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Education-only versus a multifaceted intervention for improving assessment of rehabilitation needs after stroke; a cluster randomised trial.

ABSTRACT: In 2011, more than half of the patients with stroke in Australian hospitals were not assessed for the need for rehabilitation. Further, there were no recommended criteria to guide rehabilitation assessment decisions. Subsequently, a decision-making tool called the Assessment for Rehabilitation Tool (ART) was developed. The ART was designed to assist Australian hospital clinicians to identify the rehabilitation needs of patients with stroke using evidence-based criteria. The ART was released and made freely available for use in 2012. This study evaluated the effectiveness of an education-only intervention (1 onsite education session and distribution of the ART) and a multifaceted intervention (2 or more onsite education sessions, distribution of the ART, audit and feedback, barrier identification, site-specific strategy development, promotion of interdisciplinary teamwork, opinion leaders and reminders) for improving assessments of rehabilitation needs after stroke.Ten hospitals in 2 states of Australia were randomly assigned to an education-only or a multifaceted intervention. Medical records were audited by assessors blinded to group allocation before and after the implementation period. Difference in the proportion of patients assessed for rehabilitation before and after the intervention was analysed using mixed-effects logistic regression analysis, with time period as the dependent variable, an interaction between intervention type and time included to test for differences between the interventions, and hospital included as the random effect to account for patient clustering.Data from 586 patients (284 pre-intervention; 302 post-intervention; age 76 years, 59 % male) showed that the multifaceted intervention was not more effective than education-only in improving the proportion of patients whose rehabilitation needs were assessed (reference category education-only; odds ratio 1.29, 95 % confidence interval 0.63-2.67, p = 0.483). Post-intervention, the odds of a patient's rehabilitation needs being assessed was 3.69 times greater than pre-intervention (95 % confidence interval 2.57-5.30, p < 0.001). Evidence-based criteria were not consistently used when patients were deemed to have no rehabilitation needs.A multifaceted intervention was not more effective than education-only in improving the assessment of rehabilitation needs of patients with stroke. Further interventions are required to ensure that all patients are assessed for the need for rehabilitation using evidence-based criteria.ANZCTR (Australian New Zealand Clinical Trials Registry), ACTRN12616000340437.

SUBMITTER: Lynch EA

PROVIDER: S-EPMC5015218 | biostudies-other | 2016

REPOSITORIES: biostudies-other

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Project description:BackgroundThe 'Your Care Needs You' (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay.MethodsA cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward.ResultsTen wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients' health, capacity, and preferences.ConclusionsIf implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home.Trial registrationISRCTN: 51154948.

Project description:ObjectivesThis study sought to assess the effectiveness and return on investment (ROI) of a multifaceted intervention aimed at improving antibiotic prescribing for acute respiratory infections in primary care.DesignLarge-sized, two-arm, open-label, pragmatic, cluster-randomised controlled trial.SettingAll primary care physicians working for the Spanish National Health Service (NHS) in Galicia (region in north-west Spain).ParticipantsThe seven spatial clusters were distributed by unequal randomisation (3:4) of the intervention and control groups. A total of 1217 physicians (1.30 million patients) were recruited from intervention clusters and 1393 physicians (1.46 million patients) from control clusters.InterventionsOne-hour educational outreach visits tailored to training needs identified in a previous study; an online course integrated in practice accreditation; and a clinical decision support system.Main outcome measuresChanges in the ESAC (European Surveillance of Antimicrobial Consumption) quality indicators for outpatient antibiotic use. We used generalised linear mixed and conducted a ROI analysis to ascertain the overall cost savings.ResultsMedian follow-up was 19 months. The adjusted effect on overall antibiotic prescribing attributable to the intervention was - 4.2% (95% CI: - 5.3% to - 3.2%), with this being more pronounced for penicillins - 6.5 (95% CI: - 7.9% to - 5.2%) and for the ratio of consumption of broad- to narrow-spectrum penicillins, cephalosporins, and macrolides - 9.0% (95% CI: - 14.0 to - 4.1%). The cost of the intervention was €87 per physician. Direct savings per physician attributable to the reduction in antibiotic prescriptions was €311 for the NHS and €573 for patient contributions, with an ROI of €2.57 and €5.59 respectively.ConclusionsInterventions designed on the basis of gaps in physicians' knowledge of and attitudes to misprescription can improve antibiotic prescribing and yield important direct cost savings.Trial registrationCurrent Controlled Trials ISRCTN24158380 . Registered 5 February 2009.

Project description:BackgroundThe value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BCTs) used.MethodsClinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used.ResultsTwenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO2max testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support.ConclusionRecruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention's development, a pilot study.Trial registrationClinicalTrials.gov Identifier: NCT02712385 . This study was registered prospectively on 18/03/2016.

Project description:BackgroundThere is limited evidence, mainly from high-income countries, that digital health interventions improve type 2 diabetes (T2DM) care. Large-scale implementation studies are lacking.MethodsA multifaceted digital health intervention comprising: (1) a self-management application ('app') for patients and lay 'family health promotors' (FHPs); and (2) clinical decision support for primary care doctors was evaluated in an open-label, parallel, cluster randomized controlled trial in 80 communities (serviced by a primary care facility for >1000 residents) in Hebei Province, China. People >40 years with T2DM and a glycated haemoglobin (HbA1c) ≥7% were recruited (∼25/community). After baseline assessment, community clusters were randomly assigned to intervention or control groups (1:1) via a web-based system, stratified by locality (rural/urban). Control arm clusters received usual care without access to the digital health application or family health promoters. The primary outcome was at the participant level defined as the proportion with ≥2 "ABC" risk factor targets achieved (HbA1c < 7.0%, blood pressure < 140/80 mmHg and LDL-cholesterol < 2.6 mmol/L) at 24 months.FindingsA total of 2072 people were recruited from the 80 community clusters (40 urban and 40 rural), with 1872 (90.3%) assessed at 24 months. In the intervention arm, patients used FHPs for support more in rural than urban communities (252 (48.6%) rural vs 92 (21.5%) urban, p < 0.0001). The mean monthly proportion of active app users was 46.4% (SD 7.8%) with no significant difference between urban and rural usage rates. The intervention was associated with improved ABC control rates (339 [35.9%] intervention vs 276 [29.9%] usual care; RR 1.20, 95% CI 1.02-1.40; p = 0.025), with significant heterogeneity by geography (rural 220 [42.6%] vs 158 [31.0%]; urban 119 [27.9%] vs 118 [28.6%]; p = 0.022 for interaction). Risk factor reductions were mainly driven by improved glycaemic control (mean HbA1C difference -0.33%, 95% CI -0.48 to -0.17; p = 0.00025 and mean fasting plasma glucose difference -0.58 mmol, 95% CI -0.89 to -0.27; p = 0.00013). There were no changes in blood pressure and LDL-cholesterol levels.InterpretationA multifaceted digital health intervention improved T2DM risk factor control rates, particularly in rural communities where there may be stronger relationships between patients and doctors and greater family member support.FundingNational Health and Medical Research CouncilGlobal Alliance for Chronic Diseases (ID 1094712).

Project description:BACKGROUND: Although several studies have shown that teaching EBM is effective in improving knowledge, at present, there is no convincing evidence that teaching EBM also changes professional behaviour in practice. Therefore, the primary aim of this study was to evaluate the effectiveness of a clinically integrated post-graduate training programme in EBM on evidence-based disability evaluation. METHODS AND FINDINGS: In a cluster randomised controlled trial, fifty-four case-based learning groups consisting of 132 physicians and 1680 patients were randomly assigned to the intervention or control groups. A clinically integrated, post-graduate, 5-day training programme in evidence-based medicine, consisting of (home) assignments, peer teaching, interactive training in searching databases, lectures and brainstorming sessions was provided to the intervention group. The control group received no training. The primary outcome was evidence-based disability evaluation, as indicated by the frequency in use of evidence of sufficient quality in disability evaluation reports. There are no general EBM behaviour outcome measures available. Therefore, we followed general guidelines for constructing performance indicators and defined an a priori cut-off for determination of sufficient quality as recommended for evaluating EB training. Physicians trained in EBM performed more evidence-based disability evaluations compared to physicians in the control group (difference in absolute proportion 9.7%, 95% CI 3.5 to 15.9). The primary outcome differences between groups remained significant after both cluster-adjusted analysis and additional sensitivity analyses accounting for subjects lost to follow-up. CONCLUSIONS: A EBM programme successfully improved the use of evidence in a non-hospital based medical specialty. Our findings support the general recommendations to use multiple educational methods to change physician behaviour. In addition, it appeared important that the professional context of the intervention was very supportive in the sense that searches in databases, using and applying guidelines and other forms of evidence are considered standard practice and are encouraged by colleagues and management.

Project description:BackgroundIn developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated.Methods and findingsThis cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n? =? 4) and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n ?=? 4). Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline. In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean? =? 0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05-0.29]). Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%-26.1%]); loading dose quinine (91.9% versus 66.7%, 26.3% [-3.66% to 56.3%]); and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%-48.9%]). The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; -6.5% [-12.9% to 0.20%]), and inadequate gentamicin dose (2.2% versus 9.0%; -6.8% [-11.9% to -1.6%]).ConclusionsSpecific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated with greater changes in practice spanning multiple, high mortality conditions in rural Kenyan hospitals than a partial intervention, providing one model for bridging the evidence to practice gap and improving admission care in similar settings.

Project description:Background:Patients, particularly older people, often experience safety issues when transitioning from hospital to home. Although the evidence is currently equivocal as to how we can improve this transition of care, interventions that support patient involvement may be more effective. The 'Your Care Needs You' (YCNY) intervention supports patients to 'know more' and 'do more' whilst in hospital in order that they better understand their health condition and medications, maintain their daily activities, and can seek help at home if required. The intervention aims to reduce emergency hospital readmissions and improve safety and experience during the transition to home. Methods:As part of the Partners At Care Transitions (PACT) programme of research, a multi-centred cluster randomised controlled trial (cRCT) will be conducted to explore the feasibility of the YCNY intervention and trial methodology. Data will be used to refine the intervention and develop a protocol for a definitive cRCT.Ten acute hospital wards (the clusters) from varying medical specialties including older peoples' medicine, trauma and orthopaedics, cardiology, intermediate care, and stroke will be randomised to deliver YCNY or usual care on a 3:2 basis. Up to 200 patients aged 75?years and over and discharged to their own homes will be recruited to the study. Patients will complete follow-up questionnaires at 5-, 30-, and 90-days post-discharge and readmission data up to 90-days post-discharge will be extracted from their medical records.Study outcomes will include measures of feasibility (e.g. screening, recruitment, and retention data) and processes required to collect routine data at a patient and ward level. In addition, interviews and observations involving up to 24 patients/carers and 28 staff will be conducted to qualitatively assess the acceptability, usefulness, and feasibility of the intervention and implementation package to patients and staff. A separate sub-study will be conducted to explore how accurately primary outcome data (30-day emergency hospital readmissions) can be gathered for the definitive cRCT. Discussion:This study will establish the feasibility of the YCNY intervention which aims to improve safety and experience during transitions of care. It will identify key methodological and implementation issues that need to be addressed prior to assessing the effectiveness of the YCNY intervention in a definitive cluster randomised controlled trial. Trial registration:UK Clinical Research Network Portfolio: 42191; ISTCRN: ISRCTN51154948. Registered 16/07/2019.

Project description:Taenia solium causes significant economic and public health impacts in endemic countries. This study determined effectiveness of a health education intervention at improving school children's knowledge and attitudes related to T. solium cysticercosis and taeniasis in Tanzania. A cluster randomised controlled health education intervention trial was conducted in 60 schools (30 primary, 30 secondary) in Mbulu district. Baseline data were collected using a structured questionnaire in the 60 schools and group discussions in three other schools. The 60 schools stratified by baseline knowledge were randomised to receive the intervention or serve as control. The health education consisted of an address by a trained teacher, a video show and a leaflet given to each pupil. Two post-intervention re-assessments (immediately and 6 months post-intervention) were conducted in all schools and the third (12 months post-intervention) was conducted in 28 secondary schools. Data were analysed using Bayesian hierarchical log-binomial models for individual knowledge and attitude questions and Bayesian hierarchical linear regression models for scores. The overall score (percentage of correct answers) improved by about 10% in all schools after 6 months, but was slightly lower among secondary schools. Monitoring alone was associated with improvement in scores by about 6%. The intervention was linked to improvements in knowledge regarding taeniasis, porcine cysticercosis, human cysticercosis, epilepsy, the attitude of condemning infected meat but it reduced the attitude of contacting a veterinarian if a pig was found to be infected with cysticercosis. Monitoring alone was linked to an improvement in how best to raise pigs. This study demonstrates the potential value of school children as targets for health messages to control T. solium cysticercosis and taeniasis in endemic areas. Studies are needed to assess effectiveness of message transmission from children to parents and the general community and their impacts in improving behaviours facilitating disease transmission.

Project description:Adolescence offers a window of opportunity during which improvements in health behaviours could benefit long-term health, and enable preparation for parenthood-albeit a long way off, passing on good health prospects to future children. This study was carried out to evaluate whether an educational intervention, which engages adolescents in science, can improve their health literacy and behaviours. A cluster-randomised controlled trial of 38 secondary schools in England, UK was conducted. The intervention (LifeLab) drew on principles of education, psychology and public health to engage students with science for health literacy, focused on the message "Me, my health and my children's health". The programme comprised: • Professional development for teachers. • A 2-3 week module of work for 13-14-year-olds. • A "hands-on" practical health science day visit to a dedicated facility in a university teaching hospital. Data were collected from 2929 adolescents (aged 13-14 years) at baseline and 2487 (84.9%) at 12-month follow-up. The primary outcome was change in theoretical health literacy from pre- to 12 months post- intervention. This study is registered (ISRCTN71951436) and the trial status is complete. Participation in the LifeLab educational intervention was associated with an increase in the students' standardised total theoretical health literacy score (adjusted difference between groups = 0.27 SDs (95%CI = 0.12, 0.42)) at 12-month follow-up. There was an indication that intervention participants subsequently judged their own lifestyles more critically than controls, with fewer reporting their behaviours as healthy (53.4% vs. 59.5%; adjusted PRR = 0.94 [0.87, 1.01]). We conclude that experiencing LifeLab led to improved health literacy in adolescents and that they demonstrated a move towards a more critical judgement of health behaviour 12 months after the intervention. Further work is needed to examine whether this leads to sustained behaviour change, and whether other activities are needed to support this change.

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Education-only versus a multifaceted intervention for improving assessment of rehabilitation needs after stroke; a cluster randomised trial.

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