Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training (LARC)
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|ClinicalTrials.gov Identifier: NCT01360216|
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : September 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Contraception Behavior||Behavioral: LARC education and training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cluster, Randomized Trial on Provider LARC Education and Training|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||August 2013|
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.
- Proportion of contraceptive patients choosing a LARC method [ Time Frame: Baseline ]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 ]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 ]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) ]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 ]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) ]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.
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): 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|