Clinical trial NCT04652622: Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
Official title: Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: digital therapeutic
behavioral
critical care
behavior modification
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: BC Support Unit
name: Royal Columbian Hospital Foundation
name: Mitacs
First posted: 2020-12-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be randomized to either exposure to the intervention arm in conjunction with standard care or the control arm and will receive standard care alone
Primary purpose: TREATMENT

Brief summary: Delirium is a condition of fluctuating confusion and agitation that affects as many as 80% of patients in critical care. Hyperactive delirium consumes a significant amount of clinical attention and resources due to the associated psychomotor agitation. Patients can become aggressive or combative putting both themselves and healthcare workers at risk of harm. Delirium has been linked to an increased risk of death and poor overall outcomes. Management largely relies on the use of potentially toxic medications and physical restraints despite limited proof of success of these interventions. Our research group will study the use of a novel interactive digital therapeutic behavior modification platform aimed at reducing anxiety and agitation associated with hyperactive delirium. We hypothesize that Use of the Mindful Garden behavioral modification platform will result in normalization of agitation and delirium scores when used for the management of delirium associated agitation in the adult delirious acute care population compared to standard care alone.

Detailed description: Mindful Garden is a digital behavior modification platform that utilizes screen based delivery systems and sensor technologies. Mindful Garden delivers real 2-dimensional nature video layered with hyper-real 3-dimensional animations of growing and receding flowers and butterflies in flight which aims to reduce anxiety and agitation in the delirious critical care population. In doing so, normalization of agitation and delirium scores may be achieved as well as a reduction in reliance on pharmacological interventions and the use of physical restraints, which have been linked to adverse outcomes and significant side effects.

Participants with a diagnosis of hyperactive delirium in acute care inpatient units will be randomized to receive 4 hours of exposure to the MG platform in addition to standard care or to the control arm of monitoring with standard care only for the same time period.

Eligibility criteria: Inclusion Criteria:

* Adult (age \>18yrs)
* Admitted to the Royal Columbian Hospital
* RASS +1 or greater for 2 assessments 1 hour apart within the 24-hour period directly prior to study enrollment and persisting at the time of enrollment
* Demonstrated incidence of at least 2 PRN medication events for the management of delirium-associated agitation in the preceding 24 hours and/or infusion of psycho- active medication for the management of delirium (eg: dexmeditomodine)
* ICDSC greater than or equal to 4 at time of enrollment or CAM positive

Exclusion Criteria:

* Planned procedure or test that precludes participation in the full 4-hour study session
* Unable to see (visual impairment such as documented blindness, ongoing inability to keep eyes open or documented or assessed inability to focus, track or maintain visual contact for extended periods as determined by recruitment personnel)
* Significant uncontrolled pain with a Verbal Pain scale of 5/10 or greater or a Clinical Pain Observation Tool \>4 despite intervention at the time of enrollment.
* RASS of 0 to -5 at study enrollment indicating patient is awake and calm or sedated
* Refusal for participation by the participant's responsible physician or request to not retain data by participants substitute decision maker
* Currently enrolled in any other research study involving drugs or devices which could impact on the outcomes of interest, as evaluated by the Principal Investigator

Primary outcomes:
measure: Agitation scores
timeFrame: 5 hours
Secondary outcomes:
measure: Use of unscheduled medications for the management of delirium associated agitation
timeFrame: 4 hours
measure: Delirium Scores
timeFrame: 4 hours
measure: Richmond Agitation Sedation Scale of zero
timeFrame: 4 hours
measure: Physical Restraint Use
timeFrame: 4 hours
measure: Incidence of Unplanned Line removal
timeFrame: 4 hours
measure: PRN medication use in the 2 hours post study
timeFrame: 2 hours
measure: Movement Count Average
timeFrame: 4 Hours
measure: Physiological data
timeFrame: 4 hours
measure: heart rate variability
timeFrame: 6 hours
Other outcomes:
measure: Survey of caregivers
timeFrame: 4 hours
measure: Survey of family members
timeFrame: 4 hours
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: Steven Reynolds
role: PRINCIPAL_INVESTIGATOR
References: