Background: The number of people presenting for surgery, and their risk profile, are
increasing. People presenting for surgery face substantial risk of postoperative adverse
events. Fifteen to 30% of patients suffer a serious medical or surgical complication
after surgery, and 1 in 5 develop a new patient-reported disability that reflects a loss
of independence in day-to-day life. More than 1.4 million inpatient surgical procedures
are performed in Canada each year. Globally, >300 million surgical procedures occur
annually. As an increasing number of people present for surgery, the average risk profile
of this population is rising. Surgical patients are typically older and live with
comorbidity. This means that strategies to improve patient outcomes and reduce resource
utilization are urgently needed. Patients, the public, clinicians, and policy makers
participating in 2 separate James Lind Alliance Priority Setting Partnerships (Canada &
UK) identified prehabilitation as a Top 10 priority for perioperative research.
Furthermore, prehabilitation is currently discussed in the popular media as a strategy to
improve outcomes for the growing number of high-risk patients presenting for surgery.
Overarching Aim: The STRIVE Before Surgery Trial will evaluate three pragmatic elements
(recruitment, adherence, and follow-up) that our experience in prehabilitation research
demonstrate are necessary to support successful, large-scale evaluation. The
investigators will concurrently use implementation science methodology to further refine
processes for the larger trial. As this is a vanguard pilot trial, data from this trial
will be combined with the future, large-scale trial.
Methods:
Design, setting and participants: The STRIVE Before Surgery Trial is an assessor blinded
multicenter individual patient parallel-arm vanguard pragmatic randomized controlled
trial.
People => 18 years old having inpatient abdominal, thoracic, pelvic, head-and-neck or
vascular surgery with expected length of stay of => 2 days will be included.
Intervention: The intervention includes 3 aspects (exercise, nutrition and breathing).
Our intervention is a home-based multimodal prehabilitation program supported through an
online platform.
Outcomes and sample size: Primary outcomes are monthly recruitment, intervention
adherence, retention, and elicitation of patient, clinician and researcher-identified
barriers. Secondary outcomes are days at home in the 30 days after surgery, survival,
length of stay, patient safety indicators, intensive care unit admission, non-home
discharge, readmission, emergency department visits, and health system costs. Our
vanguard trial sample size estimate is informed by a power calculation for the future
large-scale trial. For the vanguard trial, a sample size of 144 directly links to our 3
feasibility outcomes: 1) recruitment of 144 participants over 8-10 months at our 5 sites
will demonstrate our ability to average 2-4 participants per site per month. To continue
the momentum of the trial, the pilot sample size can increase up to a maximum of 190
participants, providing time for the research team to seamlessly launch the full-scale
trial. The pilot phase will merge into the full-scale trial. Having flexibility in the
pilot sample size will support this process.
Expertise: Our team features multidisciplinary clinical and methodological experts,
nationally representative knowledge users and patient representatives.
Expected outcomes: Knowledge gained from our vanguard trial will directly inform the
larger pragmatic trial, which will be powered to detect a minimally important difference
in a patient-reported outcome.
