xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05973071</url>
    </required_header>
    <id_info>
      <org_study_id>TCU020519782</org_study_id>
      <nct_id>NCT05973071</nct_id>
    </id_info>
    <brief_title>Clinical Use of a Contraceptive Decision Aid and Patient Outcomes</brief_title>
    <official_title>Clinical Use of a Contraceptive Decision Aid and Patient Outcomes: An Experimental Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Texas Christian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Oklahoma State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Texas Christian University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study at hand aims to examine whether incorporating use of a contraceptive decision aid&#xD;
        (Tuune for Clinics) improves outcomes for patients seeking contraceptive care. To achieve&#xD;
        this the investigators will test: the hypothesis that use of the Tuune decision aid in&#xD;
        contraceptive care appointments will: (a) improve patient satisfaction, (b) increase patient&#xD;
        positivity toward contraceptive use, and (c) improve patient outcomes, including: (ci)&#xD;
        greater adherence to their prescribed contraceptive and (cii) fewer negative side-effects,&#xD;
        relative to that which is observed for patients receiving a contraceptive recommendation from&#xD;
        a traditional contraceptive counseling appointment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants: Participants will be block assigned to one of two groups, an experimental and a&#xD;
        control group. In the experimental group, women will discuss the Tuune contraception&#xD;
        recommendations with their physician during their contraceptive counseling appointment. In&#xD;
        the control group, women will go through a traditional counseling appointment with their&#xD;
        physician.&#xD;
  &#xD;
        Materials and Procedure: Participants will be block-randomized to either the traditional&#xD;
        contraceptive counseling appointment or to the Tuune facilitated contraceptive counseling&#xD;
        appointment. Data for the control condition will be collected prior to data collection for&#xD;
        the Tuune condition to avoid introducing bias or contaminating the control condition viz care&#xD;
        provider increase in contraceptive knowledge as a result of using Tuune. Once 200 patients&#xD;
        have been successfully recruited and processed in the control condition, the clinic will&#xD;
        incorporate use of the Tuune decision aid into patient appointments until such a time that&#xD;
        200 patients are successfully recruited and processed. Patients scheduling appointments with&#xD;
        OSU Obstetrics and Gynecology during the intervention period (i.e., during the period in&#xD;
        which use of the Tuune decision aid is being incorporated into patient appointments) will be&#xD;
        sent a QR code in advance of their appointment that allows them to access the Tuune decision&#xD;
        aid. Participants will be instructed to complete the decision aid health questionnaire (which&#xD;
        asks patients to report on health conditions, as in a typical patient intake form, in&#xD;
        addition to numerous questions about hormonal conditions and contraception goals) in advance&#xD;
        of their appointment. Participants in the control condition will simply be asked standard&#xD;
        clinic intake questions per a typical patient appointment.&#xD;
  &#xD;
        All participants will be recruited by clinic staff at the time of their appointment.&#xD;
        Prospective participants will be informed that they must be between the ages of 18 and 50&#xD;
        years old and cannot be pregnant, breastfeeding, or wishing to become pregnant. All&#xD;
        participants will read over the recruitment materials and consent form in the waiting room of&#xD;
        the clinic when waiting for their appointment. The nurse attending to patients will then go&#xD;
        over the consent form to answer any questions for participants wishing to participate. All&#xD;
        participants will then meet with their contraceptive care provider and discuss their&#xD;
        reproductive health and contraceptive options. In the traditional appointment group,&#xD;
        physicians will proceed as they normally would. In the Tuune condition, physicians will&#xD;
        discuss the results of the Tuune health assessment with their patients by going through all&#xD;
        the hormonal contraceptive suggestions provided by the digital aide, answering any questions,&#xD;
        and providing additional information and guidance per the patient's needs.&#xD;
  &#xD;
        Both groups of participants will be given a QR code that will take them to a brief survey to&#xD;
        assess their satisfaction with their care, the degree to which they perceived their care to&#xD;
        be person-centered, their positivity toward the medication they had been prescribed, and&#xD;
        their perceived likelihood that they will take the prescribed medication. Finally,&#xD;
        participants will be asked for their contact information for follow-up purposes and for&#xD;
        delivery of a $10 digital gift card that will be sent to participants' phone or email as a&#xD;
        thank you for their participation.&#xD;
  &#xD;
        Three months after the contraceptive counseling appointment, participants will be contacted&#xD;
        via email or text using the contact information provided at the time of their patient&#xD;
        appointment to complete a brief follow-up survey in exchange for a $15 digital gift card.&#xD;
        Three months was chosen as the follow-up period because it takes about three months for the&#xD;
        body to adjust to a new hormonal contraceptive and for initial side effects to subside.&#xD;
        Participants will be asked about whether they are still on the prescribed contraceptive and&#xD;
        about their adherence and positivity toward the prescribed contraceptive. Participants will&#xD;
        also be asked to report the number of side effects that improved and the number of side&#xD;
        effects that worsened since beginning the recommended contraception.&#xD;
  &#xD;
        The exact items and scoring procedures for all measures to be used can be viewed on the Open&#xD;
        Science Framework (Open Science Project Number: 3hdm6). In particular, at Time 1 (immediately&#xD;
        following the patient appointment) the investigators will assess: (a) patient satisfaction,&#xD;
        (b) perceptions of the degree to which they received person-centered contraceptive counseling&#xD;
        (PCCC), (c) positivity toward their prescribed medication, and (d) contraceptive use&#xD;
        expectations. At Time 2 (3 months post-appointment), the investigators will assess (e)&#xD;
        whether patients are still using their prescribed contraception, (f) their adherence to their&#xD;
        contraception medication, and (g) their experience with both positive and negative side&#xD;
        effects. Each of the chosen scales has been shown to be reliable and valid in a variety of&#xD;
        clinical and non-clinical settings. Minor modifications to some established scales were made&#xD;
        for the purposes of making them tailored to research question at hand (see Open Science&#xD;
        Project Number 3hdm6 for details).&#xD;
  &#xD;
        All materials and methods for this project are pre-registered and available on the Open&#xD;
        Science Framework (Project: 3hdm6 available here: https://osf.io/3hdm6/).&#xD;
  &#xD;
        Data Handling: All data will be analyzed by a blind coding process, meaning that the&#xD;
        researchers performing the data analyses and the PI will be blind to which condition&#xD;
        participants are in prior to data analysis. To this end all date and timestamp information&#xD;
        will be removed by a trained scientist who is not affiliated with the current project and who&#xD;
        is blind to the nature of the hypothesis under investigation. This will help ensure that&#xD;
        those analyzing the data cannot infer which patients were in the Tuune condition and which&#xD;
        received a traditional patient appointment.&#xD;
  &#xD;
        Expected Outcomes: The investigators expect that patients using the Tuune decision aid will&#xD;
        exhibit higher levels of patient satisfaction and greater positivity toward their prescribed&#xD;
        contraceptive than women who receive a traditional contraceptive appointment only. Further,&#xD;
        the investigators expect that patients using the Tuune decision aid will exhibit higher rates&#xD;
        of contraceptive continuity, greater adherence to their prescription, and will report fewer&#xD;
        negative side effects than those in the control condition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be block assigned to either the Tuune condition or the traditional contraceptive counseling condition.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Satisfaction &amp; Appointment Evaluation [1]</measure>
      <time_frame>Administered at immediate follow-up.</time_frame>
      <description>This scale measures patient satisfaction with a contraceptive counseling appointment. Items include &quot;Overall, I was satisfied with the birth control counselling,&quot; and &quot;The session helped to strengthen my confidence in my method of birth control.&quot; 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.&#xD;
  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/.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Satisfaction [2]</measure>
      <time_frame>Administered at immediate follow-up.</time_frame>
      <description>This single item measures patient satisfaction with the birth control services received from healthcare providers.&#xD;
  Scoring Instructions: Scale values range from 1 = Not at all satisfied to 7 = Extremely satisfied.&#xD;
  1. In general, how satisfied or dissatisfied would you say you are with the birth control services you have received from healthcare providers?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Person Centered Contraceptive Counseling (PCCC) [3]</measure>
      <time_frame>Administered at immediate follow-up.</time_frame>
      <description>This measure is an evaluation of whether the physician provided person-centered contraceptive counseling.&#xD;
  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.&#xD;
  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).&#xD;
  Respecting me as a person.&#xD;
  Letting me say what mattered to me about my birth control method.&#xD;
  Taking my preferences about my birth control seriously.&#xD;
  Giving me enough information to make the best decision about my birth control method.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Positivity Toward Their Prescribed Medication [4]</measure>
      <time_frame>Administered at immediate follow-up</time_frame>
      <description>This scale measures patient positivity toward the prescribed medication.&#xD;
  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).&#xD;
  How positively do you feel about this medication?&#xD;
  How negatively do you feel about this medication? (R)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Contraceptive Use Expectations [4]</measure>
      <time_frame>Administered at immediate follow-up</time_frame>
      <description>This scale measures the patient's perceived likelihood that they will take the prescribed medication.&#xD;
  Scoring Instructions: Scale values range from 1 = Not at all to 7 = Extremely.&#xD;
  1.How likely are you to take this medication?</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post-Appointment Contraceptive Adherence [5,6]</measure>
      <time_frame>Administered at 3 month digital follow-up</time_frame>
      <description>This scale measures participants' degree of adherence to the prescribed medication since beginning their recommended birth control. Some example items are &quot;Do you sometimes forget to take your birth control?&quot; and &quot;How often do you have difficulty remembering to take your birth control?&quot; 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.&#xD;
  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/.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positivity Toward Their Prescribed Medication [4]</measure>
      <time_frame>Administered at 3 month digital follow-up</time_frame>
      <description>This scale measures patient positivity toward the prescribed medication.&#xD;
  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).&#xD;
  How positively do you feel about this medication?&#xD;
  How negatively do you feel about this medication? (R)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Experiences with their Birth Control</measure>
      <time_frame>Administered at 3 month digital follow-up.</time_frame>
      <description>These items ask about patient experiences on their birth control.&#xD;
  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).&#xD;
  I have experienced unpleasant side effects from my birth control. (R)&#xD;
  I feel better on my birth control than I felt when off of it.&#xD;
  I am happy with the birth control option I chose.&#xD;
  I plan to continue using my current birth control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Experiences with their Birth Control - Side Effects</measure>
      <time_frame>Administered at 3 month digital follow-up.</time_frame>
      <description>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.&#xD;
  Scoring Instructions: To calculate a score for each item sum the number of side effects indicated by the respondent.&#xD;
  Below is a list of side effects often associated with birth control. Since starting your birth control…&#xD;
  Which of the following side effects have improved? [Select all that apply]&#xD;
  Which of the following side effects have worsened? [Select all that apply]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post Appointment Contraceptive Use</measure>
      <time_frame>Administered at 3 month digital follow-up.</time_frame>
      <description>This items measures participant discontinuation rate from their prescribed method of birth control.&#xD;
  Scoring Instructions: This item has a yes/no response format.&#xD;
  1. I am still using the birth control I was prescribed at my appointment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Contraceptive Usage</condition>
    <arm_group>
      <arm_group_label>Tuune</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants complete the Tuune contraceptive decision aid health questionnaire as part of their standard OBGYN clinic appointment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will complete a standard OBGYN clinic appointment without using the Tuune contraceptive decision aid health questionnaire.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Tuune Supplemented Contraceptive Visit</intervention_name>
      <description>Participants complete the Tuune contraceptive decision aid health questionnaire (Tuune for clinics) as part of their standard OBGYN clinic appointment.</description>
      <arm_group_label>Tuune</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Traditional Contraceptive Visit</intervention_name>
      <description>Participants will complete a standard OBGYN clinic appointment without using the Tuune contraceptive decision aid health questionnaire (Tuune for Clinics).</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  New or existing patients at Oklahoma State University OBGYN seeking contraceptive&#xD;
               counseling.&#xD;
  &#xD;
            -  Native Speakers of English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who are currently pregnant or breastfeeding&#xD;
  &#xD;
            -  Women who wish to become pregnant within the next 12 months&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah E Hill, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Texas Christian University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah E Hill, PhD</last_name>
      <phone>8172576424</phone>
      <email>s.e.hill@tcu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Texas Christian University</name>
        <address>
          <city>Fort Worth</city>
          <state>Texas</state>
          <zip>76129</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>33871288</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>29729838</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33508252</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33180530</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>18453793</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>28874178</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Texas Christian University</investigator_affiliation>
      <investigator_full_name>Sarah Hill</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Decision Aid</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Contraceptive Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05973071
  org study id: TCU020519782
  nct id: NCT05973071
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be block assigned to either the Tuune condition or the traditional contraceptive counseling condition.
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: 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.
  measure: Patient Satisfaction & Appointment Evaluation [1]
  time frame: Administered at immediate follow-up.
  description: 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/.
  measure: Patient Satisfaction [2]
  time frame: Administered at immediate follow-up.
  description: 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?
  measure: Person Centered Contraceptive Counseling (PCCC) [3]
  time frame: Administered at immediate follow-up.
  description: 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.
  measure: Positivity Toward Their Prescribed Medication [4]
  time frame: Administered at immediate follow-up
  description: 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)
  measure: Contraceptive Use Expectations [4]
  time frame: Administered at immediate follow-up
  description: 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?
  measure: Post-Appointment Contraceptive Adherence [5,6]
  time frame: Administered at 3 month digital follow-up
  description: 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/.
  measure: Positivity Toward Their Prescribed Medication [4]
  time frame: Administered at 3 month digital follow-up
  description: 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)
  measure: Patient Experiences with their Birth Control
  time frame: Administered at 3 month digital follow-up.
  description: 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.
  measure: Patient Experiences with their Birth Control - Side Effects
  time frame: Administered at 3 month digital follow-up.
  description: 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]
  measure: Post Appointment Contraceptive Use
  time frame: Administered at 3 month digital follow-up.
  description: 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.
  arm group label: Tuune
  arm group type: Experimental
  description: Participants complete the Tuune contraceptive decision aid health questionnaire as part of their standard OBGYN clinic appointment.
  arm group label: Control
  arm group type: Active Comparator
  description: Participants will complete a standard OBGYN clinic appointment without using the Tuune contraceptive decision aid health questionnaire.
  intervention type: Behavioral
  intervention name: Tuune Supplemented Contraceptive Visit
  description: Participants complete the Tuune contraceptive decision aid health questionnaire (Tuune for clinics) as part of their standard OBGYN clinic appointment.
  arm group label: Tuune
  intervention type: Behavioral
  intervention name: Traditional Contraceptive Visit
  description: Participants will complete a standard OBGYN clinic appointment without using the Tuune contraceptive decision aid health questionnaire (Tuune for Clinics).
  arm group label: Control
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sarah E Hill, PhD
  role: Principal Investigator
  affiliation: Texas Christian University
  last name: Sarah E Hill, PhD
  phone: 8172576424
  email: s.e.hill@tcu.edu
  facility: 
  country: United States
  citation: 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
  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.
  PMID: 29729838
  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.
  PMID: 33508252
  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.
  PMID: 33180530
  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.
  PMID: 18453793
  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.
  PMID: 28874178
  responsible party type: Principal Investigator
  investigator affiliation: Texas Christian University
  investigator full name: Sarah Hill
  investigator title: Professor
  mesh term: Contraceptive Agents
  sharing ipd: No