Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial

ObjectivesTo assess the effectiveness of a trained district nurse individually prescribing a home based exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme.DesignRandomised controlled trial with one year''s follow up.SettingCommunity health service at a New Zealand hospital.Participants240 women and men aged 75 years and older.Intervention121 participants received the exercise programme (exercise group) and 119 received usual care (control group); 90% (211 of 233) completed the trial.ResultsFalls were reduced by 46% (incidence rate ratio 0.54, 95% confidence interval 0.32 to 0.90). Five hospital admissions were due to injuries caused by falls in the control group and none in the exercise group. The programme cost $NZ1803 (£523) (at 1998 prices) per fall prevented for delivering the programme and $NZ155 per fall prevented when hospital costs averted were considered.ConclusionA home exercise programme, previously shown to be successful when delivered by a physiotherapist, was also effective in reducing falls when delivered by a trained nurse from within a home health service. Serious injuries and hospital admissions due to falls were also reduced. The programme was cost effective in participants aged 80 years and older compared with younger participants.

What is already known on this topic

Falls are the costliest type of injury among elderly people, and the healthcare costs increase with frequency of falls and severity of injuriesAn exercise programme delivered by a physiotherapist was successful in reducing falls and moderate injuries in elderly people

What this study adds

An exercise programme to prevent falls in elderly people worked well when delivered by a district nurse from a home health service in the suburbs of a large cityResearchers, public health administrators, and health practitioners can work together to benefit elderly people in the community     

Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 2: Controlled trial in multiple centres

ObjectivesTo assess the effectiveness of trained nurses based in general practices individually prescribing a home exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme.DesignControlled trial with one year''s follow up.Setting32 general practices in seven southern New Zealand centres.Participants450 women and men aged 80 years and older.Intervention330 participants received the exercise programme (exercise centres) and 120 received usual care (control centres); 87% (371 of 426) completed the trial.ResultsFalls were reduced by 30% in the exercise centres (incidence rate ratio 0.70, 95% confidence interval 0.59 to 0.84). The programme was equally effective in men and women. The programme cost $NZ418 (£121) (at 1998 prices) per person to deliver for one year or $NZ1519 (£441) per fall prevented. Fewer participants had falls resulting in injuries, but there was no difference in the number who had serious injuries and no difference in hospital costs resulting from falls in exercise centres compared with control centres.ConclusionsAn individually tailored exercise programme, delivered by trained nurses from within general practices, was effective in reducing falls in three different centres. This strategy should be combined with other successful interventions to form part of home programmes to prevent falls in elderly people.

What is already known on this topic

One half of those aged 80 years and older will fall in any one year, often with serious health and social consequencesAn exercise programme delivered by a physiotherapist or trained district nurse was successful in reducing falls and moderate injuries in elderly people

What this study adds

An exercise programme to prevent falls in elderly people can be delivered safely and effectively by trained nurses in general practicesThe nurses obtained results that were consistent with the physiotherapist in the research setting and the district nurse in the accompanying paper     

Improving the health behaviours of elderly people: randomised controlled trial of a general practice education programme

ObjectivesTo establish the effect of an educational intervention for general practitioners on the health behaviours and wellbeing of elderly patients.DesignRandomised controlled trial with 1 year follow up.SettingMetropolitan general practices in Melbourne, Australia.Subjects42 general practitioners and 267 of their patients aged over 65 years.InterventionEducational and clinical practice audit programme for general practitioners on health promotion for elderly people.ResultsPatients in the intervention group had increased (a) walking by an average of 88 minutes per fortnight, (b) frequency of pleasurable activities, and (c) self rated health compared with the control group. No change was seen in drug usage, rate of influenza vaccination, functional status, or psychological wellbeing as a result of the intervention. Extrapolations of the known effect of these changes in behaviour suggest mortality could be reduced by 22% if activity was sustained for 5 years.ConclusionsEducation of the general practitioners had a positive effect on health outcomes of their elderly patients. General practitioners may have considerable public health impact in promotion of health for elderly patients.

Key messages

• Few educational interventions for doctors have shown benefit to the health of patients
• Elderly people were identified in the UK health initiatives as in need of additional attention, and levels of health protective behaviours were low in community surveys
• A multifaceted educational intervention for general practitioners was effective in improving walking behaviour, self rated health status, and the frequency of social contacts in elderly patients
• General practitioners are effective in improving health and health behaviours in their elderly patients

     

Randomised controlled trial of the READER method of critical appraisal in general practice

Objective: To evaluate the READER model for critical reading by comparing it with a free appraisal, and to explore what factors influence different components of the model. Design: A randomised controlled trial in which two groups of general practitioners assessed three papers from the general practice section of the BMJ. Setting: Northern Ireland. Subjects: 243 general practitioners. Main outcome measures: Scores given using the READER model (Relevance, Education, Applicability, Discrimination, overall Evaluation) and scores given using a free appraisal for scientific quality and an overall total. Results: The hierarchical order for the three papers was different for the two groups, according to the total scores. Participants using the READER method (intervention group) gave a significantly lower total score (P⩽0.01) and a lower score for the scientific quality (P⩽0.0001) for all three papers. Overall more than one in five (22%), and more men than women, read more than 5 articles a month (P⩽0.05). Those who were trainers tended to read more articles (P⩽0.05), and no trainers admitted to reading none. Overall, 58% (135/234) (68% (76/112) of the intervention group) believed that taking part in the exercise would encourage them to be more critical of published articles in the future (P⩽0.01). Conclusion: Participants using the READER model gave a consistently lower overall score and applied a more appropriate appraisal to the methodology of the studies. The method was both accurate and repeatable. No intrinsic factors influenced the scores, so the model is appropriate for use by all general practitioners regardless of their seniority, location, teaching or training experience, and the number of articles they read regularly.

Key messages

• The READER method of critical appraisal is simple and easy to apply
• The method is accurate and repeatable
• General practitioners using a structured appraisal are more critical of quality
• The model may be used by general practitioners with different backgrounds, seniority, and experience of teaching and training

     

Randomised controlled trial of health promotion in general practice for patients at high cardiovascular risk.

OBJECTIVE--To assess the value of health education for patients with angina in reducing risk factors for cardiovascular disease and lessening the effect of angina on everyday activities. DESIGN--Randomised controlled trial of personal health education given every four months. SETTING--18 general practices in the greater Belfast area. SUBJECTS--688 patients aged less than 75 years and known to have had angina for at least six months; 342 randomised to receive education and 346 to no education. MAIN OUTCOME MEASURES--Restriction of everyday activities, dietary habit, smoking habit, frequency of physical exercise; blood pressure, body mass index, and serum total cholesterol concentration at entry to trial and after two years. RESULTS--317 in the intervention group and 300 in the control group completed the trial. At the two year review more of the intervention group (140, 44%) reported taking daily physical exercise than the control group (70, 24%). The intervention group also reported eating a healthier diet than the control group and less restriction by angina in any everyday activity. No significant differences were found between the groups in smoking habit, systolic or diastolic blood pressure, cholesterol concentration, or body mass index. CONCLUSION--Despite having no significant effect on objective cardiovascular risk factors, personal health education of patients with angina seems to increase exercise and improve dietary habits and is effective in lessening the restriction of everyday activities.     

Effect of health visitors working with elderly patients in general practice: a randomised controlled trial.

Health visitors were employed specifically to care for two years for a random sample of patients in general practice who were aged over 70. Independent assessments made at the beginning and end of the study showed that the health visitor in an urban practice had some impact on her caseload of patients; she provided more services for them, their mortality was reduced, and their quality of life improved, though the last measure just failed to be statistically significant. The health visitor working in a rural practice had no such effect.     

Randomised controlled trial of routine hospital clinic care versus routine general practice care for type II diabetics.

Two hundred patients with type II diabetes were entered into a randomised controlled trial lasting five years to compare routine care of this condition by a hospital diabetic clinic with routine care in general practice. Fewer patients in the group being cared for by their general practitioner (general practice group) were regularly reviewed or had regular estimations of blood glucose concentration. More patients in the general practice group than in the hospital group were admitted to hospital for medical reasons during the study (25 (24%) compared with 17 (18%] and more patients in the general practice group died (18) than did in the hospital group (6). At the end of the study mean concentrations of haemoglobin A1 were higher in the general practice group (10.4%) than in the hospital group (9.5%). Routine care in general practice for patients with type II diabetes was less satisfactory than care by the hospital diabetic clinic.     

Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome.

OBJECTIVE: To test the efficacy of a graded aerobic exercise programme in the chronic fatigue syndrome. DESIGN: Randomised controlled trial with control treatment crossover after the first follow up examination. SETTING: Chronic fatigue clinic in a general hospital department of psychiatry. SUBJECTS: 66 patients with the chronic fatigue syndrome who had neither a psychiatric disorder nor appreciable sleep disturbance. INTERVENTIONS: Random allocation to 12 weeks of either graded aerobic exercise or flexibility exercises and relaxation therapy. Patients who completed the flexibility programme were invited to cross over to the exercise programme afterwards. MAIN OUTCOME MEASURE: The self rated clinical global impression change score, "very much better" or "much better" being considered as clinically important. RESULTS: Four patients receiving exercise and three receiving flexibility treatment dropped out before completion. 15 of 29 patients rated themselves as better after completing exercise treatment compared with eight of 30 patients who completed flexibility treatment. Analysis by intention to treat gave similar results (17/33 v 9/33 patients better). Fatigue, functional capacity, and fitness were significantly better after exercise than after flexibility treatment. 12 of 22 patients who crossed over to exercise after flexibility treatment rated themselves as better after completing exercise treatment 32 of 47 patients rated themselves as better three months after completing supervised exercise treatment 35 of 47 patients rated themselves as better one year after completing supervised exercise treatment. CONCLUSION: These findings support the use of appropriately prescribed graded aerobic exercise in the management of patients with the chronic fatigue syndrome.     

Randomised controlled trial of general practitioner intervention in patients with excessive alcohol consumption.

OBJECTIVE: To determine effectiveness of advice from general practitioners to heavy drinkers to reduce their excessive alcohol consumption (35 U or more a week for men, 21 U or more for women). DESIGN: Randomised, controlled double blind trial over 12 months with interim assessment at six months. SETTING: Group practices (n = 47; list size averaging 10,000) recruited from Medical Research Council''s general practice research framework, mostly in rural or small urban settings. PATIENTS: Patients recruited after questionnaire survey. Of total of 2571 (61.2%) of 4203 patients invited for interview who attended, 909 (35.4%) stated that in past seven days they had drunk above the limits set for study and had not received advice; they were randomised to control and treatment groups. INTERVENTIONS: Patients in treatment group were interviewed by general practitioner (who had had a training session) and received advice and information about how to reduce consumption and also given a drinking diary. END POINT: Study aimed at detecting a reduction in proportion of men with excessive alcohol consumption of 30% in treatment group and 20% in control group (for women 40% and 20%, respectively) with a power of 90% at 5% level of significance. In addition, corroborative measures such as estimation of gamma-glutamyltransferase activity were included. MEASUREMENTS AND MAIN RESULTS: At one year a mean reduction in consumption of alcohol of 18.2 (SE 1.5) U/week had occurred in treated men compared with a reduction of 8.1 (1.6) U/week in controls (p less than 0.001). The proportion of men with excessive consumption at interview had dropped by 43.7% in the treatment group compared with 25.5% in controls (p less than 0.001). A mean reduction in weekly consumption of 11.5 (1.6) U occurred in treated women compared with 6.3 (2.0) U in controls (p less than 0.05), with proportionate reductions of excessive drinkers in treatment and control groups of 47.7% and 29.2% respectively. Reduction in consumption increased significantly with number of general practitioner interventions. At one year the mean value for gamma-glutamyltransferase activity had dropped significantly more in treated men (-2.4 (0.9)IU/l) than in controls (+1.1(1.0)IU/l; t = 2.7, p less than 0.01). Reduction in gamma-glutamyltransferase activity tended to increase with number of intervention sessions in men. Changes in gamma-glutamyltransferase activity in women and changes in other indicators in both sexes did not differ significantly between treatment and control groups. CONCLUSIONS: If the results of this study were applied to the United Kingdom intervention by general practitioners could each year reduce to moderate levels the alcohol consumption of some 250000 men and 67500 women who currently drink to excess. General practitioners and other members of the primary health care team should therefore be encouraged to include counselling about alcohol consumption in their preventive activities.     

Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - study protocol of a randomised controlled trial

Background

After more than half a century of modern psychopharmacology, with billions of dollars spent on antidepressants annually world-wide, we lack good evidence to guide our everyday decisions in conducting antidepressant treatment of patients with major depression. First we did not know which antidepressant to use as first line treatment. Second we do not know which dosage we should be aiming at with that antidepressant. Because more than half of the patients with major depression starting treatment do not remit after adequate trial with the first agent, they will need a second line treatment. Dose escalation, augmentation and switching are the three often recommended second line strategies but we do not know which is better than the others. Moreover, we do not know when to start considering this second line treatment. The recently published multiple-treatments meta-analysis of 12 new generation antidepressants has provided some partial answers to the first question. Starting with these findings, this proposed trial aims to establish the optimum 1st line and 2nd line antidepressant treatment strategy among adult patients with a non-psychotic unipolar major depressive episode.

Methods

SUN(^_^)D, the Strategic Use of New generation antidepressants for Depression, is an assessor-blinded, parallel-group, multi-centre randomised controlled trial. Step I is a cluster-randomised trial comparing titration up to the minimum vs maximum of the recommended dose range among patients starting with sertraline. The primary outcome is the change in the Patient Health Questionnaire (PHQ)-9 scores administered by a blinded rater via telephone at week 1 through 3. Step II is an individually randomised trial comparing staying on sertraline, augmentation of sertraline with mirtazapine, and switching to mirtazapine among patients who have not remitted on the first line treatment by week 3. The primary outcome is the change in the PHQ-9 scores at week 4 through 9. Step III represents a continuation phase to Steps I and II and aims to establish longer-term effectiveness and acceptability of the above-examined treatment strategies up to week 25. The trial is supported by the Grant-in-Aid by the Ministry of Health, Labour and Welfare, Japan.

Discussion

SUN(^_^)D promises to be a pragmatic large trial to answer important clinical questions that every clinician treating patients with major depression faces in his/her daily practices concerning its first- and second-line treatments.

Trial registration

ClinicalTrials.gov: NCT01109693     

Randomised controlled trial of nicotine chewing-gum.

The effectiveness of 2 mg nicotine chewing-gum as an aid to stopping smoking was compared with a placebo containing 1 mg nicotine, but unbuffered, in a double-blind randomised trial. Of 58 subjects given the active gum, 27 (47%) were not smoking at one-year follow-up compared with 12 (21%) of the 58 subjects treated with placebo (p less than 0.025). By the most stringent criterion of outcome, 18 (31%) subjects in the active treatment group and eight (14%) in the placebo group had not smoked at all from the start of treatment to follow-up at one year (p less than 0.05). Subjects receiving the active gum experienced less severe withdrawal symptoms and rated their gum as more helpful than did the placebo group. Minor side effects were common but only gastric symptoms were more frequent with the active gum. Subjects receiving active gum used it for longer than those receiving placebo but most stopped using it within six months and only four (7%) developed longer-term dependence. The number of gums used daily correlated significantly with pretreatment blood nicotine concentrations in the active treatment group and with pretreatment cigarette consumption in the placebo group. A lower pretreatment blood nicotine value was the best predictor of success at one year (p less than 0.001) but there was no significant relation to cigarette consumption, sex, and social class. The results clearly confirm the usefulness of nicotine chewing-gum as an aid to stopping smoking and imply a definite role for nicotine in cigarette dependence and withdrawal. Successful use of the gum requires careful attention to subjects'' expectations and clear instructions on how to use it.     

Placebo controlled trial of nicotine chewing gum in general practice.

Of 2110 adult cigarette smokers originally recruited to a study of the effect of antismoking advice in general practice, 429 who reported at follow up after one year that they had tried unsuccessfully to stop smoking were offered "a special antismoking chewing gum," either nicotine gum or a placebo gum, in a double blind study. Of 200 who were willing to try the gum, 101 were randomly allocated to the nicotine gum and 99 to the placebo gum. They were followed up at six months by an unannounced home visit, at which they were interviewed and asked to provide a breath sample for analysis of carbon monoxide. Twenty five claimed that they had stopped smoking, but, of them, seven exhaled levels of carbon monoxide indicative of continued smoking. Of the 18 in whom giving up smoking was validated, 10 had received active gum and eight placebo gum, a difference which was not significant (odds in favour of nicotine gum = 1.25, 95% confidence limits 0.47-3.31). The value of nicotine chewing gum, if any, can be quite small when it is used in general practice.