The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.
All females ages 18-55 presenting to the University of Maryland Medical Center Emergency Department or Urgent Care whose provider suspects sexually transmitted infection will be offered study enrollment and be randomly assigned to either the control or the experimental group. Both groups will have a urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of the standard PCR. Data will be collected regarding provider decision making, length of stay in the emergency department, patient satisfaction, clinician satisfaction, further healthcare sought by patient, and cost surrounding each treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
64
This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
This is the standard of care for diagnosis of a suspected sexually transmitted infection.
University of Maryland Medical Systems
Baltimore, Maryland, United States
Number of Participants Treated With Antibiotics
Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.
Time frame: 7 days
Length of Stay (Minutes)
Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.
Time frame: 7 days
Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.
Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in subjects that have both performed (Experimental Group).
Time frame: 7 days
Healthcare Costs.
Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
Time frame: 7 days
Average Score for Patient Satisfaction With Provider Explanation.
Evaluate patient satisfaction with provider's explanations for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their provider's explanations on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Time frame: 7 days
Average Score for Patient Satisfaction With Treatment Effectiveness.
Evaluate patient satisfaction with treatment effectiveness for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their treatment effectiveness on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Time frame: 7 days
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Average Score for Patient Satisfaction With Overall Experience.
Evaluate patient satisfaction with overall experience during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Time frame: 7 days
Number of Patients That Required Follow-up Care Within 7 Days
Compare need for additional healthcare utilization between the groups.
Time frame: 7 days
Average Score for Patient Satisfaction With Wait Times During Visit.
Evaluate patient satisfaction with wait times during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Time frame: 7 days