MyVoice:CF Decision Aid for Women With Cystic Fibrosis
Condition: Cystic Fibrosis; Contraception; Physician-Patient Relations; Pregnancy Complications
MeSH terms: Cystic Fibrosis; Pregnancy Complications; Fibrosis
Study type: Interventional

Summary: 
      This project is a single-center feasibility study of MyVoice:CF, a patient-facing, web-based
      decision aid.

      Aim 1) Assess the acceptability, feasibility, and usability of MyVoice:CF for women with CF
      and multidisciplinary adult CF providers.

      Aim 2) Assess the preliminary efficacy of MyVoice:CF related to patient-provider
      communication, shared decision-making, knowledge, and self-efficacy for women with CF related
      to reproductive health concerns.
    

Detailed description: 
      This study seeks to test a decision aid created to address the disease-specific reproductive
      health concerns of women with cystic fibrosis. The decision aid was built out of research
      done by studies previously approved by the University of Pittsburgh IRB. These studies
      determined the information and decision support needs of women with cystic fibrosis
      concerning their sexual and reproductive health care.

      The purpose of this study is to pilot the decision aid prototype to evaluate its feasibility,
      appropriateness, and acceptability.

      Screening for eligibility will be conducted prior to a potential participant's visit with
      their CF care team. Eligible patients will be contacted via phone. Interested patients will
      be consented and asked to schedule a time to complete the web-based decision aid in its
      entirety and complete a follow up qualitative interview.

      The investigators will also ask participants if they are interested in two optional
      activities: having their screen activity on MyVoice:CF recorded for analysis and having their
      next appointment with their CF team recorded for conversation analyses. The RC will explain
      these recordings will be de-identified prior to analysis and that no one outside of the study
      team will see the screen capture data, listen to the recording, or read the full transcript.

      Data collection: After giving consent to participate, participants will be given the link for
      the baseline survey, hosted on REDCap, by the RC/RA. They will also schedule a time to 1)
      complete the web-based decision aid and 2) complete an exit survey about the aid.

      Immediately following their next visit with the CF care team, they will complete a survey to
      assess the tool's impact on their interaction with the team and their receipt of reproductive
      health care and complete a qualitative interview on the tool and its impact on their team
      interaction.

      The subsequent 3-month and 6-month surveys will also be completed via REDCap, and
      participants will be given the link via email, with phone calls as necessary to prompt
      completion. Six months after the last recruited patient has completed their run through of
      the tool, the adult CF care team (n=11) will be asked to complete an anonymous survey about
      their experiences with patients who have used the tool. Following this, a focus group will be
      conducted with the care team to discuss the perceived feasibility, appropriateness, and
      acceptability of the tool from the provider perspective.

      Data Analysis:

      Descriptive statistics will summarize feasibility and acceptability data. The System
      Usability Scale will be assessed via the accepted scoring scale. The investigators aim for
      >80% use of the tool (REACH), implementation integrity (IMPLEMENTATION), and satisfaction
      with MyVoice:CF (MAINTENANCE). Effectiveness will be assessed by fitting generalized linear
      mixed models with fixed effects for "period" and random effects for cluster. For outcomes
      assessed longitudinally, there will be an additional random effect for subject. Assuming a
      conservative ICC of 0.05, 5% type I error, and 15% attrition, our anticipated sample size
      would yield 80% power to detect mean differences of 0.41 for any of our continuous outcomes.
      Reproductive health outcomes and care-seeking variables will be compared to estimates from
      recent survey data as well as the National Survey for Family Growth (NSFG) as a U.S. general
      population estimate. NSFG comparisons will be adjusted for demographic differences. Survey
      data will be analyzed using SAS v9.4.

      Thematic analysis of interview transcripts will be conducted by research study staff and
      decision aid developers to identify key themes produced by the pilot testing process. Themes
      will be evaluated and used to refine the existing prototype and develop a finalized version
      of the decision making tool. Data collected from the decision aid will not be collected for
      research purposes and will not be analyzed; it will be used to test that the data collection
      system is functioning correctly.
    

Intervention name(s): MyVoice:CF
Intervention type(s): Other
Intervention description(s): Participants will be given access to MyVoice:CF, a web-based decision aid (DA). This tool includes information about fertility, genetics, parenting, pregnancy, and breastfeeding within the context of cystic fibrosis (CF). The tool includes interactive elements designed to give users the ability to assess and reflect on their own reproductive goals and experiences and promote self-efficacy to engage in shared decision-making with their CF and women's health providers.
Upon completion of use of the decision aid, a summary sheet is generated based on the user's interaction with the tool. This summary is supplied to the provider prior to the next appointment.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cystic fibrosis; shared decision-making; sexual and reproductive health