Contraception Decision Aid Use and Patient Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of a contraception decision aid mobile application on: (a) decisional conflict, (b) reproductive health self-efficacy, (c) contraceptive and reproductive health literacy, and (d) contraceptive use intentions.

Detailed Description
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After being informed about the study and the potential risks, all participants giving written informed consent will be randomly assigned in a double-blind manner (participant and investigator) in a 1:1 ratio to complete an interactive contraception decision aid health questionnaire (Tuune) or a standard medical questionnaire (Control). After, all participants will be asked questions assessing: (a) decisional conflict, (b) reproductive health self-efficacy, (c) contraceptive and reproductive health literacy, and (d) contraceptive use intentions.

Official Title
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Contraception Decision Aid Use and Patient Outcomes

Conditions
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Contraceptive Usage

Intervention / Treatment
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* Behavioral: Tuune health questionnaire
* Behavioral: Control health questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 18 to 34 years of age who enroll to participate in the study, which will take place on the campus of Texas Christian University. Exclusion Criteria: Women who are currently pregnant or breastfeeding. Women who wish to become pregnant within the next 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Parallel
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tuune<br>Participants complete the Tuune contraceptive decision aid health questionnaire. | Behavioral: Tuune health questionnaire<br>* Participants complete the Tuune contraceptive decision aid health questionnaire.<br>|
| Active Comparator: Control<br>Participants complete a standard physician intake health questionnaire. | Behavioral: Control health questionnaire<br>* Participants complete a standard physician intake health questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict | Decisional conflict about contraceptive use will be measured using a modified version of the Traditional Decisional Conflict Scale to assess decisional conflict about birth control use. The modified version of this scale is a 13-item measure utilizing a 1-7 rating scale (1 = strongly disagree | 7 = strongly agree) asking participants about their decisional conflict with respect to birth control. Higher scores on this scale indicate less decisional conflict about birth control use. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/ References: O'Connor AM (1995). Validation of a decisional conflict scale. Medical Decision Making, 15(1), 25-30. doi: 10.1177/0272989X9501500105. | Immediately upon completion of the assigned health questionnaire. | 
| Reproductive Health Self-Efficacy | Reproductive health self-efficacy will be measured using a modified version of the Menstrual Attitudes Questionnaire. The modified version is a 9-item measure utilizing a 1-7 rating scale (1 = strongly disagree | 7 = strongly agree) asking participants about their menstrual cycle and hormonal self-efficacy. Higher scores indicate lower reproductive health self-efficacy. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/ References: Brooks-Gunn, J., & Ruble, D. N. (1980). The Menstrual Attitude Questionnaire. Psychosomatic Medicine, 42(5), 503-512. https://doi.org/10.1097/00006842-198009000-00005 | Immediately upon completion of the assigned health questionnaire. | 
| Reproductive Health and Contraceptive Knowledge | Reproductive health and contraceptive knowledge will be measured using the following 6-item, 1-7 rating scale (1 = strongly disagree | 7 = strongly agree). Higher scores indicate greater reproductive health and contraceptive knowledge. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/ | Immediately upon completion of the assigned health questionnaire. | 
| Contraceptive Use Intentions | Contraceptive use intentions will be measured by asking participants to rate their likelihood of using hormonal birth control in the next week, month, and year. Each question will be measured on a 1-7 scale (1 = extremely unlikely to use | 7 = extremely likely to use). Higher scores indicate higher use intentions. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/ | Immediately upon completion of the assigned health questionnaire. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patient satisfaction with the health questionnaire will be measured using an intervention-tailored version of the Clinical Use Satisfaction Scale. The modified version is a 14-item measure utilizing two 1-7 rating scales. Items 1 - 12 use the following rating scale: 1 = strongly disagree | 7 = strongly agree. Items 13 - 14 use the scale: 1 = very unlikely | 7 = very likely. Higher scores indicate greater satisfaction with the health questionnaire. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/ References: Zimmerman, M., Gazarian, D., Multach, M., Attiullah, N., Benoff, T., Boerescu, D. A., ... & Holst, C. G. (2017). A clinically useful self-report measure of psychiatric patients' satisfaction with the initial evaluation. Psychiatry research, 252, 38-44. | Immediately upon completion of the primary measures. |