Integration of Family Planning Services Into Anticoagulation Monitoring Services

• ClinicalTrials.gov Identifier: NCT02773810
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Last Update Posted: August 10, 2018
• Sponsor: Indiana University
• Collaborator: University of Toronto
• Information provided by (Responsible Party): Caitlin Bernard, Indiana University

Study Description

Brief Summary:

Currently there are approximately 400 women of reproductive age enrolled in outpatient monitoring of warfarin therapy through AMS. The investigators do not have any data on the percentage of women who are using family planning, but anecdotally the providers report that it is very low. The investigators believe that an educational intervention with an emphasis on the safest and most effective methods, long-acting reversible contraception (LARC), aimed specifically toward women with medical conditions requiring anticoagulation, combined with on-site provision of LARC can improve uptake of these methods. Ultimately, the use of the most effective methods of contraception will prevent unplanned pregnancy and the unnecessary maternal morbidity and mortality associated with high-risk pregnancies in women with these conditions.

Condition or disease	Intervention/treatment	Phase
Contraception	Other: Integrated Family Planning Services	Not Applicable

Detailed Description:

The investigators' hypothesis is that implementation of an educational intervention emphasizing long-acting reversible contraception (LARC) combined with free on-site provision of LARC within Anticoagulation Monitoring Service (AMS) can improve uptake of these methods by 250% in this population.

Our objectives are to:

1. Determine whether integration of education about and free provision of highly effective long-acting reversible contraceptive methods within Anticoagulation Monitoring Services (AMS) is feasible.
2. Determine whether integration of education about and free provision of highly effective long-acting reversible contraceptive methods within Anticoagulation Monitoring Services (AMS) can improve uptake of long-acting reversible contraceptive methods (IUCDs and contraceptive implants).
3. Determine whether integration of education about and free provision of highly effective long-acting reversible contraceptive methods within an Anticoagulation Monitoring Services (AMS) Clinic can prevent unplanned pregnancies.

The investigators will perform a prospective cohort study of all women of reproductive age seen in Anticoagulation Monitoring Service (AMS). Women who agree to enrollment will undergo our intervention, which will include an educational intervention and free on-site provision of all reversible contraceptive options, including LARC. This educational intervention will be a one-on-one educational session on all available methods of contraception, with an emphasis on the safety and efficacy of long-acting reversible contraception (LARC) and the importance of planning a pregnancy in women with medical conditions requiring anticoagulation. A provider (clinic officer, nurse or physician) trained in family planning counseling and provision will provide all counseling and discussions in Kiswahili. Women will then be offered free, on-site provision of whichever contraceptive method they choose by a trained provider. During the intervention period we intend to capture all women currently actively enrolled in AMS, which is currently approximately 400 women. Each woman generally attends AMS clinic once per month, so the investigators expect that it will take about three months to capture all women at least once. These women will then be followed prospectively over the next one-year time period to evaluate for uptake of a contraceptive method and subsequent pregnancy. The investigators will then compare participants' method of contraception used prior to the intervention and participants' method of contraception used after the intervention. The investigators will specifically evaluate for an increase in the use of IUCDs and contraceptive implants.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 218 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Can Integration of Family Planning Services Into Anticoagulation Monitoring Services Improve Uptake of Long-Acting Reversible Contraception?
• Study Start Date: April 2014
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: March 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: Integrated Family Planning Services; Women who agree to enrollment will undergo our intervention, which will include an educational intervention and free on-site provision of all reversible contraceptive options, including LARC. This educational 5 intervention will be a one-on-one educational session on all available methods of contraception, with an emphasis on the safety and efficacy of long-acting reversible contraception (LARC) and the importance of planning a pregnancy in women with medical conditions requiring anticoagulation. A provider (clinic officer, nurse or physician) trained in family planning counseling and provision will provide all counseling and discussions in Kiswahili. Women will then be offered free, on-site provision of whichever contraceptive method they choose by a trained provider.

Other: Integrated Family Planning Services; Women who agree to enrollment will undergo our intervention, which will include an educational intervention and free on-site provision of all reversible contraceptive options, including LARC. This educational 5 intervention will be a one-on-one educational session on all available methods of contraception, with an emphasis on the safety and efficacy of long-acting reversible contraception (LARC) and the importance of planning a pregnancy in women with medical conditions requiring anticoagulation. A provider (clinic officer, nurse or physician) trained in family planning counseling and provision will provide all counseling and discussions in Kiswahili. Women will then be offered free, on-site provision of whichever contraceptive method they choose by a trained provider.

Outcome Measures

Primary Outcome Measures :

1. Percent of women who have initiated the use of contraception [ Time Frame: 3 months Post-intervention ]
   Proportion of women who initiated contraception after study enrollment

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• All women of reproductive age (age 14 to 50 or menopause) actively enrolled in Anticoagulation Monitoring Service (AMS) during the study timeframe.

Exclusion Criteria:

• Women who are pregnant.
• Women who have had a hysterectomy.
• Women who do not speak Kiswahili.

Contacts and Locations

Sponsors and Collaborators

Indiana University

University of Toronto

Investigators

• Principal Investigator: Caitlin Bernard, MD; Indiana University

More Information

• Responsible Party: Caitlin Bernard, Volunteer Clinical Assistant Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT02773810
• Other Study ID Numbers: 1504431629
• First Posted: May 16, 2016
• Last Update Posted: August 10, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No