The STRIVE Before Surgery Pilot Trial

Not Applicable

Active, not recruiting

• Conditions: Surgery-Complications; Disability Physical
• Interventions: Behavioral: Prehabilitation intervention

• Registration Number: NCT06042491
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-18
• Study Start: 2024-01-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-01
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 144

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Prehabilitation intervention	The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.

Primary Outcome Measures

Name	Time	Method
Intervention adherence	pre-surgery	The proportion of prescribed prehabilitation tasks adhered to
Retention	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	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	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)	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 Outcome Measures

Name	Time	Method
Non-home discharge (to be merged with larger trial)	1 year	Discharge from the index hospitalization via transfer to a non-home location or death
Intensive care unit admission (to be merged with larger trial)	1 year	Intensive care unit admission captured by administrative data
Re-admission (to be merged with larger trial)	1 month, 1 year	Number of re-admissions to hospital
Days at home (to be merged with larger trial)	1 month, 1 year	A 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
Survival (to be merged with larger trial)	1 year	All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics
Length of Stay (to be merged with larger trial)	1 year	Days from surgical admission to discharge
Patient Safety Events (to be merged with larger trial)	1 year	A validated set of in-hospital patient safety indicators will be captured from the index hospitalization record
Emergency department visits (to be merged with larger trial)	1 month, 1 year	Number of emergency department visits
Health system costs (to be merged with larger trial)	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
Health Related Quality of Life using the EQ-5D-5L (to be merged with larger trial)	1 month, 3 month, 1 year	EQ-5D-5L will be used to capture health related quality of life at baseline, pre-op, 30, 90, and 365 days after surgery.
In-hospital complications	Up to 1 month	Postoperative Morbidity Survey (POMS) is a tool used to used to identify complications. At time of discharge, participants will be administered a patient-reported version of the POMS tool

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada