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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 : July 14, 2020
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Behavior Behavioral: LARC education and training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Planned Parenthood Federation of America
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01360216    
Other Study ID Numbers: 2010-5442
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Keywords provided by University of California, San Francisco:
Long-acting reversible contraception
Intrauterine contraception
Intrauterine devices
Single-rod implant
Hormonal contraception