Chlamydia Females, Gonorrhea Female, Sexually Transmitted Infection
Conditions
Keywords
Rapid turnaround test, RTAT, Gonorrhea, Chlamydia, STI
Brief summary
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.
Detailed description
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.
Interventions
DEVICECepheid Xpert CT/NG Rapid Turnaround Test
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.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants, investigators, and care providers will be masked to the experimental or control arm prior to enrollment in the study. Once the participant has been enrolled in the study, they will be randomized to either the control arm or the experimental arm. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.
Intervention model description
This is a prospective, non-blinded, randomized clinical control trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients age 18-55 * Signs or symptoms consistent with sexually transmitted infection * Medical provider willing to consider the result of the rapid turnaround test in decision to treat for gonorrhea/chlamydia * Must have a urine specimen obtained and a pelvic exam performed as part of the anticipated standard of care evaluation * Provides informed consent
Exclusion criteria
* Signs of systemic infection * Patient in whom the provider is unwilling to consider the result of the rapid turnaround test * Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3 months * Patients undergoing evaluation for sexual assault * Patients that are known to be pregnant or express concern that they may be pregnant * Incarcerated patients * Students/Employees of the facility * Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Treated With Antibiotics | 7 days | Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (Minutes) | 7 days | Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department. |
| Healthcare Costs. | 7 days | Evaluate the effect of utilizing a rapid PCR test on healthcare costs. |
| Average Score for Patient Satisfaction With Provider Explanation. | 7 days | 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. |
| Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed. | 7 days | 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). |
| Average Score for Patient Satisfaction With Overall Experience. | 7 days | 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. |
| Number of Patients That Required Follow-up Care Within 7 Days | 7 days | Compare need for additional healthcare utilization between the groups. |
| Average Score for Patient Satisfaction With Wait Times During Visit. | 7 days | 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. |
| Average Score for Patient Satisfaction With Treatment Effectiveness. | 7 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rapid Turnaround Test Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection. | 30 |
| Usual Care Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection. | 33 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pregnancy | 0 | 1 |
Baseline characteristics
| Characteristic | Rapid Turnaround Test | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 33 Participants | 63 Participants |
| Age, Continuous | 30.3 years | 29 years | 29.6 years |
| Presence of signs or symptoms of STIs | 30 Participants | 33 Participants | 63 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 33 Participants | 63 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 30 participants | 33 participants | 63 participants |
| Sex: Female, Male Female | 30 Participants | 33 Participants | 63 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 33 |
| other Total, other adverse events | 0 / 30 | 0 / 33 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 |
Outcome results
Primary
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
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Turnaround Test | Number of Participants Treated With Antibiotics | 4 Participants |
| Usual Care | Number of Participants Treated With Antibiotics | 10 Participants |
Secondary
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
Population: Patient counts for average satisfaction with overall experience differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rapid Turnaround Test | Average Score for Patient Satisfaction With Overall Experience. | 3.346153846 score on a scale | Standard Deviation 0.561591146 |
| Usual Care | Average Score for Patient Satisfaction With Overall Experience. | 3.275862069 score on a scale | Standard Deviation 0.797162455 |
Secondary
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
Population: Patient counts for average satisfaction with provider explanation differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rapid Turnaround Test | Average Score for Patient Satisfaction With Provider Explanation. | 3.346153846 score on a scale | Standard Deviation 0.745241314 |
| Usual Care | Average Score for Patient Satisfaction With Provider Explanation. | 3.24137931 score on a scale | Standard Deviation 0.872401137 |
Secondary
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
Population: Patient counts for average satisfaction with treatment effectiveness differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rapid Turnaround Test | Average Score for Patient Satisfaction With Treatment Effectiveness. | 3.153846154 score on a scale | Standard Deviation 0.731699812 |
| Usual Care | Average Score for Patient Satisfaction With Treatment Effectiveness. | 3.206896552 score on a scale | Standard Deviation 0.726012118 |
Secondary
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
Population: Patient counts for average satisfaction with wait times differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rapid Turnaround Test | Average Score for Patient Satisfaction With Wait Times During Visit. | 3.038461538 score on a scale | Standard Deviation 0.999230473 |
| Usual Care | Average Score for Patient Satisfaction With Wait Times During Visit. | 2.931034483 score on a scale | Standard Deviation 0.923155864 |
Secondary
Healthcare Costs.
Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
Time frame: 7 days
Population: Heatlhcare cost data was not collected, thus could not be analyzed and reported.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rapid Turnaround Test | Length of Stay (Minutes) | 200.6896552 minutes | Standard Deviation 48.12936692 |
| Usual Care | Length of Stay (Minutes) | 129.6060606 minutes | Standard Deviation 60.9717862 |
Secondary
Number of Patients That Required Follow-up Care Within 7 Days
Compare need for additional healthcare utilization between the groups.
Time frame: 7 days
Population: Total number of participants for this analysis differ from total number of participants in overall study due to difficulty contacting some patients for data collection after initial hospital visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Turnaround Test | Number of Patients That Required Follow-up Care Within 7 Days | 4 Participants |
| Usual Care | Number of Patients That Required Follow-up Care Within 7 Days | 1 Participants |
Secondary
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
Population: Four patients received indeterminate results on either their RTAT or their Usual Care (PCR) tests.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapid Turnaround Test | Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed. | 92.307 percentage of total RTAT + PCR patients |