Exploring How Patients Are Supported to Use Online Services in Primary Care in England Through "Digital Facilitation": Survey Study.

BACKGROUND: Health service policy in many jurisdictions is driving greater investment into digital primary care services. While some patients and practices may benefit, there are concerns that not all are able or wish to access primary care services online. "Digital facilitation" is the "range of processes, procedures, and personnel seeking to support patients in their uptake and use of online services" and may address such concerns. OBJECTIVE: As part of a multimethod research program, we undertook surveys of practice staff and patients to gain insight into the support being offered by practices and explore patients' experiences of this support. METHODS: General practices from 4 regions of England were sent a questionnaire exploring the modes of digital facilitation offered, the personnel involved in its delivery, and views on the motivations and drivers for providing support. Moreover, 12,822 patients registered with 62 general practices (predominantly those providing practice survey responses) were sent a questionnaire exploring their experiences of any support offered by their practice to use online services. RESULTS: Almost one-third of practices (156/500, 31.2%) responded to the practice survey, with most reporting using passive modes of digital facilitation (eg, display, leaflets, and SMS text messages) and few using active modes (eg, offering tablets or computers or using practice champions). However, 90.9% (130/143) reported providing ad hoc support. Practices agreed that it was the responsibility of both the practice (105/144, 72.9%) and the wider National Health Service (118/143, 82.5%) to support patients in using online services and that providing such support benefited the practice (126/144, 87.5%) and their patients (132/144, 91.7%). Nearly a quarter of the patients (3051/12,822, 23.8%) responded to the patient survey, with few (522/3051, 17.11% or less) reporting awareness of any modes of digital facilitation apart from text messages and emails (1205/3051, 39.5%) and only 13.36% (392/2935) reporting receiving support to use online services. Adjusted logistic regression analyses showed that older patients had a lower likelihood of 4 outcomes: being aware of, or of using, digital facilitation efforts, or being told about or being helped to use online services (all P<.05), particularly with regard to being helped to use online services (adjusted odds ratio for patients aged 85 years versus those aged 55-64 years: 0.08, 95% CI 0.02-0.36). However, ethnic minority participants or those for whom their first language was not English had positive associations with these outcomes. CONCLUSIONS: General practices recognize that patients would benefit from support to access online services. However, the support provided is often passive or ad hoc, and patients were seldom aware of digital facilitation efforts that their practice provided. There is potential to increase engagement with online primary care services by providing more support for all patients, particularly to provide targeted support for older patients.

Much more medicine for the oldest old: trends in UK electronic clinical records.

BACKGROUND: the oldest old (85+) pose complex medical challenges. Both underdiagnosis and overdiagnosis are claimed in this group. OBJECTIVE: to estimate diagnosis, prescribing and hospital admission prevalence from 2003/4 to 2011/12, to monitor trends in medicalisation. DESIGN AND SETTING: observational study of Clinical Practice Research Datalink (CPRD) electronic medical records from general practice populations (eligible; n = 27,109) with oversampling of the oldest old. METHODS: we identified 18 common diseases and five geriatric syndromes (dizziness, incontinence, skin ulcers, falls and fractures) from Read codes. We counted medications prescribed ≥1 time in all quarters of studied years. RESULTS: there were major increases in recorded prevalence of most conditions in the 85+ group, especially chronic kidney disease (stages 3-5: prevalence <1% rising to 36.4%). The proportions of the 85+ group with ≥3 conditions rose from 32.2 to 55.1% (27.1 to 35.1% in the 65-84 year group). Geriatric syndrome trends were less marked. In the 85+ age group the proportion receiving no chronically prescribed medications fell from 29.6 to 13.6%, while the proportion on ≥3 rose from 44.6 to 66.2%. The proportion of 85+ year olds with ≥1 hospital admissions per year rose from 27.6 to 35.4%. CONCLUSIONS: there has been a dramatic increase in the medicalisation of the oldest old, evident in increased diagnosis (likely partly due to better record keeping) but also increased prescribing and hospitalisation. Diagnostic trends especially for chronic kidney disease may raise concerns about overdiagnosis. These findings provide new urgency to questions about the appropriateness of multiple diagnostic labelling.

Any versus long-term prescribing of high risk medications in older people using 2012 Beers Criteria: results from three cross-sectional samples of primary care records for 2003/4, 2007/8 and 2011/12.

BACKGROUND: High risk medications are commonly prescribed to older US patients. Currently, less is known about high risk medication prescribing in other Western Countries, including the UK. We measured trends and correlates of high risk medication prescribing in a subset of the older UK population (community/institutionalized) to inform harm minimization efforts. METHODS: Three cross-sectional samples from primary care electronic clinical records (UK Clinical Practice Research Datalink, CPRD) in fiscal years 2003/04, 2007/08 and 2011/12 were taken. This yielded a sample of 13,900 people aged 65 years or over from 504 UK general practices. High risk medications were defined by 2012 Beers Criteria adapted for the UK. Using descriptive statistical methods and regression modelling, prevalence of 'any' (drugs prescribed at least once per year) and 'long-term' (drugs prescribed all quarters of year) high risk medication prescribing and correlates were determined. RESULTS: While polypharmacy rates have risen sharply, high risk medication prevalence has remained stable across a decade. A third of older (65+) people are exposed to high risk medications, but only half of the total prevalence was long-term (any = 38.4 % [95 % CI: 36.3, 40.5]; long-term = 17.4 % [15.9, 19.9] in 2011/12). Long-term but not any high risk medication exposure was associated with older ages (85 years or over). Women and people with higher polypharmacy burden were at greater risk of exposure; lower socio-economic status was not associated. Ten drugs/drug classes accounted for most of high risk medication prescribing in 2011/12. CONCLUSIONS: High risk medication prescribing has not increased over time against a background of increasing polypharmacy in the UK. Half of patients receiving high risk medications do so for less than a year. Reducing or optimising the use of a limited number of drugs could dramatically reduce high risk medications in older people. Further research is needed to investigate why the oldest old and women are at greater risk. Interventions to reduce high risk medications may need to target shorter and long-term use separately.

Why do GPs exclude patients from participating in research? An exploration of adherence to and divergence from trial criteria.

BACKGROUND: The role of GPs in recruiting or excluding participants critically underpins the feasibility, external validity and generalizability of primary care research. A better understanding of this role is needed. AIM: To investigate why GPs excluded potentially eligible participants from a large scale randomized controlled trial (RCT), to determine the proportion of patients excluded on account of trial eligibility compared with other reasons, and to explore the impact of such exclusions on the management and generalizability of RCTs. DESIGN AND SETTING: Secondary analysis of data from the CoBalT study, a multi-centre general-practice-based RCT investigating cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression. METHOD: GPs were asked to screen patient lists generated from computerized record searches for trial eligibility and to provide narrative reasons for excluding patients. These reasons were coded independently by two researchers, with a third researcher resolving discrepancies. RESULTS: Thirty-one percent (4750/15,379) of patients were excluded at the GP screening stage, including 663 on patient lists that remained unscreened. Of the 4087 actively excluded patients, 67% were excluded on account of trial exclusion criteria, 20% for other criteria (half of which were comorbid conditions) and 13% without reason. CONCLUSION: Clear, comprehensive criteria, particularly with regards to comorbidities, are required for GPs to confidently screen patients for potential participation in research. Future studies should promote inclusivity and encourage GPs to adopt a liberal approach when screening patient lists. This would enhance the validity and generalizability of primary care research and encourage greater patient autonomy.

What helps patients access web-based services in primary care? Free-text analysis of patient responses to the Di-Facto questionnaire.

BACKGROUND: The National Health Service (NHS) and general practice are increasingly adopting digital services. These services can impact both positively and negatively upon patient experiences, and access to digital services is not equal amongst all groups. Within a wider project examining digital facilitation (the Di-Facto study) our team conducted a patient survey amongst English primary care practices aiming to investigate patient views of what supports uptake and use of web-based services. This paper reports on the analysis of the free-text responses from the patient survey. METHODS: The Di-Facto patient survey was distributed to practices in eight clinical commissioning groups (CCGs) in England between 2021-2022. We examined free-text responses to two questions relating to access to primary care web-based and support for web-based services. We used qualitative reflexive thematic analysis based on a six-stage process to analyse responses. RESULTS: Of the 3051 patients who responded to the Di-Facto survey, 2246 provided a free-text response. We present our findings in two major themes: systems and structures and their impact on use of web-based services, and 'what works for me', a description of how respondents described what worked, or did not work in terms of their interactions with web-based services. Respondents described how the technology, such as poor practice website design, confusion over multiple digital apps, data security and concerns about eConsultation offerings impacted on use of web-based services. Respondents described practice level barriers, such as a lack of or inconsistent provision, which prevented optimal use of web-based services. Respondents described personal and technical barriers that impacted on their use of digital services, and described which web-based services worked well for them. Respondents felt that web-based services were not a replacement for face-to-face interactions with a doctor. CONCLUSIONS: This analysis of free-text responses from a large patient survey highlights the system, practice, and person level barriers and facilitators to use of digital services in primary care. With an increasing push towards digital solutions in NHS primary care, practices should consider the design, rollout and communication of their web-based services to support patient access.

Supporting patients with a mental health diagnosis to use online services in primary care. A qualitative interview study.

Objective: The increase in reliance on online services for general practice has the potential to increase inequalities within some populations. Patients with a mental health condition are one such group. Digital facilitation is defined as a range of processes, procedures, and people, which seek to support NHS patients in using online services. This study aimed to examine the views and experiences of digital facilitation in primary care amongst patients living with a mental health condition. Methods: Semi-structured interviews were conducted with patients living with a mental health condition, recruited from general practices across England participating in the Di-Facto study. Thematic analysis was conducted on interview transcripts. Results: Interviews were conducted with ten participants with a mental health condition, recruited from five general practices. Three themes were identified: (1) familiarity with online services; (2) experiences of those using online services; (3) the need for digital facilitation. The need for digital facilitation was identified in the registration for online services, and in trusting online services. Conclusions: Online services offer convenience for patients, but registration for the use of such services remains a potential area of difficulty. Participants had difficulties with registering for online services and had concerns about trust in using them. Support offered by general practices in using online services needs to be varied and adaptable to meet the needs of individual patients.

Current experience and future potential of facilitating access to digital NHS primary care services in England: the Di-Facto mixed-methods study.

Background: Current National Health Service policy in England encourages enhanced digital access in primary care service provision. In this study, we investigate 'digital facilitation' - that range of processes, procedures and personnel which seeks to support National Health Service primary care patients in their uptake and use of online services. Objectives: Identify, characterise and explore the potential benefits and challenges associated with different models of digital facilitation currently in use in general practice which are aimed at improving patient access to online services in general practice in England. Use the resulting intelligence to design a framework for future evaluations of the effectiveness and cost effectiveness of such interventions. Explore how patients with mental health conditions experience digital facilitation and gauge their need for this support. Design: Observational mixed-methods study (literature review, surveys, ethnographic observation and interviews); formal synthesis of findings. Setting: General practice in four regions of England. Participants: Practice survey: 156 staff. Patient survey: 3051 patients. Mental health survey: 756 patients. General practitioner patient survey: 3 million responders. Ethnographic case-studies: 8 practices; interviews with 36 staff, 33 patients and 10 patients with a mental health condition. Stakeholder interviews: 19 participants. Intervention: Digital facilitation as undertaken in general practice. Main outcome measures: Patient and practice staff reported use of, and views of, digital facilitation. Data sources: Surveys, qualitative research; national General Practitioner Patient Survey (2019-22). Review methods: Scoping-review methodology applied to academic and grey literature published 2015-20. Results: While we did find examples of digital facilitation in routine practice, these often involved using passive or reactive modes of support. The context of COVID, and the necessary acceleration (at that time) of the move to a digital-first model of primary care, shaped the way digital facilitation was delivered. There was lack of clarity over where the responsibility for facilitation efforts lay; it was viewed as the responsibility of 'others'. Patients living with mental health conditions had similar needs and experiences regarding digital facilitation to other patients. Limitations: The context of the COVID pandemic placed limitations on the project. Fewer practices responded to the practice survey than anticipated; reconfiguration of general practices to support COVID measures was a key consideration during non-participant observation with social distancing and other measures still in place during fieldwork. Conclusions: Digital facilitation, while not a widely recognised concept, is important in supporting the move to a National Health Service with enhanced digital opportunities and enhanced digital access. General practice staff are allocating resources to provide such efforts in general practices in England. The establishment of clear lines of responsibility, the development of digital tools and platforms that work for patients and practice staff, and investment in staff time and training are needed if digital facilitation is to support the intended digital revolution. Future work: We did not find one single dominant or preferred model of digital facilitation which might reasonably be considered to form the basis of an intervention to be tested. Rather, there is a need to co-develop such an intervention with patients, general practice staff and relevant policy experts. We outline a framework for a future evaluation of such an intervention. Study registration: This study is registered as ResearchRegistry6523 (www.researchregistry.com/browse-the-registry#home/?view_2_search=Di-Facto&view_2_page=1) and PROSPERO CRD42020189019 (www.crd.york.ac.uk/prospero/display_record.php?RecordID=189019). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128268) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 32. See the NIHR Funding and Awards website for further award information.

Online services are common in the National Health Service. This research looked at 'digital facilitation' in general practices. Digital facilitation is about supporting National Health Service patients in their use of online services. We aimed to understand how much digital facilitation is being used by general practices. We also looked at how digital facilitation happens and if it affects the number of people using online services. We looked at previous research to help us understand what approaches have been used to support patients to use online services. We used surveys to ask staff at general practices what they were already doing, and to ask patients about their experiences. We observed digital facilitation in general practices and spoke to patients and staff to help us understand the benefits and challenges of different approaches. We combined findings from the three stages outlined above to identify key aspects of digital facilitation. All stages of our research included discussions with the project's patient advisory group. We found that digital facilitation is seen as important and has many forms. Most general practices are using passive and reactive types of facilitation. An example of passive facilitation, initiated by the service but not involving direct inter-personal interaction, is the use of text messaging relating to ordering of repeat prescriptions online. An example of reactive facilitation is providing a response to a patient-initiated query regarding online access. There is clear scope to develop a more proactive approach to facilitation that actively engages patients. Our research highlights a lack of clarity over who is responsible for digital facilitation. Different people (patients, staff, policy-makers) often think that the responsibility lies with others. Investment in digital facilitation is needed. Tools and platforms for digital facilitation that meet patients' and general practices' needs should be developed.

Accessing out-of-hours care following implementation of the GMS contract: an observational study.

BACKGROUND: There is widespread concern that the quality of out-of-hours primary care for patients with complex needs may be at risk now that the new general medical services contract (GMS) has been implemented. AIM: To explore changes in the use of out-of-hours services around the time of implementation of the new contract for patients with complex needs, using patients with cancer as an example. DESIGN OF STUDY: Longitudinal observational study. SETTING: Out-of-hours primary care provider covering Devon (adult population 900,000), UK. METHOD: Two, 1-year periods corresponding to pre- (April 2003 to March 2004) and post-contract implementation (October 2004 to September 2005) were sampled. Call rates per 1000 of the adult population (age>or=16 years) were calculated for all calls (any cause) and cancer-related calls. Anonymised outcome and process measures data were extracted. RESULTS: Although overall call rates per 1000 population had increased by 26% (185 pre-contract to 233 post-contract), the proportion of cancer-related calls remained relatively constant (2.08% versus 1.96%). Around half (56%) of these callers had advanced cancer needs (including palliative care). By post-contract, the time taken to triage had significantly increased (P<0.001). Although the proportions admitted to hospital or receiving a home visit remained constant, calls where a special message was sent by the out-of-hours clinician to the in-hours team had decreased (P<0.001). CONCLUSION: The demand for out-of-hours care for patients with cancer did not alter disproportionately after implementation of the contract. While potential quality indicators (for example, hospital admissions, home visiting rates) remained constant, potentially adverse changes to triage time and communication between out-of-hours and in-hours clinicians were observed. Quality standards and provider databases require further refinement to capture elements of care relevant to patients with complex needs.

Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial.

BACKGROUND: Around 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation. METHODS: An external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed. RESULTS: Eight out of twenty teams were recruited and randomised. Of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months. DISCUSSION: While valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions. TRIAL REGISTRATION: ISRCTN34701576 . Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).

Enhanced psychological care in cardiac rehabilitation services for patients with new-onset depression: the CADENCE feasibility study and pilot RCT.

BACKGROUND: Around 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy. OBJECTIVE(S): To examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation. DESIGN: A two-stage multimethods study; a feasibility study and a qualitative evaluation, followed by an external pilot cluster randomised controlled trial (RCT) with a nested qualitative study. SETTING: UK comprehensive cardiac rehabilitation teams. PARTICIPANTS: Adults eligible for cardiac rehabilitation following an acute coronary syndrome with new-onset depressive symptoms on initial nurse assessment. Patients who had received treatment for depression in the preceding 6 months were excluded. INTERVENTIONS: The EPC intervention comprised nurse-led mental health-care co-ordination and behavioural activation within cardiac rehabilitation. The comparator was usual cardiac rehabilitation care. MAIN OUTCOME MEASURES: Measures at baseline, and at the 5- (feasibility and pilot) and 8-month follow-ups (pilot only). Process measures related to cardiac team and patient recruitment, and participant retention. Outcomes included depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Interviews explored participant and nurses' views and experiences. RESULTS: Between September 2014 and May 2015, five nurses from four teams recruited participants into the feasibility study. Of the 203 patients screened, 30 were eligible and nine took part (the target was 20 participants). At interview, participants and nurses gave valuable insights into the EPC intervention design and delivery. Although acceptable, the EPC delivery was challenging for nurses (e.g. the ability to allocate sufficient time within existing workloads) and the intervention was modified accordingly. Between December 2014 and February 2015, 8 out of 20 teams approached agreed to participate in the pilot RCT [five were randomised to the EPC arm and three were randomised to the usual-care (UC) arm]. Of the 614 patients screened, 55 were eligible and 29 took part (the target was 43 participants). At baseline, the trial arms were well matched for sex and ethnicity, although the EPC arm participants were younger, from more deprived areas and had higher depression scores than the UC participants. A total of 27 out of 29 participants were followed up at 5 months. Interviews with 18 participants (12 in the EPC arm and six in the UC arm) and seven nurses who delivered EPC identified that both groups acknowledged the importance of receiving psychological support embedded within routine cardiac rehabilitation. For those experiencing/delivering EPC, the intervention was broadly acceptable, albeit challenging to deliver within existing care. LIMITATIONS: Both the feasibility and the pilot studies encountered significant challenges in recruiting patients, which limited the power of the pilot study analyses. CONCLUSIONS: Cardiac rehabilitation nurses can be trained to deliver EPC. Although valued by both patients and nurses, organisational and workload constraints were significant barriers to implementation in participating teams, suggesting that future research may require a modified approach to intervention delivery within current service arrangements. We obtained important data informing definitive research regarding participant recruitment and retention, and optimal methods of data collection. FUTURE RESEARCH: Consideration should be given to the delivery of EPC by dedicated mental health practitioners, working closely with cardiac rehabilitation services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34701576. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 30. See the NIHR Journals Library website for further project information.

Exploring the relationships between provision of welfare benefits advice and the health of elderly people: a longitudinal observational study and discussion of methodological issues.

Provision of welfare benefits advice to maximise financial benefit uptake is a shared goal for social and health policy in the UK. The study was designed to explore the wider impact on elderly people provided with specialist welfare benefits advice, in terms of their health and quality of life. This paper reports on a longitudinal postal survey of community dwellers aged 60 and over referred for specialist welfare benefits advice within social services and who were followed up at 5 months (over 2003-2004). Outcome measures included the Short Form-36 (SF-36), the General Health Questionnaire-12 (GHQ-12) and the Barthel Index (postal version), along with questions relating to chronic illness. We also report on the methodological issues that arise from conducting research of this nature. Out of 233 elderly people sent questionnaires, 77 (33%) returned a completed baseline questionnaire. Of the 156 who did not return questionnaires, 35 (22%) gave reasons of being 'too unwell' to participate. Between baseline and follow-up, 8 (10%) of the 77 respondents died; 52 of the 69 (75%) remaining participants completed follow-up questionnaires. Although low, these response rates are comparable with other similar questionnaire surveys examining the outcome of providing benefits advice to individuals. Elderly people (mean age = 80.3, SD = 8.6 years) receiving welfare benefits advice usually reported the presence of a longstanding illness or disability, and the use of healthcare services. Baseline SF-36 scores were extremely low and remained largely unchanged at follow-up; however, there were significant improvements in GHQ-12 scores (mean difference = -1.45, 95% CI = -2.63 to -0.27, P = 0.017). Significant increases in benefit income were identified in 65% of respondents with complete financial data sets (mean increase = pound14.73 per week; 95% CI = 5.27-24.18, d.f. = 39, P = 0.003). Participants were very vulnerable in their health status (compared with normative data for elderly people), and this may have contributed to the difficulty in engaging them in the research. There are methodological issues around establishing cause and effect in this type of study, which cannot be readily designed out on account of ethical issues. Extraction and analysis of financial status and benefit eligibility with a view to determining absolute changes in the material well-being of vulnerable individuals over time is a complex and challenging task. Use of suitable measures is essential. Innovative strategies are necessary to maximise survey response rates amongst the vulnerable elderly population.

Patients' and nurses' views on providing psychological support within cardiac rehabilitation programmes: a qualitative study.

OBJECTIVE: To explore patients' and nurses' views on the feasibility and acceptability of providing psychological care within cardiac rehabilitation services. DESIGN: In-depth interviews analysed thematically. PARTICIPANTS: 18 patients and 7 cardiac nurses taking part in a pilot trial (CADENCE) of an enhanced psychological care intervention delivered within cardiac rehabilitation programmes by nurses to patients with symptoms of depression. SETTING: Cardiac services based in the South West of England and the East Midlands, UK. RESULTS: Patients and nurses viewed psychological support as central to good cardiac rehabilitation. Patients' accounts highlighted the significant and immediate adverse effect a cardiac event can have on an individual's mental well-being. They also showed that patients valued nurses attending to both their mental and physical health, and felt this was essential to their overall recovery. Nurses were committed to providing psychological support, believed it benefited patients, and advocated for this support to be delivered within cardiac rehabilitation programmes rather than within a parallel healthcare service. However, nurses were time-constrained and found it challenging to provide psychological care within their existing workloads. CONCLUSIONS: Both patients and nurses highly value psychological support being delivered within cardiac rehabilitation programmes but resource constraints raise barriers to implementation. Consideration, therefore, should be given to alternative forms of delivery which do not rely solely on nurses to enable patients to receive psychological support during cardiac rehabilitation. TRIAL REGISTRATION NUMBER: ISCTRN34701576.

Development and refinement of a complex intervention within cardiac rehabilitation services: experiences from the CADENCE feasibility study.

BACKGROUND: Patients who experience a cardiac event are at higher risk of developing depression than the general population. Despite this, cardiac rehabilitation (CR) programmes do not provide a systematic approach to psychological care for depression. The CADENCE study aimed to develop and pilot an enhanced psychological care (EPC) intervention consisting of behavioural activation (BA) and mental health care coordination. Following original research commissioning guidance, the intervention was planned to be embedded in routine care and delivered by CR nurses to patients with depression attending CR. This paper describes how qualitative methods were used to develop, embed and refine the intervention. METHODS: This feasibility study involved three CR teams. Observations were made of CR nurses delivering usual care, of EPC training given to nurses, and of supervision sessions provided to the CR nurses. Four nurses were interviewed shortly after their EPC training, and three were interviewed again 6-7 months later having delivered EPC to patients. All nine patients recruited to receive EPC were interviewed. Analyses of the observation notes and interview transcripts focused on how the intervention could be improved in terms of its acceptability and implementation. RESULTS: Variations were found between the CR teams regarding patient waiting list times, how CR was delivered, what facilities were available and how many CR sessions were offered to patients. EPC was acceptable to both nurses and patients. However, nurses struggled to provide this additional care within their existing workload and resources, and patients' disrupted progression through the CR programme affected EPC delivery. Limited time and availability of private space meant nurses also delivered EPC by telephone, which was viewed as a pragmatic solution but less preferable than face-to-face. Nurses indicated that patients struggled with some of the written materials. Findings were used to revise the intervention to become a protocol of care coordination which included guided self-help BA. CONCLUSIONS: Insights gained through conducting interviews and observations enabled us to identify barriers to the implementation of EPC, and to modify the intervention to facilitate its delivery within existing services whilst remaining acceptable to both nurses and patients. The multiple method, iterative approach used was key to the success of this qualitative study. TRIAL REGISTRATION: ISRCTN34701576 Registered 29/05/2014.

Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial.

BACKGROUND: Around 17% of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of cardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and acceptability of embedding enhanced psychological care, composed of two management strategies of proven effectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within the cardiac rehabilitation care pathway. METHODS/DESIGN: This study tests the uncertainties associated with a large-scale evaluation by conducting an external pilot trial with a nested qualitative study. We aim to recruit and randomise eight comprehensive cardiac rehabilitation teams (clusters) to intervention (embedding enhanced psychological care into routine cardiac rehabilitation programmes) or control (routine cardiac rehabilitation programmes alone) arms. Up to 64 patients (eight per team) identified with depressive symptoms upon initial assessment by the cardiac rehabilitation team will be recruited, and study measures will be administered at baseline (before starting rehabilitation) and at 5 months and 8 months post baseline. Outcomes include depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Trial data on cardiac team and patient recruitment, and the retention and flow of patients through treatment will be used to assess intervention feasibility and acceptability. Qualitative interviews will be undertaken to explore trial participants' and cardiac rehabilitation nurses' views and experiences of the trial methods and intervention, and to identify reasons why patients declined to take part in the trial. Outcome data will inform a sample size calculation for a definitive trial. DISCUSSION: The pilot trial and qualitative study will inform the design of a fully powered cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the provision of enhanced psychological care within cardiac rehabilitation programmes. TRIAL REGISTRATION: ISRCTN34701576 (Registered 29 May 2014).

Facilitated physical activity as a treatment for depressed adults: randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care. DESIGN: Pragmatic, multicentre, two arm parallel randomised controlled trial. SETTING: General practices in Bristol and Exeter. PARTICIPANTS: 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more. INTERVENTIONS: In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity. MAIN OUTCOME MEASURES: The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up. RESULTS: There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score -0.54 (95% confidence interval -3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003). CONCLUSIONS: The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16900744.

The experiences and needs of people seeking palliative health care out-of-hours: a qualitative study.

AIM: To explore the experiences of people with advanced cancer and/or their caregivers accessing out-of-hours care. BACKGROUND: The organisation and delivery of out-of-hours in the United Kingdom has undergone major reforms over the past three decades culminating in the new General Medical Service contract in 2004. There are concerns around continuity of care for patients with complex needs under the new arrangements. DESIGN: A qualitative interview study was undertaken recruiting patients from two primary care trusts in Southwest England. Semi-structured interviews were conducted with 28 people with advanced cancer and/or their caregivers who had recently requested out-of-hours care. Interviews were recorded, transcribed and analysed thematically. FINDINGS: Two main themes were identified including the legitimacy of seeking help and continuities of care. Most participants were reluctant to seek help, finding it difficult to decide whether their needs were sufficient to contact services. The degree to which services legitimised participants' requests mediated their experiences. Distress arose when services were dismissive of their needs, whereas respondents were appreciative of clinicians who provided them with reassurance. Participants reported a lack of relational and informational continuity of care. Consulting with an unfamiliar clinician out-of-hours raised doubts in some participants' minds about the quality of care. Some participants recounted episodes in which there were problems with pain management. While the themes suggest that the delivery of out-of-hours care as a whole was not always perfect, around-the-clock access to professional sources of support and reassurance was highly valued. However, the transfer of information to out-of-hours providers remains a key challenge; participants did not understand why out-of-hours providers could not access more information on their medical histories given the level of computerisation within the National Health Service. The findings highlight the need to improve continuity between in-hours and out-of-hours services for patients with complex needs.

Physical activity as a treatment for depression: the TREAD randomised trial protocol.

BACKGROUND: Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. METHODS/DESIGN: The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments. DISCUSSION: The results of the trial will provide information about the effectiveness of physical activity as a treatment for depression. Given the current prevalence of depression and its associated economic burden, it is hoped that TREAD will provide a timely contribution to the evidence on treatment options for patients, clinicians and policy-makers. TRIAL REGISTRATION: ISRCTN 16900744.