Surgery Complications
Conditions
Brief summary
The Advancing Cognition and Cognitive reserve before ELective surgery to Enhance cognitive Recovery And TrajEctories (ACCELERATE) Pilot Trial estimates whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
Detailed description
Background: Delirium, a fluctuating, acute disturbance in attention and awareness, develops in 15-50% of older adults after major surgery. Promising, early stage evidence suggests that cognitive prehabilitation could decrease the absolute risk of postoperative delirium by 10% or more. However, multicenter trials that feasibly optimize cognitive prehabilitation adherence amongst populations most likely to benefit from the intervention are required to advance cognitive prehabilitation toward routine practice. Overarching Aim: The ACCELERATE Pilot Trial will estimate whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol. Methods: Design, setting and participants: The ACCELERATE Pilot trial is prospective single-arm interventional pilot trial. People \>/= 60 years old with Clinical Frailty Scale (CFS) score \>/= 4 having inpatient abdominal, orthopedic, spine, thoracic, pelvic, head-and-neck, and vascular surgery with expected time to surgery \>/= 4 weeks will be included. Intervention: Our intervention is a home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity \[Lumos Labs\]), enhanced by theory- and evidence-informed structured coaching. Outcomes and sample size: Primary outcome is intervention adherence. Secondary outcomes are monthly recruitment and fidelity to delirium assessment. Our pilot sample size of n=103 is designed to provide 80% power at a 5% level of significance to test whether the proportion of adherent patients exceeds our feasibility target of 75%. Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives. Expected outcomes: The ACCELERATE Pilot Trial will derive robust estimates of intervention adherence when supported by structured coaching, as well as trial protocol feasibility. If the pilot trial is feasible, we will proceed with the full ACCELERATE Trial, which will be powered to estimate the effectiveness of cognitive prehabilitation in reducing delirium along with partner-prioritized secondary outcomes.
Interventions
BEHAVIORALCognitive Prehabilitation
home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity \[Lumos Labs\]), enhanced by theory- and evidence-informed structured coaching.
Sponsors
Ottawa Hospital Research Institute
Canadian Anesthesiologists' Society
University of Ottawa Anesthesiology and Pain Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>/= 60 years * Planned, inpatient, surgical procedures: abdominal, orthopedic, spine, thoracic, pelvic, ENT, and vascular * Clinical Frailty Scale (CFS) score \>/= 4 * Expected time to surgery \>/= 4 weeks * Cognitive capacity to independently consent for surgery
Exclusion criteria
* Cardiac and intracranial neurosurgery procedures * Visual impairment * Lack of English fluency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention adherence | From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery) | ≥75% of intervention participants completing \>/=10 hrs of cognitive prehabilitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monthly recruitment | 1 month | ≥4 participants per center per month (a 40% recruitment rate; full trial would require 36 months to complete) |
| Primary outcome ascertainment | Delirium will be assessed at the following timepoints after surgery: 1 hour after emergence, and twice daily on postop days 1, 2 and 3 at 08:00 and 20:00; 7 total | ≥ 90% of participants with ≥ 6 complete in-hospital delirium assessments |
Countries
Canada
Contacts
CONTACTLeandra Amado, MD
CONTACTEmily Hladkowicz, PhD
PRINCIPAL_INVESTIGATORLeandra Amado, MD
The Ottawa Hospital
Outcome results
None listed