title: Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Pressure ulcers are insidious complications that affect approximately 2.5 million patients and account for approximately US$11 billion in annual health care spending each year. To date we are unaware of any study that has used a wearable patient sensor to quantify patient movement and positioning in an effort to assess whether adherence to optimal patient turning results in a reduction in pressure ulcer occurrence.
  
  
  METHODS
  This study is a single-site, open-label, two-arm, randomized controlled trial that will enroll 1812 patients from two intensive care units. All subjects will be randomly assigned, with the aid of a computer-generated schedule, to either a standard care group (control) or an optimal pressure ulcer-preventative care group (treatment). Optimal pressure ulcer prevention is defined as regular turning every 2 h with at least 15 min of tissue decompression. All subjects will receive a wearable patient sensor (Leaf Healthcare, Inc., Pleasanton, CA, USA) that will detect patient movement and positioning. This information is relayed through a proprietary mesh network to a central server for display on a user-interface to assist with nursing care. This information is used to guide preventative care practices for those within the treatment group. Patients will be monitored throughout their admission in the intensive care unit.
  
  
  CONCLUSIONS
  We plan to conduct a randomized control trial, which to our knowledge is the first of its kind to use a wearable patient sensor to quantify and establish optimal preventative care practices, in an attempt to determine whether this is effective in reducing hospital-acquired pressure ulcers.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT02533726 .
authors.affiliation: General Medical Disciplines, Stanford Medicine, Menlo Park, CA, USA. dpickham@stanfordhealthcare.org.|Office of Research, Patient Care Services, Stanford Health Care, Stanford, CA, USA. dpickham@stanfordhealthcare.org.
authors.forename: David
authors.initials: D
authors.lastname: Pickham
authors.affiliation: Office of Research, Patient Care Services, Stanford Health Care, Stanford, CA, USA.
authors.forename: Betsy
authors.initials: B
authors.lastname: Ballew
authors.affiliation: Digital Health, Stanford Health Care, Stanford, CA, USA.
authors.forename: Kristi
authors.initials: K
authors.lastname: Ebong
authors.affiliation: Patient Care Services, Stanford Health Care, Stanford, CA, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Shinn
authors.affiliation: General Medical Disciplines, Stanford Medicine, Menlo Park, CA, USA.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Lough
authors.affiliation: General Medical Disciplines, Stanford Medicine, Menlo Park, CA, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Mayer
mesh_terms: D002140:California; D002985:Clinical Protocols; D004867:Equipment Design; D006801:Humans; D007362:Intensive Care Units; D055805:Moving and Lifting Patients; D056888:Patient Positioning; D003668:Pressure Ulcer / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D011322:Primary Prevention / Q000295:instrumentation*; D058998:Remote Sensing Technology / Q000295:instrumentation*; D012107:Research Design; D013997:Time Factors; D014160:Transducers, Pressure; D016896:Treatment Outcome; D014584:User-Computer Interface