Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06042491 |
Other study ID # |
CTO - 4479 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 30, 2024 |
Est. completion date |
April 2026 |
Study information
Verified date |
January 2024 |
Source |
Ottawa Hospital Research Institute |
Contact |
Emily Hladkowicz, PhD |
Phone |
613-798-5555 |
Email |
emhladkowicz[@]toh.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence,
and follow-up) associated with participating in a home-based multimodal prehabilitation
program supported through an online platform. Half of the participants will be randomized
into the prehabilitation group, while the other half will be randomized into the control
group.
Description:
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.
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.