Clinical and economic outcomes in the hypertension and COPD arms of a multicenter outcomes study.

OBJECTIVE: To evaluate the impact of pharmaceutical care on selected clinical and economic outcomes in patients with hypertension or chronic obstructive pulmonary disease (COPD) in ambulatory care settings. DESIGN: Clinic patients with hypertension or COPD were randomly assigned to a treatment group (pharmaceutical care) or a control group (traditional pharmacy care) over a six-month period. Clinical pharmacists and pharmacy residents conducted the protocols. There were 133 evaluable patients (63 treatment and 70 control) in the hypertension study arm and 98 evaluable patients (43 treatment and 55 control) in the COPD study arm. SETTING: 10 Departments of Veterans Affairs medical centers and 1 academic medical center. INTERVENTIONS: Patient-centered pharmaceutical care model (employing standardized care) implemented by clinical pharmacy residents. MAIN OUTCOME MEASURES: Patient knowledge, medication compliance, and health resource use. RESULTS: The hypertension treatment group had a significantly greater reduction in systolic blood pressure from visit 1 to visit 5 than did the control group. In the COPD study arm, trends were positive in the treatment group for patients ratings of symptom interference with activities and dyspnea measures. There was a significant difference between the hypertension treatment and control group for compliance. There were no significant changes in compliance scores in the COPD study arm. Mean number of hospitalizations and other health care provider visits was higher for the hypertension control group. For patients with COPD, hospitalizations increased in the control group, and the number of other health care provider visits was higher in the control group. CONCLUSION: Pharmacists' participation in a pharmaceutical care program resulted in disease state improvement in ambulatory patients with hypertension and COPD.

Development, implementation, and evaluation of a multicenter pharmaceutical care outcomes study.

OBJECTIVES: To: (1) develop a pharmaceutical care multicenter outcomes research project using clinical pharmacy residents and preceptors; (2) develop two research protocols to document pharmacists' impact on clinical, economic, and humanistic outcomes of therapy; (3) develop and implement a data collection process and methodology for outcomes research; (4) evaluate the effectiveness of the multicenter outcomes research process; and (5) prepare clinical pharmacy preceptors and residents to conduct outcomes research. DESIGN AND SETTING: Two research protocols were developed, each a randomized, parallel, open-label evaluation of patients at 10 Department of Veterans Affairs and 1 university medical center. One protocol focused on patients with chronic obstructive pulmonary disease (COPD) and the other on patients with hypertension. The study evaluated pharmacists' management of these two patient groups. PATIENTS AND OTHER PARTICIPANTS: 133 patients with hypertension and 98 patients with COPD; 33 pharmacy directors and preceptors; 45 pharmacy residents. MAIN OUTCOME MEASURES: Clinical, economic, and humanistic outcomes of pharmacists' interventions. The processes of developing a multicenter outcomes study were evaluated, including the data collection process. RESULTS: The two study protocols and an educational program for study participants were developed. A data collection process was developed and implemented, with the paper process being successful and the computer data collection process not implemented due to time constraints. Overall, the multicenter outcomes research process was successful. CONCLUSION: The study provides a framework of processes and sites for the future development of other outcomes research studies. Clinical, economic, and humanistic outcomes are reported in Parts 2 and 3.

Humanistic outcomes in the hypertension and COPD arms of a multicenter outcomes study.

OBJECTIVE: To evaluate the effects of pharmaceutical care on selected humanistic outcomes in patients with hypertension or chronic obstructive pulmonary disease (COPD). DESIGN: Clinic patients with hypertension or COPD were randomly assigned to a treatment group (pharmaceutical care) or a control group (traditional pharmacy care) over a six-month period. Clinical pharmacists and pharmacy residents conducted the protocols. There were 133 evaluable patients (63 treatment, 70 control) in the hypertension study arm and 98 evaluable patients (43 treatment, 55 control) in the COPD study arm. The Pharmaceutical Care Questionnaire evaluated patient satisfaction with care. Tests specific to the disease states assessed disease and disease management knowledge. Quality of life (QOL) was evaluated using the Health Status Questionnaire 2.0 (HSQ 2.0) in the COPD arm; in the hypertension arm, the Hypertension/Lipid TyPE Specification Form 5.1 was used. SETTING: Ambulatory care centers of 10 Department of Veterans Affairs (DVA) medical centers and 1 university medical center. INTERVENTIONS: Patient-centered pharmaceutical care model (employing standardized care) implemented by clinical pharmacy residents. MAIN OUTCOME MEASURES: Satisfaction with pharmaceutical care, disease and disease management knowledge, and QOL. RESULTS: Statistically significant differences in most satisfaction items were found, with treatment patients expressing greater satisfaction. Treatment groups in both arms strongly agreed that pharmacists helped them with confidence in use of their medication and understanding of their illness, gave complete explanations about their medications, made them feel that their care was a priority, and followed up on their questions and concerns. In the hypertension arm, treatment patients demonstrated significant increases in knowledge scores. Trends in QOL were positive for both hypertension groups, with a significant decrease found in number of treatment patients reporting problems with sexual function. In the COPD arm, improvement trends were significantly stronger for treatment patients. CONCLUSION: Although patients were not dissatisfied with traditional pharmacy care, they were more satisfied overall with the pharmaceutical care model.