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Address correspondence to: Sarah M. Wood, MD, MSHP, Craig Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA 19104; Phone: (267) 258-5894
Craig A Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PennsylvaniaDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PennsylvaniaPolicyLab, Children's Hospital of Philadelphia, Philadelphia, PennsylvaniaDepartment of Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania
Craig A Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PennsylvaniaDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PennsylvaniaDepartment of Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania
To determine the impact of a multicomponent quality improvement (QI) intervention on Chlamydia trachomatis screening for young women in primary care.
Observational cohort analysis.
Urban primary care site providing adolescent primary and confidential sexual health care.
Female adolescents aged 15-19 years.
From December 2016 to April 2018, we designed and implemented a multiphase QI intervention. The final intervention, beginning March 2017, consisted of the following at all adolescent well visits: (1) dual registration for well and confidential sexual health encounters; (2) urine collection during the rooming process; and (3) electronic health record-based prompts for chlamydia screening.
Main Outcome Measures
Annual chlamydia screening rates before and after the intervention, with a goal of achieving a relative increase of 10%.
There were 1550 well adolescent encounters from December 2016 to April 2018. The preimplementation chlamydia screening rate among 15- to 19-year-old female adolescents was 312/757 (41.2%) (95% confidence interval, 20.9%-61.5%). Postintervention, this increased to 397/793 (50.0%) (95% confidence interval, 28.6%-71.5%; P < .001). The clinic chlamydia test positivity rate remained stable, at 10.7% and 11.1% in the pre- and postintervention periods, respectively. There was no significant change in median visit length in the pre- (79.2 minutes; interquartile range, 59.5-103.3) and postintervention periods (80.4 minutes; interquartile range, 61.7-102.8; P = .63).
This practice-based QI intervention resulted in a statistically significant 21% relative increase in annual Chlamydia trachomatis screening rates among female adolescents, without lengthening median visit time.
Despite significant health risks, chlamydia infection is often asymptomatic, leading to delays in diagnosis in the absence of routine screening. Previous studies have shown that asymptomatic, routine screening might lead to reductions in the prevalence of pelvic inflammatory disease.
Therefore, the Centers for Disease Control and Prevention, the US Preventative Services Task Force, American Academy of Pediatrics, and American College of Obstetrics and Gynecology have issued guidelines recommending routine, annual screening of all sexually active women younger than 25 years of age.
Compared with other providers, pediatricians have the lowest rates of screening. The National Ambulatory Medical Care Survey identified that only 0.9% of pediatrician visits for 15- to 21-year-old women had chlamydia testing performed.
In a review of primary care records of 1 large pediatric hospital system, only 21% of routine adolescent well visits had a documented sexual history and only 2.6% were tested for CT within the preceding year.
These findings indicate a critical need for efforts to improve adherence to chlamydia screening guidelines in pediatric and adolescent primary care.
Previous quality improvement (QI) interventions aiming to improve chlamydia screening have shown mixed efficacy for interventions focusing on provider education and increasing access to emergency department or expedited outpatient sexual health services.
Chlamydia and gonorrhea diagnosis, treatment, personnel cost savings, and service delivery improvements after the implementation of express sexually transmitted disease testing in Maricopa County, Arizona.
However, few QI interventions have been specifically linked to the pediatric primary care context, particularly in high-risk chlamydia prevalence areas. In addition, although there is some evidence that QI interventions might improve chlamydia case detection,
the effect of improving adherence to screening guidelines on chlamydia prevalence rates remains unknown.
The primary goal of our intervention was to increase CT screening rates for young women receiving well-adolescent care in a high chlamydia prevalence region. Secondary goals included identifying the effect of the intervention on chlamydia test positivity rates, and identifying the effect of the intervention on visit length.
Materials and Methods
The intervention occurred at an urban, pediatric and adolescent primary care clinic located in West Philadelphia. The clinic is affiliated with a nearby academic tertiary care hospital within a robust primary care network. The clinic has approximately 30,000 visits per year, and 50% of well-visit attendees are adolescents. Eighty percent of patients have Medicaid insurance, and the patient mix is overwhelmingly African American. Clinical services are provided by a multidisciplinary team consisting of medical assistants, nurses, certified registered nurse practitioners (CRNPs), and physicians. At project initiation, the clinic had 12 attending physicians and 2 CRNPs.
In addition to general pediatric and adolescent care, the clinic provides confidential adolescent sexual health services through a Title X grant-funded family planning (FP) program. Adolescents can register for general medical services and/or FP services when scheduling or at visit registration. In FP encounters, the electronic health record (EHR) contains additional privacy protections and no bills are sent to the home.
The intervention target population was 15- to 19-year-old female adolescents attending annual primary care visits during the study period of January 2016 to April 2018. The preintervention period spanned from January 2016 to February 2017. The postintervention period was from March 2017 to April 2018.
All clinic multidisciplinary staff, including nurses, registrars, and medical assistants were involved in the initial intervention design meetings and implementation process. The core QI implementation team included the clinic medical director (A.M.), 1 adolescent medicine physician from the clinical site (M.W.), an attending physician (K.C.), and a third-year fellow (S.M.W.) from the primary institution's Division of Adolescent Medicine. Consultative support was provided through the institution's Office of Clinical Quality Improvement. All clinic providers and staff were eligible to participate in the intervention and participating physicians could receive Part 4 Maintenance of Certification (MOC) credit from the American Board of Pediatrics.
In accordance with institutional standards, this study was considered QI rather than research, and was deemed exempt from Institutional Review Board oversight.
We used an existing institutional improvement framework (Supplemental Fig. 1) derived from Lean Six Sigma methodology,
including the phases define, diagnose, test, implement, and sustain to develop a multicomponent QI intervention to improve chlamydia screening among 15- to 19-year-old female adolescents. A pilot intervention at a separate West Philadelphia clinic had shown short-term gains in screening rates, and served as the model for this intervention.
we developed an intervention objective that was specific, measurable, achievable, relevant, and time-bound: to achieve a relative 10% increase in the proportion of 15- to 19-year-old females screened for chlamydia infection at or within 1 year of their annual well-visit by 10% over a 1-year period. The relative increase of 10% was chosen on the basis of feasibility data from a partner clinic showing a similar relative increase in screening after a pilot QI intervention.
We used all female adolescents receiving well care as the denominator, rather than those with documented history of sexual activity, because sexual histories are frequently incomplete or missing in the pediatric EHR, and strategies for determining sexual activity from additional features of the EHR might still lead to underestimation of sexual activity.
to identify a ceiling threshold testing rate after which increases in screening in female adolescents might no longer be efficacious.
Phase 1: Baseline Assessment
In the first phase of intervention development (January 2016), confidential surveys were administered to site clinicians to identify gaps in knowledge and self-efficacy around chlamydia screening. Questions included knowledge of screening guidelines and regional chlamydia prevalence, and assessed self-efficacy in confidential sexual history-taking and discussing positive results. Answers were provided on a 5-point Likert scale ranging from “strongly agree” to “strongly disagree” (Fig. 1).
Phase II: Staff Education
In the second phase, the team held a multidisciplinary, staff education session to improve knowledge and cultivate a culture of change among staff, including clinicians, nurses, medical assistants, and patient services representatives. The session content included screening guidelines, local prevalence, complications associated with chlamydia infection, current clinic screening rates, and potential targets for improving screening rates.
Phase III: Process Mapping
In the third phase, with support from one of the hospital's QI advisors, the multidisciplinary staff completed a process mapping activity to detail the clinic's preintervention chlamydia screening practice and identify areas for intervention. The preintervention screening process and targeted areas for improvement (in dark gray) are shown in Figure 2. Before the intervention, urine collection for chlamydia nucleic acid amplification testing (NAAT) occurred after confidential sexual history-taking.
Phase IV: Intervention Model Optimization
In the final phase, the team developed the model for intervention. A protocol was developed for universal urine collection for adolescent patients at the time of vital signs and before provider interview. Although the intervention target was 15- to 19-year-old female adolescents, the urine collection protocol was designed for all adolescents to facilitate fidelity. The final intervention, deployed in March 2017, consisted of the following components: (1) dual registration of all adolescents for well and FP encounters to streamline confidential STI test-ordering by advanced practice providers and nurses; (2) medical assistants providing labeled specimen cups to all adolescents before history and physical exam; (3) clinic room signage informing families that urine would be routinely obtained from all adolescents; (4) EHR-based prompts for ordering of chlamydia testing on the basis of confidential sexual history-taking (Fig. 3).
Study of the Intervention
To capture intervention effect on a near real-time basis, we developed a clinical application using a commercial business intelligence platform (Qlik, Radnor, PA), which continually captured chlamydia test ordering from the data warehouse that captures our EHR data (Epic Systems, Verona, WI). The application displayed STI test-ordering in electronic run charts which were made available to the QI team throughout the process. Data were reviewed weekly by the project leader, and at bimonthly meetings of the study team. In these meetings, data were reviewed to make iterative revisions to the intervention using the Plan-Do-Study-Act cycle process. Run charts showing current screening rates were sent to the entire clinic team on a monthly to bimonthly basis to encourage sustained behavior change.
Our primary outcome metric was the proportion of 15- to 19-year-old female adolescents attending annual well-visits who received chlamydia testing at or within 1 year before their well visit, with a goal of achieving a relative increase of 10%. Well-visit encounters were identified using International Classification of Diseases codes corresponding to annual pediatric preventative visits. Receipt of chlamydia testing was assessed via ordered and completed testing within the 365 calendar days before all well-visits in the observation period. Our baseline measurement period was January 2016 through February 2017 (preintervention). The postintervention measurement period was March 2017 through April 2018 to capture the a priori defined 12-month period to reach goal and an additional 2 months of follow-up to assess continued fidelity to the intervention.
Secondary outcome measures included the chlamydia test positivity rates postintervention. Because some patients received multiple chlamydia screenings in a year and/or had multiple episodes of chlamydia, this was calculated on the case, rather than the individual level (eg, cases identified/screening assays sent), with a different denominator than detailed in the screening outcome metric. Balancing measures included staff participation in the QI process; registration time, defined as time from patient check-in to first vital signs; and visit length, defined as the time of patient registration to the time to printing of the visit summary.
Results of the baseline provider survey and demographic characteristics of clinic patients were summarized via descriptive statistics. The time series analysis of pre- and postintervention screening rates were assessed via the p-chart, a type of statistical process control chart using the binomial distribution, with the following criterion used to determine positive special cause variation due to changes in the process: 8 or more values above the baseline mean.
Additionally, the equality of the pre- and postintervention screening rates were assessed using the Pearson χ2 test. As balancing measures, we compared the time from visit registration to visit vital signs, as well as total visit length for the pre- and postintervention periods using Wilcoxon rank sum testing because the data were non-normally distributed. Statistical significance was set at P < .05.
Between January 2016 and April 2018, there were 1550 well-visit encounters among 1190 unique female adolescents. The overall descriptive characteristics of the clinic sample are shown in Table 1. The patient population during the observation period was overwhelmingly African American, with most patients having Medicaid insurance.
Table 1Characteristics of Patient Encounters (n = 1550)
Before the intervention, n = 12/14 (85%) of providers completed the screening knowledge survey. Overall, median scores fell in the “strongly agree” category for questions regarding local chlamydia prevalence, self-efficacy around confidential sexual history-taking, electronic health record documentation, lab ordering, and delivery of results suggesting a high level of competency in these domains. The only item for which the median score fell below the “strongly agree” category was the question assessing knowledge regarding chlamydia screening guidelines for adolescents, where the median score was in the “agree” category. With respect to clinician participation, 9/12 (75%) of attending physicians claimed MOC credit for participation. Although the clinic CRNPs (n = 2) could not obtain MOC credit, which is available to physicians only, both attended and participated in QI meetings, for a total provider participation rate of 11/14 (78%).
In QI core team meetings, we reviewed barriers and facilitators to implementation through the Plan-Do-Study-Act process to refine the intervention. For example, we identified that specimens were not consistently packaged for laboratory transport after ordering. This was ameliorated by creating a work flow in which laboratory technologists ensured that nurses had appropriately packaged specimens for all patients for whom urine testing had been ordered. In addition, patients were not consistently being registered for well and FP encounters. To facilitate rapid dual registration, a system was developed in which charts were flagged within the EHR to alert patient service representatives that an FP encounter was needed.
Chlamydia Screening Rates
For the preintervention period, the mean annual chlamydia screening rate among 15- to 19-year-old female adolescents presenting for well-visits was 41.2% (95% confidence interval, 20.9%-61.5%), representing 312 screenings among 757 visits. Postimplementation, there was a statistically significant increase in screening rate to 50.0% (95% confidence interval, 28.6%-71.5%), representing 397 screenings among 793 visits (P = .001; Fig. 4). This represents a relative 21% increase from the baseline screening rate, exceeding the established goal of a 10% increase in screening of the baseline 41.2% rate. Although rates overall improved, increased variability in screening rates was noted in the summer and early fall, before and after the intervention. In review by the QI leadership team, it was determined that this was likely because of provider vacations and the influx of new general pediatric residents into the clinic, which might have increased competing time and training demands on the clinic's attending physicians. Despite this variation, the statistical process control methodology showed 12 values above the baseline mean in the postintervention period, confirming that the change in chlamydia screening rates before and after the intervention was not because of “normal” variation but because of a deliberate or planned change.
The proportion of positive chlamydia NAATs in the preintervention period among 15- to 19-year-old female adolescents receiving chlamydia screening at the clinic was 10.7% (n = 144 cases and 1350 screenings). The chlamydia positivity rate after the intervention remained relatively stable, at 11.1% (146 cases and 14320 screenings).
Registration Time and Visit Length
Registration data were available for 1419/1550 (92%) of the patient visits. The median time from arrival at the registration desk to first vital signs was 8 minutes (interquartile range, 4-16) before and after the intervention. Visit length data were available for 1503/1550 (97%) of visits. The preintervention period visit length was 79.2 minutes (interquartile range, 59.5-103.3). The postintervention visit length was 80.4 minutes (interquartile range, 61.7-102.8). There was no statistically significant difference in registration time (P = .59) or visit length (P = .63) before and after the intervention.
This practice-based QI intervention to improve chlamydia screening in adolescent young women resulted in a statistically significant 21% relative increase in routine chlamydia screening in a high chlamydia prevalence clinic. Our data show that practice-based QI interventions can be an important tool in improving chlamydia screening in populations at highest risk of chlamydia infection.
A central component of our intervention was universal urine collection before clinician history and physical. In a meta-analyses by Taylor et al., automatic collection of urine specimens as part of routine visits was identified as a moderately to highly effective and low-cost intervention to improve STI screening rates.
Our data reaffirm this finding, and provide additional support on how to implement this change in routine pediatric care. Other strengths of our intervention, and likely contributors to a higher than anticipated level of success, included the involvement and engagement of all levels of multidisciplinary clinical staff, the use of process mapping to identify site-specific barriers to facilitators of screening before intervention development, and the use of practice feedback to motivate ongoing behavior change. Provider education has been a mainstay of previous QI interventions to improve STI screening.
In addition to provider education, we used several strategies to enhance provider engagement, including providing MOC credit and sending screening run charts to the clinic staff to motivate ongoing behavior change. The strategy of providing continuing education credit has been demonstrated to improve human papillomavirus vaccination coverage in our network as well, and should be considered in future QI interventons.
and are similar to the effect sizes identified in other recent screening interventions in the pediatric and adolescent clinical setting. We identified challenges in implementation largely related to role definition and work flow. No intervention is without potential strategic costs, and the gains in screening achieved in this high-risk population likely offset the challenges in changing work flow. Importantly, we found no statistically significant difference in length of visit time in the pre- and postintervention periods, suggesting that there was no loss in clinically efficiency as a result of the intervention.
Our findings have strengths and limitations. The intervention site was a combined primary care and FP clinic with Title X funding, which allowed for confidential service delivery. Clinical sites without integrated sexual health services might face more extensive challenges to confidentiality management. However, many of the components of our intervention, including universal urine collection, provider education, and EHR optimization can be tailored to general pediatric practices. With respect to confidentiality, because most Medicaid plans do not send out explanation of benefits statements that could inadvertently disclose testing, in many settings confidential service delivery is possible even without Title X funding. The intervention site serves a population that is largely homogenous with respect to race and socioeconomic status. However, clinic patients, who are primarily African American and low-income, represent the population most disproportionally affected by chlamydia in the United States. This is highlighted by the fact that in Philadelphia, the prevalence of chlamydia among adolescent girls ages 15-19 years is approximately 7%
; our test positivity rate was 11%. Thus, our data show that our intervention model can work in high-risk settings, where the effect might be greatest. Our study design did not include a control site, because of the fact that similar chlamydia screening QI work had been previously attempted at the network clinic with the closest age, race, and payer patient match. Last, our data did not allow us to determine whether individual patients were sexually active and instead used an ecologic approach using background rates of sexual activity in the local population. Because rates of sexual activity among female adolescents did not increase nationally during the study period, we would not expect an increase in sexually active young women presenting to care at the clinic to lead to our results.
The lack of standardized tools for identifying sexual activity within electronic health records remains an ongoing challenge in adolescent health services research. A recent study by Tao et al. showed substantial discrepancies in estimates of sexual activity in young women between self-report, Medicaid claims data, and Healthcare Effectiveness Data and Information Set (HEDIS) definitions.
Because sexual history information was not included in our data tracking process, we could not determine whether absence of screening was because of provider nonadherence to guidelines, deferral of testing in non-sexually active patients, cancelled tests, screening at another clinical site, or patient refusal. However, our final screening rate of 50% is still below the likely proportion of sexually active young women seen at the clinical site, because of the 57% rate of sexual activity of African American high school-aged female adolescents in Philadelphia,
suggesting that lack of sexual activity was not the sole reason for nonscreening. In the future, health systems might consider requiring documentation in the EHR for reasons for not performing guideline-based testing to systematically identify reasons for nonscreening in key populations.
In conclusion, we used practice-based universal urine collection, provider education and feedback, and EHR-based utilities to successfully improve chlamydia screening rates within a high chlamydia prevalence pediatric primary care clinic. Our intervention development and implementation processes were designed to be replicable, and might serve as a template for diffusion of the intervention to additional pediatric and adolescent care sites.
Funding for the investigator's effort was provided through National Institute of Mental Health F32 MH111341 (PI: Wood) and the Children's Hospital of Philadelphia Research Institute K23 Readiness Award (PI: Wood).
The authors acknowledge the efforts of Maura Powell, The Office of Clinical Quality Improvement, Priya Dhar, MD, Caroline Salas-Humara, MD, and the clinical care providers and staff at the Children's Hospital of Philadelphia Care Network Cobbs Creek Care Primary Care Clinic.
Chlamydia and gonorrhea diagnosis, treatment, personnel cost savings, and service delivery improvements after the implementation of express sexually transmitted disease testing in Maricopa County, Arizona.