Randomized Controlled Trial of Structured Contraceptive Counseling in Adult Women

NCT00746993 | Completed

• 1 other identifier: AAAD5101
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

In the United States, highly effective methods of birth control are often not used. Healthcare providers use birth control counseling and patient education as ways to increase the usage of birth control. However, little evidence exists to show that patient education and birth control counseling changes birth control use. We want to evaluate the effectiveness of using a uniform set of birth control information to provide birth control education to women having an early pregnancy termination. The counselors will allow the clients to both read as well as hear the information. We propose to evaluate whether this counseling will lead to 1) more women choosing highly effective nonpermanent birth control methods and 2) more women continuing to use these methods for a longer time. Women in the study will complete a questionaire about their health. Half of them will have the structured counseling and half will have the routine counseling currently offered to women as a part of their routine care. We will contact all study participants with a telephone call three months and six months later to have a 10 minute conversation about what birth control they are using.

Conditions

Contraception

Keywords

Contraception; Counseling

Outcome Measures

Primary Outcomes (1)

• Choice of contraceptive method on day of enrollment.

  Day of enrollment

Study Arms (2)

1

EXPERIMENTAL

Structured contraceptive counseling and routine care.

Other: Structured contraceptive counseling

2

NO INTERVENTION

Routine care.

Interventions

Structured contraceptive counseling OTHER

Uniform set of visual information about contraception which a counselor will read out loud with each participant and answer questions.

Also known as: Family Planning Decision Making Tool

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• seeking contraception
• Spanish or English speaking
• has access to a telephone
• willing to participate in the study

You may not qualify if:

• age less than 18 years
• not fluent in English or Spanish
• not able to have access to a phone
• not seeking contraception

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

• Carolyn Westhoff, MD, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2010
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

US (1)