Primary palliative care research: opportunities and challenges.

INTRODUCTION: Primary care has a central role in palliative and end of life care: 45.6% of deaths in England and Wales occur under the care of primary care teams at home or in care homes. The Community Care Pathways at the End of Life (CAPE) study investigated primary care provided for patients in the final 6 months of life. This paper highlights the opportunities and challenges associated with primary palliative care research in the UK, describing the methodological, ethical, logistical and gatekeeping challenges encountered in the CAPE study and how these were addressed. THE STUDY METHODS: Using a mixed-methods approach, quantitative data were extracted from the general practitioner (GP) and district nurse (DN) records of 400 recently deceased patients in 20 GP practices in the East of England. Focus groups were conducted with some GPs and DNs, and individual interviews held with bereaved carers and other GPs and DNs. THE CHALLENGES ADDRESSED: Considerable difficulties were encountered with ethical permissions, with GP, DN and bereaved carer recruitment and both quantitative and qualitative data collection. These were overcome with flexibility of approach, perseverance of the research team and strong user group support. This enabled completion of the study which generated a unique primary palliative care data set.

Are Nurses and Auxiliary Healthcare Workers Equally Effective in Delivering Smoking Cessation Support in Primary Care?

INTRODUCTION: Smoking cessation support is increasingly delivered in primary care by auxiliary healthcare workers in place of healthcare professionals. However, it is unknown whether this shift might affect the quality and impact of the support delivered. METHODS: Data from the iQuit in Practice randomized control trial of cessation support in General Practice was used (N = 602). Analyses assessed whether cessation advisor type (nurse or healthcare assistant [HCA]) was associated with abstinence (primary outcome: self-reported 2-week point prevalence abstinence at 8 weeks follow-up), the advice delivered during the initial consultation, pharmacotherapies prescribed, patient satisfaction, initial consultation length, and the number and type of interim contacts. RESULTS: There were no statistically significant differences in abstinence for support delivered by HCAs versus nurses at 8 weeks (HCAs 42.8%, nurses 42.6%; unadjusted odds ratio [OR] = 1.01, 95% confidence interval [CI] = 0.73 to 1.40), or at 4 weeks or 6 months follow-up. There were no statistically significant differences in advice delivered, the types of pharmacotherapies prescribed or patient satisfaction. Compared with nurses, HCA consultations were longer on average (HCAs 23.6 minutes, nurses 20.8 minutes; P = .002) and they undertook more interim contacts (HCAs median 2, nurses median 1; P < .001), with contact more likely to be face-to-face than phone call (HCAs 91.2%, nurses 70.9%; OR = 4.23, 95% CI = 2.86 to 6.26). CONCLUSIONS: HCAs appear equally effective as nurses in supporting smoking cessation, although they do this with greater patient contact. Using auxiliary practitioners to deliver cessation support could free up nurse time and reduce costs. IMPLICATIONS: This study found that primary care patients receiving smoking cessation support from auxiliary healthcare workers were just as likely to be abstinent up to 6 months later as those patients seen by nurses. While the auxiliary healthcare workers achieved this with slightly increased patient contact time, the advice delivered, pharmacotherapies provided and patient satisfaction were similar to that of nurses. Expanding the auxiliary healthcare worker role to include smoking cessation support could increase role satisfaction and reduce the costs of cessation support delivery in primary care.

Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study).

BACKGROUND: Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked. METHODS: 211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded. RESULTS: Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients' action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group. CONCLUSIONS: It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects. TRIAL REGISTRATION: ISRCTN30522359.

Randomized controlled trial to assess the short-term effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care (iQuit in practice).

AIMS: To estimate the short-term effectiveness, feasibility and acceptability of a smoking cessation intervention (the iQuit system) that consists of tailored printed and Short Message Service (SMS) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial. DESIGN: A stratified two parallel-group randomized controlled trial comparing usual care (control) with usual care plus the iQuit system (intervention), delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence. SETTING: Thirty-two general practice (GP) surgeries in England, UK. PARTICIPANTS: A total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized (control n = 303, intervention n = 299). MEASUREMENTS: Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up. Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date, 8 weeks and 6 months follow-up. FINDINGS: There were no significant between-group differences in the primary outcome [control 40.3%, iQuit 45.2%; odds ratio (OR) = 1.22, 95% confidence interval (CI) = 0.88-1.69] or in secondary short-term smoking outcomes. Six-month prolonged abstinence was significantly higher in the iQuit arm (control 8.9%, iQuit 15.1%; OR = 1.81, 95% CI = 1.09-3.01). iQuit support took on average 7.7 minutes (standard deviation = 4.0) to deliver and 18.9% (95% CI = 14.8-23.7%) of intervention participants discontinued the text message support during the programme. CONCLUSIONS: Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence, but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone.

Does electronic monitoring influence adherence to medication? Randomized controlled trial of measurement reactivity.

BACKGROUND: Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence. PURPOSE: To test the reactive effect of electronic monitoring in a randomized controlled trial. METHODS: A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5-25) and HbA1c at 8 weeks. RESULTS: Non-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI -0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), -1.02 [-2.73 to 0.71, p = 0.25]). CONCLUSIONS: Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359).

Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care.

BACKGROUND: Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker's mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone. METHODS/DESIGN: The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking. DISCUSSION: This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness. TRIAL REGISTRATION: ISRCTN56702353.

Tinkering and tailoring individual consultations: how practice nurses try to make cardiovascular risk communication meaningful.

AIMS AND OBJECTIVES: To explore the perspectives of practice nurses in their role of communicating cardiovascular risk to patients. BACKGROUND: Nurses in primary care have for some time been engaged in cardiovascular risk discussions with patients. With the recent introduction of the NHS Health Checks, the focus on this work is set to increase. DESIGN: Qualitative using a framework approach. METHODS: Two focus groups and 16 semi-structured interviews were conducted with nurses purposively sampled from those working in primary care. RESULTS: The nurses' accounts revealed the need to develop a relationship of trust and establish a level of relevance with each individual patient whilst discussing cardiovascular risk. Potential aspects of these discussions were as follows: working within a highly structured data-collecting task; time constraints and consideration of the individual's context. We used the idea of tailoring to describe how nurses navigate and constantly modify and pitch their approach for each patient they see in response to these constraints. CONCLUSION: We suggest that in order for risk to be made meaningful to patients, practice nurses recognise the need for such information to be embedded in the more reciprocal dynamics of nurse-patient consultations. From their perspective, success is often as much about not saying something, or saying it in a particular way, as saying anything accurately or consistently. RELEVANCE TO CLINICAL PRACTICE: For practice nurses to be instrumental in the successful delivery of health prevention policy initiatives such as the NHS Health Checks, it is important to acknowledge their views and perspectives in undertaking this work. This study suggests that the nurses recognised the need for further skills and a refinement of approach for those health professionals involved.

An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes.

BACKGROUND: Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes. METHODS: This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c ≥ 7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat. RESULTS: 211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction. CONCLUSIONS: This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice.

Involving practice nurses in primary care research: the experience of multiple and competing demands.

AIM: This paper is a report of a study of the experiences of practice nurses delivering a complex research intervention in an exploratory randomized controlled trial in primary care. BACKGROUND: As practice nurses increasingly become involved in primary care research, it is important to understand not only what impact this may have on their existing role but also equally on what their potential contribution might be. METHOD: Fourteen of the 15 practice nurses involved in the delivery of a complex intervention were purposively sampled and interviewed in their workplace between June and October 2007. Interviews were audio-recorded, transcribed and analysed using a Framework Approach and NVivo software. Findings. Time influenced the nurses' engagement with the various aspects of the trial and meant that they constantly had to make judgments and decisions in response to the multiple agendas presented to them: they had to negotiate a range of competing loyalties between their professional clinical role, their role in the research and practice teams and their relationship with patients. The nurses' accounts consequently provide insight into the active role they played both in the trial process and the delivery of the complex intervention. CONCLUSION: The nurses were key to the delivery of the trial. If practice nurses are to develop a research role in their professional work, it is important to understand their perceptions and the impact such involvement has on them and their practice. Consideration of these factors is consequently valuable when developing research in primary care settings.

Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care.

BACKGROUND: The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. METHODS/DESIGN: ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention-to-treat analysis of the effect of the intervention on these measures, an assessment of cost-effectiveness, and analyse predictors of behaviour change in the cohort. DISCUSSION: The ADDITION-Plus trial will establish the medium-term effectiveness and cost-effectiveness of adding an externally facilitated intervention tailored to support change in multiple behaviours among intensively-treated individuals with recently diagnosed type 2 diabetes in primary care. Results will inform policy recommendations concerning the management of patients early in the course of diabetes. Findings will also improve understanding of the factors influencing change in multiple behaviours, and their association with health outcomes.

UK research staff perspectives on improving recruitment and retention to primary care research; nominal group exercise.

BACKGROUND: Primary care studies often encounter recruitment difficulties, but there is little evidence to inform solutions. As part of a National Institute for Health Research School for Primary Care Research and UK Clinical Research Network programme, we elicited research staff perspectives on factors facilitating or obstructing recruitment. OBJECTIVE: To identify factors that experienced research staff consider important in successful recruitment and retention and their confidence in achieving them. METHODS: An iterative series of three workshops was held. The third used a modified nominal group technique to categorize whether factors related to the 'context' in which the research took place, the 'content' of the study or the recruitment 'process' and to prioritize them by their importance to success. RESULTS: Eighteen research staff participated in the prioritization workshop. They prioritized positive attitudes of primary care staff towards research and trust of researchers by potential participants as major contextual factors affecting recruitment. Studies needed to be considered safe and relevant by staff and fit with practice systems. They proposed that researchers strengthen relationships with staff and participants and minimize workload for primary care teams. Although confident in many recruitment processes, respondents remained uncertain how to achieve cultural change so that research became part of normal practice activity and how best to motivate patients to participate. CONCLUSIONS: Research workers taking part identified factors which might be important in recruitment, several of which they expressed little confidence in addressing. Understanding how to improve recruitment is crucial if current efforts to strengthen primary care research are to bear fruit.