Primary care patients with mental health problems: outcome of a randomised clinical trial.

BACKGROUND: The prevalence of patients with mental health problems in general practice is high, and at least one-third of these problems last for 6 months or longer. Patients with these problems take up more time during a consultation and attend more frequently. AIM: This study investigated the effectiveness of problem-solving treatment for primary care patients with mental health problems. The hypothesis was that patients receiving problem-solving treatment from a nurse would have fewer symptoms after 3 months, or a lower attendance rate, compared with patients receiving the usual care from the GP. DESIGN OF THE STUDY: Randomised clinical trial. SETTING: Twelve general practices in Amsterdam and 12 nurses from a mental healthcare institution. METHOD: A sample of patients aged >or=18 years were screened for mental health problems with the general health questionnaire (GHQ-12) in the waiting room of the general practices, and were randomised. Patients receiving the problem-solving treatment were required to complete four to six treatment sessions, while patients in the control group were treated as usual by the GP. RESULTS: No significant difference was found between the groups in terms of improved psychopathology or a decrease in attendance rate. Post-hoc analyses showed a sub-group of patients with more severe pathology who may benefit from problem-solving treatment. CONCLUSION: The main results show that problem-solving treatment provided by a nurse adds little to the usual care from the GP for frequent attenders with mental health problems. Post-hoc analyses show that there may be a sub-group of more severely depressed patients who could benefit from problem-solving treatment.     

Improving uptake of influenza vaccination among older people: a randomised controlled trial.

BACKGROUND: The uptake of influenza vaccination among older people is suboptimal. Contact with a doctor or nurse is associated with older people deciding to accept influenza vaccination. AIM: To compare different forms of approach in improving uptake of influenza vaccination among patients aged 75 years and over in primary care. DESIGN OF STUDY: Randomised controlled trial. SETTING: One large rural general practice serving the town and surrounding area of Melton Mowbray, Leicestershire. METHOD: All 2,052 patients aged 75 years and over, registered with the practice and not living in nursing/residential homes or sheltered accommodation, were included in the study. One-third of patients were randomised to receive an offer of influenza vaccination as part of an over-75 health check administered by a practice nurse in the patient's home, and two-thirds of patients were randomised to receive a personal letter of invitation to attend an influenza vaccination clinic held at the surgery. The main outcome measure was uptake of influenza vaccination. RESULTS: Six hundred and eighty patients were randomised to the health check arm of the trial and 1,372 were randomised to receive a personal letter. Of those randomised to the health check arm, 468 received the health check from the nurse. Overall, the difference in influenza vaccination uptake was 6.4% (95% confidence interval [CI] = 2.2% to 10.4%) with 67.9% (n = 932) of those who were sent a personal letter actually receiving the vaccine, compared with 74.3% (n = 505) of those offered a combined health check and influenza vaccination (P = 0.003). CONCLUSION: Combining home-based over- 75 health checks with influenza vaccination can improve uptake among older patients. However this intervention is likely to be costly and its effect on influenza vaccination rates is modest. The difference in uptake is greater among those who do not routinely comeforwardfor vaccination and a more viable option may be to target these patients.     

A randomised controlled trial to test the feasibility of a collaborative care model for the management of depression in older people

BACKGROUND: Depression is the most common mental health disorder in people aged over 65 years. Late-life depression is associated with chronic illness and disability. AIM: To investigate the feasibility of a collaborative care model for depression in older people in a primary care setting. DESIGN OF STUDY: Randomised controlled trial with 16-weeks follow up. SETTING: A primary care trust in Manchester. METHOD: Participants were 105 people aged 60 years or older who scored 5 or more on the Geriatric Depression Scale; 53 were randomly allocated to an intervention group and 52 to a usual care group. The intervention group received care managed by a community psychiatric nurse who delivered an intervention comprising a facilitated self-help programme with close liaison with primary care professionals and old-age psychiatry according to a defined protocol. The usual care group received usual GP care. A nested qualitative study explored the views of the health professionals and patients regarding the acceptability and effectiveness of the intervention. RESULTS: The main outcome measure was recovery from depression. Patients in the intervention group were less likely to suffer from major depressive disorder at follow up compared with usual care (0.32, 95% confidence = interval = 0.11 to 0.93, P = 0.036). The qualitative component of the study demonstrated the acceptability of the intervention to patients. CONCLUSION: A model of collaborative care for older people with depression, used in a primary care setting with a facilitated self-help intervention is more effective than usual GP care. This study demonstrates that the implementation of a collaborative care model is feasible in UK primary care and that the intervention is effective and acceptable to patients.     

Computerised patient-specific guidelines for management of common mental disorders in primary care: a randomised controlled trial.

BACKGROUND: A large proportion of people with depression and anxiety go unrecognised by their general practitioner (GP). Case-finding does not appear to be effective on its own. AIM: To compare the effectiveness of case-finding followed by computer-generated patient-specific guidelines with usual care for the management of common mental disorders in primary care.Design of study: Individual patient randomised controlled trial. SETTING: Five general practices in Bristol and Cardiff.METHOD: 762 individuals aged >/= 16 years scoring >/= 12 on the Clinical Interview Schedule Revised were randomised. The experimental intervention required participants to complete a computerised psychosocial assessment that generated a report for the GP including patient-specific treatment recommendations. The control patients were treated as usual with access to locally agreed guidelines.RESULTS: Participants' 12-item General Health Questionnaire (GHQ) score dropped irrespective of treatment allocation. The experimental group had a significantly lower GHQ score at 6 weeks, but not at 6 months. Recovery at 6 months was 3% greater among those receiving the experimental intervention (95% confidence interval [CI] = -4 to 10). Treatment was not significantly associated with quality of life or patient satisfaction.CONCLUSION: Only small benefits are likely from using case-finding followed by patient-specific guidelines to improve clinical management of common mental disorders in primary care. However, depression and anxiety are important public health problems so the utility of such systems should be further investigated.     

Health education on self-management and seeking health care in older adults: a randomised trial

The aim of this randomised trial was to determine the effects of a health education strategy for older adults living at home on GP attendance. The health education comprised a written booklet on five frequently by GP unnoticed, highly prevalent and potentially treatable health problems: hearing impairment, visual impairment, urinary incontinence, depression and Lower Urinary Tract Symptoms (LUTS). The information comprised structured guidance to enhance decision-making on seeking health care by their GP and contained advice on self-management. The control group did not receive any intervention. Primary outcome was GP attendance of patients regarding the five health problems within 3 months. At this point we expected an increase of GP attendance. Six hundred and eighty-seven subjects completed the study. We can conclude that the health education strategy did not change the GP attendance of older adults. The results suggest that the health education was being appreciated as being useful and informative.     

Predicting costs of mental health care: a critical literature review

BACKGROUND: Cost evaluation research in the mental health field is being increasingly recognized as a way to achieve a more effective deployment of scarce resources. However, there is a paucity of studies that seek to identify predictors of psychiatric service utilization and costs. This paper aims to critically review the published research in the field of psychiatric service utilization and costs, and discusses current methodological developments in this field. METHOD: Sixteen studies were identified and are critically reviewed. RESULTS: No single variable alone can explain variations in costs between patients; instead, a range of different clinical and non-clinical variables provides a greater explanation of cost variations. Having a history of previous psychiatric service use is the most consistent predictor of higher psychiatric costs. Only one study considers indirect costs incurred by users, their families and friends and society as a whole, with the remaining 15 studies focusing on direct mental health care costs. There is a lack of studies that consider the future psychiatric service utilization and costs of care of children and older people. The cross-validation of predictive models is not yet routine, with only four of the studies including a cross-validation procedure. CONCLUSIONS: The predictive approach in mental health cost evaluation has relevance for both mental health policy and practice. However, there is a paucity of studies that focus on children, older people and indirect costs. Furthermore, there remain a number of methodological challenges to address.     

PHASE: a randomised, controlled trial of supervised self-help cognitive behavioural therapy in primary care.

BACKGROUND: Common mental health problems account for up to 40% of all general practitioner (GP) consultations. Patients have limited access to evidence-based psychological therapies. Cognitive behavioural therapy self-help strategies offer one potential solution. AIM: To determine differences in clinical outcome, patient satisfaction and costs, between a cognitive behavioural-based self-help package facilitated by practice nurses compared to ordinary care by GPs for mild to moderate anxiety and depression. DESIGN OF STUDY: Randomised controlled trial. SETTING: Seventeen primary healthcare teams. METHOD: Patients presenting to their GP with mild to moderate anxiety and/or depression were recruited to the study and randomised to receive either a self-help intervention facilitated by practice nurses or ordinary care. The self-help intervention consisted of up to three appointments: two 1 week apart and a third 3 months later. There were no restrictions on ordinary care. RESULTS: Intention-to-treat analysis showed that patients treated with practice nurse-supported cognitive behavioural therapy self-help attained similar clinical outcomes for similar costs and were more satisfied than patients treated by GPs with ordinary care. On-treatment analysis showed patients receiving the facilitated cognitive behavioural therapy self-help were more likely to be below clinical threshold at 1 month compared to the ordinary care group (odds ratio [OR] = 3.65, 95% confidence interval [CI] = 1.87 to 4.37). This difference was less well marked at 3 months (OR = 1.36, 95% CI = 0.52 to 3.56). CONCLUSION: Facilitated cognitive behavioural self-help may provide a short-term cost-effective clinical benefit for patients with mild to moderate anxiety and depression. This has the potential to help primary care provide a choice of effective psychological as well as pharmacological treatments for mental health problems.     

Applying community-oriented primary care methods in British general practice: a case study.

BACKGROUND: The '75 and over' assessments built into the 1990 contract for general practice have failed to enthuse primary care teams or make a significant impact on the health of older people. Alternative methods for improving the health of older people living at home are being sought. AIM: To test the feasibility of applying community-oriented primary care methodology to a relatively deprived sub-population of older people in a relatively deprived area. DESIGN OF STUDY: A combination of developmental and triangulation approaches to data analysis. SETTING: Four general practices in an inner London borough. METHOD: A community-oriented primary care approach was used to initiate innovative care for older people, supported financially by the health authority and practically by primary care academics. RESULTS: All four practices identified problems needing attention in the older population, developed different projects focused on particular needs among older people, and tested them in practice. Patient and public involvement were central to the design and implementation processes in only one practice. Innovations were sustained in only one practice, but some were adopted by a primary care group and others extended to a wider group of practices by the health authority. CONCLUSION: A modified community-oriented primary care approach can be used in British general practice, and changes can be promoted that are perceived as valuable by planning bodies. However, this methodology may have more impact at primary care trust level than at practice level.     

A qualitative study of older people''s views of out-of-hours services.

BACKGROUND: Out-of-hours primary care services continues to change with the growth of general practitioner (GP) co-operatives and the more recent development of NHS Direct. While older people are more likely to have increased needs for such services, evidence suggests that they are reluctant users of GP out-of-hours services. AIM: To explore older people's experiences and perceptions of different models of general practice out-of-hours services. DESIGN OF STUDY: Focus group methodology, with qualitative data analysis undertaken using a grounded theory (Framework) approach. SETTING: Thirty people aged between 65 and 81 years old from community groups based in south east London. METHOD: Four focus groups were held, each with between five and 12 participants. Each focus group session lasted 90 minutes and was audiotape-recorded with the permission of the participants. The tapes were transcribed verbatim. RESULTS: Two related themes were identified. First, attitudes to health and healthcare professionals with reference to the use of health services prior to the establishment of the NHS, a stoical attitude towards health, and not wanting to make excessive demands on health services. Second, the experience of out-of-hours care and the perceived barriers to its use, including the use of the telephone and travelling at night. Participants preferred contact with a familiar doctor and were distrustful of telephone advice, particularly from nurses. CONCLUSIONS: Older people appear reluctant to make use of out-of-hours services and are critical of the trend away from out-of-hours care being delivered by a familiar GP. With increasing numbers of older people in the population it is important to consider steps to address their reluctance to use out-of-hours and telephone advice services, particularly those based around less personal models of care.     

The economics of employing a counsellor in general practice: analysis of data from a randomised controlled trial.

BACKGROUND: Counselling is currently adopted in many general practices, despite limited evidence of clinical and cost effectiveness. AIM: To compare direct and indirect costs of counsellors and general practitioners (GPs) in providing care to people with emotional problems. METHOD: We carried out a prospective, randomized controlled trial of non-directive counselling and routine general practice care in 14 general practices in north London. Counsellors adhered to a Rogerian model of counselling. The counselling sessions ranged from one to 12 sessions over 12 weeks. As reported elsewhere, there were no differences in clinical outcomes between the two groups. Therefore, we conducted a cost minimisation analysis. We present only the economic outcomes in this paper. Main outcome measures were cost data (service utilisation, travel, and work absence) at baseline, three months, and nine months. RESULTS: One hundred and thirty-six patients with emotional problems, mainly depression, took part. Seventy patients were randomised to the counsellors and 66 to the GPs. The average direct and indirect costs for the counsellor was 162.09 Pounds more per patient after three months compared with costs for the GP group; however, over the following six months the counsellor group was 87.00 Pounds less per patient than the GP group. Over the total nine-month period, the counsellor group remained more expensive per patient. CONCLUSIONS: Referral to counselling is no more clinically effective or expensive than GP care over a nine-month period in terms of direct plus indirect costs. However, further research is needed to establish indirect costs of introducing a counsellor into general practice.     

A pragmatic, unblinded randomised controlled trial comparing an occupational therapy-led lifestyle approach and routine GP care for panic disorder treatment in primary care

BACKGROUND: Treated anxiety increased in the UK by over 30% since 1994. Medication and psychological treatment is most common, but outcomes are sometimes poor, with high relapse rates. Lifestyle has a potential role in treatment, but is not considered in clinical guidelines. Panic disorder is potentially influenced by lifestyle factors. METHODS: 16 week unblinded pragmatic randomised controlled trial in 15 East of England primary care practices (2 Primary Care Trusts). Participants met DSM-IV criteria for panic disorder with/without agoraphobia. Follow-up at 20 weeks and 10 months. Control arm, unrestricted routine GP care. Trial Arm, Occupational therapy-led lifestyle treatment comprising: lifestyle review of fluid intake, diet pattern, exercise, caffeine, alcohol and nicotine; negotiation of positive lifestyle changes; monitoring and review of impact of changes. Primary outcome measure: Beck Anxiety Inventory. DATA ANALYSIS: Intention-to-treat analysis provided between-group comparisons using analysis of co-variance. Bonferroni method to adjust p-values. RESULTS: From 199 referrals, 36 GP care and 31 lifestyle arm patients completed to final follow-up. Significantly lower lifestyle arm BAI scores at 20 weeks (p<0.001), non-significant (p=0.167) at 10 months after Bonferroni correction. 63.6% lifestyle arm, and 40% GP arm patients (p=0.045) panic-free at 20 weeks; 67.7% and 48.5% (p=0.123) respectively at 10 months. LIMITATIONS: Final study size/power calls for caution in interpreting findings. CONCLUSIONS: A lifestyle approach may provide a clinically effective intervention at least as effective as routine GP care, with significant improvements in anxiety compared with routine GP care at the end of treatment. Further study is required before suggesting practice changes.     

The development of a short instrument to identify common unmet needs in older people in general practice.

BACKGROUND: No structured needs assessment tool exists that is appropriate for older people and also suitable for use in routine consultations in general practice. AIMS: To engage older people in the development of a brief, valid, practical, and acceptable instrument to help identify common unmet needs suitable for use in routine clinical practice in primary care. DESIGN OF STUDY: User involvement in a multi-stages approach to heuristic development. SETTING: General practices, voluntary groups, and community organisations in north and central London. METHOD: Subjects included patients aged 65 years and over in purposively selected practices, voluntary organisations for older people in the same localities, community organisations involving older people, general practitioners and community nurses. Data were collected through mixed methodology interviews using a structured assessment tool (Camberwell Assessment of Need for the Elderly), a postal questionnaire, and focus groups. Synthesis and interpretation of results was done through a consensus conference followed by a Delphi process involving primary care professionals. RESULTS: Five domains of unmet need were identified as priority areas by all three data collection methods, the consensus conference, and the Delphi process: senses (vision and hearing), physical ability (mobility and falls), incontinence, cognition, and emotional distress (depression and anxiety) (SPICE). CONCLUSIONS: Public involvement in the design of clinical tools allowed the development of a brief assessment instrument that could potentially identify common, important, and tractable unmet needs in older people.     

A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of psychodynamic counselling for general practice patients with chronic depression

BACKGROUND: Counsellors have been employed in general practice with little evidence of effectiveness. This study examined the effectiveness and cost-effectiveness of short-term counselling in general practice for patients with chronic depression either alone or combined with anxiety. METHOD: A randomized controlled trial with an economic evaluation was carried out in Derbyshire. One hundred and forty-five patients were recruited at seven GP practices by screening using the Beck Depression Inventory. Both the experimental and control group received routine GP treatment but the experimental group were also referred to the practice counsellor. Depression, anxiety and other mental health symptoms, social and interpersonal functioning and social support were measured at baseline, 6 months and 12 months. Comprehensive costs were also estimated. RESULTS: There was an overall significant improvement in the actual scores over time, but there were no significant differences between the two groups on any of the measures at either 6 or 12 months. However fewer experimental group patients were still 'cases' on the BDI than controls at 12 months. There were no significant differences in the mean total costs, aggregate costs of services, or any service-group costs except for primary care, between the experimental and control groups over time. CONCLUSIONS: This trial demonstrates only very limited evidence of improved outcomes in those referred to counselling and increased primary care treatment costs in the short-term. Stricter referral criteria to exclude the more severely depressed in the group (BDI > or = 24) might have yielded more conclusive results.     

Randomized trial of a population-based care program for people with bipolar disorder

BACKGROUND: Despite the availability of efficacious medications and psychotherapies, care of bipolar disorder in everyday practice is often deficient. This trial evaluated the effectiveness of a multi-component care management program in a population-based sample of people with bipolar disorder. METHOD: Four hundred and forty-one patients treated for bipolar disorder during the prior year were randomly assigned to continued usual care or usual care plus a systematic care management program including: initial assessment and care planning, monthly telephone monitoring including brief symptom assessment and medication monitoring, feedback to and coordination with the mental health treatment team, and a structured group psychoeducational program--all provided by a nurse care manager. Blinded quarterly assessments generated week-by-week ratings of severity of depression and mania symptoms using the Longitudinal Interval Follow-Up Evaluation. RESULTS: Participants assigned to the intervention group had significantly lower mean mania ratings averaged across the 12-month follow-up period (Z= 2.44, p=0.015) and approximately one-third less time in hypomanic or manic episode (2.59 weeks v. 1.69 weeks). Mean depression ratings across the entire follow-up period did not differ significantly between the two groups, but the intervention group showed a greater decline in depression ratings over time (Z statistic for group-by-time interaction = 1.98, p = 0.048). CONCLUSIONS: A systematic care program for bipolar disorder significantly reduces risk of mania over 12 months. Preliminary results suggest a growing effect on depression over time, but longer follow-up will be needed.     

The PRO-AGE study: an international randomised controlled study of health risk appraisal for older persons based in general practice

Background

This paper describes the study protocol, the recruitment, and base-line data for evaluating the success of randomisation of the PRO-AGE (PRevention in Older people – Assessment in GEneralists' practices) project.

Methods/Design

A group of general practitioners (GPs) in London (U.K.), Hamburg (Germany) and Solothurn (Switzerland) were trained in risk identification, health promotion, and prevention in older people. Their non-disabled older patients were invited to participate in a randomised controlled study. Participants allocated to the intervention group were offered the Health Risk Appraisal for Older Persons (HRA-O) instrument with a site-specific method for reinforcement (London: physician reminders in electronic medical record; Hamburg: one group session or two preventive home visits; Solothurn: six-monthly preventive home visits over a two-year period). Participants allocated to the control group received usual care. At each site, an additional group of GPs did not receive the training, and their eligible patients were invited to participate in a concurrent comparison group. Primary outcomes are self-reported health behaviour and preventative care use at one-year follow-up. In Solothurn, an additional follow-up was conducted at two years. The number of older persons agreeing to participate (% of eligible persons) in the randomised controlled study was 2503 (66.0%) in London, 2580 (53.6%) in Hamburg, and 2284 (67.5%) in Solothurn. Base-line findings confirm that randomisation of participants was successful, with comparable characteristics between intervention and control groups. The number of persons (% of eligible) enrolled in the concurrent comparison group was 636 (48.8%) in London, 746 (35.7%) in Hamburg, and 1171 (63.0%) in Solothurn.

Discussion

PRO-AGE is the first large-scale randomised controlled trial of health risk appraisal for older people in Europe. Its results will inform about the effects of implementing HRA-O with different methods of reinforcement.     

Prioritising referrals to a community mental health team.

BACKGROUND: Current national policies encourage prioritisation of people with severe mental illness (SMI) as well as the development of a primary care-led National Health Service. Where resources for mental health are limited, there is a potential conflict between the needs of people with SMI and the much more common depressive and anxiety disorders that form the bulk of the mental health workload in primary care. AIM: To describe the re-organisation of a community mental health team in order to prioritise people with SMI. METHOD: The number and type of referrals received in the 12 months before and after re-organisation were compared, and general practitioners' (GP) views on the changes sought. RESULTS: There was a significant reduction in GP referrals of patients with less severe disorders in the second year. In both years the proportion of patients with a possible psychotic diagnosis or risk of self-harm was much higher among referrals from within the psychiatry department (92% of referrals) than among GP referrals (20% of referrals). Using data from a postal survey, 46% of referring GPs reported a significant improvement in the service provided to patients with SMI, but 34% reported a deterioration in services for other patient groups. GPs were more likely to be satisfied with the service for people with SMI than with the service for other patient groups. CONCLUSIONS: Improvements in the service provided for those with SMI can be achieved, but this may be at the expense of services for other patient groups. Primary care groups will need to consider this potential conflict in setting priorities for mental health.     

Effectiveness of nurse-delivered cardiovascular risk management in primary care: a randomised trial

Background

A substantial part of cardiovascular disease prevention is delivered in primary care. Special attention should be paid to the assessment of cardiovascular risk factors. According to the Dutch guideline for cardiovascular risk management, the heavy workload of cardiovascular risk management for GPs could be shared with advanced practice nurses.

Aim

To investigate the clinical effectiveness of practice nurses acting as substitutes for GPs in cardiovascular risk management after 1 year of follow-up.

Design of study

Prospective pragmatic randomised trial.

Setting

Primary care in the south of the Netherlands. Six centres (25 GPs, six nurses) participated.

Method

A total of 1626 potentially eligible patients at high risk for cardiovascular disease were randomised to a practice nurse group (n = 808) or a GP group (n = 818) in 2006. In total, 701 patients were included in the trial. The Dutch guideline for cardiovascular risk management was used as the protocol, with standardised techniques for risk assessment. Changes in the following risk factors after 1 year were measured: lipids, systolic blood pressure, and body mass index. In addition, patients in the GP group received a brief questionnaire.

Results

A larger decrease in the mean level of risk factors was observed in the practice nurse group compared with the GP group. After controlling for confounders, only the larger decrease in total cholesterol in the practice nurse group was statistically significant (P = 0.01, two-sided).

Conclusion

Advanced practice nurses are achieving results, equal to or better than GPs for the management of risk factors. The findings of this study support the involvement of practice nurses in cardiovascular risk management in Dutch primary care.     

Graduate mental health worker case management of depression in UK primary care: a pilot study.

BACKGROUND: Based on data from large multicentre US trials, the National Institute for Health and Clinical Excellence (NICE) is advocating a stepped-care model for the management of depression, with 'case management' or 'collaborative care' for selected patients in primary care. AIM: To conduct a pilot study examining the use of graduate mental health workers case managing depressed primary care NHS patients. DESIGN OF STUDY: A randomised controlled trial comparing usual GP care with or without case management over 16 weeks of acute antidepressant drug treatment. SETTING: Three primary care practices in the North East of England. METHOD: Patients with depression, aged 18-65 years, who had failed to adequately respond to antidepressant treatment, were randomised to the two treatments. Assessments were made at baseline, 12, and 24 weeks using a combination of observer and self ratings. RESULTS: Randomisation of 62 patients required screening of 1073 potential patients. There was little difference in outcome between the two treatment arms but a gradual improvement in symptoms over time was seen. Client satisfaction was assessed as high across both treatments. CONCLUSION: While this pilot study confirmed the integrity of the study protocol and the suitability of the outcome measures and randomisation procedure, it raises questions regarding the practicality of recruitment and feasibility of the intervention. It would be crucial to address these issues prior to the implementation of a large multi-centre randomised controlled trial.