Clinical trial NCT06042491: The STRIVE Before Surgery Pilot Trial
Official title: 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: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgery-Complications
Disability Physical
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-09-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 8-10 months at our 5 sites will demonstrate our ability to average 2-4 participants per site per month. To continue the momentum of the trial, the pilot sample size can increase up to a maximum of 190 participants, providing time for the research team to seamlessly launch the full-scale trial. The pilot phase will merge into the full-scale trial. Having flexibility in the pilot sample size will support this process.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Monthly recruitment
timeFrame: 1 year
measure: Intervention adherence
timeFrame: pre-surgery
measure: Retention
timeFrame: 1 month, year 1
measure: Elicitation of patient, clinician and researcher-identified barriers
timeFrame: 1 year
measure: Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)
timeFrame: 1 month, 3 month, 1 year
Secondary outcomes:
measure: Days at home (to be merged with larger trial)
timeFrame: 1 month, 1 year
measure: Survival (to be merged with larger trial)
timeFrame: 1 year
measure: Length of Stay (to be merged with larger trial)
timeFrame: 1 year
measure: Patient Safety Events (to be merged with larger trial)
timeFrame: 1 year
measure: Intensive care unit admission (to be merged with larger trial)
timeFrame: 1 year
measure: Non-home discharge (to be merged with larger trial)
timeFrame: 1 year
measure: Re-admission (to be merged with larger trial)
timeFrame: 1 month, 1 year
measure: Emergency department visits (to be merged with larger trial)
timeFrame: 1 month, 1 year
measure: Health system costs (to be merged with larger trial)
timeFrame: 1 month, 1 year
measure: Health Related Quality of Life using the EQ-5D-5L (to be merged with larger trial)
timeFrame: 1 month, 3 month, 1 year
measure: In-hospital complications
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Daniel McIsaac, MD
role: PRINCIPAL_INVESTIGATOR
References: