Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221351
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-09-19
Brief Title:
C-reactive Protein CRP-Guided Management Algorithm for Adults With Acute Cough
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Randomized Controlled Trial of a C-reactive Protein CRP-Guided Management Algorithm for Adults With Acute Cough Illness in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We aim to evaluate the impact of a CRP-guided management algorithm for adults with acute cough illness More specifically we will examine both process of care and clinical outcomes
1 Processes of care ie chest x-rays ordered antibiotic treatment length-of-time in the ED We hypothesize that CRP-guided management will be associated with a decrease in the antibiotic prescription for acute cough illness from 50 percent to 30 percent
2 Clinical outcomes ie duration of illness any return visit return visit with a diagnosis of pneumonia hospitalization subsequent antibiotic use satisfaction with care We hypothesize that there will be no difference in the proportion of patients feeling back to normal within 2 weeks of their ED visit for acute cough illness about 60 percent 95 confidence interval50 to 70 percent
1 Processes of care ie chest x-rays ordered antibiotic treatment length-of-time in the ED We hypothesize that CRP-guided management will be associated with a decrease in the antibiotic prescription for acute cough illness from 50 percent to 30 percent
2 Clinical outcomes ie duration of illness any return visit return visit with a diagnosis of pneumonia hospitalization subsequent antibiotic use satisfaction with care We hypothesize that there will be no difference in the proportion of patients feeling back to normal within 2 weeks of their ED visit for acute cough illness about 60 percent 95 confidence interval50 to 70 percent
Detailed Description:
We have developed a CRP-guided management algorithm based on recent studies in which the accuracy of CRP for identifying patients with pneumonia was confirmed1011 Importantly these 2 studies each confirmed that CRP levels provide additional diagnostic support beyond that gained from application of clinical prediction rules In the proposed study we will recommend that physicians first assess the probability of pneumonia based on clinical findings in accordance with current practice recommendations as follows 1 Low Clinical Suspicion 5 probability of pneumonia Absence of fever T38C tachycardia HR100 or tachypnea RR24 and normal chest examination These patients should receive symptomatic therapy and do not require CXR or antibiotic treatment 2 High Clinical Suspicion 30 probability of pneumonia At least 1 abnormal vital sign and abnormal chest examination These patients receive CXR and antibiotics based on CXR findings or high clinical suspicion 3 Intermediate Clinical Suspicion 5-30 All others Current practice guidelines recommend considering CXR in these patients however no further guidance is provided for the management of these patients
After assessing the clinical probability of pneumonia CRP levels will be provided for a random subset of patients A CRP level 10 mgL corresponds with a very low probability of bacterial pneumonia Thus for patients with low and intermediate-probability of pneumonia based on clinical grounds a CRP 10 mgL should confirm that no CXR or antibiotics are necessary in routine cases See attached algorithm A CRP level 100 mgL corresponds with a substantially elevated probability of pneumonia Thus for patients with low and intermediate-probability of pneumonia based on clinical grounds a CRP 100 mgL would support CXR ordering and for patients with high clinical suspicion antibiotic therapy should be considered regardless of the CXR result since studies show that CXR misses about 10 of community-acquired pneumonia confirmed with follow-up CXR or chest computed tomography Overall the addition of CRP test results would reduce the need for CXR ordering and antibiotic therapy in cases with an intermediate clinical probability of pneumonia and a low CRP level and increase the need for CXR ordering and possibly antibiotic therapy in cases with intermediate or high clinical probability of pneumonia and a high CRP level In this way we hypothesize that the CRP-guided management algorithm will improve the proportion of patients with acute cough illness who receive appropriate diagnostic and therapeutic interventions in the ED
We suspect that most patients with clinically apparent pneumonia will have high CRP levels However pneumonia can be a difficult diagnosis to make when patients present with atypical clinical manifestations eg the elderly or COPD patients or in practice settings where radiography is not readily available In these settings the addition of CRP testing may help identify a small number of pneumonia cases that might otherwise go undetected and result in delays in appropriate care In the large number of patients with intermediate probability of pneumonia such as adults with acute cough illness who have abnormal vital signs but normal examinations particularly in RSV and influenza season a CRP level 10 mgL could provide clinically significant reassurance to refrain from further testing or empiric antibiotic treatment A normal CRP level may also provide support to clinicians who are receiving pressure from patients to prescribe antibiotics when they are not clinically indicated Indirect or future benefits to society are possible if research results show that CRP-guided management strategies can decrease the costs of health care
Randomization using a random number generator will be conducted by investigators at the data coordinating center Philadelphia PA and results placed in sequentially number study packets The study personnel that enroll patients will be blinded to the randomization result until after the patient has provided informed consent to participate in the study
Interventions
Staff Educational Seminar Prior to beginning the study all staff will be informed about the performance characteristics of CRP in adults with acute cough illness and current clinical practice recommendations regarding evaluation and treatment of acute cough illness particularly acute bronchitis
CRP-Guided Algorithm Study subjects randomized to the CRP-guided management algorithm will have a point-of-care CRP test performed shortly after triage using a finger-stick specimen The result along with a printed management algorithm for interpreting the CRP level see Appendix will be placed in the chart The general guidelines for interpreting CRP levels will be as described above
Human Subjects Procedures
Recruitment and Initial Contact Method As described above appropriate patients will be referred to study personnel by the triage nurse Initial contact and informed consent will be conducted in a discrete manner and in a private setting
Informed consent Will be obtained from study personnel that have been trained in Human Subjects Protection The time involved for the research subject in obtaining informed consent is about 10 minutes
CRP measurement A finger-stick blood test will be performed using the NycoCard II Reader Axis-Shield Norway See testing instrument description in Appendix The US FDA has approved the diagnostic test kit as one of moderate complexity for these specific circumstances The CRP test will not be billed to the patient The time involved for the research subject in performing the CRP test is about 10 minutes
Chart abstraction The Chart Abstraction instrument will resemble that used in the baseline periods 1103-204 and 1104-205 of the currently IRB-approved study with the following modification except that we will also abstract findings from the physical examination portion of the medical record relating to the chest examination
Telephone follow-up survey Study subjects will be contacted by telephone 2-4 weeks following their emergency department visit by trained research staff using the same telephone survey instrument used in the baseline period already approved The time involved for the research subject in completing the telephone survey is about 10 minutes
After assessing the clinical probability of pneumonia CRP levels will be provided for a random subset of patients A CRP level 10 mgL corresponds with a very low probability of bacterial pneumonia Thus for patients with low and intermediate-probability of pneumonia based on clinical grounds a CRP 10 mgL should confirm that no CXR or antibiotics are necessary in routine cases See attached algorithm A CRP level 100 mgL corresponds with a substantially elevated probability of pneumonia Thus for patients with low and intermediate-probability of pneumonia based on clinical grounds a CRP 100 mgL would support CXR ordering and for patients with high clinical suspicion antibiotic therapy should be considered regardless of the CXR result since studies show that CXR misses about 10 of community-acquired pneumonia confirmed with follow-up CXR or chest computed tomography Overall the addition of CRP test results would reduce the need for CXR ordering and antibiotic therapy in cases with an intermediate clinical probability of pneumonia and a low CRP level and increase the need for CXR ordering and possibly antibiotic therapy in cases with intermediate or high clinical probability of pneumonia and a high CRP level In this way we hypothesize that the CRP-guided management algorithm will improve the proportion of patients with acute cough illness who receive appropriate diagnostic and therapeutic interventions in the ED
We suspect that most patients with clinically apparent pneumonia will have high CRP levels However pneumonia can be a difficult diagnosis to make when patients present with atypical clinical manifestations eg the elderly or COPD patients or in practice settings where radiography is not readily available In these settings the addition of CRP testing may help identify a small number of pneumonia cases that might otherwise go undetected and result in delays in appropriate care In the large number of patients with intermediate probability of pneumonia such as adults with acute cough illness who have abnormal vital signs but normal examinations particularly in RSV and influenza season a CRP level 10 mgL could provide clinically significant reassurance to refrain from further testing or empiric antibiotic treatment A normal CRP level may also provide support to clinicians who are receiving pressure from patients to prescribe antibiotics when they are not clinically indicated Indirect or future benefits to society are possible if research results show that CRP-guided management strategies can decrease the costs of health care
Randomization using a random number generator will be conducted by investigators at the data coordinating center Philadelphia PA and results placed in sequentially number study packets The study personnel that enroll patients will be blinded to the randomization result until after the patient has provided informed consent to participate in the study
Interventions
Staff Educational Seminar Prior to beginning the study all staff will be informed about the performance characteristics of CRP in adults with acute cough illness and current clinical practice recommendations regarding evaluation and treatment of acute cough illness particularly acute bronchitis
CRP-Guided Algorithm Study subjects randomized to the CRP-guided management algorithm will have a point-of-care CRP test performed shortly after triage using a finger-stick specimen The result along with a printed management algorithm for interpreting the CRP level see Appendix will be placed in the chart The general guidelines for interpreting CRP levels will be as described above
Human Subjects Procedures
Recruitment and Initial Contact Method As described above appropriate patients will be referred to study personnel by the triage nurse Initial contact and informed consent will be conducted in a discrete manner and in a private setting
Informed consent Will be obtained from study personnel that have been trained in Human Subjects Protection The time involved for the research subject in obtaining informed consent is about 10 minutes
CRP measurement A finger-stick blood test will be performed using the NycoCard II Reader Axis-Shield Norway See testing instrument description in Appendix The US FDA has approved the diagnostic test kit as one of moderate complexity for these specific circumstances The CRP test will not be billed to the patient The time involved for the research subject in performing the CRP test is about 10 minutes
Chart abstraction The Chart Abstraction instrument will resemble that used in the baseline periods 1103-204 and 1104-205 of the currently IRB-approved study with the following modification except that we will also abstract findings from the physical examination portion of the medical record relating to the chest examination
Telephone follow-up survey Study subjects will be contacted by telephone 2-4 weeks following their emergency department visit by trained research staff using the same telephone survey instrument used in the baseline period already approved The time involved for the research subject in completing the telephone survey is about 10 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IMPAACT- AHRQ VAMC | None | None | None |