Contraceptive Decision Aid for Birth Control

SE
Overseen BySarah E Hill, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Texas Christian University
Must be taking: Contraceptives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a tool called Tuune can improve the experience of individuals receiving birth control advice. It will compare two groups: one group will use the Tuune decision aid during their clinic visit (Tuune Supplemented Contraceptive Visit), while the other will have a regular appointment without it (Traditional Contraceptive Visit). The trial aims to determine if Tuune increases patient satisfaction with care, fosters a more positive attitude toward birth control, and improves adherence to the prescribed method with fewer side effects. This trial suits English-speaking patients at Oklahoma State University OBGYN who seek birth control advice and are not currently pregnant or planning to be within the next year. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance birth control consultations for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that the Tuune decision aid is safe for contraceptive care?

Research shows that the Tuune decision aid for contraceptive care meets high safety standards. This tool helps individuals make informed birth control choices by providing clear information and risk data. Although detailed safety comparisons with other tools are unavailable, testing has confirmed that the Tuune aid effectively helps users understand their options.

The tool collects health information to offer advice tailored to individual needs. While specific data on negative effects related to the Tuune aid is lacking, its focus on personalized health suggests users receive it well. Remember, this tool aids decision-making rather than directly affecting physical health, so safety concerns primarily involve proper data handling and accurate information delivery.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to making birth control decisions. Unlike the traditional method where patients have standard visits with their OBGYN, this trial includes the Tuune decision aid, which involves completing a detailed health questionnaire. This tool is designed to personalize contraceptive options based on individual health profiles, potentially making birth control choices more tailored and effective. By integrating personalized data, the Tuune approach promises to enhance patient satisfaction and improve the overall decision-making experience.

What evidence suggests that this trial's treatments could be effective for improving contraceptive care outcomes?

In this trial, participants will either complete a standard OBGYN clinic appointment using the Tuune contraceptive decision aid or attend a traditional contraceptive visit without it. Research has shown that the Tuune contraceptive decision aid can lead to better patient outcomes. Specifically, studies have found that women using Tuune feel more confident in managing their reproductive health and learn more about contraception compared to those who do not use the aid. Additionally, this tool seems to improve satisfaction with contraceptive choices and may help reduce negative side effects. Overall, Tuune appears to make choosing contraception easier and more effective.12456

Who Is on the Research Team?

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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?
2Treatment groups
Experimental Treatment
Active Control
Group I: TuuneExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

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.
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.
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.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38828482/
The Impact of a Digital Contraceptive Decision Aid on User ...Conclusions: Use of Tuune improved each of the predicted patient outcomes relative to a control decision aid. Online decision aids ...
Tuuned in: use of an online contraceptive decision aid for ...The results of the present study revealed that women assigned to use the Tuune® decision aid exhibited greater reproductive health self-efficacy ...
(PDF) Tuuned in: use of an online contraceptive decision ...Primary outcomes included reproductive health self-efficacy, reproductive health and contraceptive knowledge, and perceptions of learning. Secondary analyses ...
4.tuune.comtuune.com/
TUUNE | Personalized Hormonal HealthImproved patient outcomes with less physician time​​ Our algorithm has been developed by doctors, for doctors, and is designed to maximize efficiency in your ...
Tuuned in: use of an online contraceptive decision aid for ...Results: Women assigned to use the Tuune® decision aid exhibited greater reproductive health self-efficacy, greater knowledge about reproductive health and ...
Terms & ConditionsThe Tuune health assessment gathers physical and mental health data to assign you to one of three groups:Eligible for CHC or POP, Eligible for POP only,
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