title: Clinical and cost effectiveness of enhanced oral healthcare in stroke care settings (SOCLE II): a pilot, stepped wedge, cluster randomized, controlled trial protocol.
abstract: BACKGROUND
  Stroke-associated pneumonia, a leading cause of hospital-acquired infection after stroke, affects a fifth of stroke survivors annually. Associated with increased risk of death and poorer rehabilitation outcomes, research suggests a possible relationship between stroke-associated pneumonia and patients' oral health.
  
  
  OBJECTIVE
  The aim of this study is to evaluate the feasibility of a randomized controlled trial of the clinical and cost effectiveness of enhanced oral healthcare vs. usual oral healthcare for people in stroke care settings.
  
  
  METHODS
  Our pilot, multicentered, pragmatic, stepped wedge, cluster randomized controlled trial oral healthcare [Stroke Oral healthCare pLan Evaluation (SOCLE II)] will compare enhanced oral healthcare intervention and usual oral healthcare. Over 13 months, across 4 wards, we seek to recruit 400 patients (estimating an average of 23 beds per site and a 50% recruitment rate) and 60 nursing staff (estimating an average of 20 members of staff per site and a 75% recruitment rate). Initially, control data (usual oral healthcare) will be collected from all sites. In a randomized, stepped manner, wards will convert to deliver the enhanced oral healthcare intervention.
  Outcomes will be captured across dimensions of care (as recommended for evaluations of complex interventions) at baseline and weekly thereafter. Primary outcomes are pneumonia (patients), knowledge and attitudes (staff), and specialist dental referrals (service). Secondary outcomes include oral health quality of life, plaque, antibiotics, length of stay, death (patients), use of oral healthcare equipment and products, completed assessments, and documented oral healthcare plans (staff).
  
  
  CONCLUSIONS
  As one of the first stepped wedge, cluster randomized, controlled trials in stroke care mapping of the complex intervention, our choice of primary and secondary outcomes and choice of trial design are described.
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Marian C
authors.initials: MC
authors.lastname: Brady
authors.affiliation: Academic Section of Geriatric Medicine, Glasgow Royal Infirmary, Glasgow, UK.
authors.forename: David
authors.initials: D
authors.lastname: Stott
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.|Edinburgh Health Services Research Unit, Edinburgh, UK.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Weir
authors.affiliation: NHS Lanarkshire, Scotland, UK.
authors.forename: Campbell
authors.initials: C
authors.lastname: Chalmers
authors.affiliation: Dental School, University of Glasgow, Glasgow, UK.
authors.forename: Petrina
authors.initials: P
authors.lastname: Sweeney
authors.affiliation: Yunus Centre for Social Business & Health, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Cam
authors.initials: C
authors.lastname: Donaldson
authors.affiliation: NMAHP Research Unit, Stroke Rehabilitation Research Advisory Group, Glasgow, UK.
authors.forename: John
authors.initials: J
authors.lastname: Barr
authors.affiliation: NMAHP Research Unit, Stroke Rehabilitation Research Advisory Group, Glasgow, UK.
authors.forename: Marion
authors.initials: M
authors.lastname: Barr
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Alex
authors.initials: A
authors.lastname: Pollock
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Sheena
authors.initials: S
authors.lastname: McGowan
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Naomi
authors.initials: N
authors.lastname: Bowers
authors.affiliation: Academic Section of Geriatric Medicine, Glasgow Royal Infirmary, Glasgow, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Langhorne
mesh_terms: D003362:Cost-Benefit Analysis; D005240:Feasibility Studies; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009909:Oral Health; D009910:Oral Hygiene / Q000009:adverse effects / Q000191:economics* / Q000379:methods*; D010865:Pilot Projects; D011788:Quality of Life; D020521:Stroke / Q000191:economics* / Q000628:therapy*; D016896:Treatment Outcome
keywords: complex intervention; nursing; oral health; pneumonia; stroke