The STRIVE Before Surgery Pilot Trial

Overview

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 Title of Study: “The STRIVE Before Surgery Pilot Trial: a Vanguard Pragmatic Multicenter Randomized Trial of Structured TRaining to Improve Fitness in a Virtual Environment (STRIVE) Before Surgery”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Outcomes Assessor)
• Study Primary Completion Date: November 2024

Detailed 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 6 months at our 4 sites will demonstrate our ability to average 6 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.

Interventions

• Behavioral: Prehabilitation intervention
  • The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) aerobic exercise and 3) flexibility using individual, self-directed sessions and instructor-led group sessions. 1-hour individual, self-directed sessions are offered >3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is concurrently accessible as a smart phone app. The nutrition component includes: 1) protein supplementation; 2) nutritional advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.

Arms, Groups and Cohorts

• Experimental: Intervention
  • The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.
• No Intervention: Control
  • 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) documents will be provided to control participants (without active or online support).

Clinical Trial Outcome Measures

Primary Measures

• Monthly recruitment
  • Time Frame: 1 year
  • Recruited patients per center per month will be analyzed descriptively to generate a mean and standard deviation. Recruitment feasibility will be judged based on criteria pre-established that consider the number of available, committed sites in Ontario (>6 defines definitely feasible, 4-5 possibly and <4 infeasible)
• Intervention adherence
  • Time Frame: pre-surgery
  • The proportion of prescribed prehabilitation tasks adhered to
• Retention
  • Time Frame: 1 month, year 1
  • The proportion of participants retained at 30-day patient-reported follow up will be calculated with a 95% confidence interval based on Wilson’s method.
• Elicitation of patient, clinician and researcher-identified barriers
  • Time Frame: 1 year
  • For each target group, the frequency of domains identified as barriers will be calculated.

Secondary Measures

• Days at home
  • Time Frame: 1 month, year 1
  • A count of days at home in the 30-days after surgery is a validated patient-centered outcome that can be ascertained from routinely collected data
• Survival
  • Time Frame: 1 year
  • All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics
• Length of Stay
  • Time Frame: 1 year
  • Days from surgical admission to discharge
• Patient Safety Events
  • Time Frame: 1 year
  • A validated set of in-hospital patient safety indicators will be captured from the index hospitalization record
• Intensive care unit admission
  • Time Frame: 1 year
  • Intensive care unit admission captured by administrative data
• Non-home discharge
  • Time Frame: 1 year
  • Discharge from the index hospitalization via transfer to a non-home location or death
• Re-admission
  • Time Frame: 1 month, year 1
  • Number of re-admissions to hospital
• Emergency department visits
  • Time Frame: 1 month, year 1
  • Number of emergency department visits
• Health system costs
  • Time Frame: 1 year
  • A validated patient-level costing algorithm will be used to capture all health system costs accrued within 30-days and 1-year after surgery

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Ottawa Hospital Research Institute
• Collaborator
  • Canadian Institutes of Health Research (CIHR)
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Daniel McIsaac, MD, Principal Investigator, The Ottawa Hospital
• Overall Contact(s)
  • Emily Hladkowicz, PhD (c), 613-798-5555, emhladkowicz@toh.ca