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1.  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 
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.
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.
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.
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
PMCID: PMC4049486  PMID: 24886606
2.  Discriminant content validity of a theoretical domains framework questionnaire for use in implementation research 
To improve the implementation of innovations in healthcare settings, it is important to understand factors influencing healthcare professionals’ behaviors. We aimed to develop a generic questionnaire in English and in Dutch assessing the 14 domains of behavioral determinants from the revised TDF (Cane et al., 2012) that can be tailored to suit different targets, actions, contexts, and times of interest, and to investigate questionnaire items’ discriminant content validity.
We identified existing questionnaires including items assessing constructs within TDF domains and developed new items where needed. Nineteen judges allocated 79 items to one or more TDF domains. One-sample t-tests were used to examine the discriminant content validity of each item, i.e., whether items measured intended domains or whether items measured a combination of domains.
We identified items judged to discriminately measure 11 out of 14 domains. Items measuring the domains Reinforcement, Goals, and Behavioral regulation were judged to measure a combination of domains.
We have developed a questionnaire in English and in Dutch able to discriminately assess the majority of TDF domains. The results partly support Cane et al.’s (2012) 14-domain validation of the TDF and suggest that Michie et al.’s (2005) 12-domain original version might be more applicable in developing a TDF-based questionnaire. The identified items provide a robust basis for developing a questionnaire to measure TDF-based determinants of healthcare professionals’ implementation behaviors to suit different targets, actions, contexts, and times. Future research should investigate the concurrent and predictive validity and reliability of such a questionnaire in practice.
PMCID: PMC3896680  PMID: 24423394
Implementation; Theoretical domains framework; Discriminant content validity; Questionnaire development
3.  Correction: Diabetes Care Provision in UK Primary Care Practices 
PLoS ONE  2012;7(8):10.1371/annotation/1957ad3b-e192-4faa-bf4c-5dce22c5560e.
PMCID: PMC3414526
4.  Diabetes Care Provision in UK Primary Care Practices 
PLoS ONE  2012;7(7):e41562.
Although most people with Type 2 diabetes receive their diabetes care in primary care, only a limited amount is known about the quality of diabetes care in this setting. We investigated the provision and receipt of diabetes care delivered in UK primary care.
Postal surveys with all healthcare professionals and a random sample of 100 patients with Type 2 diabetes from 99 UK primary care practices.
326/361 (90.3%) doctors, 163/186 (87.6%) nurses and 3591 patients (41.8%) returned a questionnaire. Clinicians reported giving advice about lifestyle behaviours (e.g. 88% would routinely advise about calorie restriction; 99.6% about increasing exercise) more often than patients reported having received it (43% and 42%) and correlations between clinician and patient report were low. Patients’ reported levels of confidence about managing their diabetes were moderately high; a median (range) of 21% (3% to 39%) of patients reporting being not confident about various areas of diabetes self-management.
Primary care practices have organisational structures in place and are, as judged by routine quality indicators, delivering high quality care. There remain evidence-practice gaps in the care provided and in the self confidence that patients have for key aspects of self management and further research is needed to address these issues. Future research should use robust designs and appropriately designed studies to investigate how best to improve this situation.
PMCID: PMC3408463  PMID: 22859997
5.  Goal conflict, goal facilitation, and health professionals' provision of physical activity advice in primary care: An exploratory prospective study 
The theory of planned behaviour has well-evidenced utility in predicting health professional behaviour, but focuses on a single behaviour isolated from the numerous potentially conflicting and facilitating goal-directed behaviours performed alongside. Goal conflict and goal facilitation may influence whether health professionals engage in guideline-recommended behaviours, and may supplement the predictive power of the theory of planned behaviour. We hypothesised that goal facilitation and goal conflict contribute to predicting primary care health professionals' provision of physical activity advice to patients with hypertension, over and above predictors of behaviour from the theory of planned behaviour.
Using a prospective predictive design, at baseline we invited a random sample of 606 primary care health professionals from all primary care practices in NHS Grampian and NHS Tayside (Scotland) to complete postal questionnaires. Goal facilitation and goal conflict were measured alongside theory of planned behaviour constructs at baseline. At follow-up six months later, participants self-reported the number of patients, out of those seen in the preceding two weeks, to whom they provided physical activity advice.
Forty-four primary care physicians and nurses completed measures at both time points (7.3% response rate). Goal facilitation and goal conflict improved the prediction of behaviour, accounting for substantial additional variance (5.8% and 8.4%, respectively) in behaviour over and above intention and perceived behavioural control.
Health professionals' provision of physical activity advice in primary care can be predicted by perceptions about how their conflicting and facilitating goal-directed behaviours help and hinder giving advice, over and above theory of planned behaviour constructs. Incorporating features of multiple goal pursuit into the theory of planned behaviour may help to better understand health professional behaviour.
PMCID: PMC3224555  PMID: 21762486
6.  Instrument development, data collection, and characteristics of practices, staff, and measures in the Improving Quality of Care in Diabetes (iQuaD) Study 
Type 2 diabetes is an increasingly prevalent chronic illness and an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of primary care teams. This study aimed to: investigate theoretically-based organisational, team, and individual factors determining the multiple behaviours needed to manage diabetes; and identify multilevel determinants of different diabetes management behaviours and potential interventions to improve them. This paper describes the instrument development, study recruitment, characteristics of the study participating practices and their constituent healthcare professionals and administrative staff and reports descriptive analyses of the data collected.
The study was a predictive study over a 12-month period. Practices (N = 99) were recruited from within the UK Medical Research Council General Practice Research Framework. We identified six behaviours chosen to cover a range of clinical activities (prescribing, non-prescribing), reflect decisions that were not necessarily straightforward (controlling blood pressure that was above target despite other drug treatment), and reflect recommended best practice as described by national guidelines. Practice attributes and a wide range of individually reported measures were assessed at baseline; measures of clinical outcome were collected over the ensuing 12 months, and a number of proxy measures of behaviour were collected at baseline and at 12 months. Data were collected by telephone interview, postal questionnaire (organisational and clinical) to practice staff, postal questionnaire to patients, and by computer data extraction query.
All 99 practices completed a telephone interview and responded to baseline questionnaires. The organisational questionnaire was completed by 931/1236 (75.3%) administrative staff, 423/529 (80.0%) primary care doctors, and 255/314 (81.2%) nurses. Clinical questionnaires were completed by 326/361 (90.3%) primary care doctors and 163/186 (87.6%) nurses. At a practice level, we achieved response rates of 100% from clinicians in 40 practices and > 80% from clinicians in 67 practices. All measures had satisfactory internal consistency (alpha coefficient range from 0.61 to 0.97; Pearson correlation coefficient (two item measures) 0.32 to 0.81); scores were generally consistent with good practice. Measures of behaviour showed relatively high rates of performance of the six behaviours, but with considerable variability within and across the behaviours and measures.
We have assembled an unparalleled data set from clinicians reporting on their cognitions in relation to the performance of six clinical behaviours involved in the management of people with one chronic disease (diabetes mellitus), using a range of organisational and individual level measures as well as information on the structure of the practice teams and across a large number of UK primary care practices. We would welcome approaches from other researchers to collaborate on the analysis of this data.
PMCID: PMC3130687  PMID: 21658211
7.  Multiple goals and time constraints: perceived impact on physicians' performance of evidence-based behaviours 
Behavioural approaches to knowledge translation inform interventions to improve healthcare. However, such approaches often focus on a single behaviour without considering that health professionals perform multiple behaviours in pursuit of multiple goals in a given clinical context. In resource-limited consultations, performing these other goal-directed behaviours may influence optimal performance of a particular evidence-based behaviour. This study aimed to investigate whether a multiple goal-directed behaviour perspective might inform implementation research beyond single-behaviour approaches.
We conducted theory-based semi-structured interviews with 12 general medical practitioners (GPs) in Scotland on their views regarding two focal clinical behaviours--providing physical activity (PA) advice and prescribing to reduce blood pressure (BP) to <140/80 mmHg--in consultations with patients with diabetes and persistent hypertension. Theory-based constructs investigated were: intention and control beliefs from the theory of planned behaviour, and perceived interfering and facilitating influence of other goal-directed behaviours performed in a diabetes consultation. We coded interview content into pre-specified theory-based constructs and organised codes into themes within each construct using thematic analysis.
Most GPs reported strong intention to prescribe to reduce BP but expressed reasons why they would not. Intention to provide PA advice was variable. Most GPs reported that time constraints and patient preference detrimentally affected their control over providing PA advice and prescribing to reduce BP, respectively. Most GPs perceived many of their other goal-directed behaviours as interfering with providing PA advice, while fewer GPs reported goal-directed behaviours that interfere with prescribing to reduce BP. Providing PA advice and prescribing to reduce BP were perceived to be facilitated by similar diabetes-related behaviours (e.g., discussing cholesterol). While providing PA advice was perceived to be mainly facilitated by providing other lifestyle-related clinical advice (e.g., talking about weight), BP prescribing was reported as facilitated by pursuing ongoing standard consultation-related goals (e.g., clearly structuring the consultation).
GPs readily relate their other goal-directed behaviours with having a facilitating and interfering influence on their performance of particular evidence-based behaviours. This may have implications for advancing the theoretical development of behavioural approaches to implementation research beyond single-behaviour models.
PMCID: PMC2787492  PMID: 19941655
8.  Testing a TheoRY-inspired MEssage ('TRY-ME'): a sub-trial within the Ontario Printed Educational Message (OPEM) trial 
A challenge for implementation researchers is to develop principles that could generate testable hypotheses that apply across a range of clinical contexts, thus leading to generalisability of findings. Such principles may be provided by systematically developed theories. The opportunity has arisen to test some of these theoretical principles in the Ontario Printed Educational Materials (OPEM) trial by conducting a sub-trial within the existing trial structure. OPEM is a large factorial cluster-randomised trial evaluating the effects of short directive and long discursive educational messages embedded into informed, an evidence-based newsletter produced in Canada by the Institute for Clinical Evaluative Sciences (ICES) and mailed to all primary care physicians in Ontario. The content of educational messages in the sub-trial will be constructed using both standard methods and methods inspired by psychological theory. The aim of this study is to test the effectiveness of the TheoRY-inspired MEssage ('TRY-ME') compared with the 'standard' message in changing prescribing behaviour.
The OPEM trial participants randomised to receive the short directive message attached to the outside of informed (an 'outsert') will be sub-randomised to receive either a standard message or a message informed by the theory of planned behaviour (TPB) using a two (long insert or no insert) by three (theory-based outsert or standard outsert or no outsert) design. The messages will relate to prescription of thiazide diuretics as first line drug treatment for hypertension (described in the accompanying protocol, "The Ontario Printed Educational Materials trial"). The short messages will be developed independently by two research teams.
The primary outcome is prescription of thiazide diuretics, measured by routinely collected data available within ICES. The study is designed to answer the question, is there any difference in guideline adherence (i.e., thiazide prescription rates) between physicians in the six groups? A process evaluation survey instrument based on the TPB will be administered pre- and post-intervention (described in the accompanying protocol, "Looking inside the black box"). The second research question concerns processes that may underlie observed differences in prescribing behaviour. We expect that effects of the messages on prescribing behaviour will be mediated through changes in physicians' cognitions.
Trial registration number
Current controlled trial ISRCTN72772651
PMCID: PMC2216024  PMID: 18039363
9.  Looking inside the black box: a theory-based process evaluation alongside a randomised controlled trial of printed educational materials (the Ontario printed educational message, OPEM) to improve referral and prescribing practices in primary care in Ontario, Canada 
Randomised controlled trials of implementation strategies tell us whether (or not) an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths).
This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM) trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB) that incorporates these constructs.
We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial), in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use regression to explore the relationships between predictor and dependent variable (intention to advise diabetic patients to have annual retinopathy screening and to prescribe thiazide diuretics for first line treatment of uncomplicated hypertension). We will then compare groups using methods appropriate for comparing independent samples to determine whether there have been changes in the predicted constructs (attitudes, subjective norms, or intentions) across the study groups as hypothesised, and will assess the convergence between the process evaluation results and the main trial results.
Trial registration number
Current controlled trial ISRCTN72772651
PMCID: PMC2213685  PMID: 18039362
10.  Physicians' intentions and use of three patient decision aids 
Decision aids are evidence based tools that assist patients in making informed values-based choices and supplement the patient-clinician interaction. While there is evidence to show that decision aids improve key indicators of patients' decision quality, relatively little is known about physicians' acceptance of decision aids or factors that influence their decision to use them. The purpose of this study was to describe physicians' perceptions of three decision aids, their expressed intent to use them, and their subsequent use of them.
We conducted a cross-sectional survey of random samples of Canadian respirologists, family physicians, and geriatricians. Three decision aids representing a range of health decisions were evaluated. The survey elicited physicians' opinions on the characteristics of the decision aid and their willingness to use it. Physicians who indicated a strong likelihood of using the decision aid were contacted three months later regarding their actual use of the decision aid.
Of the 580 eligible physicians, 47% (n = 270) returned completed questionnaires. More than 85% of the respondents felt the decision aid was well developed and that it presented the essential information for decision making in an understandable, balanced, and unbiased manner. A majority of respondents (>80%) also felt that the decision aid would guide patients in a logical way, preparing them to participate in decision making and to reach a decision. Fewer physicians (<60%) felt the decision aid would improve the quality of patient visits or be easily implemented into practice and very few (27%) felt that the decision aid would save time. Physicians' intentions to use the decision aid were related to their comfort with offering it to patients, the decision aid topic, and the perceived ease of implementing it into practice. While 54% of the surveyed physicians indicated they would use the decision aid, less than a third followed through with this intention.
Despite strong support for the format, content, and quality of patient decision aids, and physicians' stated intentions to adopt them into clinical practice, most did not use them within three months of completing the survey. There is a wide gap between intention and behaviour. Further research is required to study the determinants of this intention-behaviour gap and to develop interventions aimed at barriers to physicians' use of decision aids.
PMCID: PMC1931587  PMID: 17617908

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