A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards

Marian C Brady, David J Stott, Christopher J Weir, Campbell Chalmers, Petrina Sweeney, John Barr, Alex Pollock, Naomi Bowers, Heather Gray, Brenda Jean Bain, Marissa Colins, Catriona Keerie, Peter Langhorne

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Abstract

Background
Patients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life.

Aims
We piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings.

Methods
Scottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque.

Results
We screened 1548/2613 (59%) admissions to four wards, recruiting n = 325 patients and n = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare (P = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42).

Conclusions
Our stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect.

Trial Registration
NCT01954212.
Original languageEnglish
Number of pages6
JournalInternational Journal of Stroke
Early online date30 Sep 2019
DOIs
Publication statusE-pub ahead of print - 30 Sep 2019

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Cost-Benefit Analysis
Randomized Controlled Trials
Stroke
Pneumonia
Delivery of Health Care
Confidence Intervals
Hospital Costs
Nursing Staff
Oral Health
Random Allocation
Documentation
Sample Size
Length of Stay
Odds Ratio
Nurses
Quality of Life
Equipment and Supplies
Incidence
Population

Keywords

  • clinical trial, intervention, oral healthcare, pilot, randomized controlled trial, rehabilitation, stroke

Cite this

@article{46fdab61bde24569ac0a16ab88546775,
title = "A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards",
abstract = "BackgroundPatients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life.AimsWe piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings.MethodsScottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque.ResultsWe screened 1548/2613 (59{\%}) admissions to four wards, recruiting n = 325 patients and n = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0{\%} to 21{\%}), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare (P = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42).ConclusionsOur stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect.Trial RegistrationNCT01954212.",
keywords = "clinical trial, intervention, oral healthcare, pilot, randomized controlled trial, rehabilitation, stroke",
author = "Brady, {Marian C} and Stott, {David J} and Weir, {Christopher J} and Campbell Chalmers and Petrina Sweeney and John Barr and Alex Pollock and Naomi Bowers and Heather Gray and Bain, {Brenda Jean} and Marissa Colins and Catriona Keerie and Peter Langhorne",
note = "Acceptance in SAN Author notes expected to be published OA ET 26/6/19 ^AAM: no embargo. Update rights statement/ replace with VoR as applicable. DC 2/7/19 OA ST 16.10.19 ^^Kept both files open as otherwise will need to use Gold exception. ET 22/10/19",
year = "2019",
month = "9",
day = "30",
doi = "10.1177/1747493019871824",
language = "English",
journal = "International Journal of Stroke",
issn = "1747-4930",
publisher = "SAGE Publications Ltd",

}

TY - JOUR

T1 - A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards

AU - Brady, Marian C

AU - Stott, David J

AU - Weir, Christopher J

AU - Chalmers, Campbell

AU - Sweeney, Petrina

AU - Barr, John

AU - Pollock, Alex

AU - Bowers, Naomi

AU - Gray, Heather

AU - Bain, Brenda Jean

AU - Colins, Marissa

AU - Keerie, Catriona

AU - Langhorne, Peter

N1 - Acceptance in SAN Author notes expected to be published OA ET 26/6/19 ^AAM: no embargo. Update rights statement/ replace with VoR as applicable. DC 2/7/19 OA ST 16.10.19 ^^Kept both files open as otherwise will need to use Gold exception. ET 22/10/19

PY - 2019/9/30

Y1 - 2019/9/30

N2 - BackgroundPatients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life.AimsWe piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings.MethodsScottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque.ResultsWe screened 1548/2613 (59%) admissions to four wards, recruiting n = 325 patients and n = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare (P = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42).ConclusionsOur stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect.Trial RegistrationNCT01954212.

AB - BackgroundPatients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life.AimsWe piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings.MethodsScottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque.ResultsWe screened 1548/2613 (59%) admissions to four wards, recruiting n = 325 patients and n = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare (P = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42).ConclusionsOur stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect.Trial RegistrationNCT01954212.

KW - clinical trial, intervention, oral healthcare, pilot, randomized controlled trial, rehabilitation, stroke

U2 - 10.1177/1747493019871824

DO - 10.1177/1747493019871824

M3 - Article

JO - International Journal of Stroke

JF - International Journal of Stroke

SN - 1747-4930

ER -