Primary care nurses using guidelines in Thailand: a randomized controlled trial

BACKGROUND: Nurses run primary health centres in Thailand. We examined whether clinical guidelines improved the quality of the care they provide. METHODS: Eighteen nurse-led health centres randomized to (a) guidelines, receiving a training workshop plus educational outreach visit, with guidelines for children (acute respiratory tract infection and diarrhoea) and adults (diazepam prescribing and diabetes management) or (b) usual care. Outcomes were changes at 6 months in antibiotic use, diazepam prescribing, drug costs per patient, and a composite process index for diabetes care. RESULTS: Baseline prescribing was high for antibiotics (37% of all attendees), and no difference between intervention and control sites was detected at follow-up for this variable. In children (0-5 years old), antibiotics were widely used for acute respiratory tract infection (34%), and fell with guidelines (intervention: 42% at baseline to 27% at follow-up; control: 27-30%, P=0.022), with an associated fall in drug costs per patient. Antibiotics were widely prescribed for diarrhoea in children (91%), but no change was detected with guidelines. In adults, diazepam prescribing at baseline was high (17%), and fell in the guidelines group (intervention: 17-10%; control 21-18%; P=0.029). Diabetes care was generally good, and changed little with guidelines. CONCLUSION: Staff at primary health centres over-prescribe antibiotics in children and tranquilizer in adults. Clinical guidelines implemented with workshops and educational outreach visits improved some but not all aspects of prescribing in the short-term.     

Multifaceted support to improve clinical decision making in diabetes care: a randomized controlled trial in general practice.

AIMS: To evaluate the effectiveness of a multifaceted intervention to improve the clinical decision making of general practitioners (GPs) for patients with diabetes. To identify practice characteristics which predict success. METHODS: Cluster randomized controlled trial with 124 practices and 185 GPs in The Netherlands. The intervention group received feedback reports and support from a facilitator; the control group received no special attention. Outcome measures were the compliance rates with evidence-based recommendations pertaining to discussion of body weight control, discussion of problems with medication, blood pressure measurement, foot examination, eye examination, initiating anti-diabetic medication or increasing the dosage in cases of uncontrolled blood glucose, and scheduling a follow-up appointment. RESULTS: The GPs reported on their clinical decision making in 1410 consultations with Type 2 diabetic patients at baseline and 1449 consultations after the intervention period. The intervention resulted in statistically significant improvement for two of the seven outcome measures: foot examination (odds ratio 1.68; 95% confidence interval 1.19-2.39) and eye examination (1.52; 1.07-2.16). Discussion of problems with medication showed a near significant trend towards increased benefit for the intervention group (1.52; 0.99-2.32). Practice characteristics were not found to be related to the success of the intervention. CONCLUSIONS: Feedback reports with support from facilitators appear to increase rates of foot examination and eye examination in general practice. Alternative interventions should be explored to improve the pursuit of metabolic control by GPs.     

Improving foot care for people with diabetes mellitus--a randomized controlled trial of an integrated care approach.

AIMS: To evaluate a model of integrated diabetic footcare, for identification and clinical management of the high risk diabetic foot, centred on the primary care-based diabetic annual review. METHODS: A pragmatic randomized controlled study was undertaken with matched cluster randomization of practices from 10 towns drawn from mid and east Devon responsible for the care of 1,939 people with diabetes (age > or =18 years). Outcome measures were patients' attitudes regarding the value and importance of footcare, patients' footcare knowledge, healthcare professionals' footcare knowledge and pattern of service utilization. RESULTS: Attitudes towards footcare improved in both intervention and control groups (mean percentage change 3.91, 0.68) with a significant difference in change of 3.18 (95% confidence interval (CI) 1.29-5.07) between the groups. Patients' knowledge about diabetic foot problems improved significantly in both groups (mean percentage change 1.09, 1.32) but with no significant difference in change: -0.09 (95% CI -1.81-1.63) between groups. Health professionals' knowledge scores improved in the intervention group (mean percentage change 13.2; P < 0.001). No improvement was seen in the control group (mean percentage change -0.2; P = 0.1) with a significant difference in change of 13.46 (95% CI 8.30-18.62) between groups. Appropriate referrals from intervention practices to the specialized foot clinic rose significantly (P = 0.05) compared with control practices (P = 0.14). CONCLUSIONS: Provision of integrated care arrangements for the diabetic foot has a positive impact on primary care staffs' knowledge and patients' attitudes resulting in an increased number of appropriate referrals to acute specialist services.     

Type 2 (non-insulin-dependent) diabetes mellitus,hypertension and hyperlipidaemia (syndrome X): relation to reduced fetal growth

Summary Two follow-up studies were carried out to determine whether lower birthweight is related to the occurrence of syndrome X — Type 2 (non-insulin-dependent) diabetes mellitus, hypertension and hyperlipidaemia. The first study included 407 men born in Hertfordshire, England between 1920 and 1930 whose weights at birth and at 1 year of age had been recorded by health visitors. The second study included 266 men and women born in Preston, UK, between 1935 and 1943 whose size at birth had been measured in detail. The prevalence of syndrome X fell progressively in both men and women, from those who had the lowest to those who had the highest birthweights. Of 64-year-old men whose birthweights were 2.95 kg (6.5 pounds) or less, 22% had syndrome X. Their risk of developing syndrome X was more than 10 times greater than that of men whose birthweights were more than 4.31 kg (9.5 pounds). The association between syndrome X and low birthweight was independent of duration of gestation and of possible confounding variables including cigarette smoking, alcohol consumption and social class currently or at birth. In addition to low birthweight, subjects with syndrome X had small head circumference and low ponderal index at birth, and low weight and below-average dental eruption at 1 year of age. It is concluded that Type 2 diabetes and hypertension have a common origin in sub-optimal development in utero, and that syndrome X should perhaps be re-named the small-baby syndrome.     

Efficacy and safety of community-based moxibustion for primary hypertension: A randomized controlled trial with patient preference arms

Moxibustion has been shown to have a potential antihypertensive effect, but its applicability for the primary care of hypertension is unclear. The authors conducted a multicenter randomized controlled trial (RCT) with patient preference arms to investigate the effect, safety, cost-effectiveness, and compliance of moxibustion in community patients with hypertension. Patients with primary hypertension were enrolled from seven communities randomly or nonrandomly assigned to receive self-administered moxibustion + the original hypertensive regimen or the original hypertensive regimen alone for 6 months. The authors mainly evaluated the effects of moxibustion on hypertensive outcomes and adverse events. As a result, a total of 160 and 240 patients were recruited into the randomized and nonrandomized arms, respectively, with 87.5% completing the follow-up. At month 6, there was a significantly greater reduction in systolic blood pressure (SBP) (difference: −10.57 mmHg), a higher proportion of responders (82.2% vs. 53.7%; odds ratio 4.00), and better improvements in hypertensive symptoms and quality of life (QoL) in the moxibustion group than in the control group in the randomized population, but there was no significant between-group difference in diastolic blood pressure (DBP). The nonrandomized findings showed the same effect direction for all outcomes, except for DBP. All moxibustion-related adverse events were mild. In conclusion, moxibustion can reduce SBP and improve hypertensive symptoms and QoL in community patients with hypertension, with good safety and low cost, although its effect on DBP remains uncertain. The findings suggest that moxibustion may be an appropriate technique for community primary care of hypertension.     

Cost‐effectiveness of educational outreach to primary care nurses to increase tuberculosis case detection and improve respiratory care: economic evaluation alongside a randomised trial

Objective To evaluate the cost‐effectiveness of an educational outreach intervention to improve primary respiratory care by South African nurses. Methods Cost‐effectiveness analysis alongside a pragmatic cluster randomised controlled trial, with individual patient data. The intervention, the Practical Approach to Lung Health in South Africa (PALSA), comprised educational outreach based on syndromic clinical practice guidelines for tuberculosis, asthma, chronic obstructive pulmonary disease, pneumonia and other respiratory diseases. The study included 1999 patients aged 15 or over with cough or difficult breathing, attending 40 primary care clinics staffed by nurses in the Free State province. They were interviewed at first presentation, and 1856 (93%) were interviewed 3 months later. Results The intervention increased the tuberculosis case detection rate by 2.2% and increased the proportion of patients appropriately managed (that is, diagnosed with tuberculosis or prescribed an inhaled corticosteroid for asthma or referred with indicators of severe disease) by 10%. It costs the health service $68 more for each extra patient diagnosed with tuberculosis and $15 more for every extra patient appropriately managed. Analyses were most sensitive to assumptions about how long training was effective for and to inclusion of household and tuberculosis treatment costs. Conclusion This educational outreach method was more effective and more costly than usual training in improving tuberculosis, asthma and urgent respiratory care. The extra cost of increasing tuberculosis case detection was comparable to current costs of passive case detection. The syndromic approach increased cost‐effectiveness by also improving care of other conditions. This educational intervention was sustainable, reaching thousands of health workers and hundreds of clinics since the trial.     

Case-finding for depression in primary care: a randomized trial.

PURPOSE: Depression is a highly prevalent, morbid, and costly illness that is often unrecognized and inadequately treated. Because depression questionnaires have the potential to improve recognition, we evaluated the accuracy and effects on primary care of two case-finding instruments compared to usual care. SUBJECTS AND METHODS: The study was conducted at three university-affiliated and one community-based medical clinics. Consecutive patients were randomly assigned to be asked a single question about mood, to fill out the 20-item Center for Epidemiologic Studies Depression Screen, or to usual care. Within 72 hours, patients were assessed for Diagnostic and Statistical Manual of Mental Disorders Third Revised Edition (DSM-III-R) disorders by an assessor blinded to the screening results. Process of care was assessed using chart audit and administrative databases; patient and physician satisfaction was assessed using Likert scales. At 3 months, depressed patients and a random sample of nondepressed patients were re-assessed for DSM-III-R disorders and symptom counts. RESULTS: We approached 1,083 patients, of whom 969 consented to screening and were assigned to the single question (n = 330), 20-item questionnaire (n = 323), or usual care (n = 316). The interview for DSM-III-R diagnosis was completed in 863 (89%) patients; major depression, dysthymia, or minor depression was present in 13%. Both instruments were sensitive, but the 20-item questionnaire was more specific than the single question (75% vs 66%, P = 0.03). The 20-item questionnaire was less likely to be self-administered (54% vs 90%) and took significantly more time to complete (15 vs 248 seconds). Case-finding with the 20-item questionnaire or single question modestly increased depression recognition, 30/77 (39%) compared with 11/38 (29%) in usual care (P = 0.31) but did not affect treatment (45% vs 43%, P = 0.88). Effects on DSM-III-R symptoms were mixed. Recovery from depression was more likely in the case-finding than usual care groups, 32/67 (48%) versus 8/30 (27%, P = 0.03), but the mean improvement in depression symptoms did not differ significantly (1.6 vs 1.5 symptoms, P = 0.21). CONCLUSIONS: A simple question about depression has similar performance characteristics as a longer 20-item questionnaire and is more feasible because of its brevity. Case-finding leads to a modest increase in recognition rates, but does not have consistently positive effects on patient outcomes.     

Non-pharmacological treatment of hypertension in primary health care: a 2-year open randomized controlled trial of lifestyle intervention against hypertension in eastern Finland

OBJECTIVE: To assess whether lifestyle counselling is effective in non-pharmacological treatment of hypertension in primary health care. DESIGN: Open randomized controlled trial. SETTING: Ten municipal primary health care centres in eastern Finland. PATIENTS: Seven hundred and fifteen subjects aged 25-74 years with systolic blood pressure 140-179 mmHg and/or diastolic blood pressure 90-109 mmHg or antihypertensive drug treatment. INTERVENTIONS: Systematic health counselling given by local public health nurses for 2 years. MAIN OUTCOME MEASURES: Blood pressure, lipids and lifestyle data were collected annually. RESULTS: Among participants with no antihypertensive drug treatment, the net reductions after 1 year both in systolic blood pressure [-2.6 mmHg; 95% confidence interval (CI), -4.7 to -0.5 mmHg] and in diastolic blood pressure (-2.7 mmHg; 95% CI, -4.0 to -1.4 mmHg) were significant in favour of the intervention group. This difference in blood pressure change was maintained during the second year. In participants with antihypertensive drug treatment, no significant difference in blood pressure reduction was seen between the groups during the study. CONCLUSIONS: A relatively modest, but systematic counselling in primary health care can, at least among untreated hypertensive subjects, produce reductions in blood pressure levels that are modest for the individual, but very important from the public health point of view.     

Acceptability and effects of an educational leaflet on infections in type 2 diabetes patients: a randomized controlled trial in primary care

AIM: To determine the acceptability of an educational leaflet regarding the prevention and treatment of infections of the lower respiratory tract (LRTIs) and urinary tract (UTIs) and to determine the effects of the leaflet on knowledge and attitude of DM2 patients in primary care. METHOD: In a randomized controlled intervention trial 200 DM2 patients enlisted in two practices, one urban and one rural, from the Utrecht general practitioners Research Network (HNU) were selected. Per practice, 50 patients were randomly assigned to the intervention group and 50 to the control group. The intervention was a leaflet on diabetes and LRTIs and UTIs based on the results of focus group interviews. The leaflet was sent to the patients homes. The outcome measures were acceptability of the leaflet and differences in knowledge and attitude, measured by a questionnaire. RESULTS: The mean age was 68 years and 55% was male. There were no substantial differences in characteristics between the two groups. Among the intervention group, the leaflet was appreciated as understandable (100%) and inviting (79%). Compared to the control group, specific knowledge and attitude did not substantially differ. Patients in the intervention group had a slightly more positive attitude about 'being attentive to signs indicating pneumonia' (median difference, 1 point; p=.003) and they also answered 'UTI is mostly caused by a bacteria' more often correctly (risk difference, 18%; 95% CI, 4-33%, p=.016). CONCLUSION: A leaflet on prevention and treatment of LRTIs and UTIs is considered acceptable among DM2 patients, but a multi-faceted educational approach may be needed to improve health behavioral determinants.     

Deep water running and general practice in primary care for non-specific low back pain versus general practice alone: randomized controlled trial

There is equivocal evidence regarding the benefits of aquatic aerobic exercise for non-specific chronic low back pain (NSCLBP) in addition to standard care in general practice consisting of education and advice. The purpose of this study was to compare the addition of deep water running (DWR) to standard general practice (GP) on NSCLBP versus GP care alone on pain, physical and mental health and disability. In this single-blind randomised controlled trial, 58 subjects with NSCLBP were recruited from primary care. The control group received GP care consisting of a physician's consultation and educational booklet only. The experimental group received additional 30-min sessions of DWR three times a week for 15 weeks at the individualized aerobic threshold. Measurements were made pre- and post-intervention and at 1-year follow-up. Both groups showed improvement. The difference between treatment effects at longest follow-up of 1 year was -26.0 (-40.9 to -11.1) mm on the VAS (p < 0.05), -2.5 (-5.7 to -0.2) points in RMQ for disability (p < 0.05), 3.3 (10.0 to 24.7) points on physical health in the physical summary component of the Spanish Short Form 12 (SF-12; p < 0.05) and 5.8 (8.6 to 34.7) points on the mental summary component of the SF-12 (p < 0.05), in favour of the DWR group. For patients with NSCLBP, the addition of DWR to GP was more effective in reducing pain and disability than standard GP alone, suggesting the effectiveness and acceptability of this approach with this group of patients.     

Endoscopic variceal ligation for primary prophylaxis of oesophageal variceal bleed: preliminary report of a randomized controlled trial

BACKGROUND: Prevention of variceal bleeding, a major cause of morbidity and mortality, is an important goal in the management of patients with portal hypertension (PHT). Although propranolol has been found useful in preventing the first episode of variceal bleeding (primary prophylaxis) in cirrhotic PHT, it has limitations which include side effects, contraindications, non-compliance and failure in some patients. Endoscopic variceal ligation (EVL) has not been used for primary prophylaxis. METHODS: Thirty cirrhotic patients with PHT, grade III to IV oesophageal varices, hepatic venous pressure gradient > or = 12 mmHg and no prior history of upper gastrointestinal bleeding were randomized to receive propranolol (to reduce their pulse rate by 25% from baseline, n = 15) and EVL (weekly to fortnightly until variceal eradication, n = 15). The two groups were comparable. All the patients in EVL group had variceal eradication during 3.8 +/- 2.2 sessions. RESULTS: There was no major complication or interval bleeding. During a follow-up period of 17.6 +/- 4.7 months, varices recurred in three, two of which bled (successfully treated by EVL). In contrast, during this period of follow up one patient in the propranolol group had variceal bleeding (P=NS). Side effects of propranolol included symptomatic bradycardia requiring reduction of dose in one of 15 patients. CONCLUSIONS: Although sample size in this study is small, it seems that EVL may be a good option for primary prophylaxis for variceal bleeding in patients with cirrhotic PHT; further studies on a larger number of patients and longer follow up are required.     

Development and implementation of a physiotherapy intervention for use in a pragmatic randomized controlled trial in primary care for shoulder pain

Objective: To develop a package of physiotherapy treatment for a randomized controlled trial in primary care for shoulder pain and audit its use within the trial. Methods: A survey of current physiotherapy approaches to the management of shoulder pain was conducted. The most frequently reported treatments were proposed as a package of care for a physiotherapy intervention in a trial of shoulder pain. The package was refined by a subgroup of 13 physiotherapists. For patients receiving the physiotherapy intervention in the main trial (n = 98), the frequency of use of modalities over the treatment period was calculated by percentages of modality usage per number of patient contacts. Treatment details were recorded by the physiotherapist at each patient visit. Results: The physiotherapy intervention included passive movements/mobilizations, active movement/mobilizations, a home exercise programme, education and advice, and ultrasound. The most frequently used modality at the assessment visit was the standardized education and advice leaflet for shoulder pain (85%) followed by the home exercise programme (79%), which was reinforced throughout the trial treatment course. The most frequently used modalities over the treatment period were ultrasound (42%), active mobilizations (41%) and passive mobilizations (41%). The mean number of trial treatment visits was 6.2 (SD: 2.1; range 1–8). Additional trial treatments (1–8) were delivered to 12 patients. Eighty‐five patients were given only one therapeutic diagnosis, and 13 were given two. The most common diagnoses were tendonitis (32%) and capsulitis (25%). Pain was the major problem in 78% of patients, 15% had stiffness and 7% of patients reported both pain and stiffness. Conclusions: Physiotherapists complied well with the trial protocol. Few treatments were used in isolation. This report demonstrates how physiotherapists can agree and deliver a standardized package of treatment, which reflects current practice, as part of a randomized controlled trial. Copyright © 2009 John Wiley & Sons, Ltd.     

Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomized, controlled trial

BACKGROUND: There is increased pressure on primary care physicians to monitor oral anticoagulation. OBJECTIVE: To test the null hypothesis that oral anticoagulation care can be provided at least as well in primary care through a nurse-led clinic, involving near-patient testing and computerized decision support software, compared with routine hospital management based on a variety of clinical outcome measures. METHODS: A randomized, controlled trial in 12 primary care practices in Birmingham, England (9 intervention and 3 control). Two control populations were used: patients individually randomly allocated as controls in the intervention practices (intrapractice controls) and all patients in control practices (interpractice controls). Intervention practices' patients were randomized to the intervention (practice-based anticoagulation clinic) or control (hospital clinic) group. The main outcome measure was therapeutic control of the international normalized ratio. RESULTS: Three hundred sixty-seven patients were recruited (122 intervention patients, 102 intrapractice control patients, and 143 interpractice control patients). Standard measures of control of the international normalized ratio (point prevalence) showed no significant difference between the intervention and control groups. Data on proportion of time spent in the international normalized ratio range showed significant improvement for patients in the intervention group (paired t test, P =.008). CONCLUSIONS: Nurse-led anticoagulation clinics can be implemented in novice primary care settings by means of computerized decision support software and near-patient testing. Care given by this model is at least as good as routine hospital follow-up. The model is generalizable to primary health care centers operating in developed health care systems.     

Use of coaching and technology to improve blood pressure control in Black women with hypertension: Pilot randomized controlled trial study

Hypertension is the main cause of cardiovascular disease, especially in women. Black women (58%) are affected by higher rates of hypertension than other racial/ethnic groups contributing to increased cardio-metabolic disorders. To decrease blood pressure (BP) in this population, a pilot randomized controlled trial was conducted to examine the effects of Interactive Technology Enhanced Coaching (ITEC) versus Interactive Technology (IT) alone in achieving BP control, adherence to antihypertensive medication, and adherence to lifestyle modifications among Black women diagnosed with and receiving medication for their hypertension. Participants completed a 6-week Chronic Disease Self-Management Program (CDSMP), and 83 participants were randomly assigned to ITEC versus IT. Participants were trained to use three wireless tools and five apps that were synchronized to smartphones to monitor BP, weight, physical activity (steps), diet (caloric and sodium intake), and medication adherence. Fitbit Plus, a cloud-based collaborative care platform was used to collect, track, and store data. Using a mixed-effects repeated measures model, the main effect of group means indicated no significant difference between the treatment and referent groups on study variables. The main effect of time indicated significant differences between repeated measures for systolic BP (p < .0001), weight (p < .0001), and steps (p = .018). An interaction effect revealed differences over time and was significant for study measures except diastolic BP. An important goal of this preliminary analysis is to help Black women prioritize self-care management in their everyday environment. Future research is warranted in a geographically broader population of hypertensive Black women.