Clinical trial NCT04825236: MyVoice:CF Decision Aid for Women With Cystic Fibrosis
Official title: A Feasibility Trial of the MyVoice:CF Decision Aid to Address the Reproductive Health Needs of Women With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Contraception
Physician-Patient Relations
Pregnancy Complications
Keywords: cystic fibrosis
shared decision-making
sexual and reproductive health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2021-04-01
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Cisgender female
* Age 18-44 years
* English-speaking
* Diagnosed with cystic fibrosis

Exclusion Criteria:

* Men
* Women under 18 (this tool was not designed to appropriately address the sexual and reproductive health needs and experiences of the adolescent population)
* Patients who have no computer and internet access and would be unable to access the tool
* Patients who are unable to consent

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: Patients- T2 (within 24 hours of intervention)
measure: Intervention Appropriateness Measure
timeFrame: Patients- T2 (within 24 hours of intervention)
measure: System Usability Scale
timeFrame: Patients- T2 (within 24 hours of intervention)
measure: Perceived Value of Tool to Providers
timeFrame: Providers- T5 (6 months after recruitment ends)
measure: Acceptability of intervention to providers
timeFrame: Providers- T5 (6 months after recruitment ends)
measure: Intervention Appropriateness Measure for providers
timeFrame: Providers- T5 (6 months after recruitment ends)
Secondary outcomes:
measure: ReproKnow (adapted)
timeFrame: T3 (up to 12 weeks post-tool use) compared to T0 (baseline)
measure: Shared Decision-Making (collaboRATE)
timeFrame: T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use)
measure: Perceived Efficacy in Patient-Physician Interactions
timeFrame: T3 (up to 12 weeks post-tool use)
measure: Reproductive Self Efficacy
timeFrame: T3 (up to 12 weeks post-tool use) compared to T0 (baseline)
measure: Change in Pregnancy Intention
timeFrame: Change between T3 (up to 12 weeks post-tool use) and T0 (baseline)
measure: Quantity and quality of reproductive conversations
timeFrame: T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use)
measure: Participant Feedback to Tool
timeFrame: T3 (up to 12 weeks post-tool use)
measure: Participant Change in Contraceptive Use
timeFrame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
measure: Participant Confidence in Contraceptive Method Selection
timeFrame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
measure: Participant number of pregnancies during study
timeFrame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
measure: Participant receipt of infertility care
timeFrame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
measure: Participant receipt of preconception counseling
timeFrame: T4 (up to 24 weeks post-tool use)compared to T0 (baseline)
measure: Participant Desire for future pregnancy
timeFrame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
measure: Intent to breastfeed
timeFrame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
measure: Receipt of SRH care
timeFrame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Traci M Kazmerski, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: