Intervention fidelity in primary care complex intervention trials: qualitative study using telephone interviews of patients and practitioners.

BACKGROUND: Treatment fidelity has previously been defined as the degree to which a treatment or intervention is delivered to participants as intended. Underreporting of fidelity in primary care randomised controlled trials (RCTs) of complex interventions reduces our confidence that findings are due to the treatment or intervention being investigated, rather than unknown confounders. AIM: We aimed to investigate treatment fidelity (for the purpose of this paper, hereafter referred to as intervention fidelity), of an educational intervention delivered to general practice teams and designed to improve the primary care management of insomnia. METHOD: We conducted telephone interviews with patients and practitioners participating in the intervention arm of the trial to explore trial fidelity. Qualitative analysis was undertaken using constant comparison and a priori themes (categories): 'adherence to the delivery of the intervention', 'patients received and understood intervention' and 'patient enactment'. RESULTS: If the intervention protocol was not adhered to by the practitioner then patient receipt, understanding and enactment levels were reduced. Recruitment difficulties in terms of the gap between initially being recruited into the study and attending an intervention consultation also reduced the effectiveness of the intervention. Patient attributes such as motivation to learn and engage contributed to the success of the uptake of the intervention. CONCLUSION: Qualitative methods using brief telephone interviews are an effective way of collecting the depth of data required to assess intervention fidelity. Intervention fidelity monitoring should be an important element of definitive trial design. TRIAL REGISTRATION: ClinicalTrials. gov id isrctn 55001433 - www.controlled-trials.com/isrctn55001433.

Strategies for improving patient recruitment to focus groups in primary care: a case study reflective paper using an analytical framework.

BACKGROUND: Recruiting to primary care studies is complex. With the current drive to increase numbers of patients involved in primary care studies, we need to know more about successful recruitment approaches. There is limited evidence on recruitment to focus group studies, particularly when no natural grouping exists and where participants do not regularly meet. The aim of this paper is to reflect on recruitment to a focus group study comparing the methods used with existing evidence using a resource for research recruitment, PROSPeR (Planning Recruitment Options: Strategies for Primary Care). METHODS: The focus group formed part of modelling a complex intervention in primary care in the Resources for Effective Sleep Treatment (REST) study. Despite a considered approach at the design stage, there were a number of difficulties with recruitment. The recruitment strategy and subsequent revisions are detailed. RESULTS: The researchers' modifications to recruitment, justifications and evidence from the literature in support of them are presented. Contrary evidence is used to analyse why some aspects were unsuccessful and evidence is used to suggest improvements. Recruitment to focus group studies should be considered in two distinct phases; getting potential participants to contact the researcher, and converting those contacts into attendance. The difficulty of recruitment in primary care is underemphasised in the literature especially where people do not regularly come together, typified by this case study of patients with sleep problems. CONCLUSION: We recommend training GPs and nurses to recruit patients during consultations. Multiple recruitment methods should be employed from the outset and the need to build topic related non-financial incentives into the group meeting should be considered. Recruitment should be monitored regularly with barriers addressed iteratively as a study progresses.

Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial.

BACKGROUND: Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. METHODS AND DESIGN: This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity) and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs). Clinicians randomised to the intervention will receive an educational intervention (2 x 2 hours) to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. DISCUSSION: Previous studies in adults have shown that psychological treatments for insomnia administered by specialist nurses to groups of patients can be effective within a primary care setting. This will be a pilot study to determine whether an educational intervention aimed at primary care teams to deliver problem focused therapy for insomnia can improve sleep management and outcomes for individual adult patients presenting to general practice. The study will also test procedures and collect information in preparation for a larger definitive cluster-randomised trial. The study is funded by The Health Foundation.

Magic bullets for insomnia? Patients' use and experiences of newer (Z drugs) versus older (benzodiazepine) hypnotics for sleep problems in primary care.

BACKGROUND: Little is known about patients' perceptions of newer hypnotics. AIM: To investigate use, experience, and perceptions of Z drug and benzodiazepine hypnotics in the community. DESIGN OF STUDY: Cross-sectional survey of general practice patients who had received at least one prescription for a Z drug or benzodiazepine in the previous 6 months. SETTING: Lincolnshire, UK. METHOD: Self-administered postal questionnaire. RESULTS: Of 1600 surveys posted, 935 (58.4%) responses were received, of which 705 (75.4%) were from patients taking drugs for insomnia. Of those 705 patients, 87.9% (n = 620) were first prescribed a hypnotic by their GP, and 94.9% (n = 669) had taken a sleeping tablet for 4 weeks or more. At least one side effect was reported in 41.8% (n = 295); 18.6% wished to come off hypnotic medication; and 48.5% had tried to stop treatment. Patients on Z drugs were more likely to express a wish to stop (22.7% versus 12.3%; odds ratio [OR] = 1.67, 95% confidence interval [CI] = 1.13 to 2.49), or to have attempted to come off medication, than those on benzodiazepines (52.4% versus 41.0%; OR = 1.54, 95% CI = 1.12 to 2.12). The two groups did not differ significantly in respect of benefits or adverse effects. CONCLUSION: There were no significant differences in patients' perceptions of efficacy or side-effects reported by those on Z drugs compared to patients taking benzodiazepines. Side-effects were commonly reported, which may have contributed to a high proportion of responders, particularly patients on Z drugs who were wishing to stop, or who had previously tried to stop taking this medication. Reported prescribing practices were often at variance with the licence for short-term use.

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.

Patients' and clinicians' experiences of consultations in primary care for sleep problems and insomnia: a focus group study.

BACKGROUND: Insomnia affects around one-third of adults in the UK. Many sufferers seek help from primary care. AIM: To explore patients' and primary care practitioners' expectations, experiences, and outcomes of consultations for sleep difficulties, as a basis for improving the treatment of insomnia in primary care. DESIGN OF STUDY: A qualitative phenomenological approach. METHOD: Separate focus groups for GPs and nurse prescribers and patients recruited from eight general practices that were in a quality improvement collaborative. Constant comparative analysis was used. RESULTS: Emergent themes from 14 focus groups comparing participating patients (n = 30) and practitioners (n = 15), provided insights on presentation, beliefs, expectations, and management of sleep problems. Patients initially tried to resolve insomnia themselves; consulting was often a last resort. Patients felt they needed to convince practitioners that their sleep difficulties were serious. They described insomnia in terms of the impact it was having on their life, whereas clinicians tended to focus on underlying causes. By the time patients consulted, many expected a prescription. Clinicians often assumed this was what patients wanted, and felt this would hamper patients' ability to take non-drug treatments seriously. Clinicians expected patients who were already on sleeping tablets to be resistant to stopping them, whereas patients were often open to alternatives. CONCLUSION: Better management of insomnia should take into account the perceptions and interactions of patients and practitioners. Practitioners need to empathise, listen, elicit patients' beliefs and expectations, assess sleep better, and offer a range of treatments, including cognitive and behavioural therapies, tailored to individual needs. Practitioner education should incorporate understanding of patients' decision-making processes, the clinicians' role during the consultation, and how to negotiate and deliver strategies for resolving sleep problems.

General practitioners' preferences for managing insomnia and opportunities for reducing hypnotic prescribing.

RATIONALE, AIMS AND OBJECTIVES: Insomnia and sleep problems are common with many sufferers seeking medical help from general practitioners (GPs) whose clinical response is limited, often involving prescription of hypnotic drugs. The case for improving the quality of care for patients with insomnia is compelling but there is little evidence about how better care could be achieved in a primary care setting. The aim of this study was to investigate GPs' management preferences for sleep problems and their awareness and perception of opportunities for improving care as well as reducing the use of benzodiazepines and Z drugs. METHODS: Cross-sectional survey of GPs using a self-administered postal questionnaire in 2005 to all GPs in West Lincolnshire Primary Care Trust Lincolnshire, UK. RESULTS: A total of 84 of 107 (78.5%) questionnaires sent to GP principals were returned after one reminder. Respondents favoured Z drugs over benzodiazepines for the majority of indications. Respondent attitudes to benzodiazepines and Z drugs were generally negative whereas they were positive towards initiatives to reduce hypnotic prescribing through personal guidance, awareness-raising strategies and organizational interventions. CONCLUSIONS: GPs were negative in attitude towards hypnotics and positive towards reducing prescribing for sleep problems. They need to develop resources and better strategies for assessment and non-pharmacological management of patients presenting with insomnia for the first time as well as those on long-term hypnotics. The feasibility and effectiveness of psychosocial interventions tailored to patient and service needs in primary care setting should be evaluated systematically seeking to understand potential clinical benefits as well as potential undesirable effects of service changes.