This project commenced on October 1, 2007. As the research progressed, it became apparent that additional data collection would substantially increase the impact of the results and amplify the scientific meaningfulness and applicability of the existing data. Therefore, two additional data collection efforts were proposed to: 1) compare proxy and self-responses to the AM-PAC; and 2) examine social/role function at 6 months post-stroke for participants already enrolled in the OMS-PAC study. We believe that these additions significantly increase the merit of the research.? ? The first addition calls for data collection using a new fixed form social/role function instrument, developed at the Boston University HDRI, which KFRI will administer at 6 months post-stroke to participants enrolled in the OMS-PAC study. This tool will provide insight regarding the relationship between the performance of basic tasks (such as mobility or cognition) as measured by the AM-PAC and participation in more complex social activities and roles as measured by the new social/role function instrument among adults following a stroke. Contemporary models characterize disablement as a complex, dynamic, multi-dimensional interaction between people with potentially limiting health conditions and their environments. Few studies have examined the complex relationships between major conceptual elements of these models. Exploration of the influence of performance in basic activities to role and social functioning reflects an important contribution to the scientific body of knowledge on the disablement process. We can begin to probe into this relationship in the OMS study by addition of the social/role function instrument to current OMS data collection efforts. ? ? The second addition requires researchers at KFRI to compare responses to AM-PAC items from 60 research participant/proxy sets. Initial data collection efforts revealed that the majority of study participants were not able to respond to the AM-PAC items independently and therefore, proxy respondents were required. Although this event was anticipated in the OMS study protocol, the proportion of proxy respondents has exceeded the number that was originally anticipated. Therefore, it is necessary to examine proxy and self-responses to the AM-PAC. Participant responses will be compared to proxy responses. In addition, responses from different proxy respondents (clinician versus family member) will be compared in in-patient settings where clinicians often serve as proxy respondents. This will allow identification of important differences in self and proxy responses to AM-PAC items as well as examination of potential response bias. Kaiser Foundation Research Institute IRB for the sub-studies is pending.? ? The eCAT software has been successfully tested and implemented for use in data collection within the Kaiser Permanente of Northern California environment. Minor software modifications were made to improve functionality and minimize participant response burden. These modifications were successfully tested and implemented without interruption to data collection processes. The new Social/Role Function instrument was integrated into the software program. One episode of user error with the eCat program prompted development of a solution to avoid loss of data. This solution will be incorporated into training documents associated with data collection. ? ? Enrollment of study participants was initiated February 21, 2008. Charts from two hundred and six patients have been assessed for potential inclusion in the study with forty-eight current participants; an enrollment rate of 23%. Four participants have expired and one participant withdrew. Four participants have completed the study and were successfully followed for the six-month study period. Enrollment projections were based upon 2005 data of stroke admissions to the Kaiser Foundation Research Center in Vallejo, CA. In 2007-2008, stroke admissions have decreased in the Kaiser Permanente of Northern California system affecting study enrollment. Two new acute care recruitment sites will be added to facilitate attainment of projected sample size (N=200). ? ? Situations have arisen in which study participants are refusing post-acute care services and returning home. To assure retention, a follow-up process with study participants was developed. The process is as follows:? 1. Send reminder letter and phone check-in three months after Visit 1? 2. Send reminder letter two weeks prior to six-month check? 3. Follow-up phone call three days after letter ? 4. All available contact phone numbers will be used to schedule final visit. ? 5. If contact is not made after two attempts to each available phone number, the patient will be administratively dropped from the study? ? Although initiated on a weekly basis early in the project, current bi-weekly conference calls with NIH-RMD and collaborating team members provide opportunities to discuss progress of the study, address issues and coordinate next steps.
