, logic, initial clinical trial understanding, information seeking.  Our data show that these are closely inter-related and together serve as a strong indicator of health literacy.  Our long-term research plan includes development of a protocol for real-time assessment of these dimensions by Clinical Research Coordinators (CRC) and for corresponding messages tailored to high, medium, and low CTHL. This will be followed by a large-scale KP- and UCSF-based mixed methods study of protocol impact for participants (comprehension, satisfaction, needs fulfillment, decisional conflict), for CRCs (satisfaction, perceived efficacy), and on rate of clinical research study participation.

Plan. The purpose of this RAP grant is to conduct a feasibility test of CRC assessment of CTHL dimensions in the course of clinical research study recruitment conversations, and to further refine the dimensions for subsequent validation analyses.  Our specific aims are to: 1. establish a partnership between UCSF- CTSI Community Engagement Program faculty (Pasick), DOR (Somkin), and the UCSF CTSI Participant Recruitment Services (PRS, Nasser); 2. refine and pilot-test a CTHL screening tool for (a) ease of use by Clinical Research Coordinators and (b) reliability in recruitment attempts with 25 UCSF patients; 3. develop and pre-test a training protocol on CTHL assessment as one component of a new CRS curriculum on health literacy with 10-15 CRCs enrolled in the CTSI-initiated campus-wide CRC training program. Two focus groups will be conducted with CRCs at the outset to inform design of the feasibility test.  CRCs conducting the health literacy assessments will be interviewed following each encounter and patients will be queried briefly afterward as well.  

Criteria & Metrics for Success.  Long-term measures of success will include sustained collaboration among the above partners leading to incorporation of pilot study products in ongoing UCSF and KP CRC training, acquisition of NIH funding, and increased rates of participation in studies among those of low to moderate CTHL.  Intermediate measures are demonstration of the feasibility of CRC assessments as indicated by completion of 25 audio-recorded patient encounters that produce high ratings of satisfaction and comprehension by patients and of satisfaction by CRCs; a high degree of inter-rater reliability on encounter recordings rated by multiple CRCs; and training protocol pre-test results indicating that CRCs find the information and strategies useful, new for them, and easy to adopt.  

Approximate Cost/Brief Justification.  The project will be led by Dr. Pasick (5%) and Ms. Nasser (contributed, 5%) with project coordination by Ms. Allen (recipient of NCI Diversity Supplement to conduct the above NCI-funded Kaiser-based research, now a UCSF Research Analyst, 30%).  Dr. Somkin will represent KP needs and interests as a consultant ($5,000).  Patient incentives for study participation will be provided at $35 each ($875). PRS staff will devote 340 hours ($13,600) for focus groups, interviews, audio tape ratings, and training. Total cost: $46,336.  

Collaborators.  This study is a collaboration among Dr. Rena Pasick (Professor, Faculty of CTSI Community Engagement Program, with 25 years of NIH-funded research on cancer disparities and communication across cultures, including studies that involved training of service staff on health literacy); Ms. Nasser (Senior Director, CTSI Clinical Research Services Director); and Dr. Somkin (DOR, Research Scientist).