Primary studies included in this systematic review

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Primary study

Unclassified

Authors Sadik A , Yousif M , McElnay JC
Journal British journal of clinical pharmacology
Year 2005
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AIM: The aim of this study was to investigate the impact of a pharmacist-led pharmaceutical care programme, involving optimization of drug treatment and intensive education and self-monitoring of patients with heart failure (HF) within the United Arab Emirates (UAE), on a range of clinical and humanistic outcome measures. METHODS: The study was a randomized, controlled, longitudinal, prospective clinical trial at Al-Ain Hospital, Al-Ain, UAE. Patients were recruited from the general medical wards and from cardiology and medical outpatient clinics. HF patients who fulfilled the entrance criteria, and had no exclusion criteria present, were identified for inclusion in the study. After recruitment, patients were randomly assigned to one of two groups: intervention group or control group. Intervention patients received a structured pharmaceutical care service while control patients received traditional services. Patient follow-up took place when patients attended scheduled outpatient clinics (every 3 months). A total of 104 patients in each group completed the trial (12 months). The patients were generally suffering from mild to moderate HF (NYHA Class 1, 29.5%; Class 2, 50.5%; Class 3, 16%; and Class 4, 4%). RESULTS: Over the study period, intervention patients showed significant (P < 0.05) improvements in a range of summary outcome measures [AUC (95% confidence limits)] including exercise tolerance [2-min walk test: 1607.2 (1474.9, 1739.5) m.month in intervention patients vs. 1403.3 (1256.5, 1549.8) in control patients], forced vital capacity [31.6 (30.8, 32.4) l.month in the intervention patients vs. 27.8 (26.8, 28.9) in control patients], health-related quality of life, as measured by the Minnesota living with heart failure questionnaire [463.5 (433.2, 493.9) unit.month in intervention patients vs. 637.5 (597.2, 677.7) in control patients; a lower score in this measure indicates better health-related quality of life]. The number of individual patients who reported adherence to prescribed medications was higher (P < 0.05) in the intervention group (85 vs. 35), as was adherence to lifestyle advice (75 vs. 29) at the final assessment (12 months). There was a tendency to have a higher incidence of casualty department visits by intervention patients, but a lower rate of hospitalization. CONCLUSIONS: The research provides clear evidence that the delivery of pharmaceutical care to patients with HF can lead to significant clinical and humanistic benefits.

Primary study

Unclassified

Journal Journal of the American Pharmacists Association : JAPhA
Year 2005
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Objective: To explore the impact of telephone-based education and monitoring by community pharmacists on multiple outcomes of pharmacist-patient collaboration. Design: A randomized, controlled, unblinded, mixed experimental design. Setting: Eight Wisconsin community pharmacies within a large managed care organization. Patients: A total of 63 patients presenting new antidepressant prescriptions to their community pharmacies. Interventions: Patients were randomized to receive either three monthly telephone calls from pharmacists providing pharmacist-guided education and monitoring (PGEM) or usual pharmacist's care. Usual care is defined as that education and monitoring which pharmacists may typically provide patients at the study pharmacies. Main Outcome Measures: Patient's frequency of feedback with the pharmacist, antidepressant knowledge, antidepressant beliefs, antidepressant adherence at 3 and 6 months, improvement in depression symptoms, and orientation toward treatment progress. Results: Of the 60 patients who completed the study, 28 received PGEM and 32 received usual pharmacist's care. Results showed that PGEM had a significant and positive effect on patient feedback, knowledge, medication beliefs, and perceptions of progress. There were no significant group differences in patient adherence or symptoms at 3 months; however, PGEM patients who completed the protocol missed fewer doses than did the usual care group at 6 months (P ≤ .05). Conclusion: Antidepressant telemonitoring by community pharmacists can significantly and positively affect patient feedback and collaboration with pharmacists. Longer-term studies with larger samples are needed to assess the generalizability of findings. Future research also needs to explore additional ways to improve clinical outcomes.

Primary study

Unclassified

Journal Diabetes care
Year 2005
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OBJECTIVE: To examine the effect of a 12-month pharmaceutical care (PC) program on vascular risk in type 2 diabetes. RESEARCH DESIGN AND METHODS: We recruited 198 community-based patients randomized to PC or usual care. PC patients had face-to-face goal-directed medication and lifestyle counseling at baseline and at 6 and 12 months plus 6-weekly telephone assessments and provision of other educational material. Clinical, biochemical, and medication-related data were sent regularly to each patient's physician(s). The main outcome measure was change in HbA(1c). A diabetes-specific risk engine was used to estimate changes in 10-year coronary heart disease (CHD) and stroke risk in patients without a history of cardiovascular disease. RESULTS: At total of 180 patients (91%) completed the study. Mean (95% CI) reductions were greater in PC case subjects (n = 92) than control subjects (n = 88) for HbA(1c) (-0.5% [95% CI -0.7 to -0.3] vs. 0 [-0.2 to 0.2]) and systolic (-14 mmHg [-19 to -9] vs. -7 [-11 to -2]) and diastolic (-5 mmHg [-8 to -3] vs. -2 [-4 to 1]) blood pressure (P < or = 0.043). The improvement in HbA(1c) persisted after adjustment for baseline value and demographic and treatment-specific variables. The median (interquartile range) 10-year estimated risk of a first CHD event decreased in the PC case subjects (25.1% [15.6-36.2] to 20.3 [14.6-30.2]; n = 42, P = 0.002) but not in the control subjects (26.1% [17.2-39.4] vs. 26.4 [16.7-38.0]; n = 52, P = 0.17). CONCLUSIONS: A 12-month PC program in type 2 diabetes reduced glycemia and blood pressure. Pharmacist involvement contributed to improvement in HbA(1c) independently of pharmacotherapeutic changes. PC could prove a valuable component of community-based multidisciplinary diabetes care.

Primary study

Unclassified

Journal The American journal of managed care
Year 2005
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OBJECTIVE: To evaluate the effect of case management by a clinical pharmacist on glycemic control and preventive measures in patients with type 2 diabetes mellitus. STUDY DESIGN: Randomized controlled trial in a university-affiliated primary care internal medicine clinic. METHODS: We recruited 80 patients with poorly controlled type 2 diabetes mellitus. A clinical pharmacist provided evaluation and modification of pharmacotherapy, self-management diabetes education, and reinforcement of diabetes complications screening processes through clinic visits and telephone follow-up. The main clinical outcome was hemoglobin A1C (HbA1C) level; process measures included HbA1C and low-density lipoprotein measurement, retinal examination, urine microalbumin testing (or use of angiotensin-converting enzyme inhibitors), and monofilament screening for diabetic neuropathy. RESULTS: Patients in the intervention and control groups were similar in age, sex, mean HbA1C levels (10.1% and 10.2%, respectively; P = .65), and current treatment regimens at baseline. Patients who received case management by the clinical pharmacist achieved greater reduction in HbA1C levels than those in the control group (2.1% vs 0.9%, P = .03). Three of the 5 process measures were conducted more frequently in the intervention group than the control group, including low-density lipoprotein measurement (100.0% vs 85.7%, P = .02), retinal examination (97.3% vs 74.3%), and monofilament foot screening (92.3% vs 62.9%). CONCLUSIONS: Proactive diabetes case management by a pharmacist substantially improved glycemic control and diabetes process-of-care measures. This approach, integrated with and based in the primary care setting, was an effective and efficient approach to improving care, especially for those with poor glycemic control at baseline.

Primary study

Unclassified

Journal The Annals of pharmacotherapy
Year 2005
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BACKGROUND: Inappropriate use of medications is a significant problem in health care today. A possible solution to this problem may be achieved through better control of patients' drug therapy. OBJECTIVE: To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications, while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life. METHODS: Patients at an outpatient pharmacy volunteered to be surveyed for 16 weeks. Although both the intervention and control groups were surveyed, the randomly selected intervention group was interviewed more frequently and more comprehensively. Cholesterol, triglycerides, glucose, weight, risk factors, drug-related problems (DRPs), and quality of life were measured via a survey at the onset of the study and continually measured until the study's conclusion. RESULTS: In the intervention group, 26 DRPs were detected, of which 24 were resolved; in the control group, 26 DRPs were detected, of which 5 were resolved. When comparing initial and final blood cholesterol levels in the intervention group, the mean decrease was 27.0 +/- 41.1 mg/dL (p = 0.0266); in the control group, the average blood cholesterol level decreased by a mean of 1.4 +/- 37.2 mg/dL (p = 0.6624). In the intervention group, the triglyceride level decreased an average of 50.5 +/- 80.3 mg/dL (p = 0.0169), while the control group experienced a mean triglyceride level increase of 29.6 +/- 118.5 mg/dL (p = 0.1435). As a result of the intervention, the quality of life in the intervention group was improved. CONCLUSIONS: Short-term pharmaceutical care plans developed in a retail pharmacy within the proper setting may contribute to improved blood lipid values, cardiovascular disease risk factors, and patients' quality of life.

Primary study

Unclassified

Journal The Annals of pharmacotherapy
Year 2005
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BACKGROUND: There is limited information from randomized controlled studies about the influence of pharmacist interventions on diabetes control. OBJECTIVE: To evaluate the effect of a pharmacist intervention on improving diabetes control; secondary endpoints were medication appropriateness and self-reported adherence. METHODS: A randomized, controlled, multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics. Seventy-seven subjects, > or =18 years old with a hemoglobin (Hb) A(1c) > or =9% at baseline and taking at least one oral diabetes medication, were randomized to receive a pharmacist intervention (n = 43) or usual care (n = 34) for 6 months followed by a 6-month usual-care observation period for both groups. Subjects met with a clinical pharmacist to establish and initiate a diabetes care plan followed by weekly visits or telephone calls to facilitate diabetes management and adherence. HbA(1c), medication appropriateness, and self-reported adherence were assessed at baseline, 6 months, and 12 months. RESULTS: The mean HbA(1c) did not differ between groups over the 12-month period (p = 0.61). A reduction in HbA(1c) was noted for both groups over time compared with baseline (p = 0.001); however, control subjects relied more heavily on provider visits. Medication appropriateness was not improved for diabetes medications (p = 0.65). Self-reported adherence was not significantly improved by the intervention. CONCLUSIONS: This pharmacist intervention did not significantly improve diabetes control, but did allow for similar HbA(1c) control with fewer physician visits. Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed.

Primary study

Unclassified

Journal The Annals of pharmacotherapy
Year 2004
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BACKGROUND: The practice of pharmaceutical care in primary care settings in Thailand is currently not generally accepted. OBJECTIVE: To evaluate the effect of pharmacist involvement in treatment with hypertensive patients in primary care settings. METHODS: The treatment objective was to stabilize the blood pressure (BP) of hypertensive patients in accordance with the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. Patients were randomly assigned to a pharmacist-involved group (treatment) or a group with no pharmacist involvement (control). Pre- and post-test BPs, tablet counts, lifestyle modifications, and pharmacists' recommendations were recorded. The 6-month study was carried out in Mahasarakham University pharmacy and 2 primary care units. Patients were monitored monthly by reviewing their medications and supported by providing pharmaceutical care and counseling. RESULTS: From a total of 235 patients, the treatment group (n = 118) had a significant reduction in both systolic (S) and diastolic (D) BP compared with the 117 patients of the control group (p = 0.037, 0.027, respectively). The 158 patients (76 treatment, 82 control) with BPs >or=140/90 mm Hg at the beginning of the study showed significant BP reductions (p = 0.002 SBP, 0.008 DBP). The proportion of 158 patients whose BP became stabilized was higher in the treatment group (p = 0.017). The treatment group showed significantly better adherence (p = 0.014) and exercise control (p = 0.012) at the end of the study. Physicians accepted 42.72% of medication modifications and 5.34% of the suggestions for additional investigations. CONCLUSIONS: Hypertensive patients who received pharmacist input achieved a significantly greater benefit in BP reduction, BP control, and improvement in adherence rate and lifestyle modification.

Primary study

Unclassified

Journal Journal of clinical pharmacy and therapeutics
Year 2004
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OBJECTIVE: To evaluate a pharmacist-conducted educational and monitoring programme, designed to promote dietary and lifestyle modification and compliance with lipid-lowering drug therapy, for patients with dyslipidaemia. METHODS: This was a prospective, randomized, controlled study. The participants were 94 adults, with 81 completing the study (intervention group: 39; control group: 42), with a cardiovascular-related diagnosis and discharged from hospital, between April and October 2001, on lipid-lowering drug therapy. Patients in the intervention group were visited at home monthly by a pharmacist, who educated the patients on the goals of lipid-lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy, assessed patients for drug-related problems, and measured total blood cholesterol levels using point-of-care testing. Patients in the control group received standard medical care. The main outcome measure was total blood cholesterol levels after 6 months, and an evaluation of patient and general practitioner satisfaction with the programme. RESULTS: There was no significant difference in baseline total blood cholesterol levels between the two groups. The reduction over the course of the study in cholesterol levels within the intervention group was statistically significant (4.9 +/- 0.7 to 4.4 +/- 0.6, P<0.005), whereas there was no change within the control group (P=0.26). At follow-up, 44% of the intervention group patients and 24% of the control group patients had cholesterol levels below 4.0 mmol/L (P=0.06). The reduction in total cholesterol in the intervention group should translate to an expected 21% reduction in cardiovascular mortality risk and a 16% reduction in total mortality risk--more than twice the risk reduction achieved in the control group. In addition, the programme was very well received by the patients and their general practitioners, by satisfaction questionnaire. CONCLUSION: A pharmacist-conducted educational and monitoring intervention improved the outcomes of lipid-lowering drug therapy.

Primary study

Unclassified

Authors Sarkadi A , Rosenqvist U
Journal Patient education and counseling
Year 2004
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Few studies have demonstrated an effect of educational interventions on glycaemic control in persons with Type 2 diabetes longer than 3-6 months after baseline. We aimed to investigate the effectiveness of an experience-based group educational programme 24 months after baseline and to pinpoint mediators that might play a role in achieving desired metabolic outcomes. We conducted a randomised controlled trial inviting self-referred persons with Type 2 diabetes (N=77 randomised). The pharmacist-led, year-long intervention was based on participants' experiences of glucose regulation during the monthly group discussions. We measured HbA<sub>1c</sub> at 0, 6, 12, and 24 months and a questionnaire was administered at baseline and final follow-up. Our findings indicated that participating in the intervention programme significantly decreased HbA<sub>1c</sub> by 0.4% at 24 months after baseline. Initial HbA<sub>1c</sub>, satisfaction with own diabetes-related knowledge, and treatment were found directly related to glycaemic outcomes. The intervention group exercised more in order to lower blood-glucose levels and was also more able to predict current blood-glucose levels before measuring it. Experience-based group education was effective in decreasing participants' HbA<sub>1c</sub> 1-year after completed intervention. Early effect of the intervention was followed by relapse after 12 months and a new, significant decrease at 24 months; this dual course implies that follow-up of educational interventions should involve several consecutive measurements to capture possible late effects. Both biomedical and subjective factors played a role in accounting for the variance of HbA<sub>1c</sub> at 2-year follow-up after baseline. (PsycInfo Database Record (c) 2020 APA, all rights reserved)

Primary study

Unclassified

Journal American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
Year 2004
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PURPOSE: The impact of pharmacist interventions on the care and outcomes of patients with depression in a primary care setting was evaluated. METHODS: Patients diagnosed with a new episode of depression and started on anti-depressant medications were randomized to enhanced care (EC) or usual care (UC) for one year. EC consisted of a pharmacist collaborating with primary care providers to facilitate patient education, the initiation and adjustment of antidepressant dosages, the monitoring of patient adherence to the regimen, the management of adverse reactions, and the prevention of relapse. The patients in the UC group served as controls. Outcomes were measured by the Hopkins Symptom Checklist, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for major depression, health-related quality of life, medication adherence, patient satisfaction, and use of depression-related health care services. An intent-to-treat analysis was used. RESULTS: Seventy-four patients were randomized to EC or UC. At baseline, the EC group included more patients diagnosed with major depression than did the UC group (p = 0.04). All analyses were adjusted for this difference. In both groups, mean scores significantly improved from baseline for symptoms of depression and quality of life at three months and were maintained for one year. There were no statistically significant differences between treatment groups in depression symptoms, quality of life, medication adherence, provider visits, or patient satisfaction. CONCLUSION: Frequent telephone contacts and interventions by pharmacists and UC in a primary care setting resulted in similar rates of adherence to antidepressant regimens and improvements in the outcomes of depression at one year.