The STRIVE Before Surgery Trial
NCT Number: NCT06511258
Acronym: STRIVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery-Complications|Disability Physical
Interventions: BEHAVIORAL: Prehabilitation
Sponsor: Ottawa Hospital Research Institute
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 902
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2031-12-01
Locations: The Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada

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.

Primary Outcome Measures: Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS), 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, 1 month
Secondary Outcome Measures: EuroQol Quality of Life Scale (EQ-5D-5L), 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)., 1 month, 3 months, 1 year|A count of days at home in the 30-days after surgery, 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, 1 month|Survival, All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics, 1 month, 1 year|Length of stay, Days from surgical admission to discharge will be calculated, 1 year|Details of patient safety indicators, A validated set of in-hospital patient safety indicators will be captured from the index hospitalization record, 1 year|Intensive care unit (ICU) admissions, ICU admissions will be accurately captured by administrative data, 1 year|Intensive care unit (ICU) length of stay, ICU length of stay will be accurately captured by administrative data, 1 year|Non-home discharge, Discharge from the index hospitalization via transfer to a non-home location or death will be captured, 1 year|Count of readmissions, Count of any acute hospitalization in the 30-days after surgery, 1 month|Time to first readmission, Time to first acute hospitalization in the 30-days after surgery, 1 month|Time to first emergency department visit, Time to first emergency department visit in the 30-days after surgery., 1 month|Count of emergency department visits, Count of any emergency department visits in the 30-days after surgery., 1 month|Health system costs, A validated patient-level costing algorithm will be used to capture all health system costs accrued within 30-days and 1-year after surgery, 1 month, 1 year|Elicitation of patient, clinician and researcher-identified barriers to our pragmatic trial using the Theoretical Domains Framework, For each target group, the frequency of domains identified as barriers will be calculated, 1 year|In-hospital Complications, 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., up to 1 month|Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS), 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, 3 months, 1 year