title: Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers.
  
  
  METHODS
  A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups' interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge).
  
  
  CONCLUSIONS
  This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, GD01 Teaching Research & Wellness Building, University of Calgary, 3280 Hospital Drive, NW, Calgary, AB, T2N-4Z6, Canada. hsywong@ucalgary.ca.
authors.forename: Holly
authors.initials: H
authors.lastname: Wong
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, GD01 Teaching Research & Wellness Building, University of Calgary, 3280 Hospital Drive, NW, Calgary, AB, T2N-4Z6, Canada. jbjarnso@ucalgary.ca.
authors.forename: Jaime
authors.initials: J
authors.lastname: Kaufman
authors.affiliation: Division of General Internal Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. baylis@ucalgary.ca.
authors.forename: Barry
authors.initials: B
authors.lastname: Baylis
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, GD01 Teaching Research & Wellness Building, University of Calgary, 3280 Hospital Drive, NW, Calgary, AB, T2N-4Z6, Canada. john.conly@albertahealthservices.ca.|Infection Prevention and Control, Alberta Health Services, Calgary, AB, Canada. john.conly@albertahealthservices.ca.|O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada. john.conly@albertahealthservices.ca.|Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. john.conly@albertahealthservices.ca.|Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. john.conly@albertahealthservices.ca.|Foothills Medical Centre, Special Services Building, Ground Floor, AGW5, Calgary, AB T2N 2T9, Canada. john.conly@albertahealthservices.ca.
authors.forename: John M
authors.initials: JM
authors.lastname: Conly
authors.affiliation: Brenda Strafford Foundation (Geriatric Medicine), University of Calgary, HSC-3330 Hospital Dr. NW, Calgary, AB, T2N 4N1, Canada. dhogan@ucalgary.ca.
authors.forename: David B
authors.initials: DB
authors.lastname: Hogan
authors.affiliation: O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada. tstelfox@ucalgary.ca.|Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. tstelfox@ucalgary.ca.|Department of Critical Care Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. tstelfox@ucalgary.ca.|Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. tstelfox@ucalgary.ca.|Alberta Health Services, Alberta, Canada. tstelfox@ucalgary.ca.
authors.forename: Henry T
authors.initials: HT
authors.lastname: Stelfox
authors.affiliation: O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada. dasouthe@ucalgary.ca.
authors.forename: Danielle A
authors.initials: DA
authors.lastname: Southern
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, GD01 Teaching Research & Wellness Building, University of Calgary, 3280 Hospital Drive, NW, Calgary, AB, T2N-4Z6, Canada. wghali@ucalgary.ca.|Division of General Internal Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. wghali@ucalgary.ca.|O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada. wghali@ucalgary.ca.|Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. wghali@ucalgary.ca.|Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. wghali@ucalgary.ca.
authors.forename: William A
authors.initials: WA
authors.lastname: Ghali
authors.affiliation: Division of Physical Medicine & Rehabilitation, Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 - 29th Street NW, Calgary, AB, T2N 2T9, Canada. Chester.Ho@albertahealthservices.ca.
authors.forename: Chester H
authors.initials: CH
authors.lastname: Ho
mesh_terms: D000416:Alberta; D001513:Beds; D002985:Clinical Protocols; D004867:Equipment Design; D056228:Feedback, Sensory; D006801:Humans; D008991:Monitoring, Physiologic / Q000295:instrumentation*; D056888:Patient Positioning; D011312:Pressure; D003668:Pressure Ulcer / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D012307:Risk Factors; D012815:Signal Processing, Computer-Assisted; D062606:Tertiary Care Centers; D013997:Time Factors; D014160:Transducers, Pressure