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Evaluation of a nursing intervention aimed at MENTORing family caregivers in the management of Delirium following cardiac surgery
ISRCTN ISRCTN95736036
DOI 10.1186/ISRCTN95736036
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of a nursing intervention aimed at MENTORing family caregivers in the management of Delirium following cardiac surgery
Scientific title Evaluation of a nursing intervention aimed at mentoring family caregivers in the management of delirium following cardiac surgery: a randomized pilot study
Acronym MENTOR_D
Serial number at source ICM-12-1420
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 one month post-discharge.
Lay 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 caregiverís 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 one month.

Who is funding the study?
Funding has been provided from Quebec Interuniversity Nursing Intervention Research Group and Quebecís 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
Ethics approval Montreal Hearth Institute approved on January 17th, 2013, ref: 12-1420
Study design Two groups randomized pilot study
Countries of recruitment Canada
Disease/condition/study domain Post cardiac surgery delirium
Participants - 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 (dementia prior , 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
Participants - exclusion criteria For patients: Undergo an emergency cardiac surgery that prevents obtaining informed consent before the procedure
Anticipated start date 18/02/2013
Anticipated end date 31/08/2014
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 30 dyads (30 patients and 30 family caregivers) (N = 15 dyads / group)
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 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 patientís bedside. The mentorship is based on Banduraís (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 caregiverís 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.
Primary outcome measure(s) Assessing the acceptability and feasibility of the intervention and the methodology of the study.
Secondary outcome measure(s) 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.
Sources of funding 1. Quebec Inter university Nursing Intervention Research Group [Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ)] (Canada)
2. Ministry of Education, Sports and Leisure of Quebec [Ministère de líéducation, du sport et des loisirs du Québec] (MELS) (Canada)
3. Québec Research Fund-Health [Fonds de recherche du Québec-Santé] (FRQ-S) (Canada)
4. Research Network Nursing Intervention Quebec [Réseau de recherche en interventions en sciences infirmières du Québec](RRISIQ) (Canada)
Trial website
Publications
Contact name Miss  Tanya  Mailhot
  Address Montreal Heart Institute Research Centre
S-2490
5000, Belanger Street
  City/town Montreal
  Zip/Postcode H1T 1C8
  Country Canada
  Tel +1 514 376 3330 ext.3184
  Email t.mailhot@umontreal.ca
Sponsor Montreal Heart Institute Research Center (Canada)
  Address 5000, Belanger Street
  City/town Montreal
  Zip/Postcode H1T 1C8
  Country Canada
  Tel +1 514 376 3330
  Email gilles.lefebvre@icm-mhi.org
  Sponsor website: http://www.icm-mhi.org/en/index.html
Date applied 19/02/2013
Last edited 27/03/2013
Date ISRCTN assigned 27/03/2013
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