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

This study has been completed.
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01360216
First received: May 20, 2011
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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 Intervention
Contraception Behavior
Behavioral: LARC education and training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cluster, Randomized Trial on Provider LARC Education and Training

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Proportion of contraceptive patients choosing a LARC method [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • Unintended pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Sub-analysis for primary outcome, decision to use LARC method [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 1500
Study Start Date: May 2011
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360216

Locations
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
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

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01360216     History of Changes
Other Study ID Numbers: 2010-5442
Study First Received: May 20, 2011
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Long-acting reversible contraception
Intrauterine contraception
Intrauterine devices
Single-rod implant
Hormonal contraception

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014