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

NCT ID: NCT04999865

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-19
• Study Completion Date: 2021-12-31

Brief Summary

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.

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.

Conditions

Cystic Fibrosis; Patient Engagement

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

4-part educational program to build patient-engagement methodology capacity

We created four online training sessions. Our first training for patients/caregivers only (Research 101) was an exception, however, in which we produced a 25-minute asynchronous, self-directed learning seminar intended to be viewed before the subsequent interactive PCOR sessions. Of the three following synchronous interactive training sessions, two included both learner working groups (patients/caregivers and researchers/providers) together (PCOR 101 and PCOR Team Dynamics) and one session (PCOR Study Design) was for researchers/healthcare providers only.

Intervention Type: OTHER

Eligibility Criteria

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

• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Emily Godfrey

Associate Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily M Godfrey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34863273 (View on PubMed)

Other Identifiers

STUDY00006146

Identifier Type: -

Identifier Source: org_study_id