Preventing hospital admissions by reviewing medication (PHARM) in primary care: design of the cluster randomised, controlled, multi-centre PHARM-study.

BACKGROUND: Medication can be effective but can also be harmful and even cause hospital admissions. Medication review or pharmacotherapy review has often been proposed as a solution to prevent these admissions and to improve the effectiveness and safety of pharmacotherapy. However, most published randomised controlled trials on pharmacotherapy reviews showed no or little effect on morbidity and mortality. Therefore we designed the PHARM (Preventing Hospital Admissions by Reviewing Medication)-study with the objective to study the effect of the total pharmaceutical care process on medication related hospital admissions and on adverse drug events, survival and quality of life. METHODS/DESIGN: The PHARM-study is designed as a cluster randomised, controlled, multi-centre study in an integrated primary care setting. Patients with a high risk of a medication related hospital admission are included in the study with randomisation at GP (general practitioner) level. We aim to include 14200 patients, 7100 in each arm, from at least 142 pharmacy practices.The intervention consists of a patient-centred, structured, pharmaceutical care process. This process consists of several steps, is continuous and occurs over multiple encounters of patients and clinicians. The steps of this pharmaceutical care process are a pharmaceutical anamnesis, a review of the patient's pharmacotherapy, the formulation and execution of a pharmaceutical care plan combined with the monitoring and follow up evaluation of the care plan and pharmacotherapy. The patient's own pharmacist and GP carry out the intervention. The control group receives usual care.The primary outcome of the study is the frequency of hospital admissions related to medication within the study period of 12 months of each patient. The secondary outcomes are survival, quality of life, adverse drug events and severe adverse drug events. The outcomes will be analysed by using mixed-effects Cox models. DISCUSSION: The PHARM-study is one of the largest controlled trials to study the effectiveness of the total pharmaceutical care process. The study should therefore provide evidence as to whether such a pharmaceutical care process should be implemented in the primary care setting. TRIAL NUMBER: NTR 2647.

The feasibility of a self-management education program for patients with type 2 diabetes mellitus: Do the perceptions of patients and educators match?

AIMS: To compare the feasibility experienced by patients with type 2 diabetes mellitus in a self-management educational program to the hindrance assessed by the educator of the program. METHODS: Twenty-five type 2 diabetes patients on maximally tolerated oral hypoglycaemic agents followed a 6-month educational program consisting of five components: background, medication, physical exercise, nutrition and blood glucose self-monitoring. Medication was unchanged during the study. Outcome measures were feasibility encountered by the patient, hindrance observed by the educator and HbA(1c)-level. RESULTS: The feasibility encountered by patients was significantly related to the hindrance assessed by the educators (rho 0.756, p<0.001). Feasibility increased significantly for three components but not for physical exercise and nutritional advice. Mean HbA(1c)-level decreased from 8.2+/-1.1% before onset of the program to 7.2+/-1.3% 6 weeks after termination of the program. CONCLUSIONS: Feasibility experienced by the patients matched the hindrance noticed by the educators. This might have led to an increase in patients' self-efficacy, which in turn gives an improvement in self-management and glycaemic control.

Cardiovascular risk factors in Turkish immigrants with type 2 diabetes mellitus: comparison with Dutch patients.

BACKGROUND: Based on recent epidemiological studies the need for a similar approach towards management of cardiovascular risk factors in type 2 diabetics with different ethnic background can be questioned. We compared the prevalence of cardiovascular risk factors and 10-year absolute risk for a coronary heart disease between Turkish and Dutch type 2 diabetes patients. METHODS: A cross-sectional study was performed using databases from three Dutch studies on type 2 diabetes, comparing 147 Turkish to 294 Dutch diabetes patients, matched for age and gender. Main outcome measures were: total (t-) cholesterol, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), triglyceride, blood pressure, and smoking. The 10-year absolute risk for a coronary event was calculated by means of the Framingham risk equation. RESULTS: In Turkish diabetics t-cholesterol was lower than in Dutch (5.4 vs. 5.9 mmol/l; p < 0.001), in Turkish males HDL was lower than in Dutch male patients (0.94 vs. 1.08 mmol/l; p = 0.04). The total/HDL-cholesterol ratio in Turkish and Dutch diabetics was equal (5.4 vs. 5.4). Less Turkish than Dutch females smoked (9% vs. 23%; p<0.01). The 10-year absolute risk for a coronary event in both Turkish and Dutch male patients was 24%; the risk in Turkish vs. Dutch females was 13% vs. 15% (not significant). CONCLUSION: The absolute risk for a coronary event in Turkish type 2 diabetes patients is similar to the risk in Dutch diabetes patients, although important differences in the risk profile exist, in particular, the lipid profile and smoking habits differ.

Patient characteristics do not predict poor glycaemic control in type 2 diabetes patients treated in primary care.

Many diabetic patients in general practice do not achieve good glycaemic control. The aim of this study was to assess which characteristics of type 2 diabetes patients treated in primary care predict poor glycaemic control (HbA1c > or = 7%). Data were collected from the medical records. 1641 patients were included who had mean HbA1c 7.1(SD 1.7)% , and 42% had HbA1c > or = 7%. On univariate analysis younger age; longer duration of diabetes; higher levels of blood glucose at diagnosis; most recent fasting blood glucose (FBG), total cholesterol, and triglyceride; higher body mass index (BMI); treatment with oral hypoglycaemic agents (OHA); treatment with insulin; more GP-visits for diabetes in the last year; and lower educational level were associated with poor control. Both in multiple linear regression and in multiple logistic regression higher levels of FBG (odds ratio (OR): = 1.6, 95% confidence interval (CI): 1.49, 1.70), treatment with OHA (OR: 2.1, 95% CI: 1.41, 3.04), treatment with insulin (OR: 7.2, 95% CI: 4.18, 12.52), lower educational level (OR: 1.26, 95% CI: 1.01, 1.56) were independently associated with poor levels of HbA1c. When FBG levels were excluded from the model, higher blood glucose at diagnosis, higher values for triglyceride and total cholesterol, and younger age predicted poor glycaemic control, but these variables explained only 15% of the variation in HbA1c. In conclusion prediction of poor glycaemic control from patient characteristics in diabetic patients in general practice is hardly possible. FBG appeared to be a strong predictor of HbA1c, which underlines the usefulness of this simple test in daily diabetes care. The worse metabolic control in those treated with either OHA or insulin suggests that current treatment regimes might be not sufficiently applied to reach the targets of care. Providers of diabetes care should be attentive to patients with lower educational level.

Starting insulin in type 2 diabetes: continue oral hypoglycemic agents? A randomized trial in primary care.

OBJECTIVE: To evaluate the effects of insulin 30/70 twice daily or bedtime isophane (NPH) insulin plus continued sulfonylurea and metformin in patients with type 2 diabetes in primary care. STUDY DESIGN: Open-label, randomized trial. POPULATION: Persons younger than 76 years with type 2 diabetes whose disease had not been controlled with oral hypoglycemic agents alone. A total of 64 insulin-naive patients treated with maximal feasible dosages of sulfonylurea and metformin (baseline glycosylated hemoglobin [HbA1c]=8.5%) were randomly assigned to insulin monotherapy (IM group; n=31) or insulin in addition to unchanged oral hypoglycemic medication (IC group; n=33) for 12 months. Insulin doses were adjusted to obtain fasting glucose <7.0 mmol/L and postprandial glucose <10.0 mmol/L. OUTCOMES MEASURED: Outcome measures included HbA1c, treatment failure, weight, hypoglycemic events and symptoms, satisfaction with treatment, general well-being, and fear of injecting insulin and testing. RESULTS: HbA1c improved from 8.3% to 7.6% in the IC group, and from 8.8% to 7.6% in the IM group (P=NS). The IC group had 24% treatment failures, compared with 2% in the IM group (P=.09). Patients in the IC group had less weight gain than those in the IM group (1.3 vs 4.2 kg; P=.01), and they reported fewer hypoglycemic events (2.7 vs 4.3; P=.02). Increased satisfaction with treatment was equal in the 2 groups, and general well-being improved by 3.0 points more in the IC group (P=.05). Fear of self-injecting and self-testing did not differ. CONCLUSIONS: Bedtime NPH insulin added to maximal therapy with sulfonylurea and metformin is an effective, simple, well-tolerated approach for patients with uncontrolled type 2 diabetes.

Quality of recording of data from patients with type 2 diabetes is not a valid indicator of quality of care. A cross-sectional study.

BACKGROUND: The quality of recording of clinical data in diabetes care in general practices is very variable. It has been suggested that better recording leads to improved glycaemic control. OBJECTIVES: The purpose of this study was to assess the completeness of recording by GPs of data from type 2 diabetes patients; to compare recorded and missing data; and to investigate the association between completeness and glycaemic control. METHODS: A cross-sectional survey was carried out in 52 general practices. Medical records were scrutinized for the presence of 11 variables. Examining patients through an active approach completed incomplete records. We compared recorded and unrecorded items. Completeness of recording was determined at both patient and practice levels. RESULTS: Fifty-two general practices with 1641 type 2 diabetes patients cared for by the GP participated. The frequency of absence of any particular item ranged from 20 to 70%. Weight, systolic blood pressure and HbA(1c) were slightly lower in patients with those items missing on their files, and more such patients were non-smokers (P < 0.05). The percentage of patients with unrecorded variables that exceeded target values ranged from 39 to 75. Neither at practice level nor at patient level was any association between the completeness of the data recording and HbA(1c) found. CONCLUSION: Records often were incomplete, which hampers a systematic approach to care of diabetic patients. However, the lack of association between completeness of data recording and control of glycaemia indicates that improved recording is not a valid indicator of good quality of care.