A feasibility randomised controlled trial with an embedded qualitative evaluation of perinatal emotional skills groups for women with borderline personality disorder : protocol for the EASE study

Background Borderline personality disorder (BPD) is a severe mental disorder characterised by emotional instability, impaired interpersonal functioning and an increased risk of suicide. There is no clear evidence about how best to help women with BPD during the perinatal period. Perinatal Emotional Skills Groups (ESGs) consist of 12 group sessions, focussing on core skills in emotion regulation, interpersonal effectiveness, distress tolerance and mindfulness and how these skills can best be utilised during the perinatal period. Prior observational research has shown that perinatal ESGs may help women with BPD. We set out to test the feasibility of conducting a randomised controlled trial to investigate the clinical effectiveness of perinatal ESGs. Methods A two-arm, parallel-group, feasibility randomised controlled trial of Perinatal ESGs in addition to Treatment as Usual (TAU) versus TAU for women aged over 18 years, who are likely to have a diagnosis of BPD and are either pregnant or are within 12 months of having a live birth. We will exclude women who have a co-existing organic, psychotic mental disorder or substance use dependence syndrome; those with cognitive or language difficulties that would preclude them from consenting or participating in study procedures; those judged to pose an acute risk to their baby and those requiring admission to a mother and baby unit. After consenting to participation and completing screening assessments, eligible individuals will be randomly allocated, on a 1:1 ratio, to either ESGs + TAU or to TAU. Randomisation will be stratified according to recruitment centre. Feasibility outcomes will be the proportion of participants: (1) consenting; (2) completing baseline measures and randomised; (3) completing the intervention and (4) completing follow-up assessments. All study participants will complete a battery of self-report measures at 2 and 4 months post-randomisation. A nested qualitative study will examine participants’ and therapists’ experiences of the trial and the intervention. Discussion Evidence is lacking about how to help women with BPD during the perinatal period. Perinatal ESGs are a promising intervention and if they prove to be an effective adjunct to usual care, a large population of vulnerable women and their children could experience substantial health gains. Trial registration ISRCTN80470632

Implementation of CHIldren with acute COugh (CHICO) intervention to improve antibiotics management: qualitative study

BackgroundChildhood respiratory tract infections (RTIs) are common and can lead to unnecessary antibiotic use and antimicrobial resistance. The CHIldren with COugh (CHICO) intervention incorporates a clinician focussed algorithm (STARWAVe) to predict future hospitalisation risk, elicitation of carer concerns, and a carer-focussed personalised leaflet recording treatment decisions and safety netting information. AimTo examine the intervention implementation by clinicians.Design and settingA qualitative study with primary care clinicians in England taking part in the CHICO randomised controlled trial.MethodInterviews explored the intervention’s acceptability and use. Clinicians from a range of practices with high and low antibiotic dispensing rates were recruited. Normalisation Process Theory underpinned data collection and thematic analysis. ResultsMost clinicians liked the intervention as it was quick and easy to use, it helped elicit carer concerns and reassured clinicians and carers of the appropriateness of treatment decisions. However, clinicians used it as a supportive aid for treatment decisions rather than a tool for behaviour change. The advice leaflet helped explain treatment decisions and support self-care. The intervention did not always align with clinicians’ usual processes which could affect usage. Increased familiarisation with the algorithm led to reduced intervention use, which was further reduced due to changes to practice and remote consultation during the COVID-19 pandemic. ConclusionClinicians found the CHICO intervention useful to support decision-making around antibiotic prescribing and helped discussions with carers about concerns and treatment decisions. The intervention may need to be adapted to align more with clinicians’ consultation flow and remote consultations. <br/

Protocol for an ‘efficient design’ cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: the CHICO study

Introduction Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded ‘TARGET’ programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren’s COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III ‘efficiently designed’ trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI.Methods and analysis The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0–9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost–consequence analysis.Ethics and dissemination Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences.Trial registration number ISRCTN11405239

A multi-faceted intervention to improve management of antibiotics for CHIldren presenting to primary care with acute COugh and respiratory tract infection (CHICO): an efficient cluster randomised controlled trial

Objectives: Unnecessary use of antibiotics needlessly contributes to antimicrobial resistance. Our aim was to assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections (RTI) would reduce antibiotic dispensing, without increasing hospital admissions for RTI. Design: A two-arm randomised controlled trial clustered by GP practice, using routine outcome data, with qualitative and economic evaluations. Setting: English GP practices using the EMIS® electronic medical record system. Participants: Children aged 0-9 years with RTI, before and during the COVID-19 pandemic. Intervention: Three components: i) elicitation of parental concerns during consultation; ii) a clinician-focussed prognostic algorithm to identify children at very low, normal or elevated 30-day hospitalisation risk accompanied by antibiotic prescribing guidance; and iii) a leaflet for carers including safety-netting advice. Main outcome measures: Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for RTI (non-inferiority comparison) for children aged 0-9 years over 12 months (same-age practice list-size as denominator). Results: Of 310 practices required, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year-olds in England. Of these, 12 (4%) subsequently withdrew (6 related to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). There was no evidence that antibiotic dispensing in intervention practices (155 items per year, per 1000 children [95% CI: 138 to 174]) differed from control practices (157 items per year, per 1000 children [95% CI: 140 to 176]); rate ratio(RR)=1.011 [95% CI:0.992 to 1.029]; p=0.253). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multi-site) practices, and located in areas of lower socioeconomic deprivation; although these analyses were underpowered. Pre-specified sensitivity analysis suggested reduced dispensing amongst older children in the intervention arm (p=0.03). A post-hoc sensitivity analyses suggested there was less dispensing in intervention practices pre-pandemic (RR=0.967 [95% CI:0.946 to 0.989];p=0.003). The rate of hospitalisation for RTI in the intervention practices (13 hospitalisations per 1000 children [95% CI:10 to 18)] was non-inferior compared with control practices (15 hospitalisations per 1000 children [95% CI: 12 to 20]); RR=0.952 [95% CI:0.905 to 1.003]. Conclusions: This multifaceted antibiotic stewardship intervention for children with RTIs did not reduce overall antibiotic dispensing nor increase RTI-related hospital admissions. There were some subgroups and situations (e.g. under non-pandemic conditions) where the intervention slightly reduced prescribing rates but not in a clinically meaningful way

Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?

Objectives: conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients' notes is costly and time-consuming. We investigated barriers and facilitators to running a more efficient design. Design: an RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection (RTI) with a clinician-focused intervention, embedded at the practice level. By using aggregate level, routinely collected data for the coprimary outcomes, we removed the need to recruit individual participants. Setting Primary care. Participants: baseline data from general practitioner practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data. Intervention The intervention included: (1) explicit elicitation of parental concerns, (2) a prognostic algorithm to identify children at low risk of hospitalisation and (3) provision of a printout for carers including safety-netting advice. Coprimary outcomes For 0-9 years old - (1) Dispensing data for amoxicillin and macrolide antibiotics and (2) hospital admission rate for RTI. Results: we recruited 294 of the intended 310 practices (95%) representing 336 496 registered 0-9 years old (5% of all 0-9 years old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the coprimary outcomes were almost 100%. Conclusions: the infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate.</p

Protocol for an 'efficient design' cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: The CHICO study

Introduction Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded 'TARGET' programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren's COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III 'efficiently designed' trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI. Methods and analysis The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost-consequence analysis. Ethics and dissemination Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences. Trial registration number ISRCTN11405239. </p