scholarly journals Process evaluation of an implementation trial to improve the triage, treatment and transfer of stroke patients in emergency departments (T3 trial): a qualitative study

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Elizabeth McInnes ◽  
Simeon Dale ◽  
Louise Craig ◽  
Rosemary Phillips ◽  
Oyebola Fasugba ◽  
...  
Keyword(s):  
Emergency Departments ◽  
Readiness To Change ◽  
Randomised Trial ◽  
Cost Effective ◽  
Influential Factors ◽  
Trial Registration ◽  
Normalisation Process Theory ◽  
Cluster Randomised Trial ◽  
Supporting Evidence ◽  
Trial State

Abstract Background The implementation of evidence-based protocols for stroke management in the emergency department (ED) for the appropriate triage, administration of tissue plasminogen activator to eligible patients, management of fever, hyperglycaemia and swallowing, and prompt transfer to a stroke unit were evaluated in an Australian cluster-randomised trial (T3 trial) conducted at 26 emergency departments. There was no reduction in 90-day death or dependency nor improved processes of ED care. We conducted an a priori planned process influential factors that impacted upon protocol uptake. Methods Qualitative face-to-face interviews were conducted with purposively selected ED and stroke clinicians from two high- and two low-performing intervention sites about their views on factors that influenced protocol uptake. All Trial State Co-ordinators (n = 3) who supported the implementation at the 13 intervention sites were also interviewed. Data were analysed thematically using normalisation process theory as a sensitising framework to understand key findings, and compared and contrasted between interviewee groups. Results Twenty-five ED and stroke clinicians, and three Trial State Co-ordinators were interviewed. Three major themes represented key influences on evidence uptake: (i) Readiness to change: reflected strategies to mobilise and engage clinical teams to foster cognitive participation and collective action; (ii) Fidelity to the protocols: reflected that beliefs about the evidence underpinning the protocols impeded the development of a shared understanding about the applicability of the protocols in the ED context (coherence); and (iii) Boundaries of care: reflected that appraisal (reflexive monitoring) by ED and stroke teams about their respective boundaries of clinical practice impeded uptake of the protocols. Conclusions Despite initial high ‘buy-in’ from clinicians, a theoretically informed and comprehensive implementation strategy was unable to overcome system and clinician level barriers. Initiatives to drive change and integrate protocols rested largely with senior nurses who had to overcome contextual factors that fell outside their control, including low medical engagement, beliefs about the supporting evidence and perceptions of professional boundaries. To maximise uptake of evidence and adherence to intervention fidelity in complex clinical settings such as ED cost-effective strategies are needed to overcome these barriers. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12614000939695).

scholarly journals A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC)

2016 ◽  
Vol 20 (68) ◽  
pp. 1-138 ◽  
Author(s):  
Henry C Kitchener ◽  
Matthew Gittins ◽  
Oliver Rivero-Arias ◽  
Apostolos Tsiachristas ◽  
Margaret Cruickshank ◽  
...  
Keyword(s):  
Discrete Choice ◽  
Choice Experiment ◽  
Phase 1 ◽  
Cervical Screening ◽  
Randomised Trial ◽  
Cost Effective ◽  
Health Technology ◽  
Cluster Randomised Trial ◽  
Phase 2 ◽  
Cluster Randomised

BackgroundFalling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged < 35 years. Various barriers to screening have been documented, including fear, embarrassment and inconvenience.ObjectivesTo measure the feasibility, clinical effectiveness and cost-effectiveness of a range of interventions to increase the uptake of cervical screening among young women.DesignA cluster randomised trial based on general practices performed in two phases.SettingPrimary care in Greater Manchester and the Grampian region in Scotland.ParticipantsPhase 1: 20,879 women receiving their first invitation for cervical screening. Phase 2: 10,126 women who had not attended by 6 months.InterventionsPhase 1: pre-invitation leaflet or not, and access to online booking (Manchester only). Phase 2: (1) vaginal self-sampling kits (SSKs) sent unrequested (n = 1141); or (2) offered on request (n = 1290); (3) provided with a timed appointment (n = 1629); (4) offered access to a nurse navigator (NN) (n = 1007); or (5) offered a choice between a NN or a SSK (n = 1277); and 3782 women in control practices.Main outcome measuresUplift in screening compared with control practices, cost-effectiveness of interventions, and the women’s preferences explored in a discrete choice experiment.ResultsThe pre-invitation leaflet and offer of online booking were ineffective when compared with control practices at 3 months, 18.8% versus 19.2% [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.88 to 1.06;p = 0.485] and 17.8% versus 17.2% (OR 1.02, 95% CI 0.87 to 1.20;p = 0.802), respectively. The uptake of screening at 3 months was higher among previously human papillomavirus (HPV)-vaccinated women than unvaccinated women, 23.7% versus 11% (OR 2.07, 95% CI 1.69 to 2.53;p < 0.001). Among non-attenders, the SSK sent intervention showed a statistically significant increase in uptake at 12 months post invitation, 21.3% versus 16.2% (OR 1.51, 95% CI 1.20 to 1.91;p = 0.001), as did timed appointments, 19.8% versus 16.2% (OR 1.41, 95% CI 1.14 to 1.74;p = 0.001). The offer of a NN, a SSK on request, and a choice between timed appointments and NN were ineffective. Overall, there was a gradual rather than prompt response, as demonstrated by uptake among control practices. A discrete choice experiment indicated that women invited who had not yet attended valued the attributes inherent in self-sampling. The health economic analysis showed that both timed appointments and unsolicited SSK sent were likely to be cost-effective at a cost per quality-adjusted life-year (QALY) gained of £7593 and £8434, respectively, if extended across the national 25-year-old cohort throughout the duration of screening. The certainty of these being cost-effective at a ceiling ratio of £20,000 per QALY gained was > 90%.ConclusionWomen receiving their initial screening invitation frequently delay taking up the offer and the net impact of interventions was small. Timed appointments and SSKs sent to non-attenders at 6 months are likely to be a cost-effective means of increasing uptake and should be considered further. HPV vaccination in the catch-up programme was associated with an increased uptake of cervical screening. Future work should focus on optimising self-sampling in terms of age range, timing of offer for non-attenders and use of urine testing instead of vaginal samples.Trial registrationCurrent Controlled Trials ISRCTN52303479.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 68. See the NIHR Journals Library website for further project information.

scholarly journals Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Samantha Keogh ◽  
Caroline Shelverton ◽  
Julie Flynn ◽  
Gabor Mihala ◽  
Saira Mathew ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Control Period ◽  
Randomised Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Intention To Treat ◽  
Cluster Randomised ◽  
The Impact

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

scholarly journals PO 8426 DELIVERY OF POST-DISCHARGE MALARIA CHEMOPREVENTION (PMC) WITH DIHYDROARTEMESININ-PIPERAQUINE FOR MANAGEMENT OF CHILDREN WITH SEVERE ANAEMIA IN MALAWI

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A36.2-A36
Author(s):  
Thandile Gondwe ◽  
Bjarne Robberstad ◽  
Mavuto Mukaka ◽  
Bjorn Blomberg ◽  
Kamija Phiri
Keyword(s):  
Randomised Trial ◽  
Cost Effective ◽  
Preventive Therapy ◽  
Primary Outcome Measure ◽  
Severe Anaemia ◽  
Primary Objective ◽  
Cluster Randomised Trial ◽  
Post Discharge ◽  
Delivery Strategy ◽  
Sms Reminder

BackgroundChildren hospitalised with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No strategy addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly 3 day courses of artemether-lumefantrine (AL) in children with severe malarial anaemia prevented 31% of deaths and readmissions. There is now a need to design and evaluate an effective delivery strategy for PMC.MethodsThis is a cluster-randomised trial whose primary objective is to determine the optimum PMC delivery strategy by comparing community versus health facility-based strategies with the aim to inform policy. Convalescent children under 5 years old, weighing >5 kg, admitted with severe anaemia and clinically stable are included. All children received dihydroartemisinin-piperaquine 2, 6 and 10 weeks after discharge, either: 1) at discharge with SMS reminder; 2) at discharge without an SMS reminder; 3) at discharge and community health worker reminder; 4) at the hospital with an SMS reminder; or 5) at the hospital without an SMS reminder. The primary outcome measure is uptake of courses of PMC drugs. Children will be followed up for 15 weeks. The sample size is 75 children per arm (375 total).ResultsThe study has nearly completed enrollment and preliminary data analysis is in progress. We expect to identify the most effective, cost-effective, acceptable and feasible strategy for delivering intermittent preventive therapy post-discharge for management of severe anaemia in under-five children.ConclusionThe findings of this study will be presented; they address the knowledge gap regarding the potentially preventable component of the burden that occurs after discharge from hospital, and inform the optimal delivery strategy for PMC.

scholarly journals Protocol for the process evaluation of a complex intervention delivered in schools to prevent adolescent depression: the Future Proofing Study

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042133
Author(s):  
Joanne R Beames ◽  
Raghu Lingam ◽  
Katherine Boydell ◽  
Alison L Calear ◽  
Michelle Torok ◽  
...  
Keyword(s):  
Process Evaluation ◽  
Randomised Trial ◽  
Trial Registration ◽  
School Staff ◽  
Cluster Randomised Trial ◽  
School Students ◽  
Capture Process ◽  
School Counsellors ◽  
State Education ◽  
The Future

IntroductionProcess evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a cluster randomised trial of a digital depression prevention intervention delivered to secondary school students (the Future Proofing Study). The purpose is to describe the methods that will be used to capture process evaluation data within this trial.Methods and analysisUsing a hybrid type 1 design, a mixed-methods approach will be used with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semistructured interviews with school staff and study facilitators, automatically collected intervention usage data and participant questionnaires (completed by school staff, school counsellors, study facilitators and students). Information will be collected about: (1) how the intervention was implemented in schools, including fidelity; (2) school contextual factors and their association with intervention reach, uptake and acceptability; (3) how school staff, study facilitators and students responded to delivering or completing the intervention. How these factors relate to trial effectiveness outcomes will also be assessed. Overall synthesis of the data will provide school cluster-level and individual-level process outcomes.Ethics and disseminationEthics approval was obtained from the University of New South Wales (NSW) Human Research Ethics Committee (HC180836; 21st January 2019) and the NSW Government State Education Research Applications Process (SERAP 2019201; 19th August 2019). Results will be submitted for publication in peer-reviewed journals and discussed at conferences. Our process evaluation will contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. This evaluation will inform the development of a model for rolling out digital interventions for the prevention of mental illness in schools.Trial registration numberANZCTRN12619000855123; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377664&isReview=true.

scholarly journals Addressing overcrowding in an emergency department: an approach for identifying and treating influential factors and a real-life application

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Guy Wachtel ◽  
Amir Elalouf
Keyword(s):  
Emergency Department ◽  
Length Of Stay ◽  
Emergency Departments ◽  
Real Life ◽  
Cost Effective ◽  
Influential Factors ◽  
Factors Affecting ◽  
Additional Support ◽  
Hospital Emergency Departments ◽  
First Time

Abstract Background Overcrowding in hospital emergency departments that arises from long length-of-stay is an unfortunate common occurrence. While some factors affecting length-of-stay are well known, there may be additional factors that have not yet been properly addressed. This research offers a method for emergency department managers to use available data from their departments to identify new factors that significantly influence emergency departments crowding and patient length-of-stay. Methods We propose an algorithm that can assist emergency department managers in determining which of these factors to address, given budgetary constraints. We implemented it in a case study which takes into account factors that are known to be influential, e.g., reason for arrival, occupancy in the emergency department, and arrival time, as well as factors that are explored for the first time in this paper, such as patient heart rate, the number of accompanying escorts, and the number of tests assigned to patients (e.g., blood tests and urinalysis). Results All the implemented and new factors are shown to have a significant influence on the length-of-stay and crowding. We also obtained additional support for our results by interviewing emergency departments physicians and nurses from various hospitals. Conclusions It is expected that, by taking all the above factors into consideration, emergency departments efficiency can be improved. The algorithm constructed here allows the choice of the most cost-effective factors to be improved, subject to a given budget. We have been able to derive practical recommendations that emergency departments managers might use to limit crowding and patient length-of-stay.

scholarly journals Evaluating Diuretics in Normal Care (EVIDENCE): A feasibility report of a pilot cluster randomised trial of prescribing policy in primary care to compare the effectiveness of thiazide-type diuretics in hypertension

2021 ◽  
Author(s):  
Angela Flynn ◽  
Amy Rogers ◽  
Lewis McConnachie ◽  
Rebecca Barr ◽  
Robert Flynn ◽  
...  
Keyword(s):  
Primary Care ◽  
Comparative Effectiveness ◽  
Policy Design ◽  
Randomised Trial ◽  
Pragmatic Trial ◽  
Cost Effective ◽  
Cluster Randomised Trial ◽  
Pharmacy Staff ◽  
The Uk ◽  
Primary Care Practices

ABSTRACT Background Obtaining evidence on comparative effectiveness and safety of widely prescribed drugs in a timely and cost-effective way is a major challenge for healthcare systems. Here we describe the feasibility of the Evaluating Diuretics in Normal Care (EVIDENCE) study that compares a thiazide and thiazide-like diuretics for hypertension as an exemplar of a more general framework for efficient generation of such evidence. In 2011, the UK NICE hypertension guideline included a recommendation that thiazide-like diuretics (such as indapamide) be used in preference to thiazide diuretics (such as bendroflumethiazide) for hypertension. There is sparse evidence backing this recommendation, and bendroflumethiazide remains widely used in the UK. Methods Patients prescribed indapamide or bendroflumethiazide regularly for hypertension were identified in participating General Practices. Allocation of a prescribing policy favouring one of these drugs was then randomly applied to the Practice and, where required to comply with the policy, repeat prescriptions switched by pharmacy staff. Patients were informed of the potential switch by letter and given the opportunity to opt-out. Practice adherence to the randomised policy was assessed by measuring the amount of policy drug prescribed as a proportion of total combined indapamide and bendroflumethiazide. Routinely collected hospitalization and death data in the NHS will be used to compare cardiovascular event rates between the two policies. Results This pilot recruited 30 primary care practices in five Scottish National Health Service (NHS) Boards. Fifteen practices were randomised to indapamide (2682 patients), and 15 to bendroflumethiazide (3437 patients); a study population of 6119 patients. Prior to randomisation, bendroflumethiazide was prescribed to 78% of patients prescribed either of these drugs. Only 1.6% of patients opted out of the proposed medication switch. Conclusion The pilot and subsequent recruitment confirms the methodology is scalable within NHS Scotland for a fully powered larger study, currently 102 GP practices (>12,700 patients) are participating in this study. It has the potential to efficiently produce externally valid comparative effectiveness data with minimal disruption to practice staff or patients. Streamlining this pragmatic trial approach, has demonstrated the feasibility of a random prescribing policy design framework that can be adapted to other therapeutic areas. Keywords: pilot, prescribing policy, comparative effectiveness, drug prescriptions, primary care, hypertension

Maternal and child health nurses’ experiences of implementing two community-based breastfeeding interventions in Victoria, Australia: A mixed methods process evaluation

2019 ◽  
Vol 16 (1) ◽  
pp. 4-14 ◽  
Author(s):  
Rhian L Cramer ◽  
Helen L McLachlan ◽  
Touran Shafiei ◽  
Lisa H Amir ◽  
Meabh Cullinane ◽  
...  
Keyword(s):  
Child Health ◽  
Maternal And Child Health ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Breastfeeding Initiation ◽  
Structured Interviews ◽  
Breastfeeding Support ◽  
Community Based ◽  
Significant Drop ◽  
And Child Health

Despite high rates of breastfeeding initiation in Australia, there is a significant drop in breastfeeding rates in the early postpartum period, and Australian government breastfeeding targets are not being met. The Supporting breastfeeding In Local Communities (SILC) trial was a three-arm cluster randomised trial implemented in 10 Victorian local government areas (LGAs). It aimed to determine whether early home-based breastfeeding support by a maternal and child health nurse (MCH nurse) with or without access to a community-based breastfeeding drop-in centre increased the proportion of infants receiving ‘any’ breast milk at four months. Focus groups, a written questionnaire and semi-structured interviews were undertaken to explore the interventions from the perspective of the SILC-MCH nurses (n=13) and coordinators (n=6), who established and implemented the interventions. Inductive thematic analysis was used to identify themes, then findings further examined using Diffusion of Innovations Theory as a framework. SILC-MCH nurses and coordinators reported high levels of satisfaction, valuing the opportunity to improve breastfeeding in our community; and having focused breastfeeding time with women in their own homes. They felt the SILC interventions offered benefits to women, nurses and the MCH service. Implementing new interventions into existing, complex community health services presented unforeseen challenges, which were different in each LGA and were in part due to the complexity of the individual LGAs and not the interventions themselves. These findings will help inform the planning and development of future programs aimed at improving breastfeeding and other interventions in MCH.

Sign in / Sign up

Export Citation Format

Share Document