Cystic Fibrosis Reproductive and Sexual Health Collaborative: Building Online Research Partnerships

Building Online Research Partnerships to Improve Sexual and Reproductive Health for Women With Cystic Fibrosis (CF)

This is a Patient-Centered Outcomes Research Institute engagement effort aimed at training researchers/providers and patients to work in research teams together online throughout the research process (including: development, design, and dissemination) to address critical gaps in their care. This is a change from the typical research done with people with CF as they are frequently isolated from other members of the CF community because of infection control guidelines that restrict in-person contact to avoid the spread of bacteria between patients.

This project has four aims:

1. build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
2. create and disseminate a best practices PCOR user guide for populations that solely engage online,
3. to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
4. to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.

Study Overview

• Status: Active, not recruiting
• Conditions: Patient Engagement; Cystic Fibrosis
• Intervention / Treatment: Other: 4-part educational program to build patient-engagement methodology capacity

Detailed Description

The CF Reproductive and Sexual Health Collaborative (CFReSHC) will introduce and support patient-centered outcomes research (PCOR) to the greater CF community using existing PCOR training products and adapt them so that they address key issues related to researcher-patient teams that solely engage online. We will create a best-practices user guide for online engagement by performing key-informant interviews with patient- or community-engaged teams and periodic assessments of day-to-day platform use with CFReSHC members and other PCOR teams.

This project has four aims:

1. build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
2. create and disseminate a best practices PCOR user guide for populations that solely engage online,
3. to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
4. to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants are members of the CF community (patients, caregivers, researchers, providers or other stakeholders) who have an interest in learning more about patient-engaged methodology.

Description

Inclusion Criteria:

• Any interested adult CF patients, CF caregivers, researchers or healthcare providers can be included in the online patient-engagement training program. Any interested patients/community members and researchers/providers involved in patient-centered outcomes reserach teams that engage online can be included for the online platform interviews.

Exclusion Criteria:

• Persons less than 18 years of age

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge, confidence and satisfaction regarding patient-engagement methodology	we evaluated each of our training sessions by administering a survey to participants before the training and another similar survey immediately after the training. For both the pre- and post-training surveys, we asked participants to rate their agreement about PCOR knowledge, confidence about engaging in PCOR and training session satisfaction (post-training only) using a 5 option Likert scale. Participants were given a statement related to the learning objective and asked to rate how much they agreed with the statement with options ranging from strongly disagree, disagree, neutral, agree and strongly agree. At the end of each survey, we asked open-ended questions regarding what the participants liked about the training session and how we could improve. Surveys were administered online via REDCap.	four separate training programs over the course of a year
Development of step-by-step training manual	3)4) 12-15 CF and PCOR community stakeholders, selected through an application process, will attend monthly virtual meetings to provide feedback on the development of the PCOR training manual.	March 2021-December 2021

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Emily M Godfrey, MD, MPH, University of Washington

Publications and helpful links

General Publications

• Godfrey EM, Thayer EK, Mentch L, Kazmerski TM, Brown G, Pam M, Al Achkar M. Development and evaluation of a virtual patient-centered outcomes research training program for the cystic fibrosis community. Res Involv Engagem. 2021 Dec 4;7(1):86. doi: 10.1186/s40900-021-00328-4.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Training; Patient; Evaluation; Cystic Fibrosis; Education; Patient engaged research
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: STUDY00006146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No