Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cluster, Randomized Trial on Provider LARC Education and Training

Conditions
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Contraception Behavior

Intervention / Treatment
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* Behavioral: LARC education and training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study involves two groups of human subjects: patients and staff at participating Planned Parenthood (PP) clinics in the United States. Patient participants are young women receiving contraceptive counseling at Planned Parenthood clinics and staff participants are the clinicians and health educators serving these women. Patients must be: Female; Age 18-25; Fluent in English or Spanish; Not wanting to become pregnant in the next 12 months; Sexually active in past 3 months; At risk of pregnancy; Received contraceptive counseling; Not pregnant; Willing to be contacted by telephone over the next 12 months. Clinic staff must be: Employed by a participating PP clinic; and Offer clinical care, counseling or education for abortion or contraception at the clinic. (This may include physicians, advance practice clinicians, nurses, social workers and health educators.) For clinics to be eligible to be study sites, they must: Not share staff Have no active LARC interventions ongoing Have >400 clients/year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LARC education and training<br>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<br>* 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.<br>|
| No Intervention: Standard practice- control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of contraceptive patients choosing a LARC method | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unintended pregnancy | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-acting reversible contraception, Intrauterine contraception, Intrauterine devices, Single-rod implant, Hormonal contraception