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Treatment for Patient Engagement (PIB Trial)

N/A
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

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.

Eligible Conditions
  • Gastrointestinal Bleeding
  • Patient Engagement
  • Family

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of enrolment
GI Bleeding characteristics important to patients and families

Find a Location

Who is running the clinical trial?

University of CalgaryOTHER
805 Previous Clinical Trials
883,981 Total Patients Enrolled
McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,613,190 Total Patients Enrolled
2 Trials studying Patient Engagement
848 Patients Enrolled for Patient Engagement
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,519,191 Total Patients Enrolled
1 Trials studying Patient Engagement
118 Patients Enrolled for Patient Engagement
~10 spots leftby Sep 2025