REDIRECT: cluster randomised controlled trial of GP training in first-episode psychosis

Background

Delays in accessing care for young people with a first episode of psychosis are significantly associated with poorer treatment response and higher relapse rates.

Aim

To assess the effect of an educational intervention for GPs on referral rates to early-intervention services and the duration of untreated psychosis for young people with first-episode psychosis.

Design of study

Stratified cluster randomised controlled trial, clustered at practice level.

Setting

Birmingham, England.

Method

Practices with access to the three early-intervention services in three inner-city primary care trusts in Birmingham were eligible for inclusion. Intervention practices received an educational intervention addressing GP knowledge, skills, and attitudes about first-episode psychosis. The primary outcome was the difference in the number of referrals to early-intervention services between practices. Secondary outcomes were duration of untreated psychosis, time to recovery, use of the Mental Health Act, and GP consultation rate during the developing illness.

Results

A total of 110 of 135 eligible practices (81%) were recruited; 179 young people were referred, 97 from intervention and 82 from control practices. The relative risk of referral was not significant: 1.20 (95% confidence interval [CI] = 0.74 to 1.95; P = 0.48). No effect was observed on secondary outcomes except for ‘delay in reaching early-intervention services’, which was statistically significantly shorter in patients registered in intervention practices (95% CI = 83.5 to 360.5; P = 0.002).

Conclusion

GP training on first-episode psychosis is insufficient to alter referral rates to early-intervention services or reduce the duration of untreated psychosis; however, there is a suggestion that training facilitates access to the new specialist teams for early psychosis.     

Evaluation of an intervention to improve blood culture practices: a cluster randomised trial

This study aimed to evaluate an intervention to improve blood culture practices. A cluster randomised trial in two parallel groups was performed at the Grenoble University Hospital, France. In October 2009, the results of a practices audit and the guidelines for the optimal use of blood cultures were disseminated to clinical departments. We compared two types of information dissemination: simple presentation or presentation associated with an infectious diseases (ID) specialist intervention. The principal endpoint was blood culture performance measured by the rate of patients having one positive blood culture and the rate of positive blood cultures. The cases of 130 patients in the “ID” group and 119 patients in the “simple presentation” group were audited during the second audit in April 2010. The rate of patients with one positive blood culture increased in both groups (13.62 % vs 9.89 % for the ID group, p?=?0.002, 15.90 % vs 13.47 % for the simple presentation group, p?=?0.009). The rate of positive blood cultures improved in both groups (6.68 % vs 5.96 % for the ID group, p?=?0.003, 6.52 % vs 6.21 % for the simple presentation group, p?=?0.017). The blood culture indication was significantly less often specified in the request form in the simple presentation group, while it remained stable in the ID group (p?=?0.04). The rate of positive blood cultures and the rate of patients having one positive blood culture improved in both groups. The ID specialist intervention did not have more of an impact on practices than a simple presentation of audit feedback and guidelines.     

An integrated experiential training programme with coaching to promote physical activity,and reduce fatigue among children with cancer: A randomised controlled trial

Objective

This study examined the effectiveness of an integrated programme in promoting physical activity, reducing fatigue, enhancing physical activity self-efficacy, muscle strength and quality of life among Chinese children with cancer.

Nurse-led health coaching programme to improve hospital-to-home transitional care for stroke survivors: A randomised controlled trial

ObjectiveTo evaluate the effects of a nurse-led health coaching programme for stroke survivors and family caregivers in hospital-to-home transition care.MethodsA total of 140 dyads of stroke survivors and their family caregivers were recruited and randomly assigned to either the intervention group (received a 12-week nurse-led health coaching programme) or the usual care group. The primary outcome was self-efficacy, and secondary outcomes were quality of life (QoL), stroke-related knowledge, and caregiver-related burden. The outcomes were measured at baseline, 12 and 24 weeks.ResultsStroke survivors in the intervention group demonstrated a significant improvement in self-efficacy at 12 weeks (x?: 24.9, 95%CI: 20.2–29.6, p < 0.001) and at 24 weeks (x?: 23.9, 95%CI: 19.2–28.6, p < 0.001) compared to the usual care group. Findings also demonstrated significant increases in stroke survivors’ QoL, stroke-related knowledge, and reduction in unplanned hospital readmissions and caregiver-related burden. There were no statistically significant changes in other outcomes between the two groups.ConclusionThe nurse-led health coaching programme improved health outcomes for both stroke survivors and their caregivers.Practice ImpactionFindings from the study suggest that nurse-led health coaching should be incorporated into routine practice in hospital-to-home transitional care for stroke survivors and their caregivers.     

Developing a training programme in patient-centred consulting for evaluation in a randomised controlled trial; diabetes care from diagnosis in British primary care

Aim: To develop a feasible/theoretically based training programme in patient-centred consulting, for evaluation in a randomised controlled trial of diabetes care from diagnosis. Methods: The programme was developed with four primary care teams and their patients in an action research framework, with observation of diabetes review consultations before and after training, and evaluated by questionnaire after each training session, among 23 general practitioners and 32 practice nurses from 21 practices in the trial. Results: The observation study identified opportunities and obstacles to introducing a patient-centred approach into daily practice, especially in relation to time management and skill needs. The modified training programme was rated highly by participating general practitioners and nurses. Conclusions: Developing training programmes with the help of participating primary care teams ensures relevance and feasibility. Patient-centred consulting demands a shift from habitual consulting patterns. Practitioners are implementing the approach in practice, and the impact on patients is now under evaluation in the randomised controlled trial.     

Implementation of RCGP guidelines for acute low back pain: a cluster randomised controlled trial.

BACKGROUND: The Royal College of General Practitioners (RCGP) has produced guidelines for the management of acute low back pain in primary care. AIM: To investigate the impact on patient management of an educational strategy to promote these guidelines among general practitioners (GPs). DESIGN OF STUDY: Group randomised controlled trial, using the health centre as the unit of randomisation. SETTING: Primary care teams in north-west England. METHOD: Twenty-four health centres were randomly allocated to an intervention or control arm. Practices in the intervention arm were offered outreach visits to promote national guidelines on acute low back pain, as well as access to fast-track physiotherapy and to a triage service for patients with persistent symptoms. RESULTS: Twenty-four centres were randomised. Two thousand, one hundred and eighty-seven eligible patients presented with acute low back pain during the study period: 1049 in the intervention group and 1138 in the control group. There were no significant differences between study groups in the proportion of patients who were referred for X-ray, issued with a sickness certificate, prescribed opioids or muscle relaxants, or who were referred to secondary care, but significantly more patients in the intervention group were referred to physiotherapy or the back pain unit (difference in proportion = 12.2%, 95% confidence interval [CI] = 2.8% to 21.6%). CONCLUSION: The management of patients presenting with low back pain to primary care was mostly unchanged by an outreach educational strategy to promote greater adherence to RCGP guidelines among GPs. An increase in referral to physiotherapy or educational programmes followed the provision of a triage service.     

Diagnosis of somatisation: effect of an educational intervention in a cluster randomised controlled trial.

BACKGROUND: Somatisation is highly prevalent in primary care (present in 25% of visiting patients) but often goes unrecognised. Non-recognition may lead to ineffective treatment, risk of iatrogenic harm, and excessive use of healthcare services. AIM: To examine the effect of training on diagnosis of somatisation in routine clinical practice by general practitioners (GPs). DESIGN OF STUDY: Cluster randomised controlled trial, with practices as the randomisation unit. SETTING: Twenty-seven general practices (with a total of 43 GPs) in Vejle County, Denmark. METHOD: Intervention consisted of a multifaceted training programme (the TERM [The Extended Reattribution and Management] model). Patients were enrolled consecutively over a period of 13 working days. Psychiatric morbidity was assessed by means of a screening questionnaire. GPs categorised their diagnoses in another questionnaire. The primary outcome was GP diagnosis of somatisation and agreement with the screening questionnaire. RESULTS: GPs diagnosed somatisation less frequently than had previously been observed, but there was substantial variation between GPs. The difference between groups in the number of diagnoses of somatisation failed to reach the 5% significance (P = 0.094). However, the rate of diagnoses of medically unexplained physical symptoms was twice as high in the intervention group as in the control group (7.7% and 3.9%, respectively, P = 0.007). Examination of the agreement between GPs' diagnoses and the screening questionnaire revealed no significant difference between groups. CONCLUSION: Brief training increased GPs' awareness of medically unexplained physical symptoms. Diagnostic accuracy according to a screening questionnaire remained unaffected but was difficult to evaluate, as there is no agreement on a gold standard for somatisation in general practice.     

A cluster randomised controlled trial of patient-held medical records for people with schizophrenia receiving shared care.

BACKGROUND: Patient-held records can improve communication across the primary-secondary interface. There has been no previous rigorous assessment of the utility of patient-held records for people with schizophrenia from a primary care perspective and their value for this population is unclear. AIM: To evaluate the effectiveness of a patient-held record for patients with schizophrenia receiving shared care. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Seventy-four general practices and six community mental health localities in Birmingham, England between June 1998 and June 1999. METHOD: A sample of 201 patients with schizophrenia (ICD-10 classification F20) was recruited; of these, 100 were intervention and 101 were control. Patient-held records were given to the intervention patients. At 12-month follow-up, all patients were accounted for and 191 (95%) were revisited. Primary outcomes were the Verona Service Satisfaction Scale-54 (VSSS-54) and the Krawiecka and Goldberg (K & G) rating scale of psychopathology at 12-month follow-up. Secondary outcomes were use of primary and secondary care services. RESULTS: A total of 63/92 (68.5%) patients still had the patient-held record, 64/92 (69.6%) had used it, and 39 (60.9%) of the 64 who had used it said the patient-held record was regularly used by their keyworker. However the patient-held record had no significant effect on primary outcomes (VSSS-54: F1,116 = 0.06, P = 0.801, K & G: F1,116 = 0.6, P = 0.439) or on use of services. A higher symptom score was associated with not using the patient-held record. CONCLUSIONS: The trial provides no good evidence to suggest that patient-held records should be introduced as part of routine shared care for all patients with schizophrenia. However, the patient-held record was acceptable to patients with schizophrenia and acted as a communication tool, particularly between patients and keyworkers.     

Promoting patient participation in consultations: a randomised controlled trial to evaluate the effectiveness of three patient-focused interventions

The aim of this experimental study was to evaluate the effectiveness of three patient-focused interventions designed to increase patient question asking in clinical consultations. Patients were randomly allocated to one of five conditions to receive either one of three interventions or to serve as an attention control group or a control group. The primary outcome measure was question asking by the patient of their physician. Participants in the intervention groups did not ask more questions than participants in the control groups. Immediately after the consultation participants in the intervention groups had higher levels of self-efficacy in asking questions. Three months after the index visit patients in the intervention groups were significantly more likely to be satisfied to some degree than patients in the control group. There was no difference in diabetic control. These results suggest that simple brief patient-focused interventions do not change patient behaviour in medical outpatient consultations.     

Exploratory cluster randomised controlled trial of shared care development for long-term mental illness.

BACKGROUND: Primary care clinicians have a considerable amount of contact with patients suffering from long-term mental illness. The United Kingdom's National Health Service now requires general practices to contribute more systematically to care for this group of patients. AIMS: To determine the effects of Mental Health Link, a facilitation-based quality improvement programme designed to improve communication between the teams and systems of care within general practice. Design of study: Exploratory cluster randomised controlled trial. SETTING: Twenty-three urban general practices and associated community mental health teams. METHOD: Practices were randomised to service development as usual or to the Mental Health Link programme. Questionnaires and an audit of notes assessed 335 patients' satisfaction, unmet need, mental health status, processes of mental and physical care, and general practitioners' satisfaction with services and beliefs about service development. Service use and intervention costs were also measured. RESULTS: There were no significant differences in patients' perception of their unmet need, satisfaction or general health. Intervention patients had fewer psychiatric relapses than control patients (mean = 0.39 versus 0.71, respectively, P = 0.02) but there were no differences in documented processes of care. Intervention practitioners were more satisfied and services improved significantly for intervention practices. There was an additional mean direct cost of pound 63 per patient with long-term mental illness for the intervention compared with the control. CONCLUSION: Significant differences were seen in relapse rates and practitioner satisfaction. Improvements in service development did not translate into documented improvements in care. This could be explained by the intervention working via the improvements in informal shared care developed through better link working. This type of facilitated intervention tailored to context has the potential to improve care and interface working.     

Promoting child safety in primary care: a cluster randomised controlled trial to reduce baby walker use

BACKGROUND: Baby walkers are commonly used items of nursery equipment, but cause more than 3000 injuries each year in the UK. There is currently little evidence regarding the effectiveness of interventions in primary care to reduce walker use. AIM: To evaluate the effectiveness of an educational package provided by midwives and health visitors to reduce baby walker possession and use. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Sixty-four general practices in Nottingham and North Nottinghamshire, UK. METHOD: An educational package aimed at discouraging mothers-to-be from obtaining and using a walker was delivered by midwives and health visitors to 1174 mothers-to-be of at least 28 weeks gestation. The control arm received usual care. Primary outcome measures were the possession and use of a walker. Secondary outcome measures included the frequency and duration of walker use, knowledge and attitudes towards walkers, plans to use a walker with future children, recommending a walker to a friend, and use of stair gates and fire guards. RESULTS: Intervention arm participants were significantly less likely to own (odds ratio [OR] = 0.63, 95% confidence interval [CI] = 0.43 to 0.93) or to use a walker (OR = 0.26, 95% CI = 0.08 to 0.84). They were significantly less likely to plan to use a walker with their next child (OR = 0.52, 95% CI = 0.31 to 0.86) or to agree that walkers keep children safe (OR = 0.35, 95% CI = 0.16 to 0.78). There was some evidence that they were less likely to recommend a walker to a friend (OR = 0.51, 95% CI = 0.28 to 0.91) or to agree that they help children to walk more quickly (OR = 0.53, 95% CI = 0.29 to 0.95). CONCLUSION: An educational package delivered by midwives and health visitors was effective in reducing baby walker possession and use. Providers of primary healthcare services should include baby walker education in their injury prevention strategy and child health promotion programme.     

Digital audio recordings improve the outcomes of patient consultations: A randomised cluster trial

ObjectivesTo investigate the effects on patients’ outcome of the consultations when provided with: a Digital Audio Recording (DAR) of the consultation and a Question Prompt List (QPL).MethodsThis is a three-armed randomised controlled cluster trial. One group of patients received standard care, while the other two groups received either the QPL in combination with a recording of their consultation or only the recording. Patients from four outpatient clinics participated: Paediatric, Orthopaedic, Internal Medicine, and Urology. The effects were evaluated by patient-administered questionnaires.ResultsA total of 4349 patients participated in the study. DAR significantly increased the probability of fulfilling the participants’ self-perceived information needs by 4.1% to 6.3%, particularly with regard to test results (OR = 1.41, 95%CI: 1.14-1.74, p = 0.001) and treatment options (OR = 1.39, 95%CI: 1.13-1.71, p = 0.002). Additionally, the interventions positively influenced the participants’ satisfaction with the treatment, their relationship with the health professional, and their experience of being involved in the decision-making.ConclusionProviding outpatients with a QPL and DAR of their consultation positively influences the patients’ perception of having adequate information after the consultation.Practice implicationsThe implementation of a QPL and audio recording of consultations should be considered in routine practice.     

A randomised controlled trial of patient led training in medical education: protocol

Background  

Estimates suggest that approximately 1 in 10 patients admitted to hospital experience an adverse event resulting in harm. Methods to improve patient safety have concentrated on developing safer systems of care and promoting changes in professional behaviour. There is a growing international interest in the development of interventions that promote the role of patients preventing error, but limited evidence of effectiveness of such interventions. The present study aims to undertake a randomised controlled trial of patient-led teaching of junior doctors about patient safety.     

Increased awareness of intimate partner abuse after training: a randomised controlled trial

BACKGROUND: Intimate partner abuse is very common among female patients in family practice. In general, doctors overlook the possibility of partner abuse. AIM: To investigate whether awareness of intimate partner abuse, as well as active questioning, increase after attending focus group and training, or focus group only. DESIGN OF STUDY: Randomised controlled trial in a stratified sample.Setting:Family practices in Rotterdam and surrounding areas. METHOD: A full-training group (n = 23), a group attending focus group discussions alone (n = 14), and a control group (n = 17) were formed. Data were collected with incident reporting of every female patient (aged >18 years) that was suspected of, or presented, partner abuse during a period of 6 months. The primary outcome measure was the number of reported patients; the secondary outcome measure was the number of patients with whom the GP had non-obvious reasons to suspect/discuss abuse. RESULTS: Comparison of the full-training group (n = 87 patients) versus the control group (n = 14 patients) resulted in a rate ratio of 4.54 (95% confidence interval [CI] = 2.55 to 8.09, P <0.001); the focus group only group (n = 30 cases) versus control group: rate ratio of 2.2 (95% CI = 1.14 to 4.26, P = 0.019); full-training versus the focus group only group: rate ratio of 2.19 (95% CI = 1.36 to 3.52, P = 0.001). Comparison of the fulltraining group with the untrained groups for awareness of partner abuse in case of non-obvious signs resulted in: odds ratio 5.92 (95% CI = 2.25 to 15.62, P <0.01) all corrected for sex, district, practice setting, working part/full-time, experience, and age of the doctor. CONCLUSIONS: Training was the most significant determinant to improve awareness and identification of intimate partner abuse. Active questioning increased, especially where there were non-obvious signs. The focus group on its own doubled the awareness of partner abuse.     

Promoting brief alcohol intervention by nurses in primary care: a cluster randomised controlled trial

This trial evaluated the clinical impact and cost-effectiveness of strategies promoting screening and brief alcohol intervention (SBI) by nurses in primary care. Randomisation was at the level of the practice and the interventions were: written guidelines (controls, n=76); outreach training (n=68); and training plus telephone-based support (n=68). After 3 months, just 39% of controls implemented the SBI programme compared to 74% of nurses in trained practices and 71% in trained and supported practices. Controls also screened fewer patients and delivered fewer brief interventions to risk drinkers than other colleagues. However, there was a trade-off between the extent and the appropriateness of brief intervention delivery with controls displaying the least errors in overall patient management. Thus cost-effectiveness ratios (cost per patient appropriately treated) were similar between the three strategies. Given the potential for anxiety due to misdirected advice about alcohol-related risk, the balance of evidence favoured the use of written guidelines to promote SBI by nurses in primary care.     

Effect of a structured course involving goal management training in older adults: A randomised controlled trial

OBJECTIVE: The objective of this study was to investigate the effects of a structured 6-week neuropsychological course on the executive functioning of older adults with cognitive complaints. METHODS: A randomised controlled design was used involving 69 community dwelling individuals aged 55 years and older. Both objective and subjective measures were included to assess executive functioning. General linear model with repeated measures analysis of variance was used to examine the intervention effects. RESULTS: After the intervention, the participants in the intervention group were significantly less annoyed by their cognitive failures, were better able to manage their executive failures and reported less anxiety symptoms than those in the waiting list control group. CONCLUSION: These findings indicate that a combination of psycho-education and training has the potential to change the attitude of older individuals towards their cognitive functioning. PRACTICE IMPLICATIONS: Because this training focussed on cognitive functions that are among the first to decline in older adults and the subjective evaluation of the people after training was quite favourable, the proposed intervention may be considered a valuable contribution to cognitive interventions for older adults.     

Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners' recruitment of patients

Background  

Recruitment of patients by health professionals is reported as one of the most challenging steps when undertaking studies in primary care settings. Numerous investigations of the barriers to patient recruitment in trials which recruit patients to receive an intervention have been published. However, we are not aware of any studies that have reported on the recruitment barriers as perceived by health professionals to recruiting patients into cluster randomised trials where patients do not directly receive an intervention. This particular subtype of cluster trial is commonly termed a professional-cluster trial. The aim of this study was to investigate factors that contributed to general practitioners recruitment of patients in a professional-cluster trial which evaluated the effectiveness of an intervention to increase general practitioners adherence to a clinical practice guideline for acute low-back pain.     

A cluster randomised controlled trial of the effect of a treatment algorithm for hypertension in patients with type 2 diabetes

BACKGROUND: Good blood pressure (BP) control reduces the risk of complications in people with type 2 diabetes, yet many do not achieve this. Guidelines for managing hypertension recommend increasing antihypertensive medications until control is achieved, but the effect of such recommendations in routine primary care is unknown. AIM: To evaluate the effectiveness of a BP treatment algorithm in primary care patients with type 2 diabetes. DESIGN OF STUDY: A cluster randomised controlled trial of 1534 patients with type 2 diabetes. SETTING: Forty-two practices in Nottingham, UK. METHOD: Practices were randomised to continue usual care or to use a treatment algorithm designed so that practice nurses and GPs would increase antihypertensive treatment in steps until the target of 140/80 mmHg was reached. Participants were assessed by a clinical interview and case note review at recruitment and at 1 year. The primary outcome measure was the proportion of participants achieving target BP at 1 year. RESULTS: At 1 year there was no difference between the proportions of participants with well controlled BP in the intervention and control arms (36.6% versus 34.3%; P = 0.27). Mean systolic and diastolic blood pressures were identical in the two arms (143/78 mmHg). There was some evidence that participants in the intervention arm were more likely to be receiving higher doses of their antihypertensive drugs, although there was no significant difference in the number of different antihypertensive drugs prescribed. Participants in the intervention arm had a higher rate of primary care BP-related consultations over 12 months than those receiving usual care (rate ratio = 1.55, 95% confidence interval [CI] = 1.26 to 1.88, P<0.001). CONCLUSION: Despite increased monitoring and possibly higher doses of medication there was no improvement in blood pressure control. Improvements achieved by specialist nurse-led clinics in secondary care may not translate to people with type 2 diabetes in primary care settings.