Contraceptive Decision Aid for Birth Control

Overseen By Sarah E Hill, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Texas Christian University

Must be taking: Contraceptives

Disqualifiers: Pregnant, Breastfeeding, Pregnancy plans, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study at hand aims to examine whether incorporating use of a contraceptive decision aid (Tuune for Clinics) improves outcomes for patients seeking contraceptive care. To achieve this the investigators will test: the hypothesis that use of the Tuune decision aid in contraceptive care appointments will: (a) improve patient satisfaction, (b) increase patient positivity toward contraceptive use, and (c) improve patient outcomes, including: (ci) greater adherence to their prescribed contraceptive and (cii) fewer negative side-effects, relative to that which is observed for patients receiving a contraceptive recommendation from a traditional contraceptive counseling appointment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the Tuune Supplemented Contraceptive Visit treatment differ from other contraceptive counseling methods?

The Tuune Supplemented Contraceptive Visit is unique because it incorporates a decision aid to help women choose a contraceptive method that aligns with their personal values and circumstances, potentially improving satisfaction and reducing misuse compared to traditional visits. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Traditional Contraceptive Visit, Tuune Supplemented Contraceptive Visit?

Research shows that decision aids, like the ones used in the Tuune Supplemented Contraceptive Visit, can help women choose contraceptive methods that better fit their personal needs, leading to improved satisfaction and adherence. Studies also indicate that technology-based decision aids can enhance contraceptive use and decision-making outcomes. ^{1 5 6 7 8}

Who Is on the Research Team?

Sarah E Hill, PhD

Principal Investigator

Texas Christian University

Are You a Good Fit for This Trial?

This trial is for English-speaking women who are patients at Oklahoma State University OBGYN and seeking contraceptive counseling. It's not suitable for those who are pregnant, breastfeeding, or planning to become pregnant within a year.

Inclusion Criteria

I am a native English speaker.

New or existing patients at Oklahoma State University OBGYN seeking contraceptive counseling

Exclusion Criteria

I am currently pregnant or breastfeeding.

I plan to become pregnant in the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Contraceptive Counseling Appointment

Participants attend a contraceptive counseling appointment where they either use the Tuune decision aid or receive traditional counseling

1 day

1 visit (in-person)

Immediate Post-Appointment Evaluation

Participants complete a survey to assess satisfaction, person-centered counseling, and contraceptive use expectations

Immediately after appointment

1 survey (digital)

Follow-up

Participants are contacted to complete a follow-up survey assessing adherence, side effects, and positivity toward the prescribed contraceptive

3 months

1 survey (digital)

What Are the Treatments Tested in This Trial?

Interventions

• Traditional Contraceptive Visit
• Tuune Supplemented Contraceptive Visit

Trial Overview The study tests if using the Tuune decision aid during contraceptive care appointments can improve patient satisfaction, feelings about contraception use, adherence to prescribed contraceptives, and reduce negative side effects compared to traditional counseling.

How Is the Trial Designed?

Group I: Tuune Experimental Treatment 1 Intervention

Participants complete the Tuune contraceptive decision aid health questionnaire as part of their standard OBGYN clinic appointment.

Group II: Control Active Control 1 Intervention

Participants will complete a standard OBGYN clinic appointment without using the Tuune contraceptive decision aid health questionnaire.

Who Is Running the Clinical Trial?

Texas Christian University

Lead Sponsor

Trials

31

Recruited

4,400+

Oklahoma State University

Collaborator

Trials

51

Recruited

8,600+

Published Research Related to This Trial

A study involving 949 young women at family planning clinics in Chicago and Madison showed that a computer-based contraceptive decision aid was well-accepted and improved knowledge and confidence regarding oral contraceptive efficacy.

Patients in Madison who used the decision aid had better long-term knowledge about oral contraceptives and a trend towards fewer pregnancies, while those in Chicago were more likely to adopt oral contraceptives after expressing their intention to do so.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a computerized contraceptive decision aid for adolescent patients. Chewning, B., Mosena, P., Wilson, D., et al.[2019]

The My Birth Control decision support tool did not significantly improve contraceptive continuation rates after 7 months, with continuation rates of 56.6% for the intervention group and 59.6% for the control group.

However, the tool enhanced the quality of the contraceptive counseling experience, leading to higher scores in interpersonal quality, informed decision-making, and contraceptive knowledge among users compared to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Dehlendorf, C., Fitzpatrick, J., Fox, E., et al.[2020]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a computerized contraceptive decision aid for adolescent patients. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Counseling and management of patients requesting subcutaneous contraceptive implants: proposal for a decisional algorithm. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of technology-based contraceptive decision aids: a systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Women's values in contraceptive choice: a systematic review of relevant attributes included in decision aids. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Exploring young women's decisional needs for contraceptive method choice: a qualitative study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A mixed-methods study of provider perspectives on My Birth Control: a contraceptive decision support tool designed to facilitate shared decision making. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Structured contraceptive counseling provided by the Contraceptive CHOICE Project. [2022]