TY  - JOUR
AU  - McGillion, Michael
AU  - Yost, Jennifer
AU  - Turner, Andrew
AU  - Bender, Duane
AU  - Scott, Ted
AU  - Carroll, Sandra
AU  - Ritvo, Paul
AU  - Peter, Elizabeth
AU  - Lamy, Andre
AU  - Furze, Gill
AU  - Krull, Kirsten
AU  - Dunlop, Valerie
AU  - Good, Amber
AU  - Dvirnik, Nazari
AU  - Bedini, Debbie
AU  - Naus, Frank
AU  - Pettit, Shirley
AU  - Henry, Shaunattonie
AU  - Probst, Christine
AU  - Mills, Joseph
AU  - Gossage, Elaine
AU  - Travale, Irene
AU  - Duquette, Janine
AU  - Taberner, Christy
AU  - Bhavnani, Sanjeev
AU  - Khan, James S
AU  - Cowan, David
AU  - Romeril, Eric
AU  - Lee, John
AU  - Colella, Tracey
AU  - Choinière, Manon
AU  - Busse, Jason
AU  - Katz, Joel
AU  - Victor, J Charles
AU  - Hoch, Jeffrey
AU  - Isaranuwatchai, Wanrudee
AU  - Kaasalainen, Sharon
AU  - Ladak, Salima
AU  - O'Keefe-McCarthy, Sheila
AU  - Parry, Monica
AU  - Sessler, Daniel I
AU  - Stacey, Michael
AU  - Stevens, Bonnie
AU  - Stremler, Robyn
AU  - Thabane, Lehana
AU  - Watt-Watson, Judy
AU  - Whitlock, Richard
AU  - MacDermid, Joy C
AU  - Leegaard, Marit
AU  - McKelvie, Robert
AU  - Hillmer, Michael
AU  - Cooper, Lynn
AU  - Arthur, Gavin
AU  - Sider, Krista
AU  - Oliver, Susan
AU  - Boyajian, Karen
AU  - Farrow, Mark
AU  - Lawton, Chris
AU  - Gamble, Darryl
AU  - Walsh, Jake
AU  - Field, Mark
AU  - LeFort, Sandra
AU  - Clyne, Wendy
AU  - Ricupero, Maria
AU  - Poole, Laurie
AU  - Russell-Wood, Karsten
AU  - Weber, Michael
AU  - McNeil, Jolene
AU  - Alpert, Robyn
AU  - Sharpe, Sarah
AU  - Bhella, Sue
AU  - Mohajer, David
AU  - Ponnambalam, Sem
AU  - Lakhani, Naeem
AU  - Khan, Rabia
AU  - Liu, Peter
AU  - Devereaux, PJ
PY  - 2016
DA  - 2016/08/01
TI  - Technology-Enabled Remote Monitoring and Self-Management — Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol
JO  - JMIR Res Protoc
SP  - e149
VL  - 5
IS  - 3
KW  - technology-enabled self-management
KW  - remote automated external monitoring
KW  - usability testing
KW  - randomized controlled trial
AB  - 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. 
SN  - 1929-0748
UR  - http://www.researchprotocols.org/2016/3/e149/
UR  - https://doi.org/10.2196/resprot.5763
UR  - http://www.ncbi.nlm.nih.gov/pubmed/27480247
DO  - 10.2196/resprot.5763
ID  - info:doi/10.2196/resprot.5763
ER  -