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Completed

NCT Number: NCT01360216

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.

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Key information

Conditions

Contraception Behavior Behavior Reproductive Behavior

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LARC education and training

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Planned Parenthood Federation of America

Registry information

Official study title

Cluster, Randomized Trial on Provider LARC Education and Training

Acronym: LARC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 25, 2011
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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