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IntroductionIn the past 20 years, the increasing burden of heart disease in an ageing population has resulted in cardiac surgery (CS) being offered to more frail and older patients with multiple comorbidities. Frailty and malnutrition are key geriatric syndromes that impact postoperative outcomes, including morbidity, mortality and prolonged hospital length of stay. Enhanced recovery protocols (ERPs), such as prehabilitation, have been associated with a reduction in complications after CS in vulnerable patients. The use of nutritional ERPs may enhance short-term and long-term recovery and mitigate frailty progression while improving patient-reported outcomes.Methods and analysisThis trial is a two-centre, double-blinded, placebo, randomised controlled trial with blinded endpoint assessment and intention-to-treat analysis. One-hundred and fifty CS patients will be randomised to receive either a leucine-rich protein supplement or a placebo with no supplemented protein. Patients will consume their assigned supplement two times per day for approximately 2 weeks pre-procedure, during in-hospital postoperative recovery and for 8 weeks following discharge. The primary outcome will be the Short Physical Performance Battery score. Data collection will occur at four time points including baseline, in-hospital (pre-discharge), 2-month and 6-month time points post-surgery.Ethics and disseminationThe University of Manitoba Biomedical Research Ethics Board (20 March 2018) and the St Boniface Hospital Research Review Committee (28 June 2019) approved the trial protocol for the primary site in Winnipeg, Manitoba, Canada. The second site’s (Montreal, Quebec) ethics has been submitted and pending approval from the Research Ethics and New Technology Development Committee for the Montreal Heart Institute (December 2020). Recruitment for the primary site started February 2020 and the second site will begin January 2021. Data gathered from the PROTein to Enhance outComes of (pre)frail paTients undergoing Cardiac Surgery Study will be published in peer-reviewed journals and presented at national and international conferences. Knowledge translation strategies will be created to share findings with stakeholders who are positioned to implement evidence-informed change.Potential study impactMalnutrition and frailty play a crucial role in post-CS recovery. Nutritional ERPs are increasingly being recognised as a clinically relevant aspect of perioperative care. As such, this trial is to determine if leucine-rich protein supplementation at key intervals can mitigate frailty progression and facilitate enhanced postoperative recovery.Trial registration numberClinicalTrials.gov Registry (NCT04038294).

ObjectiveThe aims of this study were to describe the impact of patient engagement on the initial design and content of a mobile health (mHealth) technology that supports enhanced recovery protocols (ERPs) for cardiac surgery.MethodsEngagement occurred at the level of consultation and took the form of an advisory panel. Patients that underwent cardiac surgery (2017-2018) at St. Boniface Hospital (Winnipeg, Manitoba) and consented to be contacted about future research, and their caregivers, were approached for participation. A qualitative exploration was undertaken to determine advisory panel members’ key messages about, and the impact of, patient engagement on mHealth technology design and content.ResultsTen individuals participated in the advisory panel. Key design-specific messages centered around access, tracking, synchronization, and reminders. Key content-specific messages centered around roles of cardiac surgery team members and medical terms, educational videos, information regarding cardiac surgery procedures, travel before/after surgery, nutrition (i.e., what to eat), medications (i.e., drug interactions), resources (i.e., medical devices), and physical activity (i.e., addressing fears and providing information, recommendations, and instructions). These key messages were a rich source of information for mHealth technology developers and were incorporated as supported by the existing capabilities of the underlying technology platform.ConclusionsPatient engagement facilitated the development of a mHealth technology whose design and content were driven by the lived experiences of cardiac surgery patients and caregivers. The result was a detail-oriented and patient-centered mHealth technology that helps to empower and inform patients and their caregivers about the patient journey across the perioperative period of cardiac surgery.KEY QUESTIONSWhat is already known about this subject?Enhanced recovery protocols (ERPs) have been proposed as a clinical strategy to effectively address complex and multi-system vulnerabilities, like those commonly present in older adults undergoing cardiac surgery. Mobile health (mHealth) technologies have the potential to improve delivery and patient experience with ERPs, but their development in the academic research setting is often limited by a lack of end-user (e.g., i.e., patient and caregiver) involvement.What does this study add?To our knowledge, this is one of the first studies to engage patients and caregivers in the development of a mHealth technology that supports ERPs for cardiac surgery. This study describes a process for engaging patients and caregivers as “co-producers” of a mHealth technology to support delivery of ERPs during the perioperative period of cardiac surgery. It also demonstrates that engaging patients and caregivers in research, through the formation of an advisory panel, yields a rich source of information to guide the design and content of mHealth technologies in cardiac research.How might this impact on clinical practice?In an era in which mHealth technologies are being increasingly looked to for the optimization of healthcare delivery, this study underscores the utility of using patient and caregiver voices to drive the development of patient-centered mHealth technologies to support clinical practice.