Improving Drug Therapy for Patients with Asthma
Improving Drug Therapy for Patients with Asthma
Objective. To evaluate the effects of a therapeutic outcomes monitoring (TOM) program on selected process and outcome measures.
Design. Prospective, controlled, multicenter study.
Setting. Community pharmacies throughout Denmark (16 intervention, 15 control).
Patients. Five hundred patients with asthma aged 16 to 60 years and treated in primary care.
Intervention. TOM is a community-based program for pharmaceutical care. Using a structured, seven-step, cyclical outcome improvement process, TOM pharmacists identify and resolve (or refer) problems with drug therapy that, if not addressed, might result in therapeutic failure or adverse effects. Equal emphasis is placed on the patient's perspective (e.g., coping, control, and empowerment) and the professional's perspective (e.g., adherence, patient knowledge, and therapeutic problems). TOM requires cooperation among pharmacists, patients, and physicians.
Main Outcome Measures. Asthma symptom status, days of sickness, health-related and asthma-specific quality of life, use of health care services and resources, and satisfaction with health care and pharmacy.
Intermediate Outcome and Process Measures. Peak expiratory flow rate (PEFR), knowledge of asthma and asthma medications, inhalation errors, and drug therapy problems in the TOM group.
Results. The mean individual differences for TOM and control patients were tested. Beneficial effects were found for the following outcome measures: asthma symptom status, days of sickness, and health-related and asthma-related quality of life. Satisfaction with health care and pharmacy varied throughout the course of the project, with no significant difference between groups at the final evaluation. Although not statistically significant, differences in use of services were considered to be clinically significant and encouraging. Beneficial effects were found for knowledge of asthma and medications, inhalation errors, drug use and drug therapy problems. No significant differences were found for PEFR.
Conclusion. The project demonstrated that therapeutic outcomes monitoring by community pharmacists is an effective strategy for improving the quality of drug therapy for asthma patients in primary health care.
Uncontrolled asthma remains a serious problem worldwide, despite improvements in asthma medications and other methods for managing the disease. The problem's persistence can be attributed in part to ineffective implementation of asthma therapy, which can be attributed to inappropriate prescribing, but also to ineffective management of therapeutic outcomes, patient nonadherence, and lack of knowledge and skills on the parts of patients and caregivers, including health care professionals. These difficulties, however, can be viewed as part of a larger problem: The medication use process is complex, and management of this disease by focusing on isolated factors within the process has not solved the implementation problem.
Studies have shown that therapeutic guidelines, patient education, adherence enhancement, written action plans, peak-flow monitoring, symptom diaries, and integrated programs for self-management of asthma can improve patients' knowledge, beliefs, behaviors, and use of drugs and other health care resources. However, the studies have not demonstrated that such single interventions positively affect outcomes such as disease status and quality of life. Systems changes involving multiple aspects of the process may therefore be necessary to achieve the best outcomes.
Patient problems cannot always be attributed to a lack of knowledge and/or lack of adherence. Adult patients and caregivers make decisions about drug therapy based on their perceptions, experiences, and preferences, and should therefore be viewed as active participants in care.
This active involvement of both patients and caregivers is an integral element of any systems-based strategy. Increasing the pharmacist's involvement in patient care has been shown to reduce the number of hospital admissions and emergency department visits and improve health status and quality of life. Therapeutic outcomes monitoring (TOM) is a model for increasing pharmacists' role in primary health care. TOM is based on the concept of pharmaceutical care, a patient-specific, continuous quality improvement program for optimizing drug use.
The purpose of the Danish TOM project was to implement and evaluate an adaptation of the TOM program originally developed at the University of Florida. The prototype has been described in detail elsewhere. In brief, to promote improved outcomes, pharmacists use the TOM strategy to identify and resolve (or refer) problems with drug therapy that, if not addressed, might result in therapeutic failure or adverse events. The major elements of the TOM program are a patient care process, clinical record system, educational materials for pharmacists and patients, and descriptive material for patients and physicians.
The general objectives of the Danish program were to improve drug therapy management and outcomes by increasing the participation of pharmacists in drug therapy management and by promoting cooperation among pharmacists, patients, and general practitioners (GPs). The overall research hypothesis was that providing TOM services in Danish community pharmacies could cost-effectively improve the overall health status, clinical and psychosocial outcomes, and quality of drug therapy for patients with moderate-to-severe asthma.
To test this hypothesis, we conducted a 12-month controlled study comparing (1) process variables and patient outcomes, (2) medication use, (3) cost-effectiveness, and (4) participants' opinions. This article presents results from the patient outcomes study. In Part 2, also appearing in this issue of JAPhA, we compare medication use by patients in the control and experimental groups. The cost-effectiveness analysis has been reported elsewhere. In addition, a study of participants' opinions and a qualitative study of patients' perceptions were performed after the controlled study in order to explain and deepen understanding of the results, make methodologic triangulations, and inform the further development of TOM programs.
Objective. To evaluate the effects of a therapeutic outcomes monitoring (TOM) program on selected process and outcome measures.
Design. Prospective, controlled, multicenter study.
Setting. Community pharmacies throughout Denmark (16 intervention, 15 control).
Patients. Five hundred patients with asthma aged 16 to 60 years and treated in primary care.
Intervention. TOM is a community-based program for pharmaceutical care. Using a structured, seven-step, cyclical outcome improvement process, TOM pharmacists identify and resolve (or refer) problems with drug therapy that, if not addressed, might result in therapeutic failure or adverse effects. Equal emphasis is placed on the patient's perspective (e.g., coping, control, and empowerment) and the professional's perspective (e.g., adherence, patient knowledge, and therapeutic problems). TOM requires cooperation among pharmacists, patients, and physicians.
Main Outcome Measures. Asthma symptom status, days of sickness, health-related and asthma-specific quality of life, use of health care services and resources, and satisfaction with health care and pharmacy.
Intermediate Outcome and Process Measures. Peak expiratory flow rate (PEFR), knowledge of asthma and asthma medications, inhalation errors, and drug therapy problems in the TOM group.
Results. The mean individual differences for TOM and control patients were tested. Beneficial effects were found for the following outcome measures: asthma symptom status, days of sickness, and health-related and asthma-related quality of life. Satisfaction with health care and pharmacy varied throughout the course of the project, with no significant difference between groups at the final evaluation. Although not statistically significant, differences in use of services were considered to be clinically significant and encouraging. Beneficial effects were found for knowledge of asthma and medications, inhalation errors, drug use and drug therapy problems. No significant differences were found for PEFR.
Conclusion. The project demonstrated that therapeutic outcomes monitoring by community pharmacists is an effective strategy for improving the quality of drug therapy for asthma patients in primary health care.
Uncontrolled asthma remains a serious problem worldwide, despite improvements in asthma medications and other methods for managing the disease. The problem's persistence can be attributed in part to ineffective implementation of asthma therapy, which can be attributed to inappropriate prescribing, but also to ineffective management of therapeutic outcomes, patient nonadherence, and lack of knowledge and skills on the parts of patients and caregivers, including health care professionals. These difficulties, however, can be viewed as part of a larger problem: The medication use process is complex, and management of this disease by focusing on isolated factors within the process has not solved the implementation problem.
Studies have shown that therapeutic guidelines, patient education, adherence enhancement, written action plans, peak-flow monitoring, symptom diaries, and integrated programs for self-management of asthma can improve patients' knowledge, beliefs, behaviors, and use of drugs and other health care resources. However, the studies have not demonstrated that such single interventions positively affect outcomes such as disease status and quality of life. Systems changes involving multiple aspects of the process may therefore be necessary to achieve the best outcomes.
Patient problems cannot always be attributed to a lack of knowledge and/or lack of adherence. Adult patients and caregivers make decisions about drug therapy based on their perceptions, experiences, and preferences, and should therefore be viewed as active participants in care.
This active involvement of both patients and caregivers is an integral element of any systems-based strategy. Increasing the pharmacist's involvement in patient care has been shown to reduce the number of hospital admissions and emergency department visits and improve health status and quality of life. Therapeutic outcomes monitoring (TOM) is a model for increasing pharmacists' role in primary health care. TOM is based on the concept of pharmaceutical care, a patient-specific, continuous quality improvement program for optimizing drug use.
The purpose of the Danish TOM project was to implement and evaluate an adaptation of the TOM program originally developed at the University of Florida. The prototype has been described in detail elsewhere. In brief, to promote improved outcomes, pharmacists use the TOM strategy to identify and resolve (or refer) problems with drug therapy that, if not addressed, might result in therapeutic failure or adverse events. The major elements of the TOM program are a patient care process, clinical record system, educational materials for pharmacists and patients, and descriptive material for patients and physicians.
The general objectives of the Danish program were to improve drug therapy management and outcomes by increasing the participation of pharmacists in drug therapy management and by promoting cooperation among pharmacists, patients, and general practitioners (GPs). The overall research hypothesis was that providing TOM services in Danish community pharmacies could cost-effectively improve the overall health status, clinical and psychosocial outcomes, and quality of drug therapy for patients with moderate-to-severe asthma.
To test this hypothesis, we conducted a 12-month controlled study comparing (1) process variables and patient outcomes, (2) medication use, (3) cost-effectiveness, and (4) participants' opinions. This article presents results from the patient outcomes study. In Part 2, also appearing in this issue of JAPhA, we compare medication use by patients in the control and experimental groups. The cost-effectiveness analysis has been reported elsewhere. In addition, a study of participants' opinions and a qualitative study of patients' perceptions were performed after the controlled study in order to explain and deepen understanding of the results, make methodologic triangulations, and inform the further development of TOM programs.
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