Comparison of Self-paced Learning Modules with Didactic Classroom Instruction
Randomized Evaluation of Normal Saline Versus Heparin in Groshong (trademark) Catheters
Clinical Evaluation of Different Methods for Endotracheal Tube Fixation
Initial Validation of the Weaning Continuum Model
Anxiety Associated with Magnetic Resonance Imaging Testing
Quality of Life in Myeloablative Versus Non-Myeloablative Bone Marrow Transplant
Quality of Life in HIV Patients Receiving Structured Versus Interrupted Treatment
Quality of Life in Melanoma Patients Receiving Vaccine Alone or Interleukin-2
Quality of Life in Patients with Heart Disease and Left Ventricular Dysfunction
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01115-05 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Comparison of Self-paced Learning Modules with Didactic Classroom Instruction
Principal Investigator:
S. Quint-Kasner, R.N., M.S.N. (Nurse Educator)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
L. Chisholm, R.N., B.S.N., NURS
R. Smith, R.N., O.N.C., NURS
H. Mayberry, R.N., M.S.N., NURS
Collaborating Unit:
None
Staff-Years:
0.005
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: The purpose of this study was to compare the effectiveness of self-paced learning modules with traditional didactic classroom instruction in teaching the Chemotherapy Course. The study randomly assigned consenting nurse participants who were scheduled to attend the course to one of two learning approaches: self-paced or traditional classroom instruction.
Subjects were evaluated with a standardized knowledge test at intervals before and after the assigned learning approach. The time spent by instructors and student subjects to prepare, present, and complete the course was determined. Thirty-two subjects were accrued into this study. Due to slow accrual of subjects an amendment was approved to expand data collection to include an HIV course. Data collection and subject accrual continued slowly. Study was terminated.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01120-05 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Randomized Evaluation of Normal Saline Versus Heparin in Groshong (trademark)
Catheters
Principal Investigator:
D.J. Mayo, R.N., B.S.N. (Research Nurse)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
None
Collaborating Unit:
HS, CP (M.K. Horne, M.D.)
Staff-Years:
0.06
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: Groshong (trademark) catheters are popular venous access devices, in part, because they can be maintained with only weekly saline flushes. Data from a recent study suggested an apparent decrease in the rate of withdrawal occlusion malfunction in Groshong (trademark) catheters flushed weekly with heparinized saline. However, a prospective, randomized trial is required to fully evaluate the differences between flushing with saline only versus flushing with heparinized saline. The study will randomly assign up to 132 subjects to either saline alone or heparinized saline flushes. Comparisons will be made between the groups for frequency of treatment for catheter occlusion with urokinase during the first 3 months of catheterization.
To date, 31 subjects have been accrued for this protocol. Despite the addition of a second data collection site at the National Naval Medical Center, subject accrual remained slow and data collection was stopped. Data analysis is pending.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01125-04 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Clinical Evaluation of Different Methods for Endotracheal Tube Fixation
Principal Investigator:
R. Blauser, R.N., B.S.N. (Clinical Nurse)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
A. Goodwin, R.N., NURS
N. Englar, R.N., O.C.N., NURS
M. Fessler, R.N., B.S.N., NURS
J. Nichols, R.N., A.D.N., NURS
J. Peretti, R.N., NURS
Collaborating Units:
Respiratory Therapy (J. Eide, R.R.T.; L. Gleaton, R.R.T., B.A.
Patient Recruitment and Referral Center (D. Dominguez, R.N., B.S.N.)
Staff-Years:
0.005
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: The purpose of this study was to compare two different methods for securing endotracheal tubes: adhesive tape (Wet-Pruf (trademark)) versus a tube fixation device. Within 4 hours of intubation, adult patients requiring oral intubation will be randomly assigned to one of the two methods of securing endotracheal tubes. The dependent variables, tube stability, skin integrity, patient comfort, nurse satisfaction, cost and family fear associated with the appearance of their loved one's face will be evaluated at fixed intervals for up to 2 weeks. Due to slow accrual of subjects, protocol was amended to allow data to be collected at the National Naval Medical Center.
Data collection continued slowly with 26 subjects accrued. Due to this slow accrual, data collection was stopped and study terminated.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01129-02 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Initial Validation of the Weaning Continuum Model
Principal Investigator:
A.R. Knebel, R.N., D.N.Sc. (Nurse Consultant)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
None
Collaborating Unit:
Suburban Hosp. (C. Spritzer, R.N., M.S.N.)
Staff-Years:
0.1
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: Weaning from mechanical ventilatory support is the process of assisting patients to breathe spontaneously without mechanical ventilation. Despite the development of advanced ventilator technology and the growing literature on weaning, the most advantageous approaches to weaning remain to be determined. The purpose of this study is to test a model of weaning by determining the pattern of physiologic stability, the readiness threshold for weaning and the patterns of ventilator support and weaning progress.
A pilot study in ten subjects will be conducted. Each subject will be followed from time of intubation until a weaning outcome is reached. The revised Burns Wean Assessment Program will be assessed every day to determine the readiness threshold and the pattern of physiologic stability. The weaning progress chart will be completed twice daily to assess the patterns of ventilator support and weaning progress. Receiver operating characteristic curves will be used to determine the readiness threshold. Growth curves will be used to determine patterns in ventilatory support and weaning progress.
Data analysis is in process.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01130-02 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Anxiety Associated with Magnetic Resonance Imaging Testing
Principal Investigator:
J. Davis, R.N., B.S.N. (Research Nurse)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
D. Gaskin, R.N., B.S.N., NURS
C. Miller-Davis, R.N., B.S.N., NURS
S. Marden, R.N., M.S.N., NURS
Collaborating Unit:
Magnetic Resonance Imaging (A. Arai, M.D.)
Staff-Years:
0.1
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: Patients who undergo cardiac magnetic resonance imaging (CMRI) demonstrate signs of anxiety associated with the procedure. Anxiety may affect these individuals' clinical status but the incidence of anxiety associated with this procedure has not been described. The purpose of this study is to examine changes in anxiety, heart rate, blood pressure and respiratory rate in patients who undergo CMRI or Stress CMRI. Subjects complete a simple questionnaire to determine anxiety level pre and post CMRI. Heart rate, blood pressure, and respiratory rate will be monitored before, during and after the CMRI as objective indicators that may change with anxiety. Data will be analyzed using repeated measures analysis of variance.
Forty-one subjects have been accrued to date. An interim analysis is underway.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01131-01 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Quality of Life in Myeloablative Versus Non-Myeloablative Bone Marrow Transplant
Principal Investigator:
S. Marden R.N., Ph.Dc. (Nurse Consultant)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
M. Bevans, R.N., M.S., NURS
P. Rivera, R.N., M.S., NURS
A.J. Barrett, M.D., NHLBI
Collaborating Unit:
None
Staff-Years:
0.06
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: Clinical research in blood stem cell and bone marrow transplantation documents improvements in disease free intervals, disease free survival, and the severity of treatment related toxicities. However, it is important for patients and families to know the quality of life (QOL) they can expect following an allogeneic transplant. The purpose of this study is to describe the QOL experienced by patients undergoing a non-myeloablative allogeneic peripheral blood stem cell transplant and compare to the QOL experienced by patients undergoing a myeloablative transplant.
Patients respond to questionnaires via Touch Screen computers that measure generic and disease specific QOL and symptom distress. The questionnaires are administered prior to transplant and at set intervals post transplant. Data will be analyzed using multivariate techniques.
Twelve subjects have been accrued to date. Data collection and subject accrual continue.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01132-01 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Quality of Life in HIV Patients Receiving Structured Versus Interrupted Treatment
Principal Investigator:
S. Marden, R.N., Ph.Dc. (Nurse Consultant)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
R. McConnel, R.N., B.S.N., NURS
A. Powers, R.N., NURS
M. Loyd, R.N., NURS
C. Campbell, R.N., NURS
J. Lorenz, R.N., NURS
R. Eckes, R.N., B.S.N., NURS
I. Gordon, R.N., NURS
D. Martell, R.N., NURS
M. McLaughlin, R.N., B.S.N., NURS
M. Menigan, R.N., NURS
S. Spisso, R.N., B.S.N., NURS
F. Sundt, R.N., B.S.N., NURS
K. McGilly-Wendal, R.N., NURS
M. Dybul, M.D., NIAID/IR
B. Barrick, R.N., M.S.N., NURS
Collaborating Unit:
None
Staff-Years:
0.15
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: Because of multi-drug regimens known as highly active antiretroviral therapy (HAART), HIV infection can now be considered a chronic, manageable disease for many people in the United States. However, these therapies come with complex medication administration regimens and numerous distressing side effects that may affect a person's quality of life (QOL). The purpose of this study is to evaluate the QOL and symptom distress in individuals receiving continuous (structured) versus intermittent HAART in the treatment of HIV disease.
Individuals respond to questionnaires via Touch Screen computers that measure QOL and symptom distress. The questionnaires are administered at seven time periods during the study. Data will be analyzed using multivariate techniques.
Twenty-five subjects have been accrued to date. Data collection and subject accrual continue.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01133-01 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Quality of Life in Melanoma Patients Receiving Vaccine Alone or Interleukin-2
Principal Investigator:
S. Marden, R.N., Ph.Dc. (Nurse Consultant)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
P. Muelbauer, R.N., M.S.N., NURS
L. McIntyre, R.N., NURS
D. Kulp, R.N., NURS
S. Gantz, R.N., NURS
C. Seipp, R.N., NURS
S. Finkelstein, M.D., NCI
Collaborating Unit:
None
Staff-Years:
0.15
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: The incidence of melanoma is rising faster than any cancer other than lung cancer in women. The primary treatment for melanoma is surgical resection. However, no universally acceptable standard treatment exists for metastatic disease; and, the prognosis of patients with Stage IV melanoma is poor. Therefore, information regarding patients perceptions of the burden imposed by their disease and treatment may enhance treatment decisions. The purpose of this study is to describe the quality of life (QOL) in patients with metastatic melanoma receiving vaccine alone or high dose bolus IV Interleukin-2 or subcutaneous Interleukin-2.
Patients respond to questionnaires via Touch Screen computers that measure generic and disease specific QOL and symptom distress. Questionnaires are administered at three timepoints: prior to, during, and post therapy. Data will be analyzed using multivariate techniques.
Thirty subjects have been accrued to date. Data collection and subject accrual continue.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-01134-01 NURS
October 1, 1999 to September 30, 2000
Title of Project:
Quality of Life in Patients with Heart Disease and Left Ventricular Dysfunction
Principal Investigator:
S. Marden, R.N., Ph.Dc. (Nurse Consultant)
NURS, CC, NIH
Bethesda, MD 20892
Other Personnel:
C. Miller-Davis, R.N., B.S.N., NURS
V. Dilsizian, M.D., NHLBI
Collaborating Unit:
None
Staff-Years:
0.12
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: A majority of the research in patients with chronic ischemic heart disease and left ventricular dysfunction deals with increasing patient survival rates and years. Very little research has focused on patients' perceptions of living with this chronic debilitating disease. The purpose of this study is to assess the quality of life (QOL) and symptom distress experienced by patients with chronic ischemic heart disease and left ventricular dysfunction.
Patients respond to questionnaires that measure generic and disease specific QOL and symptom distress. Questionnaires are administered at three time intervals over a 1-year period. Data will be analyzed using multivariate techniques.
Recruitment of subjects is currently underway.
Index:
Annual Report of Clinical Research Activities FY 2000
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