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Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D)

Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a randomized pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95736036
Enrollment
60
Registered
2013-03-27
Start date
2013-02-18
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post cardiac surgery delirium Mental and Behavioural Disorders Postoperative delirium

Interventions

Control group: No specific intervention, other than usual care, is planned for the control group. Intervention group: The nursing intervention consists of seven meetings between the nurse-mentor and

Sponsors

Montreal Heart Institute Research Center (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Assessing the acceptability and feasibility of the intervention and the methodology of the study.

Secondary

MeasureTime frame
Assessing the preliminary efficacy of the experimental nursing intervention on: 1. Delirium severity Days 1-3, measured with the Delirium Index 2. Adverse clinical events Days 1-3 (dehiscence, falls, respiratory tract infection, accidental removal of urinary catheters, drains or arterial lines or endotracheal tubes) 3. Length of hospital stay (in the intensive care unit and overall) 4. Patient psychosocial profile at one month, measured with the Sickness Impact Profile 5. Caregiver anxiety at 4 days post-intervention, hospital discharge and one month post-discharge measured with the State-Trait-Anxiety-Inventory 6. Caregiver self-efficacy at 4 days post-intervention, hospital discharge and one month post-discharge measured with a self-efficacy scale Assessing the relationship between cerebral oximetry values and standard tools for detecting and assessing the severity of delirium.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026