Clinical trial NCT01998997: A Family Intervention for Delirium Prevention
Official title: A Family Intervention to Decrease Delirium: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Delirium
Hospitalized elderly
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 79
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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).

Eligibility criteria: Inclusion Criteria:

* Age 70 years or older
* Residing in the community
* Admitted to a general medical unit at the London Health Sciences center, University Campus
* Having a willing and interested English-speaking family member
* Not delirious on admission
* Able to communicate in English

Exclusion Criteria:

* Terminal condition
* Delirious on admission
* Advanced dementia
* Admission to the ICU (or transfer to the ICU within one week of admission)

Primary outcomes:
measure: acceptance rate of intervention
timeFrame: 14 weeks
Secondary outcomes:
measure: Rate of incident delirium in each of the 2 groups
timeFrame: 14 weeks
Other outcomes:
measure: Difficulties in performing the intervention
timeFrame: 14 weeks
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: Lawson HRI
name: monidipa dasgupta, MD
role: PRINCIPAL_INVESTIGATOR
References: