scholarly journals Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study

2017 ◽  
Vol 12 (1) ◽  
Author(s):  
Shelley Roberts ◽  
Elizabeth McInnes ◽  
Tracey Bucknall ◽  
Marianne Wallis ◽  
Merrilyn Banks ◽  
...  
BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027841 ◽  
Author(s):  
Nikhil Srinivasapura Venkateshmurthy ◽  
Kevin Mc Namara ◽  
Harriet Koorts ◽  
Sailesh Mohan ◽  
Vamadevan S Ajay ◽  
...  

IntroductionIndia has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled ‘m-Power Heart Project’ is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial’s process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research.Methods and analysisThe process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick’s model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelliet al’s framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc.Ethics and disseminationEthical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations.Trial registration numberNCT03164317; Pre-results.


2016 ◽  
Vol 64 ◽  
pp. 63-71 ◽  
Author(s):  
Wendy Chaboyer ◽  
Tracey Bucknall ◽  
Joan Webster ◽  
Elizabeth McInnes ◽  
Brigid M. Gillespie ◽  
...  

2018 ◽  
Vol 68 (677) ◽  
pp. e844-e851
Author(s):  
Tim A Holt ◽  
Andrew RH Dalton ◽  
Susan Kirkpatrick ◽  
Jenny Hislop ◽  
Tom Marshall ◽  
...  

BackgroundOral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants.AimTo investigate the implementation of the software in UK general practice.Design and settingProcess evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial.MethodAn initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability.ResultsIn a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised.ConclusionAutomated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031438 ◽  
Author(s):  
Cindy Mann ◽  
Ali R G Shaw ◽  
Bruce Guthrie ◽  
Lesley Wye ◽  
Mei-See Man ◽  
...  

ObjectivesDuring a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.DesignMixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients.SettingThirty-three UK general practices in three areas.ParticipantsThe trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview.ResultsStaff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from ‘tick-box’ to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.ConclusionsImplementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention.Trial registration numberISRCTN06180958


2020 ◽  
Author(s):  
Maria Burton ◽  
Kate J Lifford ◽  
Lynda Wyld ◽  
Fiona Armitage ◽  
Alistair Ring ◽  
...  

Abstract The authors have withdrawn this preprint due to author disagreement.


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