ISRCTN95736036Completed未知
Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a randomized pilot study
Montreal Heart Institute Research Center (Canada)0 sites60 target enrollmentStarted: March 27, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 24/06/2015:
- •For patients and caregivers:
- •1. Be 18 years of age or older
- •2. Speak and read French
- •3. Present physical and cognitive abilities (before surgery) to agree to participate in the study
- •For patients:
- •1. Have delirium following a surgical procedure of coronary artery bypass graft (CABG), heart valve plasty or replacement. Delirium is defined by a score of 4 or higher on the Intensive Care Delirium Screening Checklist (ICDSC-Bergeron, et al., 2001) and confirmed by a medical diagnosis
- •For caregivers:
- •1. Identify oneself as the caregiver to the patient who will undergo surgery
- •2. Be available to go to the bedside twice daily for three consecutive days after the detection of delirium
- •Previous inclusion criteria from 12/06/2014 to 24/06/2015:
- •For patients and caregivers:
- •1. Be 18 years of age or older
- •2. Speak and read French
- •3. Present physical and cognitive abilities (before surgery) to agree to participate in the study
- •For patients:
- •1. Have had a surgical procedure of coronary artery bypass graft (CABG), heart valve plasty or replacement
- •2. Planning to spend the full length of the postoperative stay in the research center (patients from a referring center will not be eligible as their length of stay in the research environment is shorter than the time required for this protocol, even in the presence of delirium)
- •3. Present postoperative delirium defined by a score of 4 or higher on the Intensive Care Delirium Screening Checklist (ICDSC-Bergeron, et al., 2001) and confirmed by a medical diagnosis
- •For caregivers:
- •1. Identify oneself as the caregiver to the patient who will undergo surgery
- •2. Be available to go to the bedside twice daily for three consecutive days after the detection of delirium
- •Original inclusion criteria until 12/06/2014:
- •For patients and caregivers:
- •1. Be 18 years of age or older
- •2. Speak and read French
- •3. Present physical and cognitive abilities (before surgery) to agree to participate in the study
- •For patients:
- •1. Have had a surgical procedure of coronary artery bypass graft (CABG), heart valve plasty or replacement
- •2. Planning to spend the full length of the postoperative stay in the research center
- •(patients from a referring center will not be eligible as their length of stay in the research environment is shorter than the time required for this protocol, even in the presence of delirium)
- •3. Present a high risk of delirium before surgery according to the presence of at least three risk factors identified in systematic reviews: age = 65 years; history of delirium; active smoker; take three or more alcoholic drinks per day; have a cognitive impairment (prior dementia, prior cognitive decline) or a sensory impairment (hearing)
- •4. Present delirium after cardiac surgery defined by a score of 4 or higher on the Intensive Care Delirium Screening Checklist (ICDSC-Bergeron, et al., 2001), used each shift in usual care, and confirmed by diagnosis.
- •For caregivers:
- •1. Be identified in the first study information meeting as the caregiver the patient who will undergo surgery
- •2. Be available to go to the bedside twice daily for three consecutive days after the detection of delirium
Exclusion Criteria
- •Current exclusion criteria as of 12/06/2014:
- •For patients:
- •1. Expressing a refusal to participate in the study after delirium
- •2. Be referred to the palliative care team due to severe post-operative complications
- •Previous exclusion criteria:
- •For patients:
- •1. Undergo an emergency cardiac surgery that prevents obtaining informed consent before the procedure
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