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Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience.

ABSTRACT: BACKGROUND:Trials are at risk of contamination bias which can occur when participants in the control group are inadvertently exposed to the intervention. This is a particular risk in rehabilitation studies where it is easy for trial interventions to be either intentionally or inadvertently adopted in control settings. The Falls in Care Homes (FinCH) trial is used in this paper as an example of a large randomised controlled trial of a complex intervention to explore the potential risks of contamination bias. We outline the FinCH trial design, present the potential risks from contamination bias, and the strategies used in the design of the trial to minimise or mitigate against this. The FinCH trial was a multi-centre randomised controlled trial, with embedded process evaluation, which evaluated whether systematic training in the use of the Guide to Action Tool for Care Homes reduced falls in care home residents. Data were collected from a number of sources to explore contamination in the FinCH trial. Where specific procedures were adopted to reduce risk of, or mitigate against, contamination, this was recorded. Data were collected from study e-mails, meetings with clinicians, research assistant and clinician network communications, and an embedded process evaluation in six intervention care homes. During the FinCH trial, there were six new falls prevention initiatives implemented outside the study which could have contaminated our intervention and findings. Methods used to minimise contamination were: cluster randomisation at the level of care home; engagement with the clinical community to highlight the risks of early adoption; establishing local collaborators in each site familiar with the local context; signing agreements with NHS falls specialists that they would maintain confidentiality regarding details of the intervention; opening additional research sites; and by raising awareness about the importance of contamination in research among participants. CONCLUSION:Complex rehabilitation trials are at risk of contamination bias. The potential for contamination bias in studies can be minimized by strengthening collaboration and dialogue with the clinical community. Researchers should recognise that clinicians may contaminate a study through lack of research expertise.

SUBMITTER: Robinson K

PROVIDER: S-EPMC7047395 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience.

Robinson K K Allen F F Darby J J Fox C C Gordon A L AL Horne J C JC Leighton P P Sims E E Logan P A PA

BMC medical research methodology 20200227 1

<h4>Background</h4>Trials are at risk of contamination bias which can occur when participants in the control group are inadvertently exposed to the intervention. This is a particular risk in rehabilitation studies where it is easy for trial interventions to be either intentionally or inadvertently adopted in control settings. The Falls in Care Homes (FinCH) trial is used in this paper as an example of a large randomised controlled trial of a complex intervention to explore the potential risks of ...[more]

PMID: 32106827

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Project description:BackgroundCommon foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents.MethodsInformed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength.Results474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group.ConclusionsA podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised controlled trial of the intervention. Although not powered to determine effectiveness, these preliminary data provide justification for a larger trial, incorporating a full process evaluation, to determine whether this intervention can significantly reduce falls in this high-risk population.Trial registrationClinicalTrials.gov identifier: NCT02178527 ; Date of registration: 17 June 2014.

Project description:BackgroundParo and other robot animals can improve wellbeing for older adults and people with dementia, through reducing depression, agitation and medication use. However, nursing and care staff we contacted expressed infection control concerns. Little related research has been published. We assessed (i) how microbiologically contaminated robot animals become during use by older people within a care home and (ii) efficacy of a cleaning procedure.MethodsThis study had two stages. In stage one we assessed microbial load on eight robot animals after interaction with four care home residents, and again following cleaning by a researcher. Robot animals provided a range of shell-types, including fur, soft plastic, and solid plastic. Stage two involved a similar process with two robot animals, but a care staff member conducted cleaning. The cleaning process involved spraying with anti-bacterial product, brushing fur-type shells, followed by vigorous top-to-tail cleaning with anti-bacterial wipes on all shell types. Two samples were taken from each of eight robots in stage one and two robots in stage two (20 samples total). Samples were collected using contact plate stamping and evaluated using aerobic colony count and identification (gram stain, colony morphology, coagulase agglutination). Colony counts were measured by colony forming units per square centimetre (CFU/cm2).ResultsMost robots acquired microbial loads well above an acceptable threshold of 2.5 CFU/cm2 following use. The bacteria identified were micrococcus species, coagulase negative staphylococcus, diptheriods, aerobic spore bearers, and staphylococcus aureus, all of which carry risk for human health. For all devices the CFU/cm2 reduced to well within accepted limits following cleaning by both researcher and care staff member.ConclusionsCompanion robots will acquire significant levels of bacteria during normal use. The simple cleaning procedure detailed in this study reduced microbial load to acceptable levels in controlled experiments. Further work is needed in the field and to check the impact on the transmission of viruses.

Project description:IntroductionCare home residents are relatively high users of healthcare resources and may have complex needs. Comprehensive geriatric assessment (CGA) may benefit care home residents and improve efficiency of care delivery. This is an approach to care in which there is a thorough multidisciplinary assessment (physical and mental health, functioning and physical and social environments) and a care plan based on this assessment, usually delivered by a multidisciplinary team. The CGA process is known to improve outcomes for community-dwelling older people and those in receipt of hospital care, but less is known about its efficacy in care home residents.Methods and analysisRealist review was selected as the most appropriate method to explore the complex nature of the care home setting and multidisciplinary delivery of care. The aim of the realist review is to identify and characterise a programme theory that underpins the CGA intervention. The realist review will extract data from research articles which describe the causal mechanisms through which the practice of CGA generates outcomes. The focus of the intervention is care homes, and the outcomes of interest are health-related quality of life and satisfaction with services; for both residents and staff. Further outcomes may include appropriate use of National Health Service services and resources of older care home residents. The review will proceed through three stages: (1) identifying the candidate programme theories that underpin CGA through interviews with key stakeholders, systematic search of the peer-reviewed and non-peer-reviewed evidence, (2) identifying the evidence relevant to CGA in UK care homes and refining the programme theories through refining and iterating the systematic search, lateral searches and seeking further information from study authors and (3) analysis and synthesis of evidence, involving the testing of the programme theories.Ethics and disseminationThe PEACH project was identified as service development following submission to the UK Health Research Authority and subsequent review by the University of Nottingham Research Ethics Committee. The study protocols have been reviewed as part of good governance by the Nottinghamshire Healthcare Foundation Trust. We aim to publish this realist review in a peer-reviewed journal with international readership. We will disseminate findings to public and stakeholders using knowledge mobilisation techniques. Stakeholders will include the Quality Improvement Collaboratives within PEACH study. National networks, such as British Society of Gerontology and National Care Association will be approached for wider dissemination.Trial registration numberThe realist review has been registered on International Prospective Register of Systematic Reviews (PROSPERO 2017: CRD42017062601).

Project description:ObjectiveTo explain the current delivery of healthcare to residents living in UK care homes.DesignQualitative interview study using a grounded theory approach.Setting6 UK care homes and primary care professionals serving the homes.ParticipantsOf the 32 participants, there were 7 care home managers, 2 care home nurses, 9 care home assistants, 6 general practitioners (GPs), 3 dementia outreach nurses, 2 district nurses, 2 advanced nurse practitioners and 1 occupational therapist.Results5 themes were identified: complex health needs and the intrinsic nature of residents' illness trajectories; a mismatch between healthcare requirements and GP time; reactive or anticipatory healthcare?; a dissonance in healthcare knowledge and ethos; and tensions in the responsibility for the healthcare of residents. Care home managers and staff were pivotal to healthcare delivery for residents despite their perceived role in social care provision. Formal healthcare for residents was primarily provided via one or more GPs, often organised to provide a reactive service that did not meet residents' complex needs. Deficiencies were identified in training required to meet residents' needs for both care home staff as well as GPs. Misunderstandings, ambiguities and boundaries around roles and responsibilities of health and social care staff limited the development of constructive relationships.ConclusionsHealthcare of care home residents is difficult because their needs are complex and unpredictable. Neither GPs nor care home staff have enough time to meet these needs and many lack the prerequisite skills and training. Anticipatory care is generally held to be preferable to reactive care. Attempts to structure care to make it more anticipatory are dependent on effective relationships between GPs and care home staff and their ability to establish common goals. Roles and responsibilities for many aspects of healthcare are not made explicit and this risks poor outcomes for residents.

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Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience.

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Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience.

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