Clinical Trial: A Family Intervention for Delirium Prevention

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Family Intervention to Decrease Delirium: a Pilot Study

Brief Summary: To address the feasibility of implementing a randomized, educational intervention to prevent delirium, directed at family members of hospitalized older (70 years of age or older) medical in-patients. Specifically rates of recruitment and acceptance rates of such an intervention to family members will be assessed. An estimate of the effect size of this intervention will also be calculated. This is a pilot study. The investigators hypothesize that this intervention will be feasible and agreeable to family members to perform, with acceptance rates exceeding 80%.

Detailed Summary:

In a recent study in Chile, investigators randomized family members of admitted patients to an educational intervention to prevent delirium. Family members actively participated in a non-pharmacological intervention to prevent delirium. This has not been done in a North American environment, with different cultural and climactic factors.

This study will be a randomized controlled trial (pilot study) involving family members. Family members will be randomized to a control group or an educational intervention. The control group will receive a general brochure, outlining general health information published by the Ministry of Health. The intervention group will receive a specific brochure on details around delirium (what it is and how to prevent it), and then a brief educational session comprising a didactic session and to address any questions. This pilot study will examine the feasibility of doing this kind of intervention in a North American environment. The family-based intervention is similar to what was done in the Chilean study. It involves six elements including the educational session. The five other elements include: 1) family being present for extended periods (at least 5 hours if possible); 2) engaging in conversation with study patients for re-orientation to current time and current events; 3) avoiding sensory deprivation (ensuring hearing or visual aids and dentures are available as needed; 4) providing familiar objects to patients; 5) provision of a clock and calendar to the patient. The intervention brochure is similar to what was provided to family members as part of the original Chilean study (kindly provided to the principal investigator, M. Dasgupta, by the lead author of the Chilean study, Dr. F.T. Martinez).


Sponsor: Lawson Health Research Institute

Current Primary Outcome: acceptance rate of intervention [ Time Frame: 14 weeks ]

This is a feasibility study aiming to assess the acceptance of an intervention directed at family members. The acceptance rate will therefore be the primary outcome.


Original Primary Outcome: acceptance rate of intervention [ Time Frame: 30 days ]

This is a feasibility study aiming to assess the acceptance of an intervention directed at family members. The acceptance rate will therefore be the primary outcome.


Current Secondary Outcome: Rate of incident delirium in each of the 2 groups [ Time Frame: 14 weeks ]

The rate of incident delirium in each of the 2 (control or intervention) groups will be examined in order to calculate the sample size for a future similar intervention study.


Original Secondary Outcome: Rate of incident delirium in each of the 2 groups [ Time Frame: 30 days ]

The rate of incident delirium in each of the 2 (control or intervention) groups will be examined in order to calculate the sample size for a future similar intervention study.


Information By: Lawson Health Research Institute

Dates:
Date Received: November 25, 2013
Date Started: March 2014
Date Completion:
Last Updated: December 23, 2015
Last Verified: December 2015