Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhoea (including Clostridium difficile-associated diarrhoea) in care homes

Abstract

BackgroundAntibiotic prescribing rates in care homes are higher than in the general population. Antibiotics disrupt the normal gut flora, sometimes causing antibiotic-associated diarrhoea (AAD).Clostridium difficile(Hall and O’Toole 1935) Prévot 1938 is the most commonly identified cause of AAD. Little is known either about the frequency or type of antibiotics prescribed in care homes or about the incidence and aetiology of AAD in this setting.ObjectivesThe Probiotics for Antibiotic-Associated Diarrhoea (PAAD) study was designed as a two-stage study. PAAD stage 1 aimed to (1) prospectively describe antibiotic prescribing in care homes; (2) determine the incidence ofC. difficilecarriage and AAD (includingC. difficile-associated diarrhoea); and (3) to consider implementation challenges and establish the basis for a sample size estimation for a randomised controlled trial (RCT) of probiotic administration with antibiotics to prevent AAD in care homes. If justified by PAAD stage 1, the RCT would be implemented in PAAD stage 2. However, as a result of new evidence regarding the clinical effectiveness of probiotics on the incidence of AAD, a decision was taken not to proceed with PAAD stage 2.DesignPAAD stage 1 was a prospective observational cohort study in care homes in South Wales with up to 12 months’ follow-up for each resident.SettingRecruited care homes had management and owner’s agreement to participate and three or more staff willing to take responsibility for implementing the study.ParticipantsEleven care homes were recruited, but one withdrew before any residents were recruited. A total of 279 care home residents were recruited to the observational study and 19 withdrew, 16 (84%) because of moving to a non-participating care home.Main outcome measuresThe primary outcomes were the rate of antibiotic prescribing, incidence of AAD, defined as three or more loose stools (type 5–7 on the Bristol Stool Chart) in a 24-hour period, andC. difficilecarriage confirmed on stool culture.ResultsStool samples were obtained at study entry from 81% of participating residents. Over half of the samples contained antibiotic-resistant isolates, with Enterobacteriaceae resistant to ciprofloxacin in 47%. Residents were prescribed an average of 2.16 antibiotic prescriptions per year [95% confidence interval (CI) 1.90 to 2.46]. Antibiotics were less likely to be prescribed to residents from dual-registered homes. The incidence of AAD was 0.57 (95% CI 0.41 to 0.81) episodes per year among those residents who were prescribed antibiotics. AAD was more likely in residents who were prescribed co-amoxiclav than other antibiotics and in those residents who routinely used incontinence pads. AAD was less common in residents from residential homes.ConclusionsCare home residents, particularly in nursing homes, are frequently prescribed antibiotics and often experience AAD. Antibiotic resistance, including ciprofloxacin resistance, is common in Enterobacteriaceae isolated from the stool of care home residents. Co-amoxiclav is associated with greater risk of AAD than other commonly prescribed antibiotics.Trial registrationCurrent Controlled Trials ISRCTN 7954844.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 18, No. 63. See the NIHR Journals Library website for further project information.

Education and training to enhance end-of-life care for nursing home staff: a systematic literature review

“…Obtaining data relating to patient outcomes has been identified as a challenge in studies based in nursing homes because patient records have been reported as too inadequate to provide reliable data37 perhaps explaining why this approach is seldom taken.…”

Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice

“…Adults lacking capacity may only be included in a CTIMP if; (a) similar results are unlikely to be obtained with individuals who can provide informed consent for themselves; (b) the benefits of administering the medicinal product are expected to outweigh risk to the participant, and (c) the trial relates directly to a life-threatening or debilitating condition from which the subject suffers [ 10 ]. Data obtained from the preceding observational study showed that the majority of residents (71%) lacked capacity and that those without capacity were significantly more likely to be prescribed antibiotics, be more frail, be at greater nutritional risk, and more often suffer from antibiotic-associated diarrhoea [ 7 ]. These data were provided to the Research Ethics Committee to support plans to include residents without capacity, as they are most at risk of the adverse consequences of antibiotic use and most likely to benefit from the study findings.…”

“…The aim was to randomise 400 residents (200 per arm) from approximately 24 care homes in South Wales, commencing 2013. We aimed to implement this trial after an observational study of antibiotic use and associated diarrhoea in the same setting [ 7 ]. Although we did not implement the trial because of new emerging data, we encountered many specific unique challenges in setting up a clinical trial of an investigational medicinal product (CTIMP) in this largely research naïve environment that resulted in significant challenges and delay.…”

Encouraging managers of care homes for older adults to participate in research

“…While paying general practitioners to help with patient recruitment has also become accepted practice (Draper et al, 2009), paying social care organisations to support recruitment is less wellestablished although on the increase in care home research (see for example Hood et al, 2014;Livingston et al, 2017) and is accepted by some research funders. The well-rehearsed ethical concerns around payments to individuals are also applicable when organisations are provided with payment in return for participating in research.…”