Lessons Learned in the Early Phase of the MI-HEART Clinical Trial

Objective. To provide guidelines for enhancing the patient accrual process in clinical trials using communitybased Web-based Information Technology (WebIT). Background and Significance. Previous ITadministered education studies have been conducted in controlled environments: the computers are usually 1) supplied to the patients, 2) in an setting where a research facilitator can assist patients using the IT-based education or 3) are supplied by the patient but the software does not feedback measures of efficacy to the investigators. In contrast, the MI-HEART Clinical Trial education is a randomized study that measures the changes in cognitive variables of community-based patients exposed to tailored or non-tailored self-administered Web-based and paper-based education. The education is self-administered, without assistance, using patient’s accessible WebIT, at non-controlled times and locations. The MI-HEART System feeds back process and efficacy measurements to the investigators. 62 patients have applied to join the MI-HEART clinical trial, 19 of which have already completed the pre-intervention cognitive test. Content Covered. 1) The presentation will first address the barriers to recruitment and the observed patient accrual rates resulting from several patient enrollment strategies covering a period of eight months will be presented. 2) The lessons learned from interesting and unexpected preliminary demographics, process variables and findings will also be presented to foster enhanced recruitment strategies for clinical studies involving WebIT. Enrollment Strategies. 1) Direct patients solicitation 2) Repetitive brochure distribution in clinics 3) Patients Educational Events 4) Public Announcements 5) National and International Recruitment a) Internet Interest Group b) Electronic Medical Record –Based Qualification c) Personal Contact with Peers Some Lessons Learned. (1/2) 1) Self-enrollment of patients that are required to use WebIT may favor a subset of wealthy, knowledgeable and self-efficacious individuals with a low belief in treatment efficacy. This group may only portray a subset of the assortment of health education needs of a non-biased patient population. (figure 1, table 1).