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Technology-Enabled Remote Monitoring and Self-Management - Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol.

Authors:
Michael McGillion Jennifer Yost Andrew Turner Duane Bender Ted Scott Sandra Carroll Paul Ritvo Elizabeth Peter Andre Lamy Gill Furze Kirsten Krull Valerie Dunlop Amber Good Nazari Dvirnik Debbie Bedini Frank Naus Shirley Pettit Shaunattonie Henry Christine Probst Joseph Mills Elaine Gossage Irene Travale Janine Duquette Christy Taberner Sanjeev Bhavnani James S Khan David Cowan Eric Romeril John Lee Tracey Colella Manon Choinière Jason Busse Joel Katz J Charles Victor Jeffrey Hoch Wanrudee Isaranuwatchai Sharon Kaasalainen Salima Ladak Sheila O'Keefe-McCarthy Monica Parry Daniel I Sessler Michael Stacey Bonnie Stevens Robyn Stremler Lehana Thabane Judy Watt-Watson Richard Whitlock Joy C MacDermid Marit Leegaard Robert McKelvie Michael Hillmer Lynn Cooper Gavin Arthur Krista Sider Susan Oliver Karen Boyajian Mark Farrow Chris Lawton Darryl Gamble Jake Walsh Mark Field Sandra LeFort Wendy Clyne Maria Ricupero Laurie Poole Karsten Russell-Wood Michael Weber Jolene McNeil Robyn Alpert Sarah Sharpe Sue Bhella David Mohajer Sem Ponnambalam Naeem Lakhani Rabia Khan Peter Liu P J Devereaux

JMIR Res Protoc 2016 Aug 1;5(3):e149. Epub 2016 Aug 1.

McMaster University, Hamiltion, ON, Canada.

Background: Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT-VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom.

Objective: Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT).

Methods: CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise-death, myocardial infarction, and nonfatal stroke- all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups.

Results: Study start-up is underway and usability testing is scheduled to begin in the fall of 2016.

Conclusions: Given our experience, dedicated industry partners, and related RCT infrastructure, we are confident we can make a lasting contribution to improving the care of seniors who undergo CaVS.

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http://dx.doi.org/10.2196/resprot.5763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4999307PMC
August 2016

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