Dataset Information

The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people.

ABSTRACT:

Background and objectives

delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bespoke delirium prevention intervention, called 'Stop Delirium!' In preparation for a definitive trial of Stop Delirium, we sought to address key aspects of trial design for the particular circumstances of care homes.

Design

a cluster randomized feasibility study with an embedded process evaluation.

Setting and participants

residents of 14 care homes for older people in one metropolitan district in the UK.

Intervention

Stop Delirium!: a 16-month-enhanced educational package to support care home staff to address key delirium risk factors. Control homes received usual care.

Measurements

we collected data to determine the following: recruitment and attrition; delirium rates and variability between homes; feasibility of measuring delirium, resource use, quality of life, hospital admissions and falls; and intervention implementation and adherence.

Results

two-thirds (215) of eligible care home residents were recruited. One-month delirium prevalence was 4.0% in intervention and 7.1% in control homes. Proposed outcome measurements were feasible, although our approach appeared to underestimate delirium. Health economic evaluation was feasible using routinely collected data.

Conclusion

a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work.

SUBMITTER: Siddiqi N

PROVIDER: S-EPMC5027640 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people.

Siddiqi Najma N Cheater Francine F Collinson Michelle M Farrin Amanda A Forster Anne A George Deepa D Godfrey Mary M Graham Elizabeth E Harrison Jennifer J Heaven Anne A Heudtlass Peter P Hulme Claire C Meads David D North Chris C Sturrock Angus A Young John J

Age and ageing 20160520 5

<h4>Background and objectives</h4>delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bes ...[more]

PMID: 27207749

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Project description:BackgroundThe number and proportion of older people globally is growing faster than that of any other age group. At the same time the number of people retaining some of their own teeth is rising. There significant differences between those living in care and their community dwelling peers, with evidence showing those in care having fewer teeth and significantly higher levels of dental decay. There are numerous Cochrane reviews linking the use of fluoride to a reduction in dental decay, however, the majority of research on effectiveness has been conducted on children and consequently, children and adolescents tend to be the main recipients of fluoride interventions. There are to date no studies comparing the effectiveness of fluoride interventions in older people in care homes in the UK. However, prior to developing an appropriate protocol for full-scale trial comparing clinical effectiveness of fluoride interventions, there are a number of trial feasibility and statistical parameters that need to be clarified.MethodsThis trial is a single centre, multi-site randomised controlled assessor blind parallel group (three groups) trial, with the primary objective of establishing the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. Secondary and tertiary objectives will aim to explore the acceptability of the interventions from resident, care home and dental services perspectives, and estimate the efficacy of the three different fluoride treatments.DiscussionThis feasibility trial will produce new knowledge and add value to a landscape that is under researched. Although the efficacy of fluoride interventions is proven, the feasibility of dental research and prevention in this vulnerable group and in the complex care home setting is novel. This work will not only add to our understanding of the interface of dental care and social care but will also contribute to our broader understanding on undertaking research in care home settings. Dental care for older people has been a longstanding issue, and the events of this past year has shone a light on the vulnerabilities of those residing in care homes and so this research is landing at a pivotal time. Trial registration EudraCT Registration 2017-002248-34. Registered 20th February 2018 https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-002248-34 .

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Project description:BackgroundDelirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30-73%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs.MethodsThe objective is to assess the effectiveness of the multicomponent PREPARED Trial intervention in reducing the following primary outcomes: incidence, severity, duration, and frequency of delirium episodes in cognitively impaired residents. This 4-year, parallel-design, cluster randomized study will involve nursing staff and residents in 45-50 LTCFs in Montreal, Canada. Participating public and private LTCFs (clusters) that provide 24-h nursing care will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. Approximately 400-600 LTC residents aged 65 and older with dementia and/or cognitive impairment will be enrolled in the study and followed for 18 weeks. Residents must be at risk of delirium, delirium-free at baseline and have resided at the facility for at least 2 weeks. Residents who are unable to communicate verbally, have a history of specific psychiatric conditions, or are receiving end-of-life care will be excluded. The PREPARED Trial intervention consists of four main components: a decision tree, an instruction manual, a training package, and a toolkit. Primary study outcomes will be assessed weekly. Functional autonomy and cognitive levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and facility transfers will be collected retrospectively for the duration of the follow-up period. Primary outcomes will be reported at the level of intervention assignment. All researchers analyzing the data will be blinded to group allocation.DiscussionThis large-scale intervention study will contribute significantly to the development of evidence-based clinical guidelines for delirium prevention in this frail elderly population, as it will be the first to evaluate the efficacy of a multicomponent delirium prevention program translated into LTC clinical practice on a large scale.Trial registrationNCT03718156 , ClinicalTrials.gov .

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Dataset Information

The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people.

Background and objectives

Design

Setting and participants

Intervention

Measurements

Results

Conclusion

Publications

The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people.

Similar Datasets

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