# Developing a Point of Access for SCI Research at Roper Ms. Cathy Therrell, MSN, RN, NEA-BC
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1 # Developing a Point of Access for SCI Research at Roper Ms. Cathy Therrell, MSN, RN, NEA-BC Project Goals and Aims: The stated goals of the SCIRF funded project are 1) to develop a research infrastructure with the Roper Rehabilitation Hospital Center for Spinal Cord Injury clinical setting, and 2) to utilize the infrastructure to enroll participants into a clinical research database that will interface with existing surveillance and database programs within the SCIRF and state SCI research community. The primary aim of this study was to establish a long-term, prospective, patient database to collect and store comprehensive clinical, laboratory, and psychosocial data from patients with spinal cord injury (SCI) who receive care at the Center for Spinal Cord Injury. The secondary aim of this study was to develop a well-characterized pool of participants with SCI who are interested in participating in future research on SCI and who have provided consent to be contacted regarding research participation. Establishing a viable and sustainable infrastructure: In Charleston persons with SCI had no medical care options that addressed the unique clinical needs of the Spinal Cord Injury community. The Lowcountry was in need of a medical home for these persons with a multidisciplinary team approach and with a team who had expertise in spinal cord injury. The majority of persons needing this service were unfunded or underinsured making the viability and sustainability of a program difficult. Roper Rehabilitation Hospital opened the Center for SCI in July 2011 to meet this unmet need. Before a research protocol or database could be initiated, a place for patients to received multidisciplinary care had to be established and had to be financially sustainable for the future. Infrastructure development timeline: Opened the Center for first patient July 2011 Began endowment development July 2011 Submitted and received nine grants for operations July 2011 to December 2014 and for equipment/ services Hired board-certified physiatrist with subspecialty July 2013 in SCI Established fully-funded endowment to operate December 2014 the Center one day per month indefinitely Obtained CARF accreditation December 2014 Early on the Center staff identified that the non-clinical needs of the persons treated were much greater than anticipated to include basic requirements for medications, transportation, wheelchairs, cushions, ramps, and psychological support. Meeting these basic needs of the persons served was paramount to building a strong infrastructure to support the research aims. Completed patient-generated action items: Obtain grants for operations and for July 2011 to December 2014 equipment/ services totaling $692,500 Partner with MUSC to offer a basic seating May 2012 clinic mentorship Offer speech therapy and recreational therapy March 2013 services during the Center operation Partner with Carolinas to offer counseling May 2013 services during the Center operation Complete a formal peer mentoring program August 2013 Build ramps for patients unable to leave their July 2011 to December 2014 homes- 32 built in 23 cities Offer a driving program March 2014
2 Development of the database and pool of research participants: After reviewing patient charts and clinical team member documentation, most often done in a narrative note, we determined that the nursing assessment was the most strategic means to capture comprehensive, structured clinical data in a busy clinical setting. However, a generic inpatient nursing assessment form was in use; thus, we developed a comprehensive nursing assessment form, relevant to the clinical concerns of persons with SCI, based on the Spinal Outreach Service Health Questionnaire (SOS-HQ; Mann, Middleton, & Leong, 2007). The assessment collects clinical information on: SCI diagnosis and history, general health including psychological variables, bladder, bowel, autonomic dysreflexia, skin, spasticity, pain, cardiovascular health, respiratory health, musculoskeletal and neurological function, and sexual function. We collaborated with CSCI nursing staff to tailor the SOS-HQ to meet clinical assessment needs. The initial version of the tailored form proved to be unfeasible to complete during a clinic visit, so again collaborating with the nursing staff, the form was revised to prioritize information collected. Patients are requested to fill out the entire form as a new patient and again at annual follow-up visits. Specific sections of the form can be completed separately for patients who are seen more frequently for specific complaints, i.e. a 3-month visit for evaluation of a pressure ulcer. Data presented in this report reflects completed annual assessments for the 87 database participants. The nursing assessment data collection form was replicated in a REDCap longitudinal database. A study management database contains all participant identifiers to facilitate identifying those participants who would like to be notified about other SCI research studies. A separate study data database was built to contain de-identified longitudinal clinical data. The Research Project Coordinator received training in the use of REDCap for participant data entry and assumed responsibility for tracking clinic patients who are database participants and for updating database records after clinic visits. Gaining regulatory approval for implementation of the database protocol from two IRBs proved to be a time-consuming effort. During this time, MUSC IRB experienced staffing shortages leading to longer than usual review time. MUSC is currently the IRB of record and all reports and continuing reviews are sent to the Roper IRB. Timeline for regulatory approvals: Research Project Coordinator hired part-time February 2012 Research Project Coordinator hired full-time May 2012 Database protocol submitted to Roper IRB August, 2012 Roper IRB approval of database protocol September 5, 2012 Database protocol submitted to MUSC IRB September 12, 2012 MUSC IRB approval of database protocol January 9, 2013 Cooperative agreement (IAA) between MUSC and Roper IRB approved April 9, 2013 First participant consented June 4, 2013 Participants were recruited from patients who presented to the Center for Spinal Cord Injury. An IRB approved flyer on the database was included in packets of information sent to patients before their clinic visits. Recruitment occurred by face-to-face contact during the clinical appointment. Four CSCI staff, including two Peer Mentors, completed the University of Miami CITI training in human subjects protections. We trained the clinic s Peer Mentors to notify patients about the database study during clinic visits and to obtain informed consent for database participation. We found that the Peer Mentors were highly effective in finding time to meet with patients between clinicians, in explaining the database to patients and in gaining their informed consent for participation.
3 OUTCOMES: Database Participants: We consented and enrolled 87 patients for database participation. All but two agreed to future contact for other SCI-related research studies. We maintain contact information for participants wishing to receive information on other studies and mail flyers for studies as requested by other investigators. The Research Project Coordinator facilitated dissemination of information about other SCI-related research studies to clinic patients. She has coordinated with investigators at the MUSC Center for Rehabilitation Research in Neurological Conditions and the MUSC College of Nursing to provide information to clinic patients about current studies. Three investigators (Newman, DiPiro, Gregory) have successfully recruited study participants from the CSCI patient population for their research protocols. Demographic and Injury characteristics of database participants are represented in Table 1. Table 1. Demographic and Injury characteristics: Selected clinical and psychosocial characteristics: Other injuries at time of SCI: Approximately 35% of participants reported other injury at the time they sustained their SCI. Of these, nine report traumatic brain injury (TBI) representing a pool of individuals with dual diagnoses of SCI and TBI. Other commonly reported injuries included limb fractures and organ injury.
4 Rehabilitation received: The vast majority of patients reported receiving rehabilitation after SCI with approximately 50% reporting both inpatient and outpatient rehabilitation. Only 4% reported no rehabilitation. Primary locations for receiving rehabilitation included Shepherd Center and Roper Rehabilitation Hospital. Employment: The vast majority of participants report that they are currently unemployed (76.3%); however, 33% of those reporting unemployment expressed a desire to return to work. CSCI case manager facilitates referrals to Vocational Rehabilitation as needed. Psychological: Difficulty sleeping and unexplained fatigue were commonly reported psychological issues (Figure 1). Have difficulty falling or staying asleep Feel nervous tense, worried or panicked Feel that everything was an effort Feel depressed, hopeless or worthless Feel tired or lacking energy for no good reason Missing Most of the time Some of the time Never/A little Figure 1. Psychological characteristics Pain: 83% of participants reported regularly experiencing pain, and 54% indicate that pain interferes with activities of daily living or social activities. Participants most frequently described burning pain. Only 15% report ever being referred to a pain clinic. Bladder: Spontaneous voiding (35%) and clean intermittent catheterization (35%) were the most frequently reported methods of bladder management. Approximately 25% used a suprapubic catheter. 56% reported that they were independent with their bladder management routine. 48% of participants reported having a UTI requiring treatment with antibiotics in the past twelve months. 60% report having seen a urologist. Bowel: Spontaneous evacuation, suppository, and digital stimulation were the most commonly reported bowel management methods. 51% of participants reported complete independence with bowel management. Constipation (46%) was the most frequently reported recent GI issue. 11% of respondents indicate bowel problems stopped them from going out. Spasticity: 85% of participants report experiencing spasms or spasticity, occurring most commonly in the lower extremities. Position changes were the most frequently reported trigger for spasticity. Baclofen was the most commonly reported medication used to manage spasms. Skin: 43% report having a pressure ulcer in the past, with 14% reporting that hospital admission was required for management of the past pressure ulcer. 17% reported a current pressure ulcer. Stage I and II ulcers were most commonly reported.
5 Stage I Stage II Stage III Stage IV Figure 2. Current Pressure Ulcer stage 84% report that they or their caregiver inspects their skin regularly, and 81% report performing regular pressure reliefs. Of those reporting regular pressure reliefs, 39% reported doing a relief every minutes, 33% reported every 1-2 hours, and 11% reported 3-4 times a day. 50% reported being linked to a seating service. MUSC Seating and Mobility Clinic was reported as being the most common service accessed followed by the Center for Spinal Cord Injury. Laboratory data: Commonly collected labs include: BUN and Creatinine, Hemoglobin (Hgb) and Hematocrit(Hct) (H&H), Serum Glucose, TSH, and Testosterone. A noted trend is the frequency of slightly low H&H values across participants of both genders, though these are most likely not clinically significant. To decrease costs for patients, blood work is drawn only on patients who have not had recent lab work ordered by their primary care physician. CONCLUSIONS: All project goals and aims were met related to the building of infrastructure and processes to support the development of a research database at the CSCI. Eighty-seven persons with SCI agreed to participate in the database. The majority of database participants expressed an interest in future research participation thus establishing a pool of potential participants for SCI research. Analysis of data collected to date helped to identify several areas for future improvements in meeting the needs of the CSCI patient population. Those areas include working with vocational rehabilitation to assist with return to work, improving access to rehabilitation services for newly injured persons, and improving pain management issues. Additional identified needs of persons seen at the Center included support for obtaining equipment, medication, ramps, etc. Overall, the needs were overwhelming, thus we sought and obtained additional grant funding to support our efforts to address these basic patient needs. In summary, development of the CSCI database has supported optimizing clinic performance based on patient needs and has provided a foundation to support future research efforts to address these needs. Reference: Mann, L, Middleton, JW, Leong, G. (2007). Fitting disability into practice: focus on spinal cord injury. Australian Family Physician, 36(12),
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