The STRIVE Before Surgery Trial
- Conditions
- Surgery-ComplicationsDisability Physical
- Interventions
- Behavioral: Prehabilitation
- Registration Number
- NCT06511258
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
The STRIVE Before Surgery Trial evaluates patient-reported disability at 30 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 pilot phase evaluated three pragmatic elements (recruitment, adherence, and follow-up) that our experience in prehabilitation research demonstrate are necessary to support successful, large-scale evaluation. Data from the pilot phase will be combined with this full-scale trial. The full-scale trial will evaluate patient reported disability at 30 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.
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 outcome is patient-reported disability 30 days after surgery. Secondary outcomes are days at home in the 30 days after surgery, survival, health-related quality of life, length of stay, patient safety indicators, intensive care unit admission, non-home discharge, readmission, emergency department visits, health system costs, and elicitation of patient, clinician and researcher-identified barriers to our pragmatic trial using the Theoretical Domains Framework. Our trial sample size calculation is informed by parameter estimates from the pilot phase. A sample of 902 patients (451 per arm) will provide 90% power to detect a 5% minimally important difference between the mean WHODAS scores using an F-test from an Analysis of Covariance (ANCOVA) at the two-sided 5% significance level. We conservatively assumed a common standard deviation of 23 (equal to the upper limit of the 95% CI observed in our vanguard trial) and a correlation with baseline of 0.3. We also allowed for up to 10% attrition.
Expertise: The team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: Despite systematic review findings that exercise prehabilitation may improve physical performance and function, limitations exist that preclude generalizability, including many identified studies being high or unclear risk of bias and single center studies with \<100 participants. The investigators aim to conduct this low risk of bias, mutli-center study of adult surgical patients \>18 years to address this gap.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 902
- 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
-
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation 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.
- Primary Outcome Measures
Name Time Method Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 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
- Secondary Outcome Measures
Name Time Method Time to first readmission 1 month Time to first acute hospitalization in the 30-days after surgery
EuroQol Quality of Life Scale (EQ-5D-5L) 1 month, 3 months, 1 year This is a well-validated instrument with Canadian valuation statistics and national implementation used to measure health-related quality of life after surgery and to inform incremental cost per quality-adjusted life year gained. Participants are asked to select one answer under each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Responses range from having no problems with a particular domain to being unable to engage in that particular domain. Participants are asked to identify on a scale of 0-100 how good or bad their health is on that given day (0 being worst health they can imagine, 100 being best health they can imagine).
Survival 1 month, 1 year All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics
Health system costs 1 month, 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
A count of days at home in the 30-days after surgery 1 month 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
Length of stay 1 year Days from surgical admission to discharge will be calculated
Details of patient safety indicators 1 year A validated set of in-hospital patient safety indicators will be captured from the index hospitalization record
Intensive care unit (ICU) admissions 1 year ICU admissions will be accurately captured by administrative data
Elicitation of patient, clinician and researcher-identified barriers to our pragmatic trial using the Theoretical Domains Framework 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) 3 months, 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
Non-home discharge 1 year Discharge from the index hospitalization via transfer to a non-home location or death will be captured
Count of readmissions 1 month Count of any acute hospitalization in the 30-days after surgery
In-hospital Complications up to 1 month Postoperative Morbidity Survey (POMS) is a tool used to identify complications. At time of discharge, participants will be administered a patient-reported version of the POMS tool.
Intensive care unit (ICU) length of stay 1 year ICU length of stay will be accurately captured by administrative data
Time to first emergency department visit 1 month Time to first emergency department visit in the 30-days after surgery.
Count of emergency department visits 1 month Count of any emergency department visits in the 30-days after surgery.
Trial Locations
- Locations (1)
The Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada