Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia
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| ClinicalTrials.gov Identifier: NCT01140022 |
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Recruitment Status :
Completed
First Posted : June 9, 2010
Last Update Posted : October 3, 2014
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Sponsor:
University of California, San Francisco
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
University of California, San Francisco
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Brief Summary:
The purpose of this study is to conduct a quality improvement intervention to improve the ability of health care providers to deliver an important preventive health service (CT screening) in order to meet the goal of universal CT screening for young women age 25 or younger as recommended by the CDC and virtually all major health organizations. This novel approach utilizes a bilingual (English-Spanish) computer kiosk module to deliver education about CT and allow patients to request a CT screening test. This module should significantly increase CT screening among at risk women (18-25yo) attending urgent care clinics and emergency departments.
| Condition or disease | Intervention/treatment |
|---|---|
| Chlamydia Screening | Other: CT Screening |
Chlamydia trachomatis (CT) remains epidemic among sexually young adult and adolescent females especially ethnic minority women. Despite recommendations for at least annual screening of all sexually active women up to age 25, CT screening rates remain low. Most young women do not regularly attend primary care clinics where preventive care such as CT screening should be done; and clinicians lack time and comfort to address CT screening during the context of an urgent care or emergency department visit. This proposed study takes advantage of a "missed opportunity" for screening these at-risk young women for CT when they come in contact with the health care system during an urgent care or emergency department visit. The purpose of this study is to conduct a quality improvement intervention, to improve the ability of health care providers to deliver an important preventive health service (CT screening) in order to meet the goal of universal CT screening recommended by virtually all major health organizations. CT screening should be done as a routine part of health care but currently is not. In this study, we will help providers do what they should already be doing using this novel health care delivery approach. In this study, we created and are evaluating a bilingual (English-Spanish) computer kiosk module to increase CT screening among at risk English and Spanish speaking women (18-25 yo) attending urgent care clinics and emergency departments (ED). This computer technology will be able to conduct many of the steps necessary for CT screening including assessing clients' CT risk and prompting the client and health care professionals for CT urine specimen collection. This study will also examine the extent to which this computer kiosk module intervention use is acceptable and feasible among both English and Spanish speaking young women, and health care professionals who care for them in urgent care and ED settings. This type of intervention to improve CT screening is potentially translatable to a wide variety of health delivery settings as it is not dependent on staff time, motivation or skill to assess sexual history in the busy urgent care setting. This project also supports current recommendations of Healthy People 2010, the U.S. Preventive Services Task Force and other professional organizations to screen all sexually active young adult females at least annually for CT to address this important public health problem especially among our young ethnic minority women who carry the largest STI disease burden. Early detection through routine CT screening coupled with appropriate treatment of CT infections can eliminate widespread infection and prevent such major reproductive morbidity.
| Study Type : | Observational |
| Actual Enrollment : | 346 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia |
| Study Start Date : | September 2007 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | July 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Chlamydia Infections
| Group/Cohort | Intervention/treatment |
|---|---|
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Female Patients 18-25 yo
Female patients aged 18-25 who have come to one of the ED or urgent care sites for care, regardless of the presence of CT symptoms.
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Other: CT Screening
Patients will use a kiosk module that will provide information about CT screening and assess their risk for CT. Patients choosing to get a CT screening will receive a printout instructing the provider or nurse to collect a urine sample for CT screening. |
Primary Outcome Measures :
- Proportion of female patients 18-25yo receiving CT screening during ED or UC visit. [ Time Frame: one year prior to the patient's clinic or ED visit. ]
Secondary Outcome Measures :
- Acceptability of module and intervention among patients and staff. [ Time Frame: one year prior to the patient's clinic or ED visit. ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 25 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Female patients 18-25 yo receiving care at urgent care or ED sites.
Criteria
Inclusion Criteria:
- English or Spanish speaking
- Medically Stable
- Sexually active
- Female
- 18-25 years old
- Seeking health services in participating urgent care clinics and ED in San Francisco/Bay Area, California.
Exclusion Criteria:
- Clients who do not speak English or Spanish will not be eligible to participate.
- Males of any age because there is no CDC recommendation to universally screen this group.
- Women who have never had sexual intercourse are not eligible as this is a study of how to increase screening for chlamydia, a sexually transmitted infection.
- For Kiosk, clients with moderate and major trauma or illness requiring immediate medical intervention, as assessed by triage nurse as part of routine protocol, will be excluded from participation.
- Anyone who chooses not to participate (as this is voluntary) will be excluded from participation.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140022
Locations
| United States, California | |
| CMC Fresno Emergency Department | |
| Fresno, California, United States, 93701 | |
| Alameda County Medical Center, Highland Hospital | |
| Oakland, California, United States, 94602 | |
| San Francisco General Hospital - Emergency Department | |
| San Francisco, California, United States, 94110 | |
| San Francisco General Hospital, Urgent Care | |
| San Francisco, California, United States, 94110 | |
| UCSF Emergency Deparmtent | |
| San Francisco, California, United States, 94143 | |
| UCSF Screening and Acute Care Clinic | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
HRSA/Maternal and Child Health Bureau
Investigators
| Principal Investigator: | Mary-Ann Shafer, MD | University of California, San Francisco |
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01140022 History of Changes |
| Other Study ID Numbers: |
H1095-31344 |
| First Posted: | June 9, 2010 Key Record Dates |
| Last Update Posted: | October 3, 2014 |
| Last Verified: | October 2014 |
Keywords provided by University of California, San Francisco:
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Chlamydia, Screening, young women, kiosk, computer module |
Additional relevant MeSH terms:
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Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female |