Dataset Information

Effect of Probiotic Use on Antibiotic Administration Among Care Home Residents: A Randomized Clinical Trial.

ABSTRACT:

Importance

Probiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited.

Objective

To determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents.

Design, setting, and participants

Placebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018.

Interventions

Study participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year.

Main outcomes and measures

The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.

Results

Among 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group.

Conclusions and relevance

Among care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting.

Trial registration

ISRCTN Identifier:16392920.

SUBMITTER: Butler CC

PROVIDER: S-EPMC7341173 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesUp to 15% of the 1.4 million US nursing home (NH) residents receive antibiotics daily. Antibiotic use in NHs is often inappropriate, contributing to quality and safety concerns as well as antibiotic resistance. Information technology (IT) maturity-defined as the extent to which facilities possess and use diverse technological devices and software that are integrated across resident care, clinical support, and administrative activities-may improve the tracking and reporting of antibiotic use in NH residents. Thus, this research explores trends in IT maturity over time and associations with antibiotic use in US NHs.DesignRepeated cross-sectional study.Setting and participantsLong-term resident assessments from a random sample of Medicare-certified US NHs over 4 consecutive years (2013-2017).MethodsThree data sources were used: (1) 4 annual surveys measuring IT maturity, (2) Minimum Data Set (MDS) 3.0 assessments for resident characteristics, and (3) Certification and Survey Provider Enhanced Reporting data for facility characteristics. Nonadmission MDS assessments that were within a 90-day window of the IT survey were eligible. Descriptive statistics were examined. Bivariate and multivariate regressions using NH fixed effects were conducted controlling for resident and NH characteristics.ResultsThere were 219,461 MDS assessments from 80,237 long-stay residents aged ≥65 years, living in 817 NHs. Trends in IT maturity increased significantly over 4 years. IT integration in administrative processes was positively associated with antibiotic use (AOR 1.072, 95% CI 1.025, 1.122).Conclusions and implicationsIT components that integrate administrative activities, which can provide greater access to data sources across the organization as a whole, was associated with changes in antibiotic use. Further evaluation is needed to determine if antibiotic use is more appropriate with higher maturity such that policy makers can encourage IT with these capabilities to promote antibiotic stewardship.

Project description:BackgroundMedication management has a key role in the daily tasks of home care professionals delivered to older clients in home care. The aim of this study was to examine the effect of using a robot for medication management on home care professionals´ use of working time.MethodsA pragmatic non-randomized controlled clinical trial was conducted. The participants were home care professionals who carried out home care clients' medication management. Home care clients were allocated into intervention groups (IG) and control groups (CG) (n = 64 and 46, respectively) based on whether or not they received the robot. Data were collected using the Working Time Tracking Form prior to and 1 and 2 months after introducing the intervention. The t-test was used to compare the groups at each three timepoints. Analysis of Covariance was used to examine the groups' differences for the total time for medications as the number of visits per day as the covariate.ResultsWith robot use, the total amount of home visits decreased by 89.4% and 92.4% after 1 and 2 months of intervention use, respectively, compared to pre-intervention (p < 0.001). The total working time used for medication management considering the number of visits per day decreased from 54.2 min (95% CI 37.4-44.3) to 34.9 min (31.4-38.3), i.e., by slightly over 19 min (p < 0.001) in the IG group. During the follow-up, the total working time used for medication management considering the number of visits per day remained the same in the CG group.ConclusionUsing a robot for medication management had a notable effect on decreasing the use of working time of home care professionals. For health services, decreased use of working time for medication management means that the time saved can be assigned to services that cannot be replaced otherwise. More digital solutions should be developed based on home care clients' and professionals' needs to meet the challenge of the growing number of older people in need of home care and ensure their safety.Trial registrationClinicalTrials.gov Identifier: NCT05908604 retrospectively registered (18/06/2023).

Project description:ObjectiveTo evaluate whether C reactive protein point-of-care testing (CRP POCT) safely reduces antibiotic prescribing for lower respiratory tract infections in nursing home residents.DesignPragmatic, cluster randomised controlled trial.SettingThe UPCARE study included 11 nursing home organisations in the Netherlands.Participants84 physicians from 11 nursing home organisations included 241 participants with suspected lower respiratory tract infections from September 2018 to the end of March 2020.InterventionsNursing homes allocated to the intervention group had access to CRP POCT. The control group provided usual care without CRP POCT for patients with suspected lower respiratory tract infections.Main outcome measuresThe primary outcome measure was antibiotic prescribing at initial consultation. Secondary outcome measures were full recovery at three weeks, changes in antibiotic management and additional diagnostics during follow-up at one week and three weeks, and hospital admission and all cause mortality at any point (initial consultation, one week, or three weeks).ResultsAntibiotics were prescribed at initial consultation for 84 (53.5%) patients in the intervention group and 65 (82.3%) in the control group. Patients in the intervention group had 4.93 higher odds (95% confidence interval 1.91 to 12.73) of not being prescribed antibiotics at initial consultation compared with the control group, irrespective of treating physician and baseline characteristics. The between group difference in antibiotic prescribing at any point from initial consultation to follow-up was 23.6%. Differences in secondary outcomes between the intervention and control groups were 4.4% in full recovery rates at three weeks (86.4% v 90.8%), 2.2% in all cause mortality rates (3.5% v 1.3%), and 0.7% in hospital admission rates (7.2% v 6.5%). The odds of full recovery at three weeks, and the odds of mortality and hospital admission at any point did not significantly differ between groups.ConclusionsCRP POCT for suspected lower respiratory tract infection safely reduced antibiotic prescribing compared with usual care in nursing home residents. The findings suggest that implementing CRP POCT in nursing homes might contribute to reduced antibiotic use in this setting and help to combat antibiotic resistance.Trial registrationNetherlands Trial Register NL5054.

Project description:ImportanceLimited data are available on the clinical impact of multiplex polymerase chain reaction (PCR) point-of-care testing for respiratory pathogens in acutely ill children.ObjectiveTo evaluate the effect of multiplex PCR point-of-care testing for respiratory pathogens on antibiotic use in acutely ill children.Design, setting, and participantsThis unblinded, randomized clinical trial was conducted from May 6, 2019, through March 12, 2020. The participants were followed up until hospitalization or discharge from the emergency department (ED) for primary outcome. The study was conducted at the pediatric ED of Oulu University Hospital, Finland. Eligible study participants were children aged 0 to 17 years with fever and/or any respiratory signs or symptoms. Children with underlying medical conditions were included. The statistical analyses were performed between August 11, 2020, and September 14, 2021.InterventionsThe participants were randomly assigned in a 2:1 ratio either to undergo multiplex PCR point-of-care testing (18 respiratory viruses and 3 bacteria with results ready within 70 minutes) upon arrival at the ED or to receive routine care.Main outcomes and measuresThe primary outcome was the proportion of children receiving antibiotic therapy. The secondary outcomes were the numbers of diagnostic tests and radiographic imaging procedures performed and costs.ResultsA total of 1417 children were assessed for eligibility. After exclusions, 1243 children (692 boys [56%]) were randomly allocated to either the intervention (829 children) or control (414 children) group. The mean (SD) age of the participants was 3.0 (3.6) years in the intervention group (median [IQR], 1.7 [0.4-4.1] years) and 3.0 (3.5) years (median [IQR], 1.9 [0.4-4.1] years) in the control group. Multiplex PCR point-of-care testing for respiratory pathogens did not reduce the overall prescribing of antibiotics in the emergency department (226 children [27.3%] in the intervention group vs 118 children [28.5%] in the control group; risk ratio, 0.96; 95% CI, 0.79-1.16). Targeted antibiotic therapy was started in 12 children (1.4%) tested with point-of-care multiplex PCR and 2 children (0.5%) in the control group (risk ratio, 3.0; 95% CI, 0.76-11.9). The numbers of diagnostic tests did not differ between the groups, nor did the costs.Conclusions and relevanceIn this randomized clinical trial, point-of-care testing for respiratory pathogens did not reduce the use of antibiotics at the pediatric ED. Testing for respiratory pathogens appears to have a limited impact on clinical decision-making for acutely ill children.Trial registrationClinicalTrials.gov Identifier: NCT03932942.

Project description:ImportanceStandardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking.ObjectiveTo test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness.Design, setting, and participantsThe Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle.InterventionsFive 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices.Main outcomes and measuresTwelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video.ResultsThe study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]).Conclusions and relevanceThis study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes.Trial registrationClinicalTrials.gov Identifier: NCT02612688.

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