Patient-Centered Support for Contraceptive Decision-Making

NCT ID: NCT02078713

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 786 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-10-31

Brief Summary

The investigators have designed a tablet-based decision support tool to help women learn more about their birth control options and support them in choosing a method they are happy with. The investigators will test whether the decision support tool helps women choose a birth control method they can continue using successfully by having some women use the tool before their birth control-related visit to a health care provider, and some women not use the tool before their visit. The investigators will then follow up with all the women at four months and seven months after their visit to see if they are still using the birth control method they chose at the visit and how happy they are with the method.

Hypotheses:

1. Women who use the contraceptive decision support tool will be more likely to continue using their chosen method at 4 and 7 months follow-up, compared to women who receive usual care.

2. The contraceptive decision support tool will increase women's knowledge, choice of, and use of highly effective reversible contraception, compared to usual care.

3. The contraceptive decision support tool will decrease decision conflict, compared to usual care.

4. The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care.

5. Women who use the contraceptive decision support tool will have fewer unintended pregnancies during the follow-up period, compared to women who received usual care.

6. The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care.

7. The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction.

8. Women using the tool will be more likely to report use of any moderately or highly effective method of contraception at 4 and 7 months follow-up, compared to women not using the tool.

Detailed Description

The impacts of unintended pregnancy include adverse maternal and infant outcomes for women who continue their pregnancies, with higher rates of infant low birth weight, infant mortality, and maternal mortality and morbidity for these pregnancies as compared to planned pregnancies. In addition, children resulting from unplanned pregnancies have been found to be more likely to experience developmental delay.

Over the past several decades, the proportion of unintended pregnancy in the United States has remained stubbornly high at approximately 50%. Each year, one in 20 women of reproductive age experiences an unintended pregnancy, and it is estimated that over half of women will have an unintended pregnancy in their lifetime. This high rate of unintended pregnancy in the United States places a heavy burden on both women and the health care system. A disproportionate amount of this burden is experienced by minority women and women of lower socioeconomic status. Given the high rate of unintended pregnancies in this country, interventions designed to help women achieve their fertility goals could have a substantial impact on their health outcomes and life course. In addition, identifying strategies that are appropriate for use in high-risk, diverse populations could address disparities in women's ability to plan their pregnancies.

The investigators propose a cluster randomized trial to investigate the effect of an interactive, tablet-based contraceptive decision support tool that women will use immediately prior to their contraceptive counseling visits. The goal of the tool is to facilitate shared decision-making between the woman and her health care provider, with the ultimate goal of helping the woman to choose a contraceptive method that is consistent with her values and preferences, and is therefore best suited to helping her to avoid an unplanned pregnancy. The tool will be available in both English and Spanish.

The investigators will measure the tool's effect on women's contraceptive continuation, as well as on their experience of contraceptive counseling, measured both quantitatively and qualitatively. In addition, the investigators will collect quantitative and qualitative data to determine the impact of the implementation of this tool on the experiences of providers and the clinics in which they work.

Conditions

Contraception; Contraceptive Behavior

Study Design

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

Study Groups

Contraceptive Decision Support Tool

Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.

Group Type: EXPERIMENTAL

Contraceptive Decision Support Tool

Intervention Type: BEHAVIORAL

The decision support tool:

• Provides an educational session about different aspects of contraception
• Elicits patient preferences about different aspects of contraception
• Identifies potential contraindications to certain contraceptive methods
• Allows the patient to view details about and compare available contraceptive methods
• Suggests methods most appropriate based on the patient's preferences
• Collects questions the patient may have for her provider
• Generates a printout the patient can bring to her contraceptive counseling visit

Usual Care (Control)

Patients in this arm will receive usual family planning care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Contraceptive Decision Support Tool

The decision support tool:

• Provides an educational session about different aspects of contraception
• Elicits patient preferences about different aspects of contraception
• Identifies potential contraindications to certain contraceptive methods
• Allows the patient to view details about and compare available contraceptive methods
• Suggests methods most appropriate based on the patient's preferences
• Collects questions the patient may have for her provider
• Generates a printout the patient can bring to her contraceptive counseling visit

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patients

• Women of reproductive age (15-45)
• Wish to discuss starting or changing a contraceptive method during their visit
• Speak, read, and understand English or Spanish (Note: for the pre- and post-intervention audio recording phases, only patients who can speak, read, and understand English easily will be enrolled.)
• History of sexual activity with men

Providers

• Provide contraceptive counseling in one of the participating clinics
• Plan to remain in job role for at least six months

Clinic staff

• Work at one of the participating clinics
• Had a job that included patient contact, but did not solely consist of family planning counseling at the time of the implementation of the intervention

Exclusion Criteria

Patients

• Previously enrolled in the study
• Previously used the decision support tool at the Women's Community Clinic in San Francisco
• Are unable to get pregnant
• Appointment reason is for insertion of IUD or contraceptive implant
• Currently pregnant
• Desire pregnancy currently or in the next seven months (Note: The last criterion is designed to ensure we will have limited numbers of women that will discontinue their contraceptive methods during the study due to planning a pregnancy.)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Dehlendorf, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco City Clinic

San Francisco, California, United States

Planned Parenthood San Francisco Health Center

San Francisco, California, United States

San Francisco General Hospital Family Planning Clinic

San Francisco, California, United States

City College of San Francisco Student Health Services

San Francisco, California, United States

Countries

United States

References

Holt K, Kimport K, Kuppermann M, Fitzpatrick J, Steinauer J, Dehlendorf C. Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. Patient Educ Couns. 2020 Feb;103(2):315-320. doi: 10.1016/j.pec.2019.09.003. Epub 2019 Sep 4.

Reference Type: DERIVED

PMID: 31537316 (View on PubMed)

Dehlendorf C, Fitzpatrick J, Fox E, Holt K, Vittinghoff E, Reed R, Campora MP, Sokoloff A, Kuppermann M. Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Am J Obstet Gynecol. 2019 Jun;220(6):565.e1-565.e12. doi: 10.1016/j.ajog.2019.02.015. Epub 2019 Feb 11.

Reference Type: DERIVED

PMID: 30763545 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CE-1304-6874

Identifier Type: -

Identifier Source: org_study_id