The priorities to be addressed by this collaborative project are the priorities for the Spinal Cord Injury Model Systems (SCIMS) multi-site research projects (MSRP) and the priorities of the General Disability and Rehabilitation Research Projects (DRRP).  The overarching goal of this proposal is synonymous with the broad priority for the SCIMS MSRP “to conduct research that contributes to evidence-based rehabilitation interventions and clinical practice guidelines that improve the lives of individuals with spinal cord injury (SCI).  

CPI methodology is capable of identifying multiple SCI rehabilitation interventions (and combinations of interventions) that are associated with better outcomes after controlling for individual, injury, and severity differences.  A past application of the CPI methodology to stroke rehabilitation has added to evidence-based rehabilitation with an entire supplement of the premier rehabilitation research journal, Archives of Physical Medicine and Rehabilitation, as well as another dozen manuscripts in a variety of other peer reviewed journals. 

Previous CPI studies have contributed to clinical practice guidelines. We expect this SCI CPI investigation to follow in the tradition of high impact research by emulating the very successful Post-Stroke Rehabilitation Outcomes Project (PSROP), using a similar number of facilities and subjects, following a similar process (including nearly a year of intense multidisciplinary planning, point of care data collection, and sophisticated analytic techniques) in collaboration with Dr. Susan Horn’s team at ICOR that led the PSROP and several other high impact CPI studies. 

This overarching goal of  SCI CPI research will be realized by accomplishing the following four goals that mirror the four stated outcomes to which NIDRR expects the funded project to contribute:

Goal 1: Ensure utilization of SCIMS capacity by collaborating with three or more of the NIDRR-funded SCIMS centers (for a minimum of four SCIMS sites).  The applicant, the Rocky Mountain Regional Spinal Injury System (RMRSIS) has contacted and secured the collaboration of four other SCIMS centers as well as two additional collaborators to carry out the project. 

Goal 2:  Contribute to improved long-term outcomes of individuals with SCI by conducting multi-site research on questions of significance to SCI rehabilitation, using clearly identified research designs. The research must focus on one or more specific domains identified in NIDRR's Proposed Long-Range Plan for FY 2005-2009 (Plan), including health and function, participation and community living, technology, and employment, and ensure that the research study has appropriate research hypotheses and methods to generate reliable and valid findings.  We will address the significant issue of rehabilitation outcomes for individuals with SCI by assessing the degree to which all therapeutic components of the rehabilitation process contribute to improved outcomes.  All domains of the Plan will be included.  The study’s primary outcomes include health and function (medical complications, rehospitalization, neurological recovery, and functional independence), participation and community living (discharge to home and societal participation), and employment (return to productive activities), while the use of technology is one of many rehabilitation interventions that will be evaluated.  The proven rigor of the CPI methodology will investigate four a priori general hypotheses and address many issues identified by clinicians in the planning phase as well as conducting post hoc analyses to test alternative explanations offered clinicians for unexpected relationships between interventions and outcomes.  The  SCI CPI study meets NIDRR’s dual criteria of rigor and relevance.

Goal 3: Demonstrate the capacity to carry out multi-site research projects, including the ability to coordinate research among centers; maintain data quality; and adhere to research protocols, confidentiality requirements, and data safety requirements.  We will address this goal through building on well-established partnerships among the collaborators, and utilizing a wide range of statistical and methodological expertise including the design, implementation, and analysis of a CPI methodology to assess the extent to which each SCI rehabilitation activity or intervention contributes to medical, functional, and psychosocial outcomes.  Extensive intra- and inter-site training is planned to insure consistent and high quality data collection and adherence to the study methodology.  The lead center, RMRSIS at Craig Hospital, has a 15 year track record of leading NIDRR funded SCI Model System Collaborative research with our longitudinal study of aging with SCI, titled “Lifetime Outcomes and Needs:  Refining the Understanding of Aging with Spinal Cord Injury (H133A011108).  It also has over a 15-year track record of leading international collaborative research with NIDRR/CDC/PVA funding to study long-term outcomes after SCI.  Dr. Whiteneck, the Principle Investigator of the study, has led multiple collaborative studies including current TBI Model System modular research to develop a better measure of participation, and will carry out a similar effort in the SCI Model Systems. Dr. Whiteneck has also led large database projects including the Colorado TBI Registry and Follow-up System.  All of these efforts have required substantial expertise in adherence to research protocols, maintaining data quality, confidentiality, security, and safety.

All of the other participating centers have also demonstrated a capacity to either lead or, be a part of, a multi-site collaborative study of the scope planned here.  In the case of this study, we will incorporate aspects of the pressure ulcer prevention study that is a part of the National Rehabilitation Hospital’s (NRH’s) SCI model system center program (R1).  The NRH team is working with Dr. Horn’s group’s in bringing a CPI approach to help identify the interventions that are associated with pressure ulcer prevention during the rehabilitation process.  Since the same methods apply to both the pressure ulcer study and this larger study, and rely on the same data sources (e.g., nurses, therapists, chart review),  we have elected to embrace the pressure ulcer prevention as part of this larger study that looks at a broader array of rehabilitation interventions and outcomes.

Goal 4: Specify start up activities that will be required to mount the multi-site research project, including infrastructure requirements and measurement tools.  We will address this goal with an efficient, cost-effective process of collaboration regarding the design, implementation, and analysis of this CPI project, using acknowledged experts from all participating sites.  An effective infrastructure is planned to coordinate the efforts of Project Team of more than 75 people which includes the Principal Investigator, two Co-Principal Investigators, the staff at Craig and ICOR, and Co-Investigator(s) and  Lead Clinicians at each of the six SCI facilities.  Two joint meetings and weekly conference calls (some involving all the team and many involving individual disciplines designing the study and data collection) will occur during the first project year when extensive planning and the start of the data collection will occur.  The calls will occur as needed throughout the project and a third meeting will occur when data analysis is available to discuss interpretation and suggest further analysis.  Dr. Horn and her staff at ICOR have assisted many clinical groups through the collaborative CPI process and their recent experience with the PSROP has given them valuable rehabilitation experience.

The priority for the SCIMS MSRP falls under the auspicious of DRRP, which has a priority with three requirements.  The following three goals address these requirements.

Goal 5:  Address the needs of people with disabilities, including individuals from traditionally underserved populations.  The approaches an applicant may take to meet this requirement may include one or more of the following: (1) Proposing project objectives addressing the needs of individuals with disabilities from minority backgrounds. (2) Demonstrating that the project will address a problem that is of particular significance to individuals with disabilities from minority backgrounds. (3) Demonstrating that individuals from minority backgrounds will be included in study samples in sufficient numbers to generate information pertinent to individuals with disabilities from minority backgrounds. (4) Drawing study samples and program participant rosters from populations or areas that include individuals from minority backgrounds. (5) Providing outreach to individuals with disabilities from minority backgrounds to ensure that they are aware of rehabilitation services, clinical care, or training offered by the project. (6) Disseminating materials to or otherwise increasing the access to disability information among minority populations.  TheSCI CPI study includes a total of 1,500 research participants with no inclusion or exclusion criteria that would bias the sample regarding race or ethnicity.  Due to the diversity geographic locations of collaborating centers, it is estimated that the study sample will include individuals with SCI from minority backgrounds.  This number will be adequate not only for including minority status in all analyses as a covariate, but the number will also be adequate for subgroup analysis allowing the testing of whether any study finding also holds for individuals from minority backgrounds.  The Project Team will design research questions and data collection to address minority issues to insure best practices are followed to include minorities with SCI in the research and to collect all data in a culturally appropriate manner.  Dissemination of any study findings that are specific to minorities with SCI will be targeted to relevant minority populations and institutions that serve them.  In these ways, the study will meet the needs of individuals from traditionally underserved populations.           

Goal 6:  Coordinate with the NIDRR-funded Model Systems Knowledge Translation Center (MSKTC) by providing scientific results and information for dissemination to clinical and consumer audiences.  Significant coordination activities are planned with new NIDRR-funded MSKTC to ensure the broadest, most appropriate avenues for dissemination of project findings.  The new MSKTC will be named by the time this proposal is funded and they will be immediately contacted to determine how the project’s dissemination plans fit with MSKTC goals.  The SCI CPI project will alter its dissemination plan if recommended by the MSKTC and we will provide all findings and materials that the MSKTC requests.  We particularly look forward to working closely with the MSKTC to implement an effective consumer dissemination and knowledge translation plan.           

Goal 7:   Ensure participation of individuals with disabilities in all aspects of model systems research.   There are several ways the we will involve individuals with disabilities in our activities, including soliciting input from our respective SCIMS Consumer Advisory Boards; encouraging the participation of individuals with SCI working at the various collaborating sites in the planning, implementation and dissemination processes of the project; and having at least one individual with SCI be a member of the Steering Committee.