- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05506150
Patient Important Gastrointestinal Bleeding in the ICU (PIB)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Deborah Cook, MD
- Phone Number: 35325 905-522-1155
- Email: debcook@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St Joseph's Healthcare Hamilton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of enrolment
Time Frame: Through study completion; an average of 1 year
|
Enrolment will be deemed feasible when the following criteria are met: a) at least 15 surviving critically ill patients and 15 family members have been recruited; b) at least 8 focus groups have been completed; c) Representation of patients and families from several regions served by academic health sciences centres; 4) 80% participation rate for invited patients and families
|
Through study completion; an average of 1 year
|
GI Bleeding characteristics important to patients and families
Time Frame: Through study completion; an average of 1 year
|
While clinically important GI bleeding is defined in research as bleeding accompanied by hemodynamic consequences, red blood cell transfusions or other invasive interventions, the concept of patient-important upper GI bleeding has not been developed for the ICU.
In this study, the investigators will elicit views using open-ended questions about the tests and treatments about GI bleeding of greatest concern.
This information will be analyzed inductively to develop and/or refine a new patient-centred definition of important bleeding.
The investigators hypothesize that the GI bleed characteristics which are relevant to patients and families will not be the same as those relevant to clinicians.
The inductive analysis involves the generation of categories and domains directly from the data, without pre-conceived notions of what these categories or domains might be.
|
Through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIB_22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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