Quantifying and Understanding the Signs and Symptoms of Fever
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 10/8/2017 |
| Start Date: | January 13, 2011 |
| End Date: | August 9, 2017 |
Beyond Intuition: Quantifying and Understanding the Signs and Symptoms of Fever
Background:
- Fever is a common symptom of illness, but it can involve many signs (a signal that
something is not right in the body that can be seen by others, such as vomiting) and symptoms
(a signal that something is not right in the body that are felt only by the person, such as
pain) that may differ depending on the type of illness involved. Researchers are interested
in studying individuals who have a fever to examine how often these signs and symptoms are
experienced by patients.
Objectives:
- To identify and evaluate the signs and symptoms of fever and examine their frequency in
individuals who have fever.
Eligibility:
- Individuals at least 8 years of age who are admitted to the NIH Clinical Center and have a
fever (body temperature of at least 38 degrees Celsius/100.4 degrees Fahrenheit).
Design:
- Participants will be screened upon admission to the NIH Clinical Center.
- Researchers will review the Clinical Center admission records.
- Participants will complete a 15- to 20-minute survey with questions about how they are
feeling and what symptoms they have experienced before, during and after an episode of
fever.
- Fever is a common symptom of illness, but it can involve many signs (a signal that
something is not right in the body that can be seen by others, such as vomiting) and symptoms
(a signal that something is not right in the body that are felt only by the person, such as
pain) that may differ depending on the type of illness involved. Researchers are interested
in studying individuals who have a fever to examine how often these signs and symptoms are
experienced by patients.
Objectives:
- To identify and evaluate the signs and symptoms of fever and examine their frequency in
individuals who have fever.
Eligibility:
- Individuals at least 8 years of age who are admitted to the NIH Clinical Center and have a
fever (body temperature of at least 38 degrees Celsius/100.4 degrees Fahrenheit).
Design:
- Participants will be screened upon admission to the NIH Clinical Center.
- Researchers will review the Clinical Center admission records.
- Participants will complete a 15- to 20-minute survey with questions about how they are
feeling and what symptoms they have experienced before, during and after an episode of
fever.
Background:
Fever is one of the most prevalent signs in hospitalized patients, signaling the activation
of the immune system.
There is little empiric evidence related to symptoms or signs that accompany changes in body
temperature.
Understanding the nature, timing and relationship of patient signs and symptoms of fever will
provide insight into the febrile process and guide more informed treatment.
Objectives:
The protocol is divided into two phases:
Phase I
-To develop and implement a simple clinical tool for assessing and documenting
patient-reported signs and symptoms of fever.
Phase II
-To describe the prevalence and relationship of signs and symptoms that accompanies a febrile
state and related patterns of change over time.
Eligibility:
Phase I
- Adult and pediatric medical-surgical patients hospitalized at the Clinical Center
admitted to 3NE (oncology/ transplant), 3NW (surgical oncology) and 1NW (pediatric).
- Age greater than or equal to 8 years old
- Understand and speak English
Phase II
- Inpatients admitted to the Clinical Research Center
- Age greater than or equal to 8 years old.
Design:
Phase I
-Descriptive study involving qualitative interviews and chart reviews from medical surgical
inpatients. Two types of interviews with two different sets of patients will be conducted.
The maximum number of research participants for this phase will be 65. The final sample size
will be determined based on the point of saturation, defined as four consecutive interviews
during which no new signs or symptoms associated with fever are identified. The second set of
interviews will involve 20 to 30 new research participants, including at least 5 patients
less than 18 years of age who will review a list of signs and symptoms of fever for
comprehension and clarity to inform the final list and determine the terminology to be used
in the FAST.
Study of the Febrile Assessment Tool (FAST)
-Test of the FAST in 120 patients. Before placing the FAST in the electronic record (Clinical
Research Information System-CRIS) this new assessment tool will be used in approximately 120
patients during routine vital sign measurements. Patients admitted to the surgical oncology
unit (3NW) will be consented and followed with collection of the FAST assessments
Education Implementation
- Inform nursing staff of the background, content and procedures for using the Febrile
Assessment Tool (FAST)
- Educational interim will last 4 weeks
Phase II
- Approximately 2 months or at the discretion of the PI after FAST education
- Descriptive study involving chart review from unidentified inpatients. The sample size
will be a maximum of 500.
Fever is one of the most prevalent signs in hospitalized patients, signaling the activation
of the immune system.
There is little empiric evidence related to symptoms or signs that accompany changes in body
temperature.
Understanding the nature, timing and relationship of patient signs and symptoms of fever will
provide insight into the febrile process and guide more informed treatment.
Objectives:
The protocol is divided into two phases:
Phase I
-To develop and implement a simple clinical tool for assessing and documenting
patient-reported signs and symptoms of fever.
Phase II
-To describe the prevalence and relationship of signs and symptoms that accompanies a febrile
state and related patterns of change over time.
Eligibility:
Phase I
- Adult and pediatric medical-surgical patients hospitalized at the Clinical Center
admitted to 3NE (oncology/ transplant), 3NW (surgical oncology) and 1NW (pediatric).
- Age greater than or equal to 8 years old
- Understand and speak English
Phase II
- Inpatients admitted to the Clinical Research Center
- Age greater than or equal to 8 years old.
Design:
Phase I
-Descriptive study involving qualitative interviews and chart reviews from medical surgical
inpatients. Two types of interviews with two different sets of patients will be conducted.
The maximum number of research participants for this phase will be 65. The final sample size
will be determined based on the point of saturation, defined as four consecutive interviews
during which no new signs or symptoms associated with fever are identified. The second set of
interviews will involve 20 to 30 new research participants, including at least 5 patients
less than 18 years of age who will review a list of signs and symptoms of fever for
comprehension and clarity to inform the final list and determine the terminology to be used
in the FAST.
Study of the Febrile Assessment Tool (FAST)
-Test of the FAST in 120 patients. Before placing the FAST in the electronic record (Clinical
Research Information System-CRIS) this new assessment tool will be used in approximately 120
patients during routine vital sign measurements. Patients admitted to the surgical oncology
unit (3NW) will be consented and followed with collection of the FAST assessments
Education Implementation
- Inform nursing staff of the background, content and procedures for using the Febrile
Assessment Tool (FAST)
- Educational interim will last 4 weeks
Phase II
- Approximately 2 months or at the discretion of the PI after FAST education
- Descriptive study involving chart review from unidentified inpatients. The sample size
will be a maximum of 500.
- INCLUSION CRITERIA PHASE I:
Adult and pediatric medical-surgical patients hospitalized in the Clinical Center, NIH
admitted to 3NE (oncology/ transplant), 3NW (surgical oncology) and 1NW (pediatrics).
Oriented to person, time and place at time of interview
Active fever (body temperature greater than or equal to 38.0 Celsius), treated or
untreated, within the last 12 hours.
Willingness to participate in a short interview (15-20 minutes) about their symptoms
Understands and speaks English
Age 8 years and older
INCLUSION CRITERIA FOR STUDY OF FEBRILE ASSESSMENT TOOL:
Adult (18 years of age or greater) medical-surgical patients hospitalized at the Clinical
Center and admitted to 3NW.
Oriented to person, time and place at time of admission
Willingness to be asked about their symptoms of fever during vital signs assessment
Understands and speaks English
INCLUSION CRITERIA PHASE II:
Inpatients admitted to the Clinical Center
Age 8 years and older
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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