Clinical Use of a Contraceptive Decision Aid and Patient Outcomes

Contraceptive Usage Clinical Trial

Official title:

Clinical Use of a Contraceptive Decision Aid and Patient Outcomes: An Experimental Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05973071
• Other study ID #: TCU020519782
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2023
• Source: Texas Christian University
• Contact: Sarah E Hill, PhD
• Phone: 8172576424
• Email: s.e.hill[@]tcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Participants: Participants will be block assigned to one of two groups, an experimental and a control group. In the experimental group, women will discuss the Tuune contraception recommendations with their physician during their contraceptive counseling appointment. In the control group, women will go through a traditional counseling appointment with their physician.

Materials and Procedure: Participants will be block-randomized to either the traditional contraceptive counseling appointment or to the Tuune facilitated contraceptive counseling appointment. Data for the control condition will be collected prior to data collection for the Tuune condition to avoid introducing bias or contaminating the control condition viz care provider increase in contraceptive knowledge as a result of using Tuune. Once 200 patients have been successfully recruited and processed in the control condition, the clinic will incorporate use of the Tuune decision aid into patient appointments until such a time that 200 patients are successfully recruited and processed. Patients scheduling appointments with OSU Obstetrics and Gynecology during the intervention period (i.e., during the period in which use of the Tuune decision aid is being incorporated into patient appointments) will be sent a QR code in advance of their appointment that allows them to access the Tuune decision aid. Participants will be instructed to complete the decision aid health questionnaire (which asks patients to report on health conditions, as in a typical patient intake form, in addition to numerous questions about hormonal conditions and contraception goals) in advance of their appointment. Participants in the control condition will simply be asked standard clinic intake questions per a typical patient appointment.

All participants will be recruited by clinic staff at the time of their appointment. Prospective participants will be informed that they must be between the ages of 18 and 50 years old and cannot be pregnant, breastfeeding, or wishing to become pregnant. All participants will read over the recruitment materials and consent form in the waiting room of the clinic when waiting for their appointment. The nurse attending to patients will then go over the consent form to answer any questions for participants wishing to participate. All participants will then meet with their contraceptive care provider and discuss their reproductive health and contraceptive options. In the traditional appointment group, physicians will proceed as they normally would. In the Tuune condition, physicians will discuss the results of the Tuune health assessment with their patients by going through all the hormonal contraceptive suggestions provided by the digital aide, answering any questions, and providing additional information and guidance per the patient's needs.

Both groups of participants will be given a QR code that will take them to a brief survey to assess their satisfaction with their care, the degree to which they perceived their care to be person-centered, their positivity toward the medication they had been prescribed, and their perceived likelihood that they will take the prescribed medication. Finally, participants will be asked for their contact information for follow-up purposes and for delivery of a $10 digital gift card that will be sent to participants' phone or email as a thank you for their participation.

Three months after the contraceptive counseling appointment, participants will be contacted via email or text using the contact information provided at the time of their patient appointment to complete a brief follow-up survey in exchange for a $15 digital gift card. Three months was chosen as the follow-up period because it takes about three months for the body to adjust to a new hormonal contraceptive and for initial side effects to subside. Participants will be asked about whether they are still on the prescribed contraceptive and about their adherence and positivity toward the prescribed contraceptive. Participants will also be asked to report the number of side effects that improved and the number of side effects that worsened since beginning the recommended contraception.

The exact items and scoring procedures for all measures to be used can be viewed on the Open Science Framework (Open Science Project Number: 3hdm6). In particular, at Time 1 (immediately following the patient appointment) the investigators will assess: (a) patient satisfaction, (b) perceptions of the degree to which they received person-centered contraceptive counseling (PCCC), (c) positivity toward their prescribed medication, and (d) contraceptive use expectations. At Time 2 (3 months post-appointment), the investigators will assess (e) whether patients are still using their prescribed contraception, (f) their adherence to their contraception medication, and (g) their experience with both positive and negative side effects. Each of the chosen scales has been shown to be reliable and valid in a variety of clinical and non-clinical settings. Minor modifications to some established scales were made for the purposes of making them tailored to research question at hand (see Open Science Project Number 3hdm6 for details).

All materials and methods for this project are pre-registered and available on the Open Science Framework (Project: 3hdm6 available here: https://osf.io/3hdm6/).

Data Handling: All data will be analyzed by a blind coding process, meaning that the researchers performing the data analyses and the PI will be blind to which condition participants are in prior to data analysis. To this end all date and timestamp information will be removed by a trained scientist who is not affiliated with the current project and who is blind to the nature of the hypothesis under investigation. This will help ensure that those analyzing the data cannot infer which patients were in the Tuune condition and which received a traditional patient appointment.

Expected Outcomes: The investigators expect that patients using the Tuune decision aid will exhibit higher levels of patient satisfaction and greater positivity toward their prescribed contraceptive than women who receive a traditional contraceptive appointment only. Further, the investigators expect that patients using the Tuune decision aid will exhibit higher rates of contraceptive continuity, greater adherence to their prescription, and will report fewer negative side effects than those in the control condition.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

• Native Speakers of English.

Exclusion Criteria:

• Women who are currently pregnant or breastfeeding

• Women who wish to become pregnant within the next 12 months

Related Conditions & MeSH terms

• Contraceptive Usage

Intervention

Behavioral:
• Tuune Supplemented Contraceptive Visit
Participants complete the Tuune contraceptive decision aid health questionnaire (Tuune for clinics) as part of their standard OBGYN clinic appointment.
• Traditional Contraceptive Visit
Participants will complete a standard OBGYN clinic appointment without using the Tuune contraceptive decision aid health questionnaire (Tuune for Clinics).

Locations

Country	Name	City	State
United States	Texas Christian University	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Christian University	Oklahoma State University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bitzer J, Oppelt PG, Deten A. Evaluation of a patient-centred, needs-based approach to support shared decision making in contraceptive counselling: the COCO study. Eur J Contracept Reprod Health Care. 2021 Aug;26(4):326-333. doi: 10.1080/13625187.2021.1908539. Epub 2021 Apr 19. — View Citation

Dehlendorf C, Fox E, Silverstein IA, Hoffman A, Campora Perez MP, Holt K, Reed R, Hessler D. Development of the Person-Centered Contraceptive Counseling scale (PCCC), a short form of the Interpersonal Quality of Family Planning care scale. Contraception. 2021 May;103(5):310-315. doi: 10.1016/j.contraception.2021.01.008. Epub 2021 Jan 27. — View Citation

Minton AR, Young NA, Nievera MA, Mikels JA. Positivity helps the medicine go down: Leveraging framing and affective contexts to enhance the likelihood to take medications. Emotion. 2021 Aug;21(5):1062-1073. doi: 10.1037/emo0000798. Epub 2020 Nov 12. — View Citation

Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x. — View Citation

Oakley LP, Harvey SM, Lopez-Cevallos DF. Racial and Ethnic Discrimination, Medical Mistrust, and Satisfaction with Birth Control Services among Young Adult Latinas. Womens Health Issues. 2018 Jul-Aug;28(4):313-320. doi: 10.1016/j.whi.2018.03.007. Epub 2018 May 2. — View Citation

Tomaszewski D, Aronson BD, Kading M, Morisky D. Relationship between self-efficacy and patient knowledge on adherence to oral contraceptives using the Morisky Medication Adherence Scale (MMAS-8). Reprod Health. 2017 Sep 6;14(1):110. doi: 10.1186/s12978-017-0374-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction & Appointment Evaluation [1]	This scale measures patient satisfaction with a contraceptive counseling appointment. Items include "Overall, I was satisfied with the birth control counselling," and "The session helped to strengthen my confidence in my method of birth control." Scale values range from 1 = Strongly agree to 7 = Strongly disagree. Item 10 needs to be reverse coded (R). An overall score can be created for this measure by averaging items.; All items could not be pasted in this description box due to character limit. The full list of items is available at https://osf.io/3hdm6/.	Administered at immediate follow-up.
Primary	Patient Satisfaction [2]	This single item measures patient satisfaction with the birth control services received from healthcare providers.; Scoring Instructions: Scale values range from 1 = Not at all satisfied to 7 = Extremely satisfied.; 1. In general, how satisfied or dissatisfied would you say you are with the birth control services you have received from healthcare providers?	Administered at immediate follow-up.
Primary	Person Centered Contraceptive Counseling (PCCC) [3]	This measure is an evaluation of whether the physician provided person-centered contraceptive counseling.; Scoring Instructions: An overall score can be created for this measure by averaging items. Scale values range from 1 = Poor to 4 = Very good. No items need to be reverse coded.; Think about your visit. How do you think [provider name] did? Please rate them on each of the following by circling a number (1 = Poor, 2 = Fair, 3 = Good, 4 = Very good).; Respecting me as a person.; Letting me say what mattered to me about my birth control method.; Taking my preferences about my birth control seriously.; Giving me enough information to make the best decision about my birth control method.	Administered at immediate follow-up.
Primary	Positivity Toward Their Prescribed Medication [4]	This scale measures patient positivity toward the prescribed medication.; Scoring Instructions: An overall score can be created for this measure by averaging items. Scale values range from 1 = Not at all to 7 = Extremely. Item 2 needs to be reverse coded (R).; How positively do you feel about this medication?; How negatively do you feel about this medication? (R)	Administered at immediate follow-up
Primary	Contraceptive Use Expectations [4]	This scale measures the patient's perceived likelihood that they will take the prescribed medication.; Scoring Instructions: Scale values range from 1 = Not at all to 7 = Extremely.; 1.How likely are you to take this medication?	Administered at immediate follow-up
Secondary	Post-Appointment Contraceptive Adherence [5,6]	This scale measures participants' degree of adherence to the prescribed medication since beginning their recommended birth control. Some example items are "Do you sometimes forget to take your birth control?" and "How often do you have difficulty remembering to take your birth control?" Items 1 - 7 have a yes/no response format (No = 1, Yes = 0). Item 5 needs to be reverse coded (R). Scale values for item 8 range from 0 = Never/Rarely to 4 = All the time. To standardized item 8, we will divide the result by 4. All items will be summed to create a continuous measure of self-reported adherence ranging from 0 - 8 with higher values corresponding to higher adherence.; All items could not be pasted in this description box due to character limit. The full list of items is available at https://osf.io/3hdm6/.	Administered at 3 month digital follow-up
Secondary	Positivity Toward Their Prescribed Medication [4]	This scale measures patient positivity toward the prescribed medication.; Scoring Instructions: An overall score can be created for this measure by averaging items. Scale values range from 1 = Not at all to 7 = Extremely. Item 2 needs to be reverse coded (R).; How positively do you feel about this medication?; How negatively do you feel about this medication? (R)	Administered at 3 month digital follow-up
Secondary	Patient Experiences with their Birth Control	These items ask about patient experiences on their birth control.; Scoring Instructions: The following items will be loaded into a Multivariate Analysis of Variance (MANOVA). Scale values range from 1 = Strongly agree to 7 = Strongly disagree. Item 1 needs to be reverse coded (R).; I have experienced unpleasant side effects from my birth control. (R); I feel better on my birth control than I felt when off of it.; I am happy with the birth control option I chose.; I plan to continue using my current birth control.	Administered at 3 month digital follow-up.
Secondary	Patient Experiences with their Birth Control - Side Effects	Participants will be presented with a list of side effects (available at https://osf.io/3hdm6/) and asked to select which have improved/worsened since starting the recommended birth control. These items will be summed to determine 1) the number of side effects that improved since the participant began the recommended birth control and 2) the number of side effects that worsened since the participant began the recommended birth control.; Scoring Instructions: To calculate a score for each item sum the number of side effects indicated by the respondent.; Below is a list of side effects often associated with birth control. Since starting your birth control…; Which of the following side effects have improved? [Select all that apply]; Which of the following side effects have worsened? [Select all that apply]	Administered at 3 month digital follow-up.
Secondary	Post Appointment Contraceptive Use	This items measures participant discontinuation rate from their prescribed method of birth control.; Scoring Instructions: This item has a yes/no response format.; 1. I am still using the birth control I was prescribed at my appointment.	Administered at 3 month digital follow-up.