Condition category
Mental and Behavioural Disorders
Date applied
19/02/2013
Date assigned
27/03/2013
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study of 30 patients with post-cardiac surgery delirium (acute confusional state) to evaluate the acceptability and feasibility of a nursing intervention aimed at mentoring family caregivers in the management of delirium. Our goal is to mentor caregivers in adopting specific behaviours, for example communication strategies, which have been linked to lowering delirium severity in patients. We will also want to look at the preliminary effect of the intervention on the severity of delirium, delirium-related complications, length of hospital stay and the patient's recovery, as well as caregiver anxiety and sense of self-efficacy. In addition, the validity of a physiological indicator of delirium, cerebral oximetry, will be explored and compared to standard measures of delirium. The study's findings should help us determine if such an intervention is feasible and acceptable within a critical care context as well as suggest adjustments for a larger trial.

Who can participate?
The MENTOR_D study aims to recruit 30 patients paired with 30 family caregivers from a cardiology center in Canada. The patients must undergo heart surgery and be at high risk of delirium and the family caregivers must be aged > 18 years and be available for daily visits at the patient's bedside.

What does the study involve?
Over a period of three days following delirium onset, the family caregiver’s participants who were randomly assigned to the intervention group will be mentored by a nurse to enhance their participation in delirium management. The intervention will mentor caregivers in adopting specific behaviours, for example communication strategies, which have been linked to lowering delirium severity in patients. The nurse mentor will provide two daily meetings for three consecutive days after the onset of delirium aimed at enabling the caregiver to respond appropriately at the bedside of the delirious patient. At the end of the study, we will compare patient and family caregiver outcomes in the control group to the outcomes in the intervention group. Patient outcomes will include delirium severity, delirium related complications and recovery. Family caregiver outcomes will include anxiety level and self-efficacy. Finally, cerebral oxygen saturation measurements will also be taken on the 30 patients. These measures will be compared to standard delirium rating scales such as the Confusion Assessment Method.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to future patients and family caregivers affected by post-cardiac surgery delirium, as this study will inform nurses on how to better intervene with this clientele. This study does not implicate any particular physical risks, although the time required to complete the questionnaires can be a disadvantage.

Where is the study run from?
The study has been set up by the Montreal Heart Institute Research Center.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start mid-winter 2013. Participants will be enrolled in the study for a period of 1 month.

Who is funding the study?
Funding has been provided from Quebec Interuniversity Nursing Intervention Research Group and Quebec’s Minister of Education, Recreation and Sports.

Who is the main contact?
Professor Sylvie Cossette, sylvie.cossette.inf@umontreal.ca
PhD candidate Tanya Mailhot, t.mailhot@umontreal.ca

Trial website

Contact information

Type

Scientific

Primary contact

Miss Tanya Mailhot

ORCID ID

Contact details

Montreal Heart Institute Research Centre
S-2490
5000
Belanger Street
Montreal
H1T 1C8
Canada
+1 514 376 3330 ext.3184
t.mailhot@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICM-12-1420

Study information

Scientific title

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

Acronym

MENTOR_D

Study hypothesis

The purpose of this pilot trial is to assess the acceptability, feasibility and preliminary efficacy of the intervention.

The study hypothesis was that following the onset of delirium, compared with patients in the control group, those in the intervention group would present less severe delirium and a lower number of adverse clinical events in the first 3 days, as well as a shorter length of hospital stay and a better psychosocial profile at one month. Additionally, compared with caregivers in the control group, those in the intervention group will present a lower level of anxiety and a higher sense of self-efficacy at 4 days following the intervention, at hospital discharge, and at 1 month post-discharge.

On 12/06/2014 the following changes were made to the trial record:
1. The public title was changed from 'Evaluation of a nursing intervention aimed at MENTORing family caregivers in the management of Delirium following cardiac surgery' to 'Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D)'
2. The scientific title was changed from 'Evaluation of a nursing intervention aimed at mentoring family caregivers in the management of delirium following cardiac surgery: a randomized pilot study' to 'Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a randomized pilot study'

Ethics approval

Montreal Heart Institute, 17/01/2013, ref: 12-1420

Study design

Two groups randomized pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post cardiac surgery delirium

Intervention

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 the family caregiver: two daily meetings during the first three consecutive days following a delirium episode and the seventh meeting before hospital discharge. This number of meetings was chosen because of the intensity required to observe an effect, the involvement required from caregivers, and the constraints of an acute care patient following cardiac surgery (visiting hours, fragility, critical care). The six daily meetings will enable the nurse to mentor caregivers in adopting key behaviors when at the delirious patient’s bedside. The mentorship is based on Bandura’s (1986) social-cognitive theory with principles of self-efficacy based on Watson's caring theory (2008). Using this framework of learned behaviour, the nurse-mentor will focus on enhancing the caregiver’s perception of his capacity to manage the manifestations of delirium.
Several behaviors will be suggested to the caregivers and can be classified into three categories: 1) being attentive, 2) maintaining contact with the delirious person using communication strategies and 3) being a reassuring presence.
Finally, a seventh meeting will be offered to caregivers and patients just before hospital discharge, to better prepare participants for home and enable them to discuss the delirium experienced during hospitalization.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

18/02/2013

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 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 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

Previous inclusion criteria:
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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 dyads (30 patients and 30 family caregivers) (N = 15 dyads/group)

Participant 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

Recruitment start date

18/02/2013

Recruitment end date

31/08/2014

Locations

Countries of recruitment

Canada

Trial participating centre

Montreal Heart Institute Research Centre
Montreal
H1T 1C8
Canada

Sponsor information

Organisation

Montreal Heart Institute Research Center (Canada)

Sponsor details

5000
Belanger Street
Montreal
H1T 1C8
Canada
+1 514 376 3330
gilles.lefebvre@icm-mhi.org

Sponsor type

Research organisation

Website

http://www.icm-mhi.org/en/index.html

Funders

Funder type

Government

Funder name

Quebec Interuniversity Nursing Intervention Research Group [Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ)] (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Education, Sports and Leisure of Quebec [Ministère de l’éducation, du sport et des loisirs du Québec] (MELS) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Québec Research Fund-Health [Fonds de recherche du Québec-Santé] (FRQ-S) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Network Nursing Intervention Quebec [Réseau de recherche en interventions en sciences infirmières du Québec] (RRISIQ) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25073881

Publication citations

  1. Protocol

    Mailhot T, Cossette S, Bourbonnais A, Côté J, Denault A, Côté MC, Lamarche Y, Guertin MC, Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial., Trials, 2014, 15, 306, doi: 10.1186/1745-6215-15-306.

Additional files

Editorial Notes