Clinical trial NCT01140022: Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia
Official title: Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chlamydia
Screening
Keywords: Chlamydia, Screening, young women, kiosk, computer module
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2010-06-09
Enrollment: 346
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients 18-25 yo receiving care at urgent care or ED sites.

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Proportion of female patients 18-25yo receiving CT screening during ED or UC visit.
timeFrame: one year prior to the patient's clinic or ED visit.
Secondary outcomes:
measure: Acceptability of module and intervention among patients and staff.
timeFrame: one year prior to the patient's clinic or ED visit.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: CMC Fresno Emergency Department
state: California
city: Oakland
country: United States
facility: Alameda County Medical Center, Highland Hospital
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital - Emergency Department
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital, Urgent Care
state: California
city: San Francisco
country: United States
facility: UCSF Emergency Deparmtent
state: California
city: San Francisco
country: United States
facility: UCSF Screening and Acute Care Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mary-Ann Shafer, MD
role: PRINCIPAL_INVESTIGATOR
References: