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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01360216

Collaborator

Planned Parenthood Federation of America (Other)

1,500

Enrollment

Location

Arms

Duration (Months)

55.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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.

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

Primary Outcome Measures

Proportion of contraceptive patients choosing a LARC method [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

Unintended pregnancy [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

Sub-analysis for primary outcome, decision to use LARC method [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).
Sub-analyses for pregnancy during 12-month study [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).
Provider LARC knowledge and practices [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.
LARC use over time [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

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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