Clinical Use of a Contraceptive Decision Aid and Patient Outcomes

NCT05973071 | Unknown

• 1 other identifier: TCU020519782
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraceptive Usage

Keywords

Decision Aid

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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). 1. Respecting me as a person. 2. Letting me say what mattered to me about my birth control method. 3. Taking my preferences about my birth control seriously. 4. Giving me enough information to make the best decision about my birth control method.

  Administered at immediate follow-up.

• 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). 1. How positively do you feel about this medication? 2. How negatively do you feel about this medication? (R)

  Administered at immediate follow-up

• 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 Outcomes (5)

• Post-Appointment Contraceptive Adherence [5,6]

  Administered at 3 month digital follow-up

• Positivity Toward Their Prescribed Medication [4]

  Administered at 3 month digital follow-up

• Patient Experiences with their Birth Control

  Administered at 3 month digital follow-up.

• Patient Experiences with their Birth Control - Side Effects

  Administered at 3 month digital follow-up.

• Post Appointment Contraceptive Use

  Administered at 3 month digital follow-up.

Study Arms (2)

Tuune

EXPERIMENTAL

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

Behavioral: Tuune Supplemented Contraceptive Visit

Control

ACTIVE COMPARATOR

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

Behavioral: Traditional Contraceptive Visit

Interventions

Tuune Supplemented Contraceptive Visit BEHAVIORAL

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

Tuune

Traditional Contraceptive Visit BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• New or existing patients at Oklahoma State University OBGYN seeking contraceptive counseling.
• Native Speakers of English.

You may not qualify if:

• Women who are currently pregnant or breastfeeding
• Women who wish to become pregnant within the next 12 months

Sponsors & Collaborators

• Texas Christian University: lead
• Oklahoma State University: collaborator

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related 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.

  PMID: 33871288 BACKGROUND

• 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.

  PMID: 29729838 BACKGROUND

• 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.

  PMID: 33508252 BACKGROUND

• 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.

  PMID: 33180530 BACKGROUND

• 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.

  PMID: 18453793 BACKGROUND

• 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.

  PMID: 28874178 BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Sarah E Hill, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Hill, PhD

CONTACT

8172576424; s.e.hill@tcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data will be analyzed by a blind coding process, meaning that the researcher performing the analyses will be unaware of our research hypotheses. All date and timestamp information will also be removed to ensure that those analyzing the data cannot infer which patients were in the Tuune condition and which received a traditional patient appointment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be block assigned to either the Tuune condition or the traditional contraceptive counseling condition.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: August 2, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)