Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training
The purpose of the study is to measure whether an education and training intervention for clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will result in greater use of the methods among contraceptive patients.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Cluster, Randomized Trial on Provider LARC Education and Training|
- Proportion of contraceptive patients choosing a LARC method [ Time Frame: Baseline ] [ Designated as safety issue: No ]We are measuring the proportion of patients deciding to use a LARC method at intervention and control clinics in a patient cohort aged 18-25 years (n=1500). We are also measuring with clinic service statistics the proportion of contraceptive patients selecting LARC v. non-LARC methods during the 12 month-period before the intervention and the 12-month period after the intervention, to supplement the analysis with individual patient data.
- Unintended pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]We are measuring unintended pregnancy among contraceptive patients receiving contraceptive counseling at intervention and control clinics (total number 1,500) during a 12 month period.
- Sub-analysis for primary outcome, decision to use LARC method [ Time Frame: Baseline ] [ Designated as safety issue: No ]We will assess the outcome decision to use LARC, by important factors affecting contraceptive methods, including policy variables for contraceptive coverage (Medicaid expansion waiver states, mandates for contraceptive coverage for private insurance), clinic visit type (post-abortion or family planning), pregnancy intentions, mental health and domestic violence, male partner, provider-patient interaction, sociodemographic factors (age, race/ethnicity, education).
- Sub-analyses for pregnancy during 12-month study [ Time Frame: 12 months (Baseline to 12-month Follow-up) ] [ Designated as safety issue: Yes ]We will assess the secondary outcome, pregnancy during 12-month study, by important pregnancy risk variables, including clinic visit type (post-abortion or family planning), pregnancy intentions, mental health and domestic violence, provider-patient interaction, male partner, sociodemographic (age, race/ethnicity, education) and policy variables (Medicaid expansion waiver states, mandates for contraceptive coverage for private insurance).
- Provider LARC knowledge and practices [ Time Frame: Baseline and 12-month Follow-up ] [ Designated as safety issue: No ]We will measure providers' LARC knowledge and practices (discuss LARC methods with contraceptive clients) at baseline and 12-month follow-up, using provider survey data) to assess whether they integrate LARC into standard clinic practice in the intervention arm.
- LARC use over time [ Time Frame: 12 months (baseline to 12 month follow-up) ] [ Designated as safety issue: No ]We will measure patient use of LARC methods with patient data (n=1500) over the course of the study, and assess factors associated with continued use over time, including sociodemographic, reproductive, mental health, and contraceptive policy factors.
|Study Start Date:||May 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: LARC education and training
Clinicians and contraceptive educators practicing in clinics assigned to this arm receive a special half-day Continuing Medical Education (CME/CEU) accredited LARC education and training session.
Behavioral: LARC education and training
A CME/CEU accredited Grand Rounds education and training session will be given to clinicians and contraceptive educators practicing in clinics assigned to the intervention arm. Clinicians will have hands-on training as well. The half-day session emphasizes evidence-based contraceptive counseling and provision.
No Intervention: Standard practice- control
Clinicians and contraceptive educators practicing in clinics assigned to this arm do not receive special LARC training and education session. Standard practice will be followed at clinics assigned to the control arm.
Unintended pregnancy is extremely high in the United States among young women, and use of contraceptives with top-tier effectiveness, intrauterine contraception and implants, is low. Contraceptive providers in the US have low knowledge of current scientific evidence on LARC methods, and do not routinely include these methods in counseling patients at highest risk of unintended pregnancy. This intervention provides evidence-based education and hands-on training to clinicians and contraceptive educators in Planned Parenthood affiliated Title X clinics throughout the US on LARC methods.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360216
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94118|
|Principal Investigator:||Cynthia C Harper, PhD||University of California San Francisco School of Medicine|
|Principal Investigator:||J. Joseph Speidel, MD, MPH||University of California San Francisco School of Medicine|