General Clinical Research Center
The General Clinical Research Center (GCRC) is a 10-bed inpatient/outpatient unit supported by a grant from the National Institute of Health via a competitive grant renewal process. The unit occupies 9,400 sq. ft. on the third floor of UF Health Shands Hospital. Facilities in the unit include outpatient exam spaces, administrative offices, a data services lab, an exercise physiology room, and a special procedure room equipped to do complex exams such as bronchoscopy and gene therapy. There are a total of 7 inpatient rooms, including one for sleep studies and one that is handicap accessible. There are 7 outpatient exam areas/spaces. Within the GCRC there is a Core Lab and a Metabolic Kitchen. Last year over 72,000 research specimens per year were collected, prepared, and analyzed for Principle Investigators in the Specimen Preparation Laboratory. The Metabolic Kitchen provides calculated diets as needed for specific protocols. A patient lounge/activity room provides space for the Arts-In-Medicine (AIM) program available to our research participants. The Data Services Lab (DSL), a multi-use computer facility, provides statistical and computer support for all GCRC investigators and their staff.
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The General Clinical Research Center has provisions for conducting research on all age groups from neonates to geriatrics. The average length of stay for inpatients in 2009 is 2-3 days. Outpatient visits vary from 15 minutes to 12 hours in length. Nursing care is provided for a diverse patient population including, but not limited to the following:
- Alpha-1-antitrysin Deficiency
- Diabetes and pre-diabetes
- Mitochondrial diseases
- Congenital lactic acidosis
- Cardio-vascular diseases
- Rheumatoid arthritis
- Parkinson’s Disease
- Barth Syndrome
- Glycogen Storage Disease
- Pompe Disease
- Renal Disease
- Gastro-Intestinal Disease
- Cystic Firbrosis
- Pancreatic Insufficiency
- Infectious Disease
- Prader-Willi Syndrome
- Obsessive Compulsive Disorder
- Lebers Congenital Amaurosis
- Aphthous Stomatitis
- Periodontal Disease
Studies are also conducted on patients who are not housed on the GCRC. “Scatterbed” RN’s provide research services Monday through Friday from 0800 until 1600 for inpatients and outpatient through the UF Health system. Currently, scatterbed nurses provide services in the NICU, SICU, L&D, Mother Baby and Clinic settings.
Hospital “C” category boarders are housed and cared for on the GCRC when space and staff are available. Patient population that are frequently boarded on the GCRC include: post-partum patients, cystic fibrosis patients who are hospitalized for “tune-ups”, patients undergoing gastric manometry testing and overflow non-complex medical-surgical patients.
Nursing responsibilities include assisting with special procedures such as bronchoscopies, conscious sedation and analgesia monitoring. Nurses are also responsible for understanding all aspects of the research protocols. Nurses on the GCRC routinely administer and monitor investigational drugs and perform pharmacokinetic studies. Proficiency in IV skills and core lab procedures is required. Education of patients and their families as described in the Hospital Plan for Nursing Care is ongoing with specific attention being given to the understanding of the research protocol.
Patient assignments are based on the following:
- Experience of staff
- Acuity of patient care determined by protocol
- Studies requiring 1:1 research nursing care
- Previous days assignment to provide continuity of care
The Nurse Manager, or in her absence, the Clinical Nurse Leader will make decisions regarding increasing or decreasing staff according to patient census and acuity.
Nurses-to-patients ratios on the unit vary according to patient acuity. High intensity protocols, such as protocols requiring administration of investigational drugs and pharmacokinetics, may require 1:1 nursing care. Other inpatient and outpatient protocols may require a lower nurse to patient ratio.
NIH (National Institute of Health) guidelines require GCRC staff to cover their own sick calls, vacation, etc. In essence, the GCRC functions as a closed unit. Staff members are flexible in changing their hours, days off, and working overtime as required to adequately staff the unit. The need for overtime is determined by the Nurse Manager, or in her absence, the Clinical Nurse Leader.
The Medical Directors of the GCRC are a Pediatric Endocrinologist and an Adult Pulmonologist. Investigators and their staff provide 24 hour a day routine medical care, with appropriate in-house adult and pediatric house staff providing emergent coverage. Multidisciplinary, comprehensive care of patients and families on GCRC is provided by medicine, nursing, social work services, case management, pastoral care, food and nutritional services, pharmacy, rehab services, cardiopulmonary services, and other health care providers as indicated by the patient’s health status and identified needs. A full-time research dietitian, one diet technician and three cooks who assist with all patients’ nutritional needs staff the GCRC metabolic kitchen. Specific requirements for metabolic studies involving constant diets are addressed by that group. Two full-time, laboratory technicians are employed in the GCRC specimen preparation laboratory, headed by the director of the Core laboratory functions of GCRC. Nursing staff assume the technician’s duties when they are unavailable thus offering 24 hour a day specimen prep service to the investigators. The Research Patient Advocate assists participants in research protocols to access their full range of rights and responsibilities.
Nursing management for the unit includes a registered nurse with a Baccalaureate degree in the position of Nurse Manager and a clinically experienced Clinical Coordinator. Unit staff is made up of registered nurses and clerks. Staff nurses assume responsibility for charge nurse duties on a rotational basis. Unit based committees such as CQI, procedure committee, and other task forces are established as required. Research Nursing staff function in accordance with the unit-based job description, as described in the Hospital Plan for Nursing Care. They must demonstrate a positive attitude toward family-centered care and have the ability, willingness, and interest to work with all ages of patients. Five nurses are certified as Clinical Research Coordinators.
Unit clerks meet the basic requirements for their position and function in accordance with their unit based job description, as described in the Hospital Plan for Nursing Care. In addition, day shift clerks schedule patient visits, and evening shift clerks do data entry for NIH productivity program.