NCT05506150

Patient Important Gastrointestinal Bleeding in the ICU

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will engage patients and families to create a definition of what matters most to them about upper gastrointestinal (GI) bleeding. This information will help to define the outcome of "patient-important GI bleeding" which is a secondary endpoint for the ongoing international randomized trial REVISE (NCT03374800), comparing acid suppression versus no acid suppression in the intensive care unit (ICU). Other outcomes in REVISE are clinically important upper GI bleeding, mortality, pneumonia and Clostridioides difficile infection. Guided by patient and family input, a series of open-ended questions will elicit patient and family views about what matters most about this complication in interviews and focus groups. The investigators will develop the definition of "patient-important GI bleeding" by analyzing interview and focus group transcripts of critically ill survivors and family members of critically ill patients who may or may not have had GI bleeding, and who were not enrolled in the REVISE trial. Patient and family perspectives (anticipated to be different from what clinicians consider to be clinically important GI bleeding), will be used to refine a new trial outcome for research on GI bleeding in the intensive care unit (ICU). Also, study results will help clinicians understand how to better support patients and families; to explain testing and treatment options when GI bleeding occurs in practice in the ICU.

Detailed description

This is a parallel mixed-methods multi-center study. Design: This is a parallel mixed-methods multi-center study in which the qualitative data are dominant and patient and family involvement is paramount. Data collection will be quantitative and qualitative interviews and focus groups. The objective is to elicit views from patients and families regarding the features of a GI bleed that are important to patients. The investigators will recruit 6-10 patients and 6-10 family members for individual interviews, along with 6-10 focus groups consisting of 3-4 patients and family members.

Conditions

• Gastro Intestinal Bleeding
• Patient Engagement
• Family Members

Interventions

Type	Name	Description
BEHAVIORAL	Interviews	Focused conversations to understand features of a GI bleed that are important to patients and families. Patients and family members are invited to participate in focused conversations. For interviews and focus groups, criterion sampling will be used. Investigators employed qualitative and quantitative methods to collect and analyze data. Quantitative data includes self-reported demographic characteristics of the patient and family members. Qualitative data about participants will be obtained through individual interviews and focused groups and project team field notes.

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-07-31
• Completion: 2024-01-31
• First posted: 2022-08-18
• Last updated: 2024-03-15

Locations

1 site across 1 country: Canada