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1.  Perceived difficulty and appropriateness of decision making by General Practitioners: a systematic review of scenario studies 
Background
Health-care quality in primary care depends largely on the appropriateness of General Practitioners’ (GPs; Primary Care or Family Physicians) decisions, which may be influenced by how difficult they perceive decisions to be. Patient scenarios (clinical or case vignettes) are widely used to investigate GPs’ decision making. This review aimed to identify the extent to which perceived decision difficulty, decision appropriateness, and their relationship have been assessed in scenario studies of GPs’ decision making; identify possible determinants of difficulty and appropriateness; and investigate the relationship between difficulty and appropriateness.
Methods
MEDLINE, EMBASE, PsycINFO, the Cochrane Library and Web of Science were searched for scenario studies of GPs’ decision making. One author completed article screening. Ten percent of titles and abstracts were checked by an independent volunteer, resulting in 91% agreement. Data on decision difficulty and appropriateness were extracted by one author and descriptively synthesised. Chi-squared tests were used to explore associations between decision appropriateness, decision type and decision appropriateness assessment method.
Results
Of 152 included studies, 66 assessed decision appropriateness and five assessed perceived difficulty. While no studies assessed the relationship between perceived difficulty and appropriateness, one study objectively varied the difficulty of the scenarios and assessed the relationship between a measure of objective difficulty and appropriateness. Across 38 studies where calculations were possible, 62% of the decisions were appropriate as defined by the appropriateness standard used. Chi-squared tests identified statistically significant associations between decision appropriateness, decision type and decision appropriateness assessment method. Findings suggested a negative relationship between decision difficulty and appropriateness, while interventions may have the potential to reduce perceived difficulty.
Conclusions
Scenario-based research into GPs’ decisions rarely considers the relationship between perceived decision difficulty and decision appropriateness. The links between these decisional components require further investigation.
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-014-0621-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s12913-014-0621-2
PMCID: PMC4258016  PMID: 25471752
Systematic review; Clinical decision making; Decision difficulty; Decision appropriateness; General Practitioner; Primary care physician; Patient scenario; Vignette
2.  Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians’ diabetic retinopathy referrals [Trial registration number ISRCTN72772651] 
Background
Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians’ intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control.
Methods
Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main outcome measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control.
Results
At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influence whether patients received retinopathy screening.
Conclusions
Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial. High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care. Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior.
Trial registration
ISRCTN72772651.
Electronic supplementary material
The online version of this article (doi:10.1186/1748-5908-9-86) contains supplementary material, which is available to authorized users.
doi:10.1186/1748-5908-9-86
PMCID: PMC4261878  PMID: 25098442
Process evaluation; Theory of planned behavior; Printed educational material; Healthcare professional behavior; Behavior change
3.  Application of theory to enhance audit and feedback interventions to increase the uptake of evidence-based transfusion practice: an intervention development protocol 
Background
Audits of blood transfusion demonstrate around 20% transfusions are outside national recommendations and guidelines. Audit and feedback is a widely used quality improvement intervention but effects on clinical practice are variable, suggesting potential for enhancement. Behavioural theory, theoretical frameworks of behaviour change and behaviour change techniques provide systematic processes to enhance intervention. This study is part of a larger programme of work to promote the uptake of evidence-based transfusion practice.
Objectives
The objectives of this study are to design two theoretically enhanced audit and feedback interventions; one focused on content and one on delivery, and investigate the feasibility and acceptability.
Methods
Study A (Content): A coding framework based on current evidence regarding audit and feedback, and behaviour change theory and frameworks will be developed and applied as part of a structured content analysis to specify the key components of existing feedback documents. Prototype feedback documents with enhanced content and also a protocol, describing principles for enhancing feedback content, will be developed. Study B (Delivery): Individual semi-structured interviews with healthcare professionals and observations of team meetings in four hospitals will be used to specify, and identify views about, current audit and feedback practice. Interviews will be based on a topic guide developed using the Theoretical Domains Framework and the Consolidated Framework for Implementation Research. Analysis of transcripts based on these frameworks will form the evidence base for developing a protocol describing an enhanced intervention that focuses on feedback delivery. Study C (Feasibility and Acceptability): Enhanced interventions will be piloted in four hospitals. Semi-structured interviews, questionnaires and observations will be used to assess feasibility and acceptability.
Discussion
This intervention development work reflects the UK Medical Research Council’s guidance on development of complex interventions, which emphasises the importance of a robust theoretical basis for intervention design and recommends systematic assessment of feasibility and acceptability prior to taking interventions to evaluation in a full-scale randomised study. The work-up includes specification of current practice so that, in the trials to be conducted later in this programme, there will be a clear distinction between the control (usual practice) conditions and the interventions to be evaluated.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0092-1) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0092-1
PMCID: PMC4243714  PMID: 25070404
Audit and feedback; Blood transfusion; Implementation; Health services research; Study protocol; Health professional behaviour change
4.  Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial 
Trials  2014;15:281.
Background
Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed.
Methods/design
The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).
doi:10.1186/1745-6215-15-281
PMCID: PMC4107995  PMID: 25012235
Mild traumatic brain injury; Cluster trial; Emergency department
5.  Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals 
Background
New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes, likely requiring them to change multiple different clinical behaviours. The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing, advising, and examining consistent with high-quality diabetes care.
Aim
To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes.
Design/methods
We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention. We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes: prescribing for hypertension; prescribing for glycaemic control; providing physical activity advice; providing nutrition advice; providing on-going education; and ensuring that feet have been examined. The primary outcome will be the proportion of patients appropriately prescribed and examined (using anonymised computer records), and advised (using anonymous patient surveys) at 12 months. We will use behaviour change techniques targeting motivational, volitional, and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care. We will also investigate whether the intervention was delivered as designed (fidelity) by coding audiotaped workshops and interventionist delivery reports, and operated as hypothesised (process evaluation) by analysing responses to theory-based postal questionnaires. In addition, we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation, and a post-trial economic analysis to estimate the costs of the intervention and cost of service use.
Discussion
Consistent with UK Medical Research Council guidance and building on previous development research, this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care.
Trial registration
ISRCTN66498413.
doi:10.1186/1748-5908-9-61
PMCID: PMC4049486  PMID: 24886606
6.  Valuing patients' experiences of healthcare processes: Towards broader applications of existing methods☆ 
Social Science & Medicine (1982)  2014;106(100):194-203.
Healthcare policy leaders internationally recognise that people's experiences of healthcare delivery are important, and invest significant resources to monitor and improve them. However, the value of particular aspects of experiences of healthcare delivery – relative to each other and to other healthcare outcomes – is unclear.
This paper considers how economic techniques have been and might be used to generate quantitative estimates of the value of particular experiences of healthcare delivery.
A recently published conceptual map of patients' experiences served to guide the scope and focus of the enquiry. The map represented both what health services and staff are like and do and what individual patients can feel like, be and do (while they are using services and subsequently).
We conducted a systematic search for applications of economic techniques to healthcare delivery. We found that these techniques have been quite widely used to estimate the value of features of healthcare systems and processes (e.g. of care delivery by a nurse rather than a doctor, or of a consultation of 10 minutes rather than 15 minutes), but much less to estimate the value of the implications of these features for patients personally.
To inform future research relating to the valuation of experiences of healthcare delivery, we organised a workshop for key stakeholders. Participants undertook and discussed ‘exercises’ that explored the use of different economic techniques to value descriptions of healthcare delivery that linked processes to what patients felt like and were able to be and do. The workshop identified a number of methodological issues that need careful attention, and highlighted some important concerns about the ways in which quantitative estimates of the value of experiences of healthcare delivery might be used. However the workshop confirmed enthusiasm for efforts to attend directly to the implications of healthcare delivery from patients' perspectives, including in terms of their capabilities.
Highlights
•Significant efforts have been made to measure experiences of healthcare delivery.•Efforts to value experiences have focused on healthcare systems and processes.•The value of their implications for patients personally has been neglected.•Economic valuation techniques are promising but face challenges in this domain.
doi:10.1016/j.socscimed.2014.01.013
PMCID: PMC3988932  PMID: 24568844
Quality of healthcare; Patient acceptance of healthcare; Economic evaluation; Process utility; Capabilities approach
7.  Understanding diagnosis and management of dementia and guideline implementation in general practice: a qualitative study using the theoretical domains framework 
Background
Dementia is a growing problem, causing substantial burden for patients, their families, and society. General practitioners (GPs) play an important role in diagnosing and managing dementia; however, there are gaps between recommended and current practice. The aim of this study was to explore GPs’ reported practice in diagnosing and managing dementia and to describe, in theoretical terms, the proposed explanations for practice that was and was not consistent with evidence-based guidelines.
Methods
Semi-structured interviews were conducted with GPs in Victoria, Australia. The Theoretical Domains Framework (TDF) guided data collection and analysis. Interviews explored the factors hindering and enabling achievement of 13 recommended behaviours. Data were analysed using content and thematic analysis. This paper presents an in-depth description of the factors influencing two behaviours, assessing co-morbid depression using a validated tool, and conducting a formal cognitive assessment using a validated scale.
Results
A total of 30 GPs were interviewed. Most GPs reported that they did not assess for co-morbid depression using a validated tool as per recommended guidance. Barriers included the belief that depression can be adequately assessed using general clinical indicators and that validated tools provide little additional information (theoretical domain of ‘Beliefs about consequences’); discomfort in using validated tools (‘Emotion’), possibly due to limited training and confidence (‘Skills’; ‘Beliefs about capabilities’); limited awareness of the need for, and forgetting to conduct, a depression assessment (‘Knowledge’; ‘Memory, attention and decision processes’). Most reported practising in a manner consistent with the recommendation that a formal cognitive assessment using a validated scale be undertaken. Key factors enabling this were having an awareness of the need to conduct a cognitive assessment (‘Knowledge’); possessing the necessary skills and confidence (‘Skills’; ‘Beliefs about capabilities’); and having adequate time and resources (‘Environmental context and resources’).
Conclusions
This is the first study to our knowledge to use a theoretical approach to investigate the barriers and enablers to guideline-recommended diagnosis and management of dementia in general practice. It has identified key factors likely to explain GPs’ uptake of the guidelines. The results have informed the design of an intervention aimed at supporting practice change in line with dementia guidelines, which is currently being evaluated in a cluster randomised trial.
doi:10.1186/1748-5908-9-31
PMCID: PMC4015883  PMID: 24581339
Dementia; General practitioners (GPs); Cognitive assessment; Depression assessment; Theoretical Domains Framework (TDF); Guideline implementation
8.  Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians 
BMJ Open  2014;4(2):e003875.
Objective
The inclusion of the Community Health Index in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilisation. This linkage could be the basis for identification of adverse drug reactions. The aim of this article is to report the views of healthcare professionals on data sharing, ownership and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data.
Design
Qualitative study using semistructured face-to-face interviews addressing the study aims.
Participants
Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach.
Results
Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important factors to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified.
Conclusions
A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source datasets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership and responsibilities of data owners.
doi:10.1136/bmjopen-2013-003875
PMCID: PMC3927931  PMID: 24523422
Pharmacovigilance; Prescribing; Data Sharing; Data Ownership; Data Linkage
9.  No more ‘business as usual’ with audit and feedback interventions: towards an agenda for a reinvigorated intervention 
Background
Audit and feedback interventions in healthcare have been found to be effective, but there has been little progress with respect to understanding their mechanisms of action or identifying their key ‘active ingredients.’
Discussion
Given the increasing use of audit and feedback to improve quality of care, it is imperative to focus further research on understanding how and when it works best. In this paper, we argue that continuing the ‘business as usual’ approach to evaluating two-arm trials of audit and feedback interventions against usual care for common problems and settings is unlikely to contribute new generalizable findings. Future audit and feedback trials should incorporate evidence- and theory-based best practices, and address known gaps in the literature.
Summary
We offer an agenda for high-priority research topics for implementation researchers that focuses on reviewing best practices for designing audit and feedback interventions to optimize effectiveness.
doi:10.1186/1748-5908-9-14
PMCID: PMC3896824  PMID: 24438584
Audit and feedback; Synthesis; Best practice; Implementation; Optimization
10.  Understanding practice: the factors that influence management of mild traumatic brain injury in the emergency department-a qualitative study using the Theoretical Domains Framework 
Background
Mild traumatic brain injury is a frequent cause of presentation to emergency departments. Despite the availability of clinical practice guidelines in this area, there is variation in practice. One of the aims of the Neurotrauma Evidence Translation program is to develop and evaluate a targeted, theory- and evidence-informed intervention to improve the management of mild traumatic brain injury in Australian emergency departments. This study is the first step in the intervention development process and uses the Theoretical Domains Framework to explore the factors perceived to influence the uptake of four key evidence-based recommended practices for managing mild traumatic brain injury.
Methods
Semi-structured interviews were conducted with emergency staff in the Australian state of Victoria. The interview guide was developed using the Theoretical Domains Framework to explore current practice and to identify the factors perceived to influence practice. Two researchers coded the interview transcripts using thematic content analysis.
Results
A total of 42 participants (9 Directors, 20 doctors and 13 nurses) were interviewed over a seven-month period. The results suggested that (i) the prospective assessment of post-traumatic amnesia was influenced by: knowledge; beliefs about consequences; environmental context and resources; skills; social/professional role and identity; and beliefs about capabilities; (ii) the use of guideline-developed criteria or decision rules to inform the appropriate use of a CT scan was influenced by: knowledge; beliefs about consequences; environmental context and resources; memory, attention and decision processes; beliefs about capabilities; social influences; skills and behavioral regulation; (iii) providing verbal and written patient information on discharge was influenced by: beliefs about consequences; environmental context and resources; memory, attention and decision processes; social/professional role and identity; and knowledge; (iv) the practice of providing brief, routine follow-up on discharge was influenced by: environmental context and resources; social/professional role and identity; knowledge; beliefs about consequences; and motivation and goals.
Conclusions
Using the Theoretical Domains Framework, factors thought to influence the management of mild traumatic brain injury in the emergency department were identified. These factors present theoretically based targets for a future intervention.
doi:10.1186/1748-5908-9-8
PMCID: PMC3895840  PMID: 24418161
Emergency department management; Mild traumatic brain injury; Theoretical Domains Framework; Semi-structured interviews
11.  Prevalence and Causes of Prescribing Errors: The PRescribing Outcomes for Trainee Doctors Engaged in Clinical Training (PROTECT) Study 
PLoS ONE  2014;9(1):e79802.
Objectives
Study objectives were to investigate the prevalence and causes of prescribing errors amongst foundation doctors (i.e. junior doctors in their first (F1) or second (F2) year of post-graduate training), describe their knowledge and experience of prescribing errors, and explore their self-efficacy (i.e. confidence) in prescribing.
Method
A three-part mixed-methods design was used, comprising: prospective observational study; semi-structured interviews and cross-sectional survey. All doctors prescribing in eight purposively selected hospitals in Scotland participated. All foundation doctors throughout Scotland participated in the survey. The number of prescribing errors per patient, doctor, ward and hospital, perceived causes of errors and a measure of doctors' self-efficacy were established.
Results
4710 patient charts and 44,726 prescribed medicines were reviewed. There were 3364 errors, affecting 1700 (36.1%) charts (overall error rate: 7.5%; F1:7.4%; F2:8.6%; consultants:6.3%). Higher error rates were associated with : teaching hospitals (p<0.001), surgical (p = <0.001) or mixed wards (0.008) rather thanmedical ward, higher patient turnover wards (p<0.001), a greater number of prescribed medicines (p<0.001) and the months December and June (p<0.001). One hundred errors were discussed in 40 interviews. Error causation was multi-factorial; work environment and team factors were particularly noted. Of 548 completed questionnaires (national response rate of 35.4%), 508 (92.7% of respondents) reported errors, most of which (328 (64.6%) did not reach the patient. Pressure from other staff, workload and interruptions were cited as the main causes of errors. Foundation year 2 doctors reported greater confidence than year 1 doctors in deciding the most appropriate medication regimen.
Conclusions
Prescribing errors are frequent and of complex causation. Foundation doctors made more errors than other doctors, but undertook the majority of prescribing, making them a key target for intervention. Contributing causes included work environment, team, task, individual and patient factors. Further work is needed to develop and assess interventions that address these.
doi:10.1371/journal.pone.0079802
PMCID: PMC3880263  PMID: 24404122
12.  Feedback GAP: pragmatic, cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care 
Background
Audit and feedback to physicians is a commonly used quality improvement strategy, but its optimal design is unknown. This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning, appended to feedback reports on chronic disease management, compared to feedback reports provided without these worksheets.
Methods
A two-arm pragmatic cluster randomized trial was conducted, with allocation at the level of primary care clinics. Participants were family physicians who contributed data from their electronic medical records. The ‘usual feedback’ arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease. The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Blood pressure (BP) and low-density lipoprotein cholesterol (LDL) values were compared after two years as the primary outcomes. Process outcomes measured the proportion of guideline-recommended actions (e.g., testing and prescribing) conducted within the appropriate timeframe. Intention-to-treat analysis was performed.
Results
Outcomes were similar across groups at baseline. Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm (15% loss to follow up) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm (10% loss to follow up). Ten of 20 physicians completed the worksheet at least once during the study. Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm, while LDL was 2.1 and 2.0, respectively. Thus, no significant differences were observed across groups in the primary outcomes, but mean haemoglobin A1c was lower in the feedback plus worksheet arm (7.2% versus 7.4%, p<0.001). Improvements in both arms were noted over time for one-half of the process outcomes.
Discussion
Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes. The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention.
Trial registration
ClinicalTrials.gov NCT00996645
doi:10.1186/1748-5908-8-142
PMCID: PMC3878579  PMID: 24341511
16.  Clinical stakeholders’ opinions on the use of selective decontamination of the digestive tract in critically ill patients in intensive care units: an international Delphi study 
Critical Care  2013;17(6):R266.
Introduction
Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic regimen that is not widely used in practice. We aimed to describe the opinions of key ‘stakeholders’ about the validity of the existing evidence base, likely consequences of implementation, relative importance of their opinions in influencing overall practice, likely barriers to implementation and perceptions of the requirement for further research to inform the decision about whether to embark on a further large randomised controlled trial.
Methods
This was a Delphi study informed by comprehensive framework of possible determinants of health professionals’ behaviour to study Critical Care practice in four countries. There were four key stakeholder participant groups including ICU physicians, pharmacists, clinical leads, and clinical microbiologists/ infectious disease physicians. Round one comprised participant interviews and Rounds two and three were online questionnaires using Delphi method.
Results
In this study, 141 participants were recruited of whom 82% were retained. Participants rated themselves as knowledgeable about SDD. Antibiotic resistance was identified as the most important issue. SDD was seen as a low clinical priority but few participants reported strong opposition. There was moderate agreement that research to date has not adequately addressed concerns about antibiotic resistance and lacks generalizability. Participants indicated equipoise with regard to benefits and harms of SDD, and indicated strong support for a further randomised trial.
Conclusions
Clinicians have clinical equipoise about the effectiveness of SDD. Future research requires longer follow up to assess antibiotic resistance as well as greater validity/generalizability to provide definitive answers on the effectiveness of decontamination and effects on antibiotic resistance. SDD was regarded as not being a high clinical priority, which may limit future trial participation. These results have identified that further large randomised controlled trial of SDD in critical care is both warranted and appropriate.
doi:10.1186/cc13096
PMCID: PMC4056354  PMID: 24207137
17.  Evidence-based care of older people with suspected cognitive impairment in general practice: protocol for the IRIS cluster randomised trial 
Background
Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers.
Aims
This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs’ (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial).
Methods
The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs’ detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In addition to receipt of the printed guideline, practitioners in the intervention group will be invited to participate in an interactive, opinion leader-led, educational face-to-face workshop. The theory-informed intervention aims to address identified barriers to and enablers of implementation of recommendations. Researchers responsible for identifying the cohort of patients with suspected cognitive impairment, and their detection and diagnosis outcomes, will be blind to group allocation.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN12611001032943 (date registered 28 September, 2011).
doi:10.1186/1748-5908-8-91
PMCID: PMC3765181  PMID: 23958469
18.  ‘Help for Hay Fever’, a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial 
Trials  2013;14:217.
Background
Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based ‘goal-focused’ intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT).
Methods/Design
A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants’ experiences during the trial will be collected to inform the future RCT.
Discussion
This work will lay the foundations for a definitive RCT of a community pharmacy-based ‘goal-focused’ self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013.
Trial registration
Current Controlled Trials ISRCTN43606442
doi:10.1186/1745-6215-14-217
PMCID: PMC3721993  PMID: 23856015
Respiratory; Allergy; Community pharmacy; Self-care
19.  Evaluation of a Theory-Informed Implementation Intervention for the Management of Acute Low Back Pain in General Medical Practice: The IMPLEMENT Cluster Randomised Trial 
PLoS ONE  2013;8(6):e65471.
Introduction
This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice.
Methods
General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation.
Results
47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan.
Conclusions
The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour.
Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN012606000098538
doi:10.1371/journal.pone.0065471
PMCID: PMC3681882  PMID: 23785427
20.  Active ingredients are reported more often for pharmacologic than non-pharmacologic interventions: an illustrative review of reporting practices in titles and abstracts 
Trials  2013;14:146.
Key components of healthcare interventions include ‘active ingredients’ (intervention components that can be specifically linked to effects on outcomes such that, were they omitted, the intervention would be ineffective). These should be reported in titles and abstracts of published reports of randomized controlled trials (RCTs). However, reporting of non-pharmacologic interventions (NPIs), particularly behaviour change interventions (BCIs), is difficult, owing to their complexity. This illustrative review compares how pharmacologic interventions (PIs), NPIs and BCIs are specified in titles and abstracts to clarify how reporting of NPIs and BCIs can be improved. MEDLINE and Embase were searched for RCTs published in the British Medical Journal, The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and Annals of Behavioral Medicine from 2009 to March 2011. All types of intervention, participant and outcome were included. A random sample of 198 studies (sampled proportionally from included journals) stratified by intervention type (PI/NPI) was taken: 98 evaluated PIs, 96 evaluated NPIs and four evaluated both. Studies were coded for the presence or absence of key components. The frequency data were analyzed using the chi-square test. Active ingredients were named in 88% titles and 95% abstracts of PI reports, and in 51% titles and 71% abstracts of NPI reports, with a significant association between intervention type and reporting of active ingredients in titles (χ2(1) = 28.90; P < 0.001) and abstracts (χ2(1) = 16.94; P < 0.001). Active ingredients were named in BCI reports in 37% titles and 56% abstracts, and in other NPI reports in 66% titles and 86% abstracts. There was also a significant association between intervention type and reporting of active ingredients in titles (χ2(1) = 6.68; P = 0.010) and abstracts (χ2(1) = 8.66; P = 0.003). Reporting practices also differed for such components as the trial setting and intervention provider. This review highlights the need for improved reporting of NPIs (particularly BCIs) and indicates that a set of agreed labels and definitions for complex NPIs could facilitate standardized reporting. This would ensure that interventions can be faithfully replicated and that evidence for interventions can be appropriately synthesized.
doi:10.1186/1745-6215-14-146
PMCID: PMC3663666  PMID: 23688143
Active ingredients; Behaviour change interventions; Complex interventions; Illustrative review; Non-pharmacologic interventions; Pharmacologic interventions; Reporting standards
21.  Specifying content and mechanisms of change in interventions to change professionals’ practice: an illustration from the Good Goals study in occupational therapy 
Background
It is widely agreed that interventions to change professionals’ practice need to be clearly specified. This involves (1) selecting and defining the intervention techniques, (2) operationalising the techniques and deciding their delivery, and (3) formulating hypotheses about the mechanisms through which the techniques are thought to result in change. Descriptions of methods to achieve these objectives are limited. This paper reports methods and illustrates outputs from a study to meet these objectives, specifically from the Good Goals study to improve occupational therapists’ caseload management practice.
Methods
(1) Behaviour change techniques were identified and selected from an existing matrix that maps techniques to determinants. An existing coding manual was used to define the techniques. (2) A team of occupational therapists generated context-relevant, acceptable modes of delivery for the techniques; these data were compared and contrasted with previously collected data, literature on caseload management, and the aims of the intervention. (3) Hypotheses about the mechanisms of change were formulated by drawing on the matrix and on theories of behaviour change.
Results
(1) Eight behaviour change techniques were selected: goal specified; self-monitoring; contract; graded tasks; increasing skills (problem solving, decision making, goal setting); coping skills; rehearsal of relevant skills; social processes of encouragement, support, and pressure; demonstration by others; and feedback. (2) A range of modes of delivery were generated (e.g., graded tasks’ consisting of series of clinical cases and situations that become increasingly difficult). Conditions for acceptable delivery were identified (e.g., ‘self-monitoring’ was acceptable only if delivered at team level). The modes of delivery were specified as face-to-face training, task sheets, group tasks, DVDs, and team-based weekly meetings. (3) The eight techniques were hypothesized to target caseload management practice through eleven mediating variables. Three domains were hypothesized to be most likely to change: beliefs about capabilities, motivation and goals, and behavioural regulation.
Conclusions
The project provides an exemplar of a systematic and reportable development of a quality-improvement intervention, with its methods likely to be applicable to other projects. A subsequent study of the intervention has provided early indication that use of systematic methods to specify interventions may help to maximize acceptability and effectiveness.
doi:10.1186/1748-5908-7-100
PMCID: PMC3502268  PMID: 23078918
Complex interventions; Developing interventions; Behaviour change; Professionals’ practice; Goal setting; Occupational therapy
22.  A cross-country comparison of intensive care physicians’ beliefs about their transfusion behaviour: A qualitative study using the theoretical domains framework 
Background
Evidence of variations in red blood cell transfusion practices have been reported in a wide range of clinical settings. Parallel studies in Canada and the United Kingdom were designed to explore transfusion behaviour in intensive care physicians. The aim of this paper is three-fold: first, to explore beliefs that influence Canadian intensive care physicians’ transfusion behaviour; second, to systematically select relevant theories and models using the Theoretical Domains Framework (TDF) to inform a future predictive study; and third, to compare its results with the UK study.
Methods
Ten intensive care unit (ICU) physicians throughout Canada were interviewed. Physicians’ responses were coded into theoretical domains, and specific beliefs were generated for each response. Theoretical domains relevant to behaviour change were identified, and specific constructs from the relevant domains were used to select psychological theories. The results from Canada and the United Kingdom were compared.
Results
Seven theoretical domains populated by 31 specific beliefs were identified as relevant to the target behaviour. The domains Beliefs about capabilities (confident to not transfuse if patients’ clinical condition is stable), Beliefs about consequences (positive beliefs of reducing infection and saving resources and negative beliefs about risking patients’ clinical outcome and potentially more work), Social influences (transfusion decision is influenced by team members and patients’ relatives), and Behavioural regulation (wide range of approaches to encourage restrictive transfusion) that were identified in the UK study were also relevant in the Canadian context. Three additional domains, Knowledge (it requires more evidence to support restrictive transfusion), Social/professional role and identity (conflicting beliefs about not adhering to guidelines, referring to evidence, believing restrictive transfusion as professional standard, and believing that guideline is important for other professionals), and Motivation and goals (opposing beliefs about the importance of restrictive transfusion and compatibility with other goals), were also identified in this study. Similar to the UK study, the Theory of Planned Behaviour, Social Cognitive Theory, Operant Learning Theory, Action Planning, and Knowledge-Attitude-Behaviour model were identified as potentially relevant theories and models for further study. Personal project analysis was added to the Canadian study to explore the Motivation and goals domain in further detail.
Conclusions
A wide range of beliefs was identified by the Canadian ICU physicians as likely to influence their transfusion behaviour. We were able to demonstrate similar though not identical results in a cross-country comparison. Designing targeted behaviour-change interventions based on unique beliefs identified by physicians from two countries are more likely to encourage restrictive transfusion in ICU physicians in respective countries. This needs to be tested in future prospective clinical trials.
doi:10.1186/1748-5908-7-93
PMCID: PMC3527303  PMID: 22999460
23.  Learning curves, taking instructions, and patient safety: using a theoretical domains framework in an interview study to investigate prescribing errors among trainee doctors 
Background
Prescribing errors are a major source of morbidity and mortality and represent a significant patient safety concern. Evidence suggests that trainee doctors are responsible for most prescribing errors. Understanding the factors that influence prescribing behavior may lead to effective interventions to reduce errors. Existing investigations of prescribing errors have been based on Human Error Theory but not on other relevant behavioral theories. The aim of this study was to apply a broad theory-based approach using the Theoretical Domains Framework (TDF) to investigate prescribing in the hospital context among a sample of trainee doctors.
Method
Semistructured interviews, based on 12 theoretical domains, were conducted with 22 trainee doctors to explore views, opinions, and experiences of prescribing and prescribing errors. Content analysis was conducted, followed by applying relevance criteria and a novel stage of critical appraisal, to identify which theoretical domains could be targeted in interventions to improve prescribing.
Results
Seven theoretical domains met the criteria of relevance: “social professional role and identity,” “environmental context and resources,” “social influences,” “knowledge,” “skills,” “memory, attention, and decision making,” and “behavioral regulation.” From critical appraisal of the interview data, “beliefs about consequences” and “beliefs about capabilities” were also identified as potentially important domains. Interrelationships between domains were evident. Additionally, the data supported theoretical elaboration of the domain behavioral regulation.
Conclusions
In this investigation of hospital-based prescribing, participants’ attributions about causes of errors were used to identify domains that could be targeted in interventions to improve prescribing. In a departure from previous TDF practice, critical appraisal was used to identify additional domains that should also be targeted, despite participants’ perceptions that they were not relevant to prescribing errors. These were beliefs about consequences and beliefs about capabilities. Specifically, in the light of the documented high error rate, beliefs that prescribing errors were not likely to have consequences for patients and that trainee doctors are capable of prescribing without error should also be targeted in an intervention. This study is the first to suggest critical appraisal for domain identification and to use interview data to propose theoretical elaborations and interrelationships between domains.
doi:10.1186/1748-5908-7-86
PMCID: PMC3546877  PMID: 22967756
Prescribing; Patient safety; Theoretical domains framework
24.  Identifying factors likely to influence compliance with diagnostic imaging guideline recommendations for spine disorders among chiropractors in North America: a focus group study using the Theoretical Domains Framework 
Background
The Theoretical Domains Framework (TDF) was developed to investigate determinants of specific clinical behaviors and inform the design of interventions to change professional behavior. This framework was used to explore the beliefs of chiropractors in an American Provider Network and two Canadian provinces about their adherence to evidence-based recommendations for spine radiography for uncomplicated back pain. The primary objective of the study was to identify chiropractors’ beliefs about managing uncomplicated back pain without x-rays and to explore barriers and facilitators to implementing evidence-based recommendations on lumbar spine x-rays. A secondary objective was to compare chiropractors in the United States and Canada on their beliefs regarding the use of spine x-rays.
Methods
Six focus groups exploring beliefs about managing back pain without x-rays were conducted with a purposive sample. The interview guide was based upon the TDF. Focus groups were digitally recorded, transcribed verbatim, and analyzed by two independent assessors using thematic content analysis based on the TDF.
Results
Five domains were identified as likely relevant. Key beliefs within these domains included the following: conflicting comments about the potential consequences of not ordering x-rays (risk of missing a pathology, avoiding adverse treatment effects, risks of litigation, determining the treatment plan, and using x-ray-driven techniques contrasted with perceived benefits of minimizing patient radiation exposure and reducing costs; beliefs about consequences); beliefs regarding professional autonomy, professional credibility, lack of standardization, and agreement with guidelines widely varied ( social/professional role & identity); the influence of formal training, colleagues, and patients also appeared to be important factors ( social influences); conflicting comments regarding levels of confidence and comfort in managing patients without x-rays ( belief about capabilities); and guideline awareness and agreements ( knowledge).
Conclusions
Chiropractors’ use of diagnostic imaging appears to be influenced by a number of factors. Five key domains may be important considering the presence of conflicting beliefs, evidence of strong beliefs likely to impact the behavior of interest, and high frequency of beliefs. The results will inform the development of a theory-based survey to help identify potential targets for behavioral-change strategies.
doi:10.1186/1748-5908-7-82
PMCID: PMC3444898  PMID: 22938135
Theoretical domains framework; Focus groups; Content analysis; Social/professional role and identity; Social influence; Chiropractors; Radiography; X-ray guidelines; Back pain
25.  Using shared goal setting to improve access and equity: a mixed methods study of the Good Goals intervention in children’s occupational therapy 
Background
Access and equity in children’s therapy services may be improved by directing clinicians’ use of resources toward specific goals that are important to patients. A practice-change intervention (titled ‘Good Goals’) was designed to achieve this. This study investigated uptake, adoption, and possible effects of that intervention in children’s occupational therapy services.
Methods
Mixed methods case studies (n = 3 services, including 46 therapists and 558 children) were conducted. The intervention was delivered over 25 weeks through face-to-face training, team workbooks, and ‘tools for change’. Data were collected before, during, and after the intervention on a range of factors using interviews, a focus group, case note analysis, routine data, document analysis, and researchers’ observations.
Results
Factors related to uptake and adoptions were: mode of intervention delivery, competing demands on therapists’ time, and leadership by service manager. Service managers and therapists reported that the intervention: helped therapists establish a shared rationale for clinical decisions; increased clarity in service provision; and improved interactions with families and schools. During the study period, therapists’ behaviours changed: identifying goals, odds ratio 2.4 (95% CI 1.5 to 3.8); agreeing goals, 3.5 (2.4 to 5.1); evaluating progress, 2.0 (1.1 to 3.5). Children’s LoT decreased by two months [95% CI −8 to +4 months] across the services. Cost per therapist trained ranged from £1,003 to £1,277, depending upon service size and therapists’ salary bands.
Conclusions
Good Goals is a promising quality improvement intervention that can be delivered and adopted in practice and may have benefits. Further research is required to evaluate its: (i) impact on patient outcomes, effectiveness, cost-effectiveness, and (ii) transferability to other clinical contexts.
doi:10.1186/1748-5908-7-76
PMCID: PMC3444894  PMID: 22898191

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