Cluster randomised controlled trial of a theory-based multiple behaviour change intervention aimed at healthcare professionals to improve their management of type 2 diabetes in primary care.

BACKGROUND: National diabetes audits in the UK show room for improvement in the quality of care delivered to people with type 2 diabetes in primary care. Systematic reviews of quality improvement interventions show that such approaches can be effective but there is wide variability between trials and little understanding concerning what explains this variability. A national cohort study of primary care across 99 UK practices identified modifiable predictors of healthcare professionals' prescribing, advising and foot examination. Our objective was to evaluate the effectiveness of an implementation intervention to improve six guideline-recommended health professional behaviours in managing type 2 diabetes in primary care: prescribing for blood pressure and glycaemic control, providing physical activity and nutrition advice and providing updated diabetes education and foot examination. METHODS: Two-armed cluster randomised trial involving 44 general practices. Primary outcomes (at 12 months follow-up): from electronic medical records, the proportion of patients receiving additional prescriptions for blood pressure and insulin initiation for glycaemic control and having a foot examination; and from a patient survey of a random sample of 100 patients per practice, reported receipt of updated diabetes education and physical activity and nutrition advice. RESULTS: The implementation intervention did not lead to statistically significant improvement on any of the six clinical behaviours. 1,138,105 prescriptions were assessed. Intervention (29% to 37% patients) and control arms (31% to 35%) increased insulin initiation relative to baseline but were not statistically significantly different at follow-up (IRR 1.18, 95%CI 0.95-1.48). Intervention (45% to 53%) and control practices (45% to 50%) increased blood pressure prescription from baseline to follow-up but were not statistically significantly different at follow-up (IRR 1.05, 95%CI 0.96 to 1.16). Intervention (75 to 78%) and control practices (74 to 79%) increased foot examination relative to baseline; control practices increased statistically significantly more (OR 0.84, 95%CI 0.75-0.94). Fewer patients in intervention (33%) than control practices (40%) reported receiving updated diabetes education (OR = 0.74, 95%CI 0.57-0.97). No statistically significant differences were observed in patient reports of having had a discussion about nutrition (intervention = 73%; control = 72%; OR = 0.98, 95%CI 0.59-1.64) or physical activity (intervention = 57%; control = 62%; OR = 0.79, 95%CI 0.56-1.11). Development and delivery of the intervention cost £1191 per practice. CONCLUSIONS: There was no measurable benefit to practices' participation in this intervention. Despite widespread use of outreach interventions worldwide, there is a need to better understand which techniques at which intensity are optimally suited to address the multiple clinical behaviours involved in improving care for type 2 diabetes. TRIAL REGISTRATION: ISRCTN, ISRCTN66498413 . Registered April 4, 2013.

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.

Reflective and automatic processes in health care professional behaviour: a dual process model tested across multiple behaviours.

BACKGROUND: Clinicians' behaviours require deliberate decision-making in complex contexts and may involve both impulsive (automatic) and reflective (motivational and volitional) processes. PURPOSE: The purpose of this study was to test a dual process model applied to clinician behaviours in their management of type 2 diabetes. METHODS: The design used six nested prospective correlational studies. Questionnaires were sent to general practitioners and nurses in 99 UK primary care practices, measuring reflective (intention, action planning and coping planning) and impulsive (automaticity) predictors for six guideline-recommended behaviours: blood pressure prescribing (N = 335), prescribing for glycemic control (N = 288), providing diabetes-related education (N = 346), providing weight advice (N = 417), providing self-management advice (N = 332) and examining the feet (N = 218). RESULTS: Respondent retention was high. A dual process model was supported for prescribing behaviours, weight advice, and examining the feet. A sequential reflective process was supported for blood pressure prescribing, self-management and weight advice, and diabetes-related education. CONCLUSIONS: Reflective and impulsive processes predict behaviour. Quality improvement interventions should consider both reflective and impulsive approaches to behaviour change.

Theory-based predictors of multiple clinician behaviors in the management of diabetes.

UNLABELLED: Behavioral theory is often tested on one behavior in isolation from other behaviors and theories. We aimed to test the predictive validity of constructs from motivation and action theories of behavior across six diabetes-related clinician behaviors, within the same sample of primary care clinicians. Physicians and nurses (n = 427 from 99 practices in the United Kingdom) completed questionnaires at baseline and 12 months. PRIMARY OUTCOMES: six self-reported clinician behaviors related to advising, prescribing and examining measured at 12 months; secondary outcomes: baseline intention and patient-scenario-based simulated behavior. Across six behaviors, each theory accounted for a medium amount of variance for 12-month behavior (median R adj (2)  = 0.15), large and medium amount of variance for two intention measures (median R adj (2)  = 0.66; 0.34), and small amount of variance for simulated behavior (median R adj (2)  = 0.05). Intention/proximal goals, self-efficacy, and habit predicted all behaviors. Constructs from social cognitive theory (self-efficacy), learning theory (habit) and action and coping planning consistently predicted multiple clinician behaviors and should be targeted by quality improvement interventions.

Is organizational justice associated with clinical performance in the care for patients with diabetes in primary care? Evidence from the improving Quality of care in Diabetes study.

BACKGROUND: Type 2 diabetes is an increasingly prevalent illness, and there is considerable variation in the quality of care provided to patients with diabetes in primary care. OBJECTIVES: The aim of this study was to explore whether organizational justice and organizational citizenship behaviour are associated with the behaviours of clinical staff when providing care for patients with diabetes. METHODS: The data were from an ongoing prospective multicenter study, the 'improving Quality of care in Diabetes' (iQuaD) study. Participants (N = 467) were clinical staff in 99 primary care practices in the UK. The outcome measures were six self-reported clinical behaviours: prescribing for glycaemic control, prescribing for blood pressure control, foot examination, giving advice about weight management, providing general education about diabetes and giving advice about self-management. Organizational justice perceptions were collected using a self-administered questionnaire. The associations between organizational justice and behavioural outcomes were tested using linear multilevel regression modelling. RESULTS: Higher scores on the procedural component of organizational justice were associated with more frequent weight management advice, self-management advice and provision of general education for patients with diabetes. The associations between justice and clinical behaviours were not explained by individual or practice characteristics, but evidence was found for the partial mediating role of organizational citizenship behaviour. CONCLUSIONS: Quality improvement efforts aimed at increasing advice and education provision in diabetes management in primary care could target also perceptions of procedural justice.

Diabetes care provision in UK primary care practices.

BACKGROUND: 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. METHODS: Postal surveys with all healthcare professionals and a random sample of 100 patients with Type 2 diabetes from 99 UK primary care practices. RESULTS: 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. CONCLUSIONS: 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.

A cluster randomised trial of educational messages to improve the primary care of diabetes.

BACKGROUND: Regular laboratory test monitoring of patient parameters offers a route for improving the quality of chronic disease care. We evaluated the effects of brief educational messages attached to laboratory test reports on diabetes care. METHODS: A programme of cluster randomised controlled trials was set in primary care practices in one primary care trust in England. Participants were the primary care practices' constituent healthcare professionals and patients with diabetes. Interventions comprised brief educational messages added to paper and electronic primary care practice laboratory test reports and introduced over two phases. Phase one messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control, and foot inspection. Main outcome measures comprised practice mean HbA1c and cholesterol levels, diastolic and systolic BP, and proportions of patients having undergone foot inspections. RESULTS: Initially, 35 out of 37 eligible practices participated. Outcome data were available for a total of 8,690 patients with diabetes from 32 practices. The BP message produced a statistically significant reduction in diastolic BP (-0.62 mmHg; 95% confidence interval -0.82 to -0.42 mmHg) but not systolic BP (-0.06 mmHg, -0.42 to 0.30 mmHg) and increased the odds of achieving target BP control (odds ratio 1.05; 1.00, 1.10). The foot inspection message increased the likelihood of a recorded foot inspection (incidence rate ratio 1.26; 1.18 to 1.36). The glycaemic control message had no effect on mean HbA1c (increase 0.01%; -0.03 to 0.04) despite increasing the odds of a change in likelihood of HbA1c tests being ordered (OR 1.06; 1.01, 1.11). The cholesterol message had no effect (decrease 0.01 mmol/l, -0.04 to 0.05). CONCLUSIONS: Three out of four interventions improved intermediate outcomes or process of diabetes care. The diastolic BP reduction approximates to relative reductions in mortality of 3% to 5% in stroke and 3% to 4% in ischaemic heart disease over 10 years. The lack of effect for other outcomes may, in part, be explained by difficulties in bringing about further improvements beyond certain thresholds of clinical performance. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN2186314.

Instrument development, data collection, and characteristics of practices, staff, and measures in the Improving Quality of Care in Diabetes (iQuaD) Study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. DISCUSSION: 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.

Maternal complications in diabetic pregnancy.

Pregnant women with diabetes have to manage both the effect of pregnancy on glucose control and its effect on pre-existing diabetic complications. Most women experience hypoglycaemia as a consequence of tightened glycaemic control and this impacts on daily living. Less commonly, diabetic ketoacidosis, a serious metabolic decompensation of diabetic control and a medical emergency, can cause foetal and maternal mortality. Microvascular complications of diabetes include retinopathy and nephropathy. Retinopathy can deteriorate during pregnancy; hence, regular routine examination is required and, if indicated, ophthalmological input. Diabetic nephropathy significantly increases the risk of obstetric complications and impacts on foetal outcomes. Pregnancy outcome is closely related to pre-pregnancy renal function. Diabetic pregnancy is contraindicated if the maternal complications of ischaemic heart disease or diabetic gastropathy are known to be present before pregnancy as there is a significant maternal mortality associated with both of these conditions.

Improving the delivery of care for patients with diabetes through understanding optimised team work and organisation in primary care.

BACKGROUND: Type 2 diabetes is an increasingly prevalent chronic illness and is an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of the primary care team. Studies of the quality of care for patients with diabetes suggest less than optimum care in a number of areas. AIM: The aim of this study is to improve the quality of care for patients with diabetes cared for in primary care in the UK by identifying individual, team, and organisational factors that predict the implementation of best practice. DESIGN: Participants will be clinical and non-clinical staff within 100 general practices sampled from practices who are members of the MRC General Practice Research Framework. Self-completion questionnaires will be developed to measure the attributes of individual health care professionals, primary care teams (including both clinical and non-clinical staff), and their organisation in primary care. Questionnaires will be administered using postal survey methods. A range of validated theories will be used as a framework for the questionnaire instruments. Data relating to a range of dimensions of the organisational structure of primary care will be collected via a telephone interview at each practice using a structured interview schedule. We will also collect data relating to the processes of care, markers of biochemical control, and relevant indicator scores from the quality and outcomes framework (QOF). Process data (as a proxy indicator of clinical behaviours) will be collected from practice databases and via a postal questionnaire survey of a random selection of patients from each practice. Levels of biochemical control will be extracted from practice databases. A series of analyses will be conducted to relate the individual, team, and organisational data to the process, control, and QOF data to identify configurations associated with high quality care. STUDY REGISTRATION: UKCRN ref:DRN120 (ICPD).

A cluster randomised controlled trial of educational prompts in diabetes care: study protocol.

BACKGROUND: Laboratory services have a central role in supporting screening, diagnosis, and management of patients. The increase in chronic disease management in primary care for conditions such as diabetes mellitus requires regular monitoring of patients' biochemical parameters. This process offers a route for improving the quality of care that patients receive by using test results as a vehicle for delivering educational messages as well as the test result itself. AIM: To develop and evaluate the effectiveness of a quality improvement initiative to improve the care of patients with diabetes using test report reminders. DESIGN: A programme of four cluster randomised controlled trials within one population of general practices. PARTICIPANTS: General practices in Newcastle-upon-Tyne, UK. INTERVENTION: Brief educational messages added to paper and electronic general practice laboratory test reports introduced over two phases. Phase One messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase Two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control and foot inspection. OUTCOMES: General practice mean levels of HbA1c and cholesterol (Phase One) and diastolic and systolic BP and proportions of patients having undergone foot inspections (Phase Two); number of tests requested.

A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial.

BACKGROUND: Following the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide 'extended,' computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines. METHODS: The study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations. RESULTS: Patients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91), to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21), have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29), and have a recording of blood pressure (BP) (OR 2.14, 95% CI 1.06, 4.36). There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06). There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these. CONCLUSION: This study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN32042030.

Rapid assessment methods used for health-equity audit: diabetes mellitus among frail British care-home residents.

BACKGROUND: To perform a health-equity audit of diabetes care among elderly care-home residents. STUDY DESIGN: Health-need assessment using rapid-evaluation methods. SETTING: Residents of care homes in Newcastle upon Tyne, UK. PARTICIPANTS: All care-home residents in the city. OUTCOME MEASURES FOR DIABETES: To carry out health-need assessment, agree partners and issues, assess equity profile, and to agree high-impact local action to narrow the gap, according to the guidance on health-equity audit provided by the Department of Health. RESULTS: A combination of qualitative and quantitative methods were used to develop a methodology to complete the health-need assessment component of the health-equity audit. A number of criteria for an appropriate standard of care, and how the current service met these standards, were reported in a timely fashion to the primary care trust. The domains comprised national standards for care, diabetes prevalence, adequacy of coverage and standard of care delivered, and environment, including availability of equipment and knowledge and attitudes of care staff. The output was structured to identify a number of key issues: the diabetes register under-represents the number of cases of known diabetes mellitus (3.5% vs. 11.5%); weights and blood-pressure measurements were incorporated into the care-home environment; this population had inappropriately high rates of glucose monitoring, secondary care involvement and little evidence of co-ordinated eye screening; and staff needed training for diabetes care, which they recognized. Finally, recommendations were agreed for the immediate response and a local action plan agreed to narrow the health gap. CONCLUSIONS: It is feasible to use rapid-evaluation methodologies to initiate a health-equity audit of current diabetes services for care-home residents in a large health district, informing the primary care trust about health equity for this vulnerable group of patients. The tools developed can be used again to inform the iterative process of health-equity audit in the future. We would recommend the use of these methods and similar combined qualitative/quantitative techniques as valuable alternatives for a health-equity audit in the absence of extensive databases on which to assess health equity.

Preconception care in diabetes.

Preconception care is key to improving the outcome of diabetic pregnancy. Despite evidence showing that preconception care reduces congenital malformation in the offspring of diabetic mothers, most women do not plan their pregnancies with their diabetes team. Issues around managing this complex behaviour include the quality of the relationship with health care providers and the woman's health care beliefs. The elements of good preconception care have recently been defined, but there are problems around access to preconception services. There is a small number of preconception services within England, Wales and Northern Ireland; provision of these services needs to be increased if the goal set by the NSF for diabetes is to be achieved.

A randomised controlled trial of a patient based Diabetes Recall and Management System: the DREAM trial: a study protocol [ISRCTN32042030].

BACKGROUND: Whilst there is broad agreement on what constitutes high quality health care for people with diabetes, there is little consensus on the most efficient way of delivering it. Structured recall systems can improve the quality of care but the systems evaluated to date have been of limited sophistication and the evaluations have been carried out in small numbers of relatively unrepresentative settings. Hartlepool, Easington and Stockton currently operate a computerised diabetes register which has to date produced improvements in the quality of care but performance has now plateaued leaving substantial scope for further improvement. This study will evaluate the effectiveness and efficiency of an area wide 'extended' system incorporating a full structured recall and management system, actively involving patients and including clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines. METHODS: The study design is a two-armed cluster randomised controlled trial of 61 practices incorporating evaluations of the effectiveness of the system, its economic impact and its impact on patient wellbeing and functioning.