The STRIVE Before Surgery Pilot Trial

Ottawa Hospital Research Institute

Status: Active, not recruiting

Conditions: Surgery-Complications; Disability Physical

Treatments: Behavioral: Prehabilitation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06042491

CTO - 4479

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years
2. Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery
3. Expected surgery date between 3 and 12 weeks from enrollment
4. Valid provincial health insurance number
5. Access to internet-enabled device
6. Email address

Exclusion criteria

1. Inability to read and communicate in English

2. Cognitive impairment preventing ability to provide informed consent independently

3. No telephone/cell phone

4. Cardiac, neurological or orthopedic procedure

5. Surgery with no curative intent (palliative surgery)

6. Patient not interested in participating in the context of their Telephone Assessment of Physical Activity (TAPA) score

7. Any of the following cardiovascular conditions:

   1. Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
   2. Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
   3. Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's Heart Walk program)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.

Treatment:

Behavioral: Prehabilitation intervention

Control

No Intervention group

Description:

To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and \>65) and healthy eating recommendations (Canada's Food Guide Snapshot) documents will be provided to control participants (without active or online support).