Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
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: August 7, 2012
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 20, 2011 | ||||||||
| Last Updated Date | August 7, 2012 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of contraceptive patients choosing a LARC method [ Time Frame: 12 months before intervention & 12 months afterward ] [ Designated as safety issue: No ] We are 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01360216 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 1,600) during a 12 month period. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training | ||||||||
| Official Title ICMJE | Cluster, Randomized Trial on Provider LARC Education and Training | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Contraception Behavior | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 1500 | ||||||||
| Estimated Completion Date | April 2013 | ||||||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: This study involves two groups of human subjects: patients and staff at participating Planned Parenthood 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;
Clinic staff must be:
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| Gender | Female | ||||||||
| Ages | 18 Years to 25 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01360216 | ||||||||
| Other Study ID Numbers ICMJE | 2010-5442 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | Planned Parenthood Federation of America | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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