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. There are a total of 7 inpatient rooms, including one for sleep studies, one that is handicap accessible and there are 7 outpatient exam areas/spaces. Within the GCRC there is a Core Lab and a Metabolic Kitchen. Last year over 24,000 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.
Description of Patient Population
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 2006 was 2-3 days. Outpatient visits vary from 15 minutes to 12 hours. Nursing care is provided for a diverse patient population including, but not limited to the following:
- Alpha-1-antitrysin Deficiency
- Barth Syndrome
- Cardio-vascular diseases
- Congenital lactic acidosis
- Cystic fibrosis
- Diabetes and pre-diabetes
- Gastro-intestinal disease
- Glycogen Storage Disease
- Infectious disease
- Mitochondrial diseases
- Normal Volunteers
- Obsessive Compulsive Disorder
- Orthopedic surgery patients
- Pancreatic insufficiency
- Parkinson’s Disease
- Prader-Willi syndrome
- Rheumatoid arthritis
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 Shands Healthcare system. Currently, scatterbed nurses provide services in the NICU, SICU, L&D, PICU, Obstetrics, Clinic settings, and Shands at AGH.
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”, surgery II patients, patients undergoing gastric manometry testing and overflow non-complex medical-surgical patients.
The Medical Director of the GCRC is an adult endocrinologist who has directed the activities of the GCRC for fifteen years. The 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 four 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 An Administrative Manager and her secretary handle the clerical and administrative issues related to the competitive grant. 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 an clinically experience 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. Four 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.
Nursing responsibilities include assisting with special procedures such as lumbar punctures, bronchoscopies, liver biopsies, 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 (HPNC) is ongoing with specific attention being given to the understanding of the research protocol.
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.
The General Clinical Research Center (GCRC) is staffed by 15 RN FTEs and 2 unit clerk FTEs. The number of Full Time Equivalents (FTE) is determined by the funding source, National Institutes of Health.