Dataset Information

The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes.

ABSTRACT:

Objectives

To determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents.

Design

The Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy.

Setting

35 Sydney nursing homes.

Participants

All eligible residents within geographically defined areas within each nursing home were invited to participate.

Intervention

Professional 'ElderClowns' provided 9-12 weekly humour therapy sessions, augmented by resident engagement by trained staff 'LaughterBosses'. Controls received usual care.

Measurements

Depression scores on the Cornell Scale for Depression in Dementia, agitation scores on the Cohen-Mansfield Agitation Inventory, behavioural disturbance scores on the Neuropsychiatric Inventory, social engagement scores on the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and self-rated and proxy-rated quality-of-life scores on a health-related quality-of-life tool for dementia, the DEMQOL. All outcomes were measured at the participant level by researchers blind to group assignment.

Randomisation

Sites were stratified by size and level of care then assigned to group using a random number generator.

Results

Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Groups did not differ significantly over time on the primary outcome of depression, or on behavioural disturbances other than agitation, social engagement and quality of life. The secondary outcome of agitation was significantly reduced in the intervention group compared with controls over 26 weeks (time by group interaction adjusted for covariates: p=0.011). The mean difference in change from baseline to 26 weeks in Blom-transformed agitation scores after adjustment for covariates was 0.17 (95% CI 0.004 to 0.34, p=0.045).

Conclusions

Humour therapy did not significantly reduce depression but significantly reduced agitation.

Trial registration

Australian New Zealand Clinical Trials Registry -ACTRN12611000462987.

SUBMITTER: Low LF

PROVIDER: S-EPMC3549213 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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Publications

The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes.

Low Lee-Fay LF Brodaty Henry H Goodenough Belinda B Spitzer Peter P Bell Jean-Paul JP Fleming Richard R Casey Anne-Nicole AN Liu Zhixin Z Chenoweth Lynn L

BMJ open 20130111 1

<h4>Objectives</h4>To determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents.<h4>Design</h4>The Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy.<h4>Setting</h4>35 Sydney nursing homes.<h4>Participants</h4>All eligible residents within geographically defined areas within ea ...[more]

PMID: 23315520

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Project description:BackgroundDementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes.MethodsDementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units.Results34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02).ConclusionsDCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method.Trial registrationDutch Trials Registry NTR2314.

Project description:BackgroundDeprescribing polypharmacy and potentially inappropriate medications (PIMs) has been shown to be beneficial to nursing home (NH) residents' health. Medication reviews are the most widely studied deprescribing intervention; in a previous trial, we showed that another intervention, a deprescribing-focused interprofessional quality circle, can reduce the use of inappropriate medications at the NH level. However, this intervention cannot account for the variety of the residents' clinical situations. Therefore, we trialled a subsequent intervention in NH that enacted the quality circle intervention in the previous year.MethodsIn 7 NHs, the most heavily medicated residents were recruited and randomised to receive usual care or the intervention. The intervention was a pharmacist-led, deprescribing-focused medication review, followed by the creation of an individualised treatment modification plan in collaboration with nurses and physicians. Intervention's effects were assessed after four months on the number and dose of PIMs used, quality of life, and safety outcomes (mortality, hospitalisations, falls, and use of physical restraints). Data were analysed using Poisson multivariate regression models.ResultsSixty-two NH residents participated, falling short of the expected 100 participants; 4 died before initial data collection. Participants used a very high number of drugs (median 15, inter-quartile range [12-19]) and PIMs (median 5, IQR [3-7]) at baseline. The intervention did not reduce the number of PIMs prescribed to the participants; however, it significantly decreased their dose (incidence rate ratio 0.763, CI95 [0.594; 0.979]), in particular for chronic drugs (IRR 0.716, CI95 [0.546; 0.938]). No adverse effects were seen on mortality, hospitalisations, falls, and restraints use, but, in the intervention group, three participants experienced adverse events that required the reintroduction of withdrawn treatments, and a decrease in quality of life is possible.ConclusionsAs it did not reach its recruitment target, this trial should be seen as exploratory. Results indicate that, following a NH-level deprescribing intervention, a resident-level intervention can further reduce some aspects of PIMs use. Great attention must be paid to residents' well-being when further developing such deprescribing interventions, as a possible reduction in quality of life was found in the intervention group, and some participants suffered adverse events following deprescribing.Trial registrationClinicalTrials.gov (NCT03688542, https://clinicaltrials.gov/ct2/show/NCT03688542 ), registered on 31.08.2018.

Project description:ObjectivesTo pilot a complex intervention to support healthcare and improve early detection and treatment for common health conditions experienced by nursing home (NH) residents.DesignPilot cluster randomised controlled trial.Setting14 NHs (7 intervention, 7 control) in London and West Yorkshire.ParticipantsNH residents, their family carers and staff.InterventionComplex intervention to support healthcare and improve early detection and treatment of urinary tract and respiratory infections, chronic heart failure and dehydration, comprising: (1) 'Stop and Watch (S&W)' early warning tool for changes in physical health, (2) condition-specific care pathway and (3) Situation, Background, Assessment and Recommendation tool to enhance communication with primary care. Implementation was supported by Practice Development Champions, a Practice Development Support Group and regular telephone coaching with external facilitators.Outcome measuresData on NH (quality ratings, size, ownership), residents, family carers and staff demographics during the month prior to intervention and subsequently, numbers of admissions, accident and emergency visits, and unscheduled general practitioner visits monthly for 6 months during intervention. We collected data on how the intervention was used, healthcare resource use and quality of life data for economic evaluation. We assessed recruitment and retention, and whether a full trial was warranted.ResultsWe recruited 14 NHs, 148 staff, 95 family carers and 245 residents. We retained the majority of participants recruited (95%). 15% of residents had an unplanned hospital admission for one of the four study conditions. We were able to collect sufficient questionnaire data (all over 96% complete). No NH implemented intervention tools as planned. Only 16 S&W forms and 8 care pathways were completed. There was no evidence of harm.ConclusionsRecruitment, retention and data collection processes were effective but the intervention not implemented. A full trial is not warranted.Trial registration numberISRCTN74109734 (https://doi.org/10.1186/ISRCTN74109734). ORIGINAL PROTOCOL: BMJ Open. 2019;9(5):e026510. doi:10.1136/bmjopen-2018-026510.

Project description:ImportanceMultidrug-resistant organisms (MDROs) can cause significant morbidity and mortality. Preventing MDROs can reduce the risk of subsequent transmission and infection.ObjectiveTo determine whether a multicomponent infection prevention intervention can reduce MDRO prevalence in nursing homes (NHs).Design, setting, and participantsThis cluster randomized clinical trial of a multicomponent intervention was conducted in 6 NHs in Michigan from September 2016 to August 2018. Three NHs adopted a multicomponent intervention, while 3 control NHs continued without investigator intervention. Study visits were conducted at baseline; days 7, 14, 21, and 30; and monthly thereafter for up to 6 months or discharge. Visits included clinical data collection and MDRO surveillance culturing of multiple body sites and high-touch surfaces in patient rooms. Any patients who provided informed consent within 14 days of admission to the NH were enrolled in this study. Non-English speakers and patients receiving hospice care were ineligible. Analysis was performed from November 2018 to February 2020.InterventionsIntervention NHs adopted a multicomponent intervention that included enhanced barrier precautions, chlorhexidine bathing, MDRO surveillance, environmental cleaning education and feedback, hand hygiene promotion, and health care worker education and feedback. Control nursing homes continued standard care practices.Main outcomes and measuresThe primary outcome, presence of MDROs, was measured longitudinally in the patient and room environment and was evaluated using generalized mixed effect models. The secondary outcome, time to new MDRO acquisition, was assessed using Cox proportional hazard models.ResultsA total of 6 NHs were included, with 245 patients (mean [SD] age, 72.5 [13.6] years; 134 [54.7%] women) enrolled; 3 NHs with 113 patients (46.1%) were randomized to the intervention group and 3 NHs with 132 patients (53.9%) were randomized to the control group. A total of 132 patients (53.9%) were White, and 235 patients (95.9%) were receiving postacute care. Over 808 study visits, 3654 patient cultures and 5606 environmental cultures were obtained. The intervention reduced the odds of MDRO prevalence in patients' environment by 43% (aOR, 0.57; 95% CI, 0.35-0.94), but there was no statistically significant difference on the patient level before or after adjustment (aOR, 0.57; 95% CI, 0.29-1.14). There were no significant reductions in time to new acquisition for methicillin-resistant Staphylococcus aureus (hazard ratio [HR], 0.20; 95% CI, 0.04-1.09), vancomycin-resistant enterococci (HR, 0.84; 95% CI, 0.46-1.53), or resistant gram-negative bacilli (HR, 1.14; 95% CI, 0.73-1.78).Conclusions and relevanceThis cluster randomized clinical trial found that the multicomponent intervention reduced the prevalence of MDROs in the environment of NH patients. Our findings highlight the potential for multicomponent interventions to directly and indirectly reduce MDRO prevalence in NHs.Trial registrationClinicalTrials.gov Identifier: NCT02909946.

Project description:BACKGROUND:Joint contractures in frail older people are associated with serious restrictions in participation. We developed the Participation Enabling CAre in Nursing (PECAN) intervention, a complex intervention to enable nurses to promote participation in nursing home residents with joint contractures. The aim of this study was to examine the feasibility of the implementation strategy and to identify enablers and barriers for a successful implementation. METHODS:The implementation of PECAN was investigated in a 6-month pilot cluster-randomised controlled trial (c-RCT). As a key component of the implementation strategy, nominated nurses were trained as facilitators in a one-day workshop and supported by peer-mentoring (visit, telephone counselling). A mixed-methods approach was conducted in conjunction with the pilot trial and guided by a framework for process evaluations of c-RCTs. Data were collected using standardised questionnaires (nursing staff), documentation forms, problem-centred qualitative interviews (facilitators, therapists, social workers, relatives, peer-mentors), and a group discussion (facilitators). A set of predefined criteria on the nursing home level was examined. Quantitative data were analysed using descriptive statistics. Qualitative data were analysed using directed content analysis. RESULTS:Seven nursing homes (n =?4 intervention groups, n =?3 control groups) in two regions of Germany took part in the study. Facilitators responded well to the qualification measures (workshop participation: 14/14; workshop rating: "good"; peer-mentor visit participation: 10/14). The usage of peer-mentoring via telephone varied (one to seven contacts per nursing home). Our implementation strategy was not successful in connection with supplying the intervention to all the nurses. The clear commitment of the entire nursing home and the respect for the expertise of different healthcare professionals were emphasised as enablers, whereas a lack of impact on organisational conditions and routines and a lack of time and staff competence were mentioned as barriers. CONCLUSION:The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents. Strategies to systematically include the management and the nursing team from the beginning are needed to support the facilitators during implementation in the main trial. TRIAL REGISTRATION:German clinical trials register, DRKS00010037 . Registered 12 February 2016.

Project description:ObjectiveTo determine whether a systematic approach to the treatment of pain can reduce agitation in people with moderate to severe dementia living in nursing homes.DesignCluster randomised controlled trial.Setting60 clusters (single independent nursing home units) in 18 nursing homes within five municipalities of western Norway.Participants352 residents with moderate to severe dementia and clinically significant behavioural disturbances randomised to a stepwise protocol for the treatment of pain for eight weeks with additional follow-up four weeks after the end of treatment (33 clusters; n = 175) or to usual treatment (control, 27 clusters; n = 177).InterventionParticipants in the intervention group received individual daily treatment of pain for eight weeks according to the stepwise protocol, with paracetamol (acetaminophen), morphine, buprenorphine transdermal patch, or pregabaline. The control group received usual treatment and care.Main outcome measuresPrimary outcome measure was agitation (scores on Cohen-Mansfield agitation inventory). Secondary outcome measures were aggression (scores on neuropsychiatric inventory-nursing home version), pain (scores on mobilisation-observation-behaviour-intensity-dementia-2), activities of daily living, and cognition (mini-mental state examination).ResultsAgitation was significantly reduced in the intervention group compared with control group after eight weeks (repeated measures analysis of covariance adjusting for baseline score, P < 0.001): the average reduction in scores for agitation was 17% (treatment effect estimate -7.0, 95% confidence interval -3.7 to -10.3). Treatment of pain was also significantly beneficial for the overall severity of neuropsychiatric symptoms (-9.0, -5.5 to -12.6) and pain (-1.3, -0.8 to -1.7), but the groups did not differ significantly for activities of daily living or cognition.ConclusionA systematic approach to the management of pain significantly reduced agitation in residents of nursing homes with moderate to severe dementia. Effective management of pain can play an important part in the treatment of agitation and could reduce the number of unnecessary prescriptions for psychotropic drugs in this population. Trial registration ClinicalTrials.gov NCT01021696 and Norwegian Medicines Agency EudraCTnr 2008-007490-20.

Project description:BackgroundThe primary goal of hand hygiene is to reduce infectious disease rates. We examined if a nursing home's participation in a hand hygiene intervention resulted in residents having fewer healthcare associated infections (HAIs) when compared to nursing homes without the hand hygiene intervention.MethodsThis study is a part of a cluster randomized controlled trial (RCT) in 33 nursing homes to improve hand hygiene (HANDSOME). The incidence of five illnesses was followed over 13 months: gastroenteritis, influenza-like illness, pneumonia, urinary tract infections and infections from methicillin-resistant Staphylococcus aureus (MRSA). Incidence rates per study arm were reported for baseline (October-December 2016) and two follow-up periods (January-April 2017, May-October 2017). HAI rates were compared in a Poisson multilevel analysis, correcting for baseline differences (the baseline infection incidence and the size of the nursing home), clustering of observations within nursing homes, and period in the study.ResultsThere was statistically significantly more gastroenteritis (p < 0.001) and statistically significantly less influenza-like illness (p < 0.01) in the intervention arm when compared to the control arm. There were no statistically significant differences or pneumonia, urinary tract infections, and MRSA infections in the intervention arm when compared to the control arm. In a sensitivity analysis, gastroenteritis was no longer statistically significantly higher in the intervention arm (p = 0.92).ConclusionsAs in comparable studies, we could not conclusively demonstrate the effectiveness of an HH intervention in reducing HAIs among residents of nursing homes, despite the use of clearly defined outcome measures, a standardized reporting instrument, and directly observed HH in a multicenter cluster RCT. Trial registration Netherlands Trial Register, trial NL6049 (NTR6188). Registered October 25, 2016, https://www.trialregister.nl/trial/6049 .

Project description:BACKGROUND:Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis. OBJECTIVE:The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality. METHODS:The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period. RESULTS:The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020. CONCLUSIONS:The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI. TRIAL REGISTRATION:ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17710.

Project description:BackgroundThe majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions.Methods/designThe study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study.DiscussionTo improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected.Trial registrationClinicalTrials.gov: NCT02295462.

Dataset Information

The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes.

Objectives

Design

Setting

Participants

Intervention

Measurements

Randomisation

Results

Conclusions

Trial registration

Publications

The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes.

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