Anna-Barbara Moscicki1, Charlene Chang2, Sitaram Vangala3, Xinkai Zhou3, David A Elashoff3, Christine Dehlendorf4, George F Sawaya5, Miriam Kuppermann6, Ysabel Duron7, Fred L Wyand8, Sandy K Navarro9, Heike Thiel de Bocanegra10. 1. Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California. Electronic address: amoscicki@mednet.ucla.edu. 2. Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California. 3. Department of Medicine Statistics Core, School of Medicine, University of California, Los Angeles, California. 4. Department of Family and Community Medicine, University of California, San Francisco, California. 5. Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, California. 6. Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, California; Department of Epidemiology & Biostatistics, University of California, San Francisco, California. 7. Latina Cancer Institute, San Jose, California. 8. National Cervical Cancer Coalition, American Sexual Health Association, Research Triangle Park, North Carolina. 9. Health Informatics, University of California Davis Health, Davis, California. 10. Department of Obstetrics & Gynecology, University of California, Irvine, California.
Abstract
INTRODUCTION: This study sought to determine whether a provider mobile phone application, used with or without a patient educational tool accessed on a computer tablet, would promote adherence to guidelines for cervical cancer screening and management of abnormal cytology in young women. METHODS: The study was conducted as a prospective cohort study in which 14 Family Planning, Access, Care, and Treatment provider clinics were randomized to 1 of 2 arms: (1) provider mobile phone application only or (2) provider mobile phone application plus patient educational tool. The provider mobile phone application gave information to providers regarding cervical cancer screening and management of abnormal cytology. The patient educational tool accessed on a computer tablet was a patient-centered educational tool. Each arm was compared with clinic control groups (no intervention) in a 2:1 ratio (control:intervention). Claims data were used to calculate and compare 18-month cytology (Pap) and colposcopy rates before the intervention and during the 18 months using the Poisson mixed-effect regression model. A sensitivity analysis examined the differences in the rate of change between each arm and controls. The study took place between July 2015 and December 2016, and analysis was performed in 2019. RESULTS: The clinics randomized to the provider mobile phone application plus patient educational tool arm and their control group achieved similar 18-month Pap rates (0.52, 95% CI=0.37, 0.74 and 0.68, 95% CI=0.53, 0.86, respectively) as well as the provider mobile phone application arm and their control group (0.44, 95% CI=0.33, 0.58 and 0.41, 95% CI=0.34, 0.51; p-values >0.1). In the sensitivity analysis, the difference in the rate of change in Pap rates for the provider mobile phone application plus patient educational tool arm and their control group before and during the intervention was -0.22 and -0.09, respectively (p=0.02), but no differences were seen between the provider mobile phone application arm and their control group. No significant changes were observed for colposcopy rates. CONCLUSIONS: Providing clinicians and patients with information on guidelines had no demonstrable effect on 18-month Pap and colposcopy rates in the regression model; however, results from the sensitivity analysis for the patient educational tool were encouraging. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02270021.
RCT Entities:
INTRODUCTION: This study sought to determine whether a provider mobile phone application, used with or without a patient educational tool accessed on a computer tablet, would promote adherence to guidelines for cervical cancer screening and management of abnormal cytology in young women. METHODS: The study was conducted as a prospective cohort study in which 14 Family Planning, Access, Care, and Treatment provider clinics were randomized to 1 of 2 arms: (1) provider mobile phone application only or (2) provider mobile phone application plus patient educational tool. The provider mobile phone application gave information to providers regarding cervical cancer screening and management of abnormal cytology. The patient educational tool accessed on a computer tablet was a patient-centered educational tool. Each arm was compared with clinic control groups (no intervention) in a 2:1 ratio (control:intervention). Claims data were used to calculate and compare 18-month cytology (Pap) and colposcopy rates before the intervention and during the 18 months using the Poisson mixed-effect regression model. A sensitivity analysis examined the differences in the rate of change between each arm and controls. The study took place between July 2015 and December 2016, and analysis was performed in 2019. RESULTS: The clinics randomized to the provider mobile phone application plus patient educational tool arm and their control group achieved similar 18-month Pap rates (0.52, 95% CI=0.37, 0.74 and 0.68, 95% CI=0.53, 0.86, respectively) as well as the provider mobile phone application arm and their control group (0.44, 95% CI=0.33, 0.58 and 0.41, 95% CI=0.34, 0.51; p-values >0.1). In the sensitivity analysis, the difference in the rate of change in Pap rates for the provider mobile phone application plus patient educational tool arm and their control group before and during the intervention was -0.22 and -0.09, respectively (p=0.02), but no differences were seen between the provider mobile phone application arm and their control group. No significant changes were observed for colposcopy rates. CONCLUSIONS: Providing clinicians and patients with information on guidelines had no demonstrable effect on 18-month Pap and colposcopy rates in the regression model; however, results from the sensitivity analysis for the patient educational tool were encouraging. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02270021.