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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 902
- Locations
- 2
- Primary Endpoint
- Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Study Overview
Brief Summary
The STRIVE Before Surgery Trial evaluates patient-reported disability at 90 days after surgery following 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.
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 full-scale trial will evaluate patient reported disability at 90 days after surgery.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Patient-reported outcome assessors will be blinded and abstractors collecting routine data are unaware of allocation.
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).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery
- •Expected surgery date between 3 and 12 weeks from enrollment
- •Valid provincial health insurance number
- •Access to internet-enabled device
- •Email address
Exclusion Criteria
- •Inability to read and communicate in English
- •Cognitive impairment preventing ability to provide informed consent independently
- •No telephone/cell phone
- •Cardiac, neurological or orthopedic procedure
- •Surgery with no curative intent (palliative surgery)
- •Patient not interested in participating in the context of their TAPA score
- •Any of the following cardiovascular conditions:
- •Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- •Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- •Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's HeartWalk program)
Arms & Interventions
Prehabilitation
The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) cardio and 3) stretching. Participants will be encouraged to complete self-directed and/or group sessions >= 3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is the STRIVE Trial website. The nutrition component includes: 1) protein supplementation; 2) nutrition 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/huffing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.
Intervention: Prehabilitation (Behavioral)
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 Snapshot) documents will be provided to control participants (without active or online support).
Outcomes
Primary Outcomes
Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Time Frame: 1 month
The WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score
Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Time Frame: 3 months
The WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score
Secondary Outcomes
- EuroQol Quality of Life Scale (EQ-5D-5L)(1 month, 3 months, 1 year)
- Survival(1 month, 1 year)
- Health system costs(1 month, 1 year)
- A count of days at home in the 30-days after surgery(1 month)
- Length of stay(1 year)
- Details of patient safety indicators(1 year)
- Intensive care unit (ICU) admissions(1 year)
- Elicitation of patient, clinician and researcher-identified barriers to our pragmatic trial using the Theoretical Domains Framework(1 year)
- Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(3 months, 1 year)
- Non-home discharge(1 year)
- Count of readmissions(1 month)
- In-hospital Complications(up to 1 month)
- Intensive care unit (ICU) length of stay(1 year)
- Time to first readmission(1 month)
- Time to first emergency department visit(1 month)
- Count of emergency department visits(1 month)
- Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(1 month, 1 year)