Clinical trial NCT05506150: Patient Important Gastrointestinal Bleeding in the ICU
Official title: Patient Important Gastrointestinal Bleeding in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro Intestinal Bleeding
Patient Engagement
Family Members
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Calgary
First posted: 2022-08-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been survived a stay in the ICU, and family members of critically ill patients.

Brief 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.

Eligibility criteria: Patient Inclusion Criteria:

* Was admitted to an ICU, whether or not a GI bleed developed in the ICU
* \> 18 years of age

Family Member Inclusion Criteria:

* Family members of ICU patients whose loved one was in the ICU for at least 72 hours, whether or not their family member developed a GI bleed
* \> 18 years of age

Patient/Family Member Exclusion Criteria:

* Prohibitive communication challenges (e.g., serious psychological or psychiatric illness in the patient and/or family, inability of patient and/or family to communicate reasonably well in English or other languages for which an interpreter exists - professional staff or otherwise);
* Patient or family declines.
* Family member whose loved one died in ICU

Primary outcomes:
measure: Feasibility of enrolment
timeFrame: Through study completion; an average of 1 year
measure: GI Bleeding characteristics important to patients and families
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References: