Brigitte Colwell

Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice

Objective To determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT). Design A cluster RCT. Setting 49 general practices in UK randomised into intervention (n=25) and control (n=24). Participants General practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy. Exclusion criteria: currently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and analysis. Intervention Brief training of clinicians and use of PDA with patients in single consultation. Primary outcomes Decision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c). Secondary outcomes Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications. Results Intervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of ‘hypo’, ‘weight gain’, ‘complications’; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups. Conclusions Use of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice. ISRCTN Trials Register Number 14842077.

Is it cost effective to introduce paramedic practitioners for older people to the ambulance service? Results of a cluster randomised controlled trial.

Background: A scheme to train paramedics to undertake a greater role in the care of older people following a call for an emergency ambulance was developed in a large city in the UK. Objectives: To assess the cost effectiveness of the paramedic practitioner (PP) scheme compared with usual emergency care. Methods: A cluster randomised controlled trial was undertaken of PP compared with usual care. Weeks were allocated to the study group at random to the PP scheme either being active (intervention) or inactive (control). Resource use data were collected from routine sources, and from patient-completed questionnaires for events up to 28 days. EQ-5D data were also collected at 28 days. Results: Whereas the intervention group received more PP contact time, it reduced the proportion of emergency department (ED) attendances (53.3% vs 84.0%) and time in the ED (126.6 vs 211.3 minutes). There was also some evidence of increased use of health services in the days following the incident for patients in the intervention group. Overall, total costs in the intervention group were £140 lower when routine data were considered (p = 0.63). When the costs and QALY were considered simultaneously, PP had a greater than 95% chance of being cost effective at £20 000 per QALY. Conclusion: Several changes in resource use are associated with the use of PP. Given these economic results in tandem with the clinical, operational and patient-related benefits, the wider implementation and evaluation of similar schemes should be considered.

Developing a method to identify medicines non-adherence in a community sample of adults with epilepsy.

The aim is to propose a simple way of identifying patients at risk of antiepileptic drug (AED) non-adherence during epilepsy review (a scheduled consultation to review the patient and their condition). The use of a multi-modal approach to the problem of non-adherence is necessary because of the limitations of existing methods. A mixed methodology was developed in a nested study using a case record review to calculate the medicine possession ratio (MPR) from the AED medication records of a community sample, a literature review and a consensus panel to develop a questionnaire to address how people manage their epilepsy, particularly medicine management, and how to collect information about non-adherence through stated findings in keeping with non-adherent behavior. Results show that a medicine record can be used to estimate the MPR (<80% indicates non-adherence) and that an open and non-confrontational consultation style can be fostered by using key questions within the consultation to identify those at risk of non-adherence.

An initiative to provide emergency healthcare for older people in the community: the impact on carers

The increase in the size and age of the UK older population has had a major effect on emergency services. Many older people will visit the emergency department but not necessarily require significant clinical intervention. The Paramedic Practitioner in Older Peoples Support (PPOPS) scheme was set up to provide community-based clinical assessment of older patients contacting the emergency services with minor acute conditions as an alternative approach to emergency department transfer. Patient carers were followed-up to evaluate the impact of this scheme when compared with standard transfer to the emergency department. Postal questionnaires, including items on the level of care provided, satisfaction with care received and carer impact, were administered to 561 carers. The overall response rate was 71.5% (401/561). The carers were predominantly female, approximately 60 years of age and family members, with more than three-quarters providing some form of physical care before the patient episode. Overall, carers did report an increase in the level of care provided before episode, significantly more so in the emergency department group (p=0.003). These increases related to more input needed in supporting physical activities. The carers in the PPOPS group were more likely to report greater satisfaction with their impression of care and staff attitude and would prefer treatment at home for the patient than those in the emergency department group (p<0.001). A minor health event does impact on the life of a carer. However, community-based schemes, such as PPOPS, do not increase the burden on carers and have high levels of satisfaction among this important group of the community.

Levels of distress in breast cancer survivors approaching discharge from routine hospital follow-up

Hospital‐based breast cancer follow‐up provides reassurance to patients despite limited evidence for clinical efficacy. Although alternative models of hospital/community‐based follow‐up have yielded encouraging results, traditional hospital follow‐up continues to be offered to all patients. Survival rates continue to rise; consequently, more patients are likely to require support, as many have a limited understanding of the long‐term physical and emotional consequences of cancer and its treatment. We examine levels of psychological distress in breast cancer patients in follow‐up 2 years or more from diagnosis.

Sudden Unexpected Death in Epilepsy: Addressing the Challenges

Epilepsy is associated with a higher rate of premature death than the general population, and the commonest cause of epilepsy mortality is sudden unexpected death in epilepsy (SUDEP). It is difficult to quantify because of the variable reporting of this cause of death. Death occurs due to autonomic deregulation of cardio-respiratory pathways as a result of seizures. Measures to reduce cardio-respiratory dysfunction are discussed together with the importance of seizure control in preventing SUDEP. The role of seizure detection devices, antiepileptic drugs and the importance of providing information about SUDEP to people with epilepsy are highlighted. There is increasing interest in SUDEP and some current initiatives are discussed.

Improving recruitment to primary care trials: some lessons from the use of modern marketing techniques

Successful recruitment to primary care studies is critical if high quality research is to be undertaken and if the research findings are to be representative of the population being researched.1 However, a recent survey of UK primary care trials found that problems with recruitment was the norm; for example, over half of the trials reported in one study ran past their recruitment timetable or had to seek additional funding to complete their data collection.2 Non-completion of studies is costly both in economic terms as well as in participants’ time. It is discouraging to the participation of primary care professionals in research if it is perceived that completion of a trial is both difficult and a potential waste of their resources. Non-completion can also increase the reluctance of funders to support primary care research.3–5 In an effort to facilitate primary care research, the National Institute for Health Research (NIHR) Primary Care Research Network (PCRN) was set up in 2006. One of its key aims is to provide local researchers with the means to achieve better recruitment into primary care studies.6 Since the PCRN’s inception, it has become clear that there is not a ‘one size fits all’ recruitment strategy. There are marked differences between the approaches adopted by academia and industry to trial recruitment: in industry, practices may be treated as a ‘research substrate’ rather than as ‘active partners’ (the NIHR approach) and are generally offered financial incentives for each individual patient recruited.7 Other differences include a greater emphasis on marketing and communication strategies by industry and recognition of the need to create a ‘strong identity’ for the study, reinforced by project material that has a ‘strong visual impact’.6 As the demand on general practice time grows, there is the real risk that …

Investigating active ingredients in a complex intervention: A nested study within the Patient and Decision Aids (PANDAs) randomised controlled trial for people with type 2 diabetes

BackgroundRandomised trials provide evidence that patient decision aids improve outcomes with respect to patient knowledge, involvement and satisfaction in decision making. It is less clear how these complex interventions are implemented within patient-clinician interactions and which components are active for improving decision processes. To investigate the experiences of using a diabetes treatment decision aid and to explore how components within a complex intervention influenced the decision making process.MethodsA pragmatic mixed methods study nested within the PANDAs cluster randomised trial of a patient decision aid. Themes inductively derived from interviews and observation of consultations with further triangulation with results of decision quality and involvement measurements and case analyses.ResultsThe decision aid intervention was employed flexibly within the consultation with both the patient and clinician active in marshalling elements. The decision aid improved processing and organization of information needed for decision making within the consultation interaction. It also improved decision quality by preparing the patient for active involvement within the clinical consultation.ConclusionThe intervention was acceptable, flexible and readily implemented in primary care consultations. The decision aid was effective in facilitating cognitive processing. The intervention also facilitated rehearsal in preparation for active roles in a shared decision process.Trial registrationTrials Register Number: ISRCTN14842077. Date registered: 24.06.2010.

A ‘combined framework’ approach to developing a patient decision aid: the PANDAs model

BackgroundThere is a lack of practical research frameworks to guide the development of patient decision aids [PtDAs]. This paper described how a PtDA was developed using the International Patient Decision Aids (IPDAS) guideline and UK Medical Research Council (UKMRC) frameworks to support patients when making treatment decisions in type 2 diabetes mellitus.MethodsThis study used mixed methods to develop a PtDA for use in a UK general practice setting. A 10-member expert panel was convened to guide development and patients and clinicians were also interviewed individually using semi-structured interview guides to identify their decisional needs. Current literature was reviewed systematically to determine the best available evidence. The Ottawa Decision Support Framework was used to guide the presentation of the information and value clarification exercise. An iterative draft-review-revise process by the research team and review panel was conducted until the PtDA reached content and format `saturation’. The PtDA was then pilot-tested by users in actual consultations to assess its acceptability and feasibility. The IPDAS and UKMRC frameworks were used throughout to inform the development process.ResultsThe PANDAs PtDA was developed systematically and iteratively. Patients and clinicians highlighted the needs for information, decisional, emotional and social support, which were incorporated into the PtDA. The literature review identified gaps in high quality evidence and variations in patient outcome reporting. The PtDA comprised five components: background of the treatment options; pros and cons of each treatment option; value clarification exercise; support needs; and readiness to decide.ConclusionsThis study has demonstrated the feasibility of combining the IPDAS and the UKMRC frameworks for the development and evaluation of a PtDA. Future studies should test this model for developing PtDAs across different decisions and healthcare contexts.