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
- Completed
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Intervention adherence
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Group allocation will not be indicated in data analyzed by the outcome assessors.
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 Telephone Assessment of Physical Activity (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 Heart Walk program)
Arms & Interventions
Intervention
The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.
Intervention: Prehabilitation intervention (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
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.
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.
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.
Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)
Time Frame: 1 month, 3 month, 1 year
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
- Non-home discharge (to be merged with larger trial)(1 year)
- Intensive care unit admission (to be merged with larger trial)(1 year)
- Re-admission (to be merged with larger trial)(1 month, 1 year)
- Days at home (to be merged with larger trial)(1 month, 1 year)
- Survival (to be merged with larger trial)(1 year)
- Length of Stay (to be merged with larger trial)(1 year)
- Patient Safety Events (to be merged with larger trial)(1 year)
- Emergency department visits (to be merged with larger trial)(1 month, 1 year)
- Health system costs (to be merged with larger trial)(1 month, 1 year)
- Health Related Quality of Life using the EQ-5D-5L (to be merged with larger trial)(1 month, 3 month, 1 year)
- In-hospital complications(Up to 1 month)