Pragmatic Cluster-randomised Controlled Trial Research Articles

The effectiveness of a knowledge translation intervention on the implementation of NEWS2 in nursing homes, a pragmatic cluster RCT

BackgroundImproving the uptake of relevant and reliable research is an important priority in long-term care to achieve sustainable and high-quality services for the increasingly older population.AimThe purpose was to assess the effectiveness of a tailored, adaptive and a multifaceted KT capacity program, relative to usual practice, on the implementation of National Early Warning Score 2 (NEWS2).MethodsThis study was carried out as a pragmatic cluster-randomized controlled trial. The capacity program consisted of an educational part to address implementation capacity gaps and a facilitation-upon-implementation part to address a relevant knowledge gap in nursing homes. A collective decision was made to address the challenge of early detection of clinical deterioration among nursing home residents, by implementing the (NEWS2) as clinical innovation.Public nursing homes in a Norwegian municipality (n = 21) with a total of 1 466 beds were eligible for inclusion. The study-period spanned over a 22-month period, including a 12-month follow-up.Data was extracted from the Electronic Patient Journal system and analyzed using multilevel growth model analysis.ResultsThe intervention had a large effect on the use of NEWS2 among care staff in intervention nursing homes, compared to the control group (standardized mean difference, d = 2.42). During the final month of the implementation period, residents in the intervention group was assessed with NEWS2 1.44 times (95% CI: 1.23, 1.64) per month, which is almost four times more often than in the control group (mean = 0.38, 95% CI: 0.19, 0.57). During the follow-up period, the effect of the intervention was not only sustained in the intervention group but there was a substantial increase in the use of NEWS2 in both the intervention (mean = 1.75, 95% CI: 1.55, 1.96) and control groups (mean = 1.45, 95% CI: 1.27, 1.65).ConclusionsThis tailored implementation strategy had a large effect on the use of NEWS2 among care staff, demonstrating that integrated knowledge translation strategies can be a promising strategy to achieve evidence-based care in the nursing home sector.Trial registrationISRCTN12437773. Registered 19/3 2020, retrospectively.

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: statistical analysis plan for a pragmatic cluster randomised controlled trial

BackgroundGlobally, violence against children poses substantial health and economic challenges, with estimated costs nearing USD 7 trillion. This prompts the urgent call for effective evidence-based interventions in preventing and mitigating violence against children. ParentApp is a mobile, open-source application designed to offer a remote version of the Parenting for Lifelong Health (PLH) programme. ParentApp is the first digital parenting intervention for caregivers of adolescents aged 10–17 years to be tested in low- and middle-income settings.MethodsThis study is a pragmatic, two-arm, cluster-randomised trial in Mwanza, Tanzania’s urban and peri-urban areas. Assessments are set for baseline, 1 month post-intervention, and 12 months post-intervention. We randomised 80 clusters, each with about 30 caregiver-adolescent dyads, with a 1:1 ratio stratified by urban or peri-urban location. Both arms receive an entry-level smartphone preloaded with Kiswahili apps—ParentApp for intervention and WashApp control.The primary method of analysis will be generalised linear mixed-effects models with adjustment for person-level characteristics and multiple imputation. In three-level models, measurement waves are nested within a person, nested within a sub-ward. Regressions will constrain groups to be equal at baseline and include covariates for stratification, percentage of male caregivers, and individual-level characteristics.DiscussionsPreparations for the trial began in December 2022, including community mobilisation and sensitisation. Rolling recruitment, baseline data collection, and implementation onboarding took place between April and September 2023. One-month post-test data collection began in August 2023 and thus far achieved 97% and 94% retention rates for caregivers and adolescents respectively. Final post-test data collection will begin in September 2024, anticipated to run until April 2025. This SAP was submitted to the journal before the interim analysis to preserve scientific integrity under a superiority hypothesis testing framework.Trial registrationThe trial was registered on the Open Science Framework on 14 March 2023: https://doi.org/10.17605/OSF.IO/T9FXZ.The trial protocol was published in Trials 25, 119 (2024): Baerecke, L., Ornellas, A., Wamoyi, J. et al. A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial. Trials 25, 119 (2024). https://doi.org/10.1186/s13063-023-07893-x.

Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars)

BackgroundWe aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting.MethodsThe PolyPars Study is a two-arm...

Effects of adding early cooperation and a work-place dialogue meeting to primary care management for sick-listed patients with stress-related disorders: CO-WORK-CARE-Stress – a pragmatic cluster randomised controlled trial

Objectives To investigate whether intensified cooperation between general practitioner (GP), care manager and rehabilitation coordinator (RC) for patients sick-listed for stress-related mental disorder, combined with a person-centred dialogue meeting with employer, could reduce sick-leave days compared with usual care manager contact. Design Pragmatic cluster-randomised controlled trial, randomisation at primary care centre (PCC) level. Setting PCCs in Region Västra Götaland, Sweden, with care manager organisation. Participants Of 30 invited PCCs, 28 (93%) accepted the invitation and recruited 258 patients newly sick-listed due to stress-related mental disorder (n = 142 intervention, n = 116 control PCCs). Intervention Cooperation between GP, care manager and rehabilitation coordinator from start of illness notification plus a person-centred dialogue meeting between patient and employer within 3 months. Regular contact with care manager was continued at the control PCCs. Main outcome measures 12-months net and gross number of sick-leave days. Secondary outcomes: Symptoms of stress, depression, anxiety; work ability and health related quality of life (EQ-5D) over 12 months. Results There were no significant differences between intervention and control groups after 12 months: days on sick-leave (12-months net sick-leave days, intervention, mean = 110.7 days (95% confidence interval (CI) 82.6 − 138.8); control, mean = 99.1 days (95% CI 73.9 − 124.3)), stress, depression, or anxiety symptoms, work ability or EQ-5D. There were no significant differences between intervention and control groups concerning proportion on sick-leave after 3, 6, 12 months. At 3 months 64.8% were on sick-leave in intervention group vs 54.3% in control group; 6 months 38% vs 32.8%, and12 months 16.9% vs 15.5%. Conclusion Increased cooperation at the PCC between GP, care manager and RC for stress-related mental disorder coupled with an early workplace contact in the form of a person-centred dialogue meeting does not reduce days of sick-leave or speed up rehabilitation. Trial registration: ClinicalTrials.gov Identifier: NCT03250026 https://clinicaltrials.gov/study/NCT03250026?tab=results#publications CO-WORK-CARE First Posted: August 15, 2017. Recruitment of PCCs: September 2017. Inclusion of patients from December 2017

Effectiveness of bubble continuous positive airway pressure for treatment of children aged 1–59 months with severe pneumonia and hypoxaemia in Ethiopia: a pragmatic cluster-randomised controlled trial

The safety and efficacy of bubble continuous positive airway pressure (bCPAP) for treatment of childhood severe pneumonia outside tertiary care hospitals is uncertain. We did a cluster-randomised effectiveness trial of locally made bCPAP compared with WHO-recommended low-flow oxygen therapy in children with severe pneumonia and hypoxaemia in general hospitals in Ethiopia. This open, cluster-randomised trial was done in 12 general (secondary) hospitals in Ethiopia. We randomly assigned six hospitals to bCPAP as first-line respiratory support for children aged 1-59 months who presented with severe pneumonia and hypoxaemia and six hospitals to standard low-flow oxygen therapy. Cluster (hospital) randomisation was stratified by availability of mechanical ventilation. All children received treatment in paediatric wards (in a dedicated corner in front of a nursing station) with a similar level of facilities (equipment for oxygen therapy and medications) and staffing (overall, one nurse per six patients and one general practitioner per 18 patients) in all hospitals. All children received additional care according to WHO guidelines, supervised by paediatricians and general practitioners. The primary outcome was treatment failure (defined as any of the following: peripheral oxygen saturation <85% at any time after at least 1 h of intervention plus signs of respiratory distress; indication for mechanical ventilation; death during hospital stay or within 72 h of leaving hospital against medical advice; or leaving hospital against medical advice during intervention). The analysis included all children enrolled in the trial. We performed both unadjusted and adjusted analyses of the primary outcome, with the latter adjusted for the stratification variable and for the design effect of cluster randomisation, as well as selected potentially confounding variables, including age. We calculated effectiveness as the relative risk (RR) of the outcomes in the bCPAP group versus low-flow oxygen group. This trial is registered with ClinicalTrial.gov, NCT03870243, and is completed. From June 8, 2021, to July 27, 2022, 1240 children were enrolled (620 in hospitals allocated to bCPAP and 620 in hospitals allocated to low-flow oxygen). Cluster sizes ranged from 103 to 104 children. Five (0·8%) of 620 children in the bCPAP group had treatment failure compared with 21 (3·4%) of 620 children in the low-flow oxygen group (unadjusted RR 0·24, 95% CI 0·09-0·63, p=0·0015; adjusted RR 0·24, 0·07-0·87, p=0·030). Six children died during hospital stay, all of whom were in the low-flow oxygen group (p=0·031). No serious adverse events were attributable to bCPAP. In Ethiopian general hospitals, introduction of locally made bCPAP, supervised by general practitioners and paediatricians, was associated with reduced risk of treatment failure and in-hospital mortality in children with severe pneumonia and hypoxaemia compared with use of standard low-flow oxygen therapy. Implementation research is required in higher mortality settings to consolidate our findings. SIDA Sweden and Grand Challenges Ethiopia.

Transforming nursing assessment in acute hospitals: A cluster randomised controlled trial of an evidence-based nursing core assessment (the ENCORE trial)

BackgroundPatient safety is threatened when early signs of clinical deterioration are missed or not acted upon. This research began as a clinical-academic partnership established around a shared concern of nursing physical assessment practices on general wards and delayed recognition of clinical deterioration. The outcome was the development of a complex intervention facilitated at the ward level for proactive nursing surveillance. MethodsThe evidence-based nursing core assessment (ENCORE) trial was a pragmatic cluster-randomised controlled trial. We hypothesised that ward intervention would reduce the incidence of patient rescue events (medical emergency team activations) and serious adverse events. We randomised 29 general wards in a 1:2 allocation, across 5 Australian hospitals to intervention (n = 10) and usual care wards (n = 19). Skilled facilitation over 12 months enabled practitioner-led, ward-level practice change for proactive nursing surveillance. The primary outcome was the rate of medical emergency team activations and secondary outcomes were unplanned intensive care unit admissions, on-ward resuscitations, and unexpected deaths. Outcomes were prospectively collected for 6 months following the initial 6 months of implementation. Analysis was at the patient level using generalised linear mixed models to account for clustering by ward. ResultsWe analysed 29,385 patient admissions to intervention (n = 11,792) and control (n = 17,593) wards. Adjusted models for overall effects suggested the intervention increased the rate of medical emergency team activations (adjusted incidence rate ratio 1.314; 95 % confidence interval 0.975, 1.773), although the confidence interval was compatible with a marginal decrease to a substantial increase in rate. Confidence intervals for secondary outcomes included a range of plausible effects from benefit to harm. However, considerable heterogeneity was observed in intervention effects by patient comorbidity. Among patients with few comorbid conditions in the intervention arm there was a lower medical emergency team activation rate and decreased odds of unexpected death. Among patients with multimorbidity in the intervention arm there were higher rates of medical emergency team activation and intensive care unit admissions. ConclusionTrial outcomes have refined our assumptions about the impact of the ENCORE intervention. The intervention appears to have protective effects for patients with low complexity where frontline teams can respond locally. It also appears to have redistributed medical emergency team activations and unplanned intensive care unit admissions, mobilising higher rates of rescue for patients with multimorbidity. Trial registration numberACTRN12618001903279 (Date of registration: 22/11/2018; First participant recruited: 01/02/2019).

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial

BackgroundEvidence-based parenting programmes have strong evidence in preventing and mitigating violence, but in-person programmes are challenging to deliver at scale. ParentApp is an open-source, offline-first app-based adaptation of the Parenting for Lifelong Health for Parents and Teens programme to promote playful and positive parenting, reduce risks for sexual violence victimisation, and prevent violence against adolescents. This study aims to evaluate the effectiveness and cost-effectiveness of ParentApp compared to an attention-control group.MethodsThis study is a two-arm pragmatic cluster-randomised controlled trial to test whether ParentApp reduces adolescent physical abuse, emotional abuse, and sexual violence risks and victimisation at 1 month and 12 months post-intervention. Caregivers of adolescents aged 10–17 years and their adolescent children (N = 2400 caregiver-adolescent dyads) will be recruited in urban and peri-urban communities in the Mwanza region of Tanzania. A total of 80 study clusters will be stratified and randomised (1:1) to the intervention group, who will receive ParentApp with support through a WhatsApp group, or to an attention-control group, who will receive a water, sanitation, and hygiene app. Quantitative data will be collected through outcomes questionnaires with caregivers and adolescents, administered at baseline, 4 months post-baseline, and 16 months post-baseline, as well as through routine implementation data and ParentApp engagement data. Qualitative data will be collected through individual interviews and focus groups with caregivers, adolescents, and implementing partner staff.DiscussionApp-based interventions have the potential to expand access to evidence-based parenting support, but currently lack rigorous evidence in low- and middle-income countries. This is the first known randomised control trial of a hybrid digital parenting programme to prevent the abuse of adolescents in low- and middle-income settings.Trial registrationThe trial was registered on the Open Science Framework on 14 March 2023, registration: OSF.IO/T9FXZ.

Improving access to family planning for women with disabilities in Kaduna city, Nigeria: study protocol for a pragmatic cluster-randomized controlled trial with integrated process evaluation

BackgroundGlobally, women with disabilities are less likely to have access to family planning services compared to their peers without disabilities. However, evidence of effective interventions for promoting their sexual and reproductive health and rights remains limited, particularly in low- and middle-income settings. To help address disparities, an inclusive sexual and reproductive health project was developed to increase access to modern contraceptive methods and reduce unmet need for family planning for women of reproductive age with disabilities in Kaduna city, Nigeria. The project uses demand-side, supply-side and contextual interventions, with an adaptive management approach. This protocol presents a study to evaluate the project’s impact.MethodsA pragmatic cluster-randomized controlled trial design with surveys at baseline and endline will be used to evaluate interventions delivered for at least 1 year at health facility and community levels in comparison to ‘standard’ state provision of family planning services, in the context of state-wide and national broadcast media and advocacy. Randomization will be conducted based on the health facility catchment area, with 19 clusters in the intervention arm and 18 in the control arm. The primary outcome measure will be access to family planning. It was calculated that at least 950 women aged 18 to 49 years with disabilities (475 in each arm) will be recruited to detect a 50% increase in access compared to the control arm. For each woman with disabilities enrolled, a neighbouring woman without disabilities in the same cluster and age group will be recruited to assess whether the intervention has a specific effect amongst women with disabilities. The trial will be complemented by an integrated process evaluation. Ethical approval for the study has been given by the National Health Research Ethics Committee of Nigeria and London School of Hygiene & Tropical Medicine.DiscussionDefining access to services is complex, as it is not a single variable that can be measured directly and need for family planning is subjectively defined. Consequently, we have conceptualized ‘access to family planning’ based on a composite of beliefs about using services if needed.Trial registrationISRCTN registry ISRCTN12671153. Retrospectively registered on 17/04/2023.

Psychosocial impacts of Baby Friendly Spaces for Rohingya refugee mothers in Bangladesh: A pragmatic cluster-randomized controlled trial.

This study evaluated the effectiveness of Baby Friendly Spaces (BFS), a psychosocial support program for Rohingya refugee mothers of malnourished young children in Bangladesh. Because BFS was already being implemented, we examined the benefit of enhancing implementation supports. In matched pairs, 10 sites were randomized to provide BFS treatment as usual (BFS-TAU) or to receive enhanced implementation support (BFS-IE). 600 mothers were enrolled and reported on maternal distress, functional impairment, subjective well-being and coping at baseline and 8-week follow-up. Data were analyzed using multilevel linear regression models to account for clustering; sensitivity analyses adjusted for the small number of clusters. Significant within-group improvements in BFSIE were observed for distres (-.48, p=.014), functional impairment (-.30, p=.002) and subjective well-being (.92, p=.011); improvements in BFS-TAU were smaller and not statistically significant. Between-group comparisons favored BFS-IE for distress (β=-.30, p=.058) and well-being (β=.58, p=.038). Sensitivity adjustments produced p-values above .05 for all between-group comparisons. Feasible adjustments to implementation can improve program delivery to increase impact on maternal distress and well-being. Although results should be interpreted with caution, study design limitations are common in pragmatic, field-based research.

Customized Career Development Platform (CCDP) for clinical and translational researchers: A pragmatic cluster-randomized controlled trial.

Early-stage clinical and translational researchers who set and track career goals, milestones, and progress are successful in career development. We aimed to determine the effectiveness of the Customized Career Development Platform (CCDP), an online individual development plan (IDP), versus the traditional IDP template in improving research success and career satisfaction. We conducted a pragmatic cluster-randomized controlled trial of 340 scholars and trainees at 27 US academic healthcare institutions. The primary outcome was number of published manuscripts 24 months post-intervention. Secondary outcomes included the number of grant proposals submitted and funded, job satisfaction, and level of communication with mentors. An analysis of CCDP participants assessed proficiency level for the 14 Clinical and Translational Science Award (CTSA) competencies. Data were analyzed using intention-to-treat. Participants were mostly female (60.3%) and Caucasian (67.2%); mean age was 34 years. Twenty-four months following the intervention, the CCDP versus traditional IDP groups showed a similar number of publications (9.4 vs 8.6), grants submitted (4.1 vs 4.4) and funded (1.3 vs 2.0), and job satisfaction score (3.6 vs 3.7). The CCDP group had higher odds of discussing communication (OR = 2.08) and leadership skills (OR = 2.62) and broadening their network (2.31) than the traditional IDP group. The CCDP arm reported improvements in 9 of the 14 CTSA competencies. The CCDP offers CTSA hubs an innovative alternative to traditional IDP tools. Future studies are needed to elucidate why the CCDP users did not fully appreciate or adopt the functionality of the online platform.

Evaluation of the impact of letters to GP practices to promote asthma prescription uptake in school-age children during summer (TRAINS study): a pragmatic cluster-randomised controlled trial

BackgroundAsthma exacerbations peak in school-aged children after the return to school in September. Previous studies have shown a decline in collections of asthma prescriptions during August. The PLEASANT trial demonstrated that sending a reminder letter to parents increased prescription uptake; reduced unscheduled care, and was cost saving to the health service. We aimed to assess whether informing general practitioner (GP) practices about the PLEASANT trial and its results could lead to its implementation in routine practice. MethodsThe trial to assess implementation of new research in a primary care setting (TRAINS) was a pragmatic cluster-randomised (1:1) trial conducted in England involving GP practices contributing to the Clinical Practice Research Datalink (CPRD). The intervention was a letter informing the GP practice of the PLEASANT trial results with recommendations for implementation. GP practices in the control group continued with usual care without receiving any letters about PLEASANT trial. The intervention was distributed via CPRD by both mail and email in June 2021. The trial received both University of Sheffield Ethics approval and Independent Scientific Advisory Committee (ISAC) approval. The primary outcome was the proportion of children with asthma (aged 4–15 years) who had a prescription for a preventer between Aug 1 and Sept 30, 2021. This trial is registered with ClinicalTrials.gov, NCT05226091. FindingsA total of 1326 GP practices, including 90 583 children with asthma, were included in the study. These practices were randomly allocated to the intervention group (664 practices, 44 708 children) or the control group (662 practices, 45 875 children). In assessing the impact of the intervention on the proportion of children collecting a preventer prescription, 15 716 (35·3%) of 44 708 children from the intervention group and 16 001 (35·1%) of 45 559 children from the control group picked up a prescription. There was no statistically significant difference observed (odds ratio [OR] 1·01, 95% CI 0·97–1·05), indicating that the intervention had no effect. InterpretationThe study findings suggest that passive intervention of providing a letter to GPs did not achieve the intended outcomes. To bridge the gap between evidence and practice, alternative, more proactive strategies could be explored to address the identified issues. FundingJazan University.

Effectiveness of an individually tailored complex intervention to improve activities and participation in nursing home residents with joint contractures (JointConEval): a multicentre pragmatic cluster-randomised controlled trial

ObjectiveThis study aims to examine the effects of the individually tailored complex intervention Participation Enabling Care in Nursing (PECAN) on activities and participation of residents with joint contractures.DesignMulticentre pragmatic cluster-randomised...

O.1.2-6 Music and Movement for Health: an arts-based Intervention to promote health and wellbeing of community dwelling older adults in Ireland

Abstract Purpose The Music and Movement for Health study is a pragmatic cluster-randomised controlled feasibility trial that aims to assess the feasibility of an innovative music and dance intervention that was developed to promote health and wellbeing of community dwelling older adults in Ireland. This study also aims to obtain preliminary data on the effect of the arts-based intervention on health and wellbeing in older adults. Methods One hundred community-dwelling adults aged 65 years or older were recruited across seven clusters in the Mid-West region of Ireland. The seven clusters were randomly allocated to either the intervention group (n = 56, 4 clusters) or the control group (n = 44, 3 clusters). The intervention group participated in the Music and Movement for Health intervention which consisted of a 1.5-hour session and a 1-hour home-based programme weekly for 12-weeks. Music and Movement for Health is a complex intervention developed following the Medical Research Council Framework, co-designed with stakeholders using research evidence and theories to optimise engagement. Participants completed assessments at baseline and after 12 weeks and participated in focus group or interview after their participation. Results The targeted feasibility outcomes including the recruitment rates, the retention rates, attendance, and participation rates were achieved. Randomisation was completed according to the protocol and no safety issues were identified. The outcome measures used were acceptable and feasible for this population. The results on secondary outcomes and process evaluation of this trial are awaited. Conclusion This research strives to strengthen collaborative efforts to implement effective, sustainable and cost-effective programmes for older adults to support community connection, enhancing health and wellbeing, in turn reducing demands on the healthcare system. To our knowledge, Music and Movement for Health is the first evidence-based arts intervention that has incorporated music therapy with dance to improve health and wellbeing of community dwelling older adults. Feasibility results demonstrate that Music and Movement for Health is feasible, acceptable and safe for community dwelling older adults in the Mid-West region of Ireland.

Study protocol of an economic evaluation embedded in the Midwives and Obstetricians Helping Mothers to Quit Smoking (MOHMQuit) trial

BackgroundTobacco smoking during pregnancy is the most important preventable risk factor for pregnancy complications and adverse birth outcomes and can have lifelong consequences for infants. Smoking during pregnancy is associated with higher healthcare costs related to birth complications and during childhood. Psychosocial interventions to support pregnant women to quit are effective, yet provision of smoking cessation support has been inconsistent. The Midwives and Obstetricians Helping Mothers to Quit Smoking (MOHMQuit) intervention provides systems change, and leadership and clinician elements, to support clinicians to help women stop smoking in pregnancy. There have been few long-term analyses conducted of the cost-effectiveness of smoking cessation interventions for pregnant women that target healthcare providers. This protocol describes the economic evaluation of the MOHMQuit trial, a pragmatic stepped-wedge cluster-randomised controlled implementation trial in nine public maternity services in New South Wales (NSW), Australia, to ascertain whether MOHMQuit is cost-effective in supporting clinicians to help women quit smoking in pregnancy compared to usual care.MethodsTwo primary analyses will be carried out comparing MOHMQuit with usual care from an Australian health care system perspective: i) a within-trial cost-effectiveness analysis with results presented as the incremental cost per additional quitter; and ii) a lifetime cost-utility analysis using a published probabilistic decision analytic Markov model with results presented as incremental cost per quality-adjusted life-year (QALY) gained for mother and child. Patient-level data on resource use and outcomes will be used in the within-trial analysis and extrapolated and supplemented with national population statistics and published data from the literature for the lifetime analysis.DiscussionThere is increasing demand for information on the cost-effectiveness of implementing healthcare interventions to provide policy makers with critical information for the best value for money within finite budgets. Economic evaluation of the MOHMQuit trial will provide essential, policy-relevant information for decision makers on the value of evidence-based implementation of support for healthcare providers delivering services for pregnant women.Trial registrationsACTRN12622000167763, registered 2 February 2022.

Quality improvement intervention to increase colorectal cancer screening at the primary care setting: a cluster-randomised controlled trial

BackgroundApproximately 81% of deaths in Argentina are from chronic non-communicable diseases and 21% caused by cancer. Colorectal cancer (CRC) is the second most frequent cancer in Argentina. Even though CRC...

Implementation of point-of-care testing of C-reactive protein concentrations to improve antibiotic targeting in respiratory illness in Vietnamese primary care: a pragmatic cluster-randomised controlled trial

In previous trials, point-of-care testing of C-reactive protein (CRP) concentrations safely reduced antibiotic use in non-severe acute respiratory infections in primary care. However, these trials were done in a research-oriented context with close support from research staff, which could have influenced prescribing practices. To better inform the potential for scaling up point-of-care testing of CRP in respiratory infections, we aimed to do a pragmatic trial of the intervention in a routine care setting. We did a pragmatic, cluster-randomised controlled trial at 48 commune health centres in Viet Nam between June 1, 2020, and May 12, 2021. Eligible centres served populations of more than 3000 people, handled 10-40 respiratory infections per week, had licensed prescribers on site, and maintained electronic patient databases. Centres were randomly allocated (1:1) to provide point-of-care CRP testing plus routine care or routine care only. Randomisation was stratified by district and by baseline prescription level (ie, the proportion of patients with suspected acute respiratory infections to whom antibiotics were prescribed in 2019). Eligible patients were aged 1-65 years and visiting the commune health centre for a suspected acute respiratory infection with at least one focal sign or symptom and symptoms lasting less than 7 days. The primary endpoint was the proportion of patients prescribed an antibiotic at first attendance in the intention-to-treat population. The per-protocol analysis included only people who underwent CRP testing. Secondary safety outcomes included time to resolution of symptoms and frequency of hospitalisation. This trial is registered with ClinicalTrials.gov, NCT03855215. 48 commune health centres were enrolled and randomly assigned, 24 to the intervention group (n=18 621 patients) and 24 to the control group (n=21 235). 17 345 (93·1%) patients in the intervention group were prescribed antibiotics, compared with 20 860 (98·2%) in the control group (adjusted relative risk 0·83 [95% CI 0·66-0·93]). Only 2606 (14%) of 18 621 patients in the intervention group underwent CRP testing and were included in the per-protocol analysis. When analyses were restricted to this population, larger reductions in prescribing were noted in the intervention group compared with the control group (adjusted relative risk 0·64 [95% CI 0·60-0·70]). Time to resolution of symptoms (hazard ratio 0·70 [95% CI 0·39-1·27]) and frequency of hospitalisation (nine in the intervention group vs 17 in the control group; adjusted relative risk 0·52 [95% CI 0·23-1·17]) did not differ between groups. Use of point-of-care CRP testing efficaciously reduced prescription of antibiotics in patients with non-severe acute respiratory infections in primary health care in Viet Nam without compromising patient recovery. The low uptake of CRP testing suggests that barriers to implementation and compliance need to be addressed before scale-up of the intervention. Australian Government, UK Government, and the Foundation for Innovative New Diagnostics.

A culturally competent systems intervention in primary health care to reduce domestic violence among immigrant communities: HARMONY a pragmatic cluster-randomised controlled trial in Melbourne, Australia

A culturally competent systems intervention in primary health care to reduce domestic violence among immigrant communities: HARMONY a pragmatic cluster-randomised controlled trial in Melbourne, Australia

Music and Movement for Health: Protocol for a pragmatic cluster-randomised feasibility pilot trial of an arts-based programme for the health and wellbeing of older adults.

Background: Arts-based health programmes (ABHP) can enhance the physical and psychosocial health and wellbeing of older people. However, the feasibility and usefulness of such programmes in Ireland are currently unknown. The primary aim of this study is to examine the feasibility of the study design, its application to a music and movement for health programme and associated costs. The secondary aim is to obtain preliminary effect estimates of an ABHP on health and wellbeing in older adults. Methods: This study is a pragmatic cluster-randomised controlled feasibility trial. Community-dwelling adults, aged 65 years or older will be recruited in the mid-west region of Ireland via methods including social prescription, traditional and social media. The clusters, based on geographical region, will be block randomised to either the ABHP or control using 1:1 allocation ratio. The programme will comprise a 1.5-hour music and dance session each week for 12-weeks together with a 1-hour home-based music and movement programme for 12-weeks. A qualitative and quantitative process evaluation of the arts-based health programme will be performed. Outcomes: Primary outcomes for feasibility include recruitment rates (the number of participants recruited per cluster per month); retention rate (the number of participants who complete measures at baseline and at follow up post intervention, and minimum average attendance. Secondary outcomes will include physical function, balance, physical activity, loneliness, social isolation, cognition, mood, as well as quality of life and cost. Conclusions: If this pioneering study finds evidence to support feasibility and acceptability, a future larger-scale definitive trial will be conducted to examine the effectiveness of an arts-based health programme for older adults. This research aims to strengthen collaborative efforts to implement effective, sustainable and cost-effective programmes for older adults to support community connection, enhancing health and wellbeing, in turn reducing demands on the healthcare system. ISRCTN registration: ISRCTN35313497 (18/02/2022).

Influence of a guideline or an additional rapid strep test on antibiotic prescriptions for sore throat: the cluster randomized controlled trial of HALS (Hals und Antibiotika Leitlinien Strategien)

BackgroundPharyngitis due to Group A beta-hemolytic streptococci (GAS) is seen as the main indication for antibiotics for sore throat. In primary care settings prescription rates are much higher than the prevalence of GAS. Recommendations in international guidelines differ considerably. A German guideline suggested to consider antibiotics for patients with Centor or McIsaac scores ≥ 3, first choice being penicillin V for 7 days, and recommended analgesics for all. We investigated, if the implementation of this guideline lowers the antibiotic prescription rate, and if a rapid antigen detection strep-test (RADT) in patients with scores ≥ 3 lowers the rate further.MethodsHALS was an open pragmatic parallel group three-arm cluster-randomized controlled trial. Primary care practices in Northern Germany were randomized into three groups: Guideline (GL-group), modified guideline with a RADT for scores ≥ 3 (GL-RADT-group) or usual care (UC-group). All practices were visited and instructed by the study team (outreach visits) and supplied with material according to their group. The practices were asked to recruit 11 consecutive patients ≥ 2 years with an acute sore throat and being at least moderately impaired. A study throat swab for GAS was taken in every patient. The antibiotic prescription rate at the first consultation was the primary outcome.ResultsFrom October 2010 to March 2012, 68 general practitioners in 61 practices recruited 520 patients, 516 could be analyzed for the primary endpoint. Antibiotic prescription rates did not differ between groups (p = 0.162) and were about three times higher than the GAS rate: GL-group 97/187 patients (52%; GAS = 16%), GL-RADT-group 74/172 (43%; GAS = 16%) and UC-group 68/157 (43%; GAS = 14%). In the GL-RADT-group 55% of patients had scores ≥ 3 compared to 35% in GL-group (p < 0.001). After adjustment, in the GL-RADT-group the OR was 0.23 for getting an antibiotic compared to the GL-group (p = 0.010), even though 35 of 90 patients with a negative Strep-test got an antibiotic in the GL-RADT-group. The prescription rates per practice covered the full range from 0 to 100% in all groups.ConclusionThe scores proposed in the implemented guideline seem inappropriate to lower antibiotic prescriptions for sore throat, but better adherence of practitioners to negative RADTs should lead to fewer prescriptions.Trial registrationDRKS00013018, retrospectively registered 28.11.2017.

Improving rural and regional access to long-acting reversible contraception and medical abortion through nurse-led models of care, task-sharing and telehealth (ORIENT): a protocol for a stepped-wedge pragmatic cluster-randomised controlled trial in Australian general practice

IntroductionWomen living in rural and regional Australia often experience difficulties in accessing long-acting reversible contraception (LARC) and medical abortion services. Nurse-led models of care can improve access to these services...