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

July 9, 2020 updated by: University of California, San Francisco

Cluster, Randomized Trial on Provider 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline
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).
12 months (Baseline to 12-month Follow-up)
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.
Baseline and 12-month Follow-up
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.
12 months (baseline to 12 month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Planned Parenthood Federation of America

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (ESTIMATE)

May 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-5442

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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