Randomized Controlled Trial of Structured Contraceptive Counseling in Adult Women

NCT ID: NCT00746993

Last Updated: 2012-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-02-28

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.

Detailed Description

The proposed study will be a randomized controlled trial to evaluate the primary study hypothesis that structured counseling immediately before a first trimester vacuum aspiration procedure will result in more women choosing a highly effective contraceptive method compared to women receiving routine care.

The study population consists of pregnant women seeking a first trimester suction procedure in a single Medicaid-based practice in New York City. We need 125 participants in both the control group and the intervention group for a total of 250 participants. The inclusion criteria for enrollment in the study are (1) age greater than or equal to 18 years,(2) seeking contraception, (3) Spanish or English speaking, (4) access to a telephone, and (5) willing to participate in the study. We recognize that patients may be anxious about their scheduled procedure. Information about the procedure will be available to all patients in our clinic to inform and help alleviate anxiety.

After being consented, all participants will complete the baseline questionnaire. Participants will then be randomized in a 1:1 ratio.

Those randomized to the control group will proceed to routine care. Routine care consists of contraceptive counseling by the clinician performing the vacuum procedure. The clinician will evaluate the medical eligibility of each participant for FDA-approved contraceptive methods as part of routine care. Every clinician in the practice is a faculty member, fellow, or resident physician training under faculty supervision.

Those randomized to the intervention group will engage in structured counseling with the research coordinator, and then proceed to routine care. The structured counseling will take place while the participant would normally be waiting for care. We will pay attention to ensure that study participation does not prolong the clinic visit.

Structured counseling consists of a bilingual research coordinator going through the 2005 Decision Making Tool (D.M.T.) for family planning clients and providers developed by the World Health Organization(W.H.O.). Samples of each FDA-approved method will be present during the structured counseling session for participants to directly see and touch as desired. The link to this freely available counseling tool in English and Spanish is www.who.int/reproductivehealth/publications/dmt/index.html.

For our study, we modified the original version to include only FDA-approved contraceptive methods available in the United States suitable for a post-abortion population. Information about methods not available in the United States(NETEN injections, monthly injections and norplant) was removed. Information about new FDA-approved methods available in the United States (contraceptive patch, contraceptive ring, levonorgestrel IUS, and etonogestrel implant),but not previously included, was added. Information about methods not appropriate for post abortion patients (lactational amenorrhea and fertility awareness) was removed. We performed all modifications with the full support and cooperation of Sarah Johnson, technical officer in the Department of Reproductive Health and Research at the World Health Organization. We have attached our modified version with this application.

All FDA-approved methods will be available to participants on the day of their scheduled procedure for immediate initiation. Participants choosing an intrauterine device or implant will be able to have them placed that day.

Participants choosing depot medroxyprogesterone acetate will be able to have the injection that day. Participants choosing the pill, ring, or patch will receive a one month supply and continuing prescription that day. All participants will receive condoms and information about emergency contraception.

At the end of the visit, we will perform a brief secondary questionnaire. We will ask participants to indicate their chosen FDA-approved method and identify if the method was initiated that day.

Follow-up will take place at three months and six months with phone calls to obtain data from participants about the contraceptive method adopted and the contraceptive method use since enrollment.

Conditions

Contraception

Keywords

Contraception; Counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Structured contraceptive counseling and routine care.

Group Type: EXPERIMENTAL

Structured contraceptive counseling

Intervention Type: OTHER

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

2

Routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Structured contraceptive counseling

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

Intervention Type: OTHER

Other Intervention Names

Family Planning Decision Making Tool

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Carolyn L. Westhoff

Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Westhoff, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAD5101

Identifier Type: -

Identifier Source: org_study_id