Telemonitoring in Chronic Obstructive Pulmonary Disease (CHROMED). A Randomized Clinical Trial.

RATIONALE: Early detection of chronic obstructive pulmonary disease (COPD) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization. OBJECTIVES: To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities. METHODS: This multicenter, randomized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grades II to IV COPD (median age, 71 yr [interquartile range, 66-76 yr]; 49.6% grade II, 50.4% grades III-IV), with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity. Patients were randomized to usual care (n = 158) or telemonitoring (n = 154) and followed for 9 months. All telemonitoring patients self-assessed lung mechanics daily, and in a subgroup with congestive heart failure (n = 37) cardiac parameters were also monitored. An algorithm identified deterioration, triggering a telephone contact to determine appropriate interventions. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were time to first hospitalization (TTFH) and change in the EuroQoL EQ-5D utility index score. Secondary outcomes included: rate of antibiotic/corticosteroid prescription; hospitalization; the COPD Assessment Tool, Patient Health Questionnaire-9, and Minnesota Living with Heart Failure questionnaire scores; quality-adjusted life years; and healthcare costs. Telemonitoring did not affect TTFH, EQ-5D utility index score, antibiotic prescriptions, hospitalization rate, or questionnaire scores. In an exploratory analysis, telemedicine was associated with fewer repeat hospitalizations (-54%; P = 0.017). CONCLUSIONS: In older patients with COPD and comorbidities, remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ-5D. Clinical trial registered with www.clinicaltrials.gov (NCT 01960907).

Perceptions on use of home telemonitoring in patients with long term conditions - concordance with the Health Information Technology Acceptance Model: a qualitative collective case study.

BACKGROUND: Health information technology (HIT) may be used to improve care for increasing numbers of older people with long term conditions (LTCs) who make high demands on health and social care services. Despite its potential benefits for reducing disease exacerbations and hospitalisations, HIT home monitoring is not always accepted by patients. Using the Health Information Technology Acceptance Model (HITAM) this qualitative study examined the usefulness of the model for understanding acceptance of HIT in older people (≥60 years) participating in a RCT for older people with Chronic Obstructive Pulmonary Disease (COPD) and associated heart diseases (CHROMED). METHODS: An instrumental, collective case study design was used with qualitative interviews of patients in the intervention arm of CHROMED. These were conducted at two time points, one shortly after installation of equipment and again at the end of (or withdrawal from) the study. We used Framework Analysis to examine how well the HITAM accounted for the data. RESULTS: Participants included 21 patients aged between 60-99 years and their partners or relatives where applicable. Additional concepts for the HITAM for older people included: concerns regarding health professional access and attachment; heightened illness anxiety and desire to avoid continuation of the 'sick-role'. In the technology zone, HIT self-efficacy was associated with good organisational processes and informal support; while ease of use was connected to equipment design being suitable for older people. HIT perceived usefulness was related to establishing trends in health status, detecting early signs of infection and potential to self-manage. Due to limited feedback to users opportunities to self-manage were reduced. CONCLUSIONS: HITAM helped understand the likelihood that older people with LTCs would use HIT, but did not explain how this might result in improved self-management. In order to increase HIT acceptance among older people, equipment design and organisational factors need to be considered. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01960907 October 9 2013 (retrospectively registered) Clinical tRials fOr elderly patients with MultiplE Disease (CHROMED). Start date October 2012, end date March 2016. Date of enrolment of the first participant was February 2013.

Comparison of coronary heart disease genetic assessment with conventional cardiovascular risk assessment in primary care: reflections on a feasibility study.

AIM: This study assesses the feasibility of collecting genetic samples and self-reported outcome measures after cardiovascular risk assessment, and presenting the genetic test results to participants. BACKGROUND: Coronary heart disease (CHD) genetic tests are increasingly available through direct-to-consumer marketing, but their potential clinical impact on cardiovascular risk assessment is unclear. METHODS: Observational study in 10 British general practices in Central England. A total of 320 individuals, who had completed conventional cardiovascular risk assessment, were offered CHD genetic test, with follow-up outcome questionnaire at eight months for lifestyle change and State-Trait Anxiety. FINDINGS: A total of 119 (37%) participants returned genetic test specimens, with over a third reporting family history of CHD in a specified relative; 79 (66.4%) were categorized above-average risk on conventional cardiovascular risk assessment, 65 of whom (82.3%) were only average risk on genetic assessment. The dietary fat questionnaire was poorly completed while study participation was not associated with increased anxiety (mean increase in anxiety score=2.1; 95% CI -0.1-4.3; P=0.06). CONCLUSION: As a feasibility study, over a third of individuals offered genetic testing in primary care, as part of CVD risk assessment, took up the offer. Although intervention did not appear to increase anxiety, this needs further evaluation. To improve generalizability and effect size, future studies should actively engage individuals from wider socio-economic backgrounds who may not have already contemplated lifestyle change. The current research suggests general practitioners will face the clinical challenge of patients presenting with direct-to-consumer genetic results that are inconsistent with conventional cardiovascular risk assessment.

Patients' and clinicians' experiences and perceptions of the primary care management of insomnia: qualitative study.

BACKGROUND: Insomnia is common leading to patients with sleep problems often presenting to primary care services including general practice, community pharmacies and community mental health teams. Little is known about how health professionals in primary care respond to patients with insomnia. AIM: We aimed to explore health professionals' and patients' experiences and perceptions of the management of insomnia in primary care. DESIGN: We used a qualitative design and thematic approach. SETTING: Primary care in Nottinghamshire and Lincolnshire. METHOD: We undertook focus groups and one-to-one interviews with a purposive sample of health professionals and adults with insomnia. RESULTS: We interviewed 28 patients and 23 health professionals. Practitioners focused on treating the cause of insomnia rather than the insomnia itself. They described providing stepped care for insomnia, but this focused on sleep hygiene which patients often disregarded, rather than cognitive behavioural therapy for insomnia (CBT-I). Practitioners were ambivalent towards hypnotic drugs but often colluded with patients to prescribe to avoid confrontation or express empathy. Patients sometimes took hypnotics in ways that were not intended, for example together with over-the-counter medication. Practitioners and patients were sometimes but not always concerned about addiction. Practitioners sometimes prescribed despite these concerns but at other times withdrew hypnotics abruptly without treating insomnia. Both patients and practitioners wanted more options and better training for the management of insomnia in primary care. CONCLUSION: A better understanding of the current approaches and difficulties in the management of insomnia will help to inform more therapeutic options and health professional training.

Introducing genetic testing for cardiovascular disease in primary care: a qualitative study.

BACKGROUND: While primary care systematically offers conventional cardiovascular risk assessment, genetic tests for coronary heart disease (CHD) are increasingly commercially available to patients. It is unclear how individuals may respond to these new sources of risk information. AIM: To explore how patients who have had a recent conventional cardiovascular risk assessment, perceive additional information from genetic testing for CHD. DESIGN AND SETTING: Qualitative interview study in 12 practices in Nottinghamshire from both urban and rural settings. METHOD: Interviews were conducted with 29 adults, who consented to genetic testing after having had a conventional cardiovascular risk assessment. RESULTS: Individuals' principal motivation for genetic testing was their family history of CHD and a desire to convey the results to their children. After testing, however, there was limited recall of genetic test results and scepticism about the value of informing their children. Participants dealt with conflicting findings from the genetic test, family history, and conventional assessment by either focusing on genetic risk or environmental lifestyle factors. In some participants, genetic test results appeared to reinforce healthy behaviour but others were falsely reassured, despite having an 'above-average' conventional cardiovascular risk score. CONCLUSION: Although genetic testing was acceptable, participants were unclear how to interpret genetic risk results. To facilitate healthy behaviour, health professionals should explore patients' understanding of genetic test results in light of their family history and conventional risk assessment.

Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration.

OBJECTIVES: To investigate the effectiveness of non-benzodiazepine hypnotics (Z drugs) and associated placebo responses in adults and to evaluate potential moderators of effectiveness in a dataset used to approve these drugs. DESIGN: Systematic review and meta-analysis. DATA SOURCE: US Food and Drug Administration (FDA). STUDY SELECTION: Randomised double blind parallel placebo controlled trials of currently approved Z drugs (eszopiclone, zaleplon, and zolpidem). DATA EXTRACTION: Change score from baseline to post-test for drug and placebo groups; drug efficacy analysed as the difference of both change scores. Weighted raw and standardised mean differences with their confidence intervals under random effects assumptions for polysomnographic and subjective sleep latency, as primary outcomes. Secondary outcomes included waking after sleep onset, number of awakenings, total sleep time, sleep efficiency, and subjective sleep quality. Weighted least square regression analysis was used to explain heterogeneity of drug effects. DATA SYNTHESIS: 13 studies containing 65 separate drug-placebo comparisons by type of outcome, type of drug, and dose were included. Studies included 4378 participants from different countries and varying drug doses, lengths of treatment, and study years. Z drugs showed significant, albeit small, improvements (reductions) in our primary outcomes: polysomnographic sleep latency (weighted standardised mean difference, 95% confidence interval -0.57 to -0.16) and subjective sleep latency (-0.33, -0.62 to -0.04) compared with placebo. Analyses of weighted mean raw differences showed that Z drugs decreased polysomnographic sleep latency by 22 minutes (-33 to -11 minutes) compared with placebo. Although no significant effects were found in secondary outcomes, there were insufficient studies reporting these outcomes to allow firm conclusions. Moderator analyses indicated that sleep latency was more likely to be reduced in studies published earlier, with larger drug doses, with longer duration of treatment, with a greater proportion of younger and/or female patients, and with zolpidem. CONCLUSION: Compared with placebo, Z drugs produce slight improvements in subjective and polysomnographic sleep latency, especially with larger doses and regardless of type of drug. Although the drug effect and the placebo response were rather small and of questionable clinical importance, the two together produced to a reasonably large clinical response.

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study.

BACKGROUND: Insomnia is a common psychological complaint. Cognitive behavioural therapy for insomnia (CBT-I), although effective, is little used because of lack of trained providers. Computerised CBT-I (CCBT-I) may be a solution to this shortfall in access. AIM: To explore patient and health professional perspectives and the role of social networking, to develop a novel CCBT-I programme to increase access to this form of intervention. DESIGN AND SETTING: Qualitative methods underpinned by the theory of planned behaviour in primary care in Lincolnshire and Nottinghamshire. METHOD: Semi-structured interviews and focus groups with a purposive sample of health professionals and adults with insomnia. RESULTS: A total of 23 health professionals and 28 patients were interviewed. Features designed to engender trust and improve functionality were perceived to improve uptake and adherence to CCBT-I. Trust lay in programme accreditation; for professionals, trust derived from evidence of effectiveness; for patients, trust depended on the doctor-patient relationship, professional support, the quality of online peer support, and perceptions of risk. Patients wanted mobile applications; access in short periods; self-assessment; interactive, personalised information on sleep; and moderated contact with other users. Patients and practitioners differed over whether useful information could be distinguished from less useful or potentially incorrect information. CONCLUSION: Improving uptake and adherence to online programmes for insomnia requires design features focusing on trust and functionality. Enabling greater patient control and interaction with other users and professionals may stimulate positive experiences of online therapy. CCBT-I would enable greater access to treatment but is limited by lack of online access or poor computer literacy.

Realising the potential of the family history in risk assessment and primary prevention of coronary heart disease in primary care: ADDFAM study protocol.

BACKGROUND: Coronary heart disease (CHD) is the leading cause of death in the developed world, and its prevention a core activity in current UK general practice. Currently, family history is not systematically integrated into cardiovascular risk assessment in the UK, Europe or the US. Further, primary health care professionals' lack the confidence to interpret family history information and there is a low level of recording of family history information in General Practice (GP) records. Primary prevention of CHD through lifestyle advice has sometimes yielded modest results although, for example, behavioural interventions targeted at "at risk" patients have produced encouraging findings. A family history approach, targeted at those requesting CHD assessment, could motivate lifestyle change. The project will assess the clinical value of incorporating systematic family history information into CHD risk assessment in primary care, from the perspective of the users of this service, the health care practitioners providing this service, and the National Health Service. METHODS/DESIGN: The study will include three distinct phases: (1) cross-sectional survey to ascertain baseline information on current recording of family information; (2) through an exploratory matched-pair cluster randomised study, with nested qualitative semi-structured interview and focus group study, to assess the impact of systematic family history recording on participants' and primary care professionals' experience; (3) develop an economic model of the costs and benefits of incorporating family history into CHD risk assessment. DISCUSSION: On completion of the project, users and primary care practitioners will be more informed of the value and utility of including family history in CHD risk assessment. Further, this approach will also act as a model of how familial risk information can be integrated within mainstream primary care preventive services for common chronic diseases. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17943542.

Drivers for change in primary care of diabetes following a protected learning time educational event: interview study of practitioners.

BACKGROUND: A number of protected learning time schemes have been set up in primary care across the United Kingdom but there has been little published evidence of their impact on processes of care. We undertook a qualitative study to investigate the perceptions of practitioners involved in a specific educational intervention in diabetes as part of a protected learning time scheme for primary health care teams, relating to changing processes of diabetes care in general practice. METHODS: We undertook semistructured interviews of key informants from a sample of practices stratified according to the extent they had changed behaviour in prescribing of ramipril and diabetes care more generally, following a specific educational intervention in Lincolnshire, United Kingdom. Interviews sought information on facilitators and barriers to change in organisational behaviour for the care of diabetes. RESULTS: An interprofessional protected learning time scheme event was perceived by some but not all participants as bringing about changes in processes for diabetes care. Participants cited examples of change introduced partly as a result of the educational session. This included using ACE inhibitors as first line for patients with diabetes who developed hypertension, increased use of aspirin, switching patients to glitazones, and conversion to insulin either directly or by referral to secondary care. Other reported factors for change, unrelated to the educational intervention, included financially driven performance targets, research evidence and national guidance. Facilitators for change linked to the educational session were peer support and teamworking supported by audit and comparative feedback. CONCLUSION: This study has shown how a protected learning time scheme, using interprofessional learning, local opinion leaders and early implementers as change agents may have influenced changes in systems of diabetes care in selected practices but also how other confounding factors played an important part in changes that occurred in practice.

Confidentiality in the waiting room: an observational study in general practice.

An ethnographic study using overt non-participatory observation was used to investigate confidentiality breaches in 13 GP practice reception and/or waiting areas in Lincolnshire. Staff and patient behaviours were observed for 2 hours. Aspects of management systems and physical environment were also thematically analysed. Forty-four instances occurred where patient-identifiable information was overheard. Of these instances, 22 were initiated by staff, 22 by patients, 33 face-to-face, and 10 from telephone conversations. Breaches included name and address, symptoms, conditions, or test results. Interaction between systems and physical environment in relation to 'attention focus', 'sound' and 'layout', increased the likelihood of breach of confidentiality. Further research on the patient perspective is recommended.

Are they really refusing to travel? A qualitative study of prehospital records.

BACKGROUND: Refusal by the patient to travel after calling an emergency ambulance may lead to a preventable waste of scarce resources if it can be shown that an alternative more appropriate response could be employed. A greater understanding is required of the reasons behind 'refusal to travel' (RTT) in order to find appropriate solutions to address this issue. We sought to investigate the reasons why patients refuse to travel following emergency call-out in a rural county. METHODS: Written records made by ambulance crews for patients (n = 397) who were not transported to hospital following an emergency call-out during October 2004 were retrospectively analysed. RESULTS: Twelve main themes emerged for RTT which included non injury or minor injury, falls and recovery after treatment on scene; other themes included alternative supervision, follow-up and treatment arrangements or patients arranging their own transport. Importantly, only 8% of the sample was recorded by ambulance crews as truly refusing to travel against advice. CONCLUSION: A system that facilitates standardised recording of RTT information including social reasons for non-transportation needs to be designed. 'Refused to travel' disclaimers need to reflect instances when crew and patient are satisfied that not going to hospital is the right outcome. These recommendations should be considered within the context of the plans for widening the role of ambulance services.

General practitioners, revalidation and appraisal: a cross sectional survey of attitudes, beliefs and concerns in Lincolnshire.

BACKGROUND: All general practitioners (GPs) are expected to have an appraisal from 2002 and the first cohort will experience revalidation in 2005. Although there is a link between appraisal and revalidation, this has yet to be clarified. OBJECTIVE: To investigate the knowledge, attitudes and beliefs of GPs towards revalidation and appraisal. DESIGN: Cross sectional survey. SETTING: Lincolnshire, UK. PARTICIPANTS: General practitioners. METHOD: In 2000 a self-administered postal questionnaire survey was sent to all 343 GP principals on the list of Lincolnshire Health Authority. The questionnaire consisted of 47 attitudinal statements on appraisal and revalidation. It also included open questions on concerns about appraisal and revalidation and questions on attributes of responders. RESULTS: Of the 343 GPs sent questionnaires, 272 (79%) replied. Lincolnshire GPs had more positive attitudes towards appraisal than towards revalidation. They welcomed appraisal provided that it had local ownership and took into account their views and concerns on the process. Other factors that correlated with a positive attitude towards appraisal included agreement that the purpose of appraisal is educational and that it should result in an agreed development plan. Those who had a positive view of appraisal were more likely to agree set objectives. Previous experience of appraisal either as an appraiser or appraisee was associated with a positive attitude towards appraisal. General practitioners who felt they had more control over the process tended to be more positive. General practitioners who were in favour of appraisal were also more likely to be in favour of revalidation and agree that appraisal formed part of the revalidation process. They were less likely to feel that there was a hidden agenda on the part of government and more likely to agree that revalidation would provide evidence of acceptable care being provided to patients. Time involved and lack of resources were the two main concerns. CONCLUSIONS: A better understanding of knowledge, beliefs and attitudes towards appraisal will ultimately help in setting up a successful appraisal system for GPs. The current emphasis on appraisal as an educational tool will help to foster positive attitudes. The relationship between appraisal and revalidation needs to be clarified. Concerns relating to lack of time and resources for appraisal and revalidation need to be addressed by primary care organisations.