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

NCT01360216 | Completed

• 1 other identifier: 2010-5442
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception Behavior

Keywords

Long-acting reversible contraception; Intrauterine contraception; Intrauterine devices; Single-rod implant; Hormonal contraception

Outcome Measures

Primary Outcomes (1)

• Proportion of contraceptive patients choosing a LARC method

  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 Outcomes (1)

• Unintended pregnancy

  12 months

Other Outcomes (4)

• Sub-analysis for primary outcome, decision to use LARC method

  Baseline

• Sub-analyses for pregnancy during 12-month study

  12 months (Baseline to 12-month Follow-up)

• Provider LARC knowledge and practices

  Baseline and 12-month Follow-up

Study Arms (2)

LARC education and training

EXPERIMENTAL

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

Standard practice- control

NO INTERVENTION

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.

Interventions

LARC education and training BEHAVIORAL

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.

LARC education and training

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Planned Parenthood Federation of America: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (28)

• Thompson KM, Speidel JJ, Saporta V, Waxman NJ, Harper CC. Contraceptive policies affect post-abortion provision of long-acting reversible contraception. Contraception. 2011 Jan;83(1):41-7. doi: 10.1016/j.contraception.2010.06.008. Epub 2010 Sep 20.

  PMID: 21134502 BACKGROUND

• Harper CC, Blum M, de Bocanegra HT, Darney PD, Speidel JJ, Policar M, Drey EA. Challenges in translating evidence to practice: the provision of intrauterine contraception. Obstet Gynecol. 2008 Jun;111(6):1359-69. doi: 10.1097/AOG.0b013e318173fd83.

  PMID: 18515520 BACKGROUND

• Speidel JJ, Harper CC, Shields WC. The potential of long-acting reversible contraception to decrease unintended pregnancy. Contraception. 2008 Sep;78(3):197-200. doi: 10.1016/j.contraception.2008.06.001. Epub 2008 Jul 9. No abstract available.

  PMID: 18692608 BACKGROUND

• Goodman S, Hendlish SK, Reeves MF, Foster-Rosales A. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception. 2008 Aug;78(2):143-8. doi: 10.1016/j.contraception.2008.03.003. Epub 2008 May 14.

  PMID: 18672116 BACKGROUND

• Goodman S, Hendlish SK, Benedict C, Reeves MF, Pera-Floyd M, Foster-Rosales A. Increasing intrauterine contraception use by reducing barriers to post-abortal and interval insertion. Contraception. 2008 Aug;78(2):136-42. doi: 10.1016/j.contraception.2008.03.008. Epub 2008 Jun 18.

  PMID: 18672115 BACKGROUND

• Kavanaugh ML, Jones RK, Finer LB. How commonly do US abortion clinics offer contraceptive services? Contraception. 2010 Oct;82(4):331-6. doi: 10.1016/j.contraception.2010.04.010. Epub 2010 May 21.

  PMID: 20851226 BACKGROUND

• Kavanaugh ML, Jones RK, Finer LB. Perceived and insurance-related barriers to the provision of contraceptive services in U.S. abortion care settings. Womens Health Issues. 2011 May-Jun;21(3 Suppl):S26-31. doi: 10.1016/j.whi.2011.01.009.

  PMID: 21530835 BACKGROUND

• Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.

  PMID: 17138775 BACKGROUND

• Hladky KJ, Allsworth JE, Madden T, Secura GM, Peipert JF. Women's knowledge about intrauterine contraception. Obstet Gynecol. 2011 Jan;117(1):48-54. doi: 10.1097/AOG.0b013e318202b4c9.

  PMID: 21173643 BACKGROUND

• Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.

  PMID: 20541171 BACKGROUND

• Madden T, Allsworth JE, Hladky KJ, Secura GM, Peipert JF. Intrauterine contraception in Saint Louis: a survey of obstetrician and gynecologists' knowledge and attitudes. Contraception. 2010 Feb;81(2):112-6. doi: 10.1016/j.contraception.2009.08.002. Epub 2009 Sep 16.

  PMID: 20103447 BACKGROUND

• Kittur ND, Secura GM, Peipert JF, Madden T, Finer LB, Allsworth JE. Comparison of contraceptive use between the Contraceptive CHOICE Project and state and national data. Contraception. 2011 May;83(5):479-85. doi: 10.1016/j.contraception.2010.10.001. Epub 2010 Nov 23.

  PMID: 21477693 BACKGROUND

• Fleming KL, Sokoloff A, Raine TR. Attitudes and beliefs about the intrauterine device among teenagers and young women. Contraception. 2010 Aug;82(2):178-82. doi: 10.1016/j.contraception.2010.02.020. Epub 2010 Apr 13.

  PMID: 20654760 BACKGROUND

• Darney P, Patel A, Rosen K, Shapiro LS, Kaunitz AM. Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials. Fertil Steril. 2009 May;91(5):1646-53. doi: 10.1016/j.fertnstert.2008.02.140. Epub 2008 Apr 18.

  PMID: 18423453 BACKGROUND

• Raine TR, Foster-Rosales A, Upadhyay UD, Boyer CB, Brown BA, Sokoloff A, Harper CC. One-year contraceptive continuation and pregnancy in adolescent girls and women initiating hormonal contraceptives. Obstet Gynecol. 2011 Feb;117(2 Pt 1):363-371. doi: 10.1097/AOG.0b013e31820563d3.

  PMID: 21252751 BACKGROUND

• Shelton JD. Risk of clinical pelvic inflammatory disease attributable to an intrauterine device. Lancet. 2001 Feb 10;357(9254):443. doi: 10.1016/S0140-6736(00)04012-5.

  PMID: 11273068 BACKGROUND

• Grimes DA, Lopez LM, Schulz KF, Stanwood NL. Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001777. doi: 10.1002/14651858.CD001777.pub3.

  PMID: 20556754 BACKGROUND

• Allen RH, Goldberg AB, Grimes DA. Expanding access to intrauterine contraception. Am J Obstet Gynecol. 2009 Nov;201(5):456.e1-5. doi: 10.1016/j.ajog.2009.04.027. Epub 2009 Jun 13.

  PMID: 19527902 BACKGROUND

• Deans EI, Grimes DA. Intrauterine devices for adolescents: a systematic review. Contraception. 2009 Jun;79(6):418-23. doi: 10.1016/j.contraception.2008.12.009. Epub 2009 Feb 7.

  PMID: 19442775 BACKGROUND

• Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet. 2000 Sep 16;356(9234):1013-9. doi: 10.1016/S0140-6736(00)02699-4.

  PMID: 11041414 BACKGROUND

• Stanwood NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002 Feb;99(2):275-80. doi: 10.1016/s0029-7844(01)01726-4.

  PMID: 11814509 BACKGROUND

• Postlethwaite D, Shaber R, Mancuso V, Flores J, Armstrong MA. Intrauterine contraception: evaluation of clinician practice patterns in Kaiser Permanente Northern California. Contraception. 2007 Mar;75(3):177-84. doi: 10.1016/j.contraception.2006.10.010. Epub 2007 Jan 16.

  PMID: 17303486 BACKGROUND

• Hubacher D, Vilchez R, Gmach R, Jarquin C, Medrano J, Gadea A, Grey T, Pierre-Louis B. The impact of clinician education on IUD uptake, knowledge and attitudes: results of a randomized trial. Contraception. 2006 Jun;73(6):628-33. doi: 10.1016/j.contraception.2006.02.003. Epub 2006 Mar 29.

  PMID: 16730497 BACKGROUND

• Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzman-Rodriguez R. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001 Aug 23;345(8):561-7. doi: 10.1056/NEJMoa010438.

  PMID: 11529209 BACKGROUND

• Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J. Cost effectiveness of contraceptives in the United States. Contraception. 2009 Jan;79(1):5-14. doi: 10.1016/j.contraception.2008.08.003. Epub 2008 Sep 25.

  PMID: 19041435 BACKGROUND

• Steinberg JR, Adler NE, Thompson KM, Westhoff C, Harper CC. Current and past depressive symptoms and contraceptive effectiveness level method selected among women seeking reproductive health services. Soc Sci Med. 2018 Oct;214:20-25. doi: 10.1016/j.socscimed.2018.08.009. Epub 2018 Aug 13.

  PMID: 30138841 DERIVED

• Rocca CH, Goodman S, Grossman D, Cadwallader K, Thompson KMJ, Talmont E, Speidel JJ, Harper CC. Contraception after medication abortion in the United States: results from a cluster randomized trial. Am J Obstet Gynecol. 2018 Jan;218(1):107.e1-107.e8. doi: 10.1016/j.ajog.2017.09.020. Epub 2017 Oct 3.

  PMID: 28986072 DERIVED

• Gibbs SE, Rocca CH, Bednarek P, Thompson KMJ, Darney PD, Harper CC. Long-Acting Reversible Contraception Counseling and Use for Older Adolescents and Nulliparous Women. J Adolesc Health. 2016 Dec;59(6):703-709. doi: 10.1016/j.jadohealth.2016.07.018. Epub 2016 Sep 21.

  PMID: 27665153 DERIVED

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 25, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)